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Ho T, Lailo JM, Ramoran E, Mutreja K, Gomez A, Gallo M, Neukom J. Leveraging a digital network of pharmacy professionals to test a technology-assisted model to improve pharmacy access to quality-assured COVID-19 rapid antigen tests approved for self-use in Vietnam. PLoS One 2025; 20:e0318331. [PMID: 40106421 PMCID: PMC11922224 DOI: 10.1371/journal.pone.0318331] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/14/2024] [Accepted: 01/15/2025] [Indexed: 03/22/2025] Open
Abstract
Expanding access to rapid and self-use diagnostics in low-and-middle-income countries (LMICs) is crucial for advancing universal health coverage and creating more self-care opportunities. This study aimed to test the ability of a technology-assisted pharmacy activation model in Vietnam to improve access to quality-assured COVID-19 self-tests through the retail pharmacy channel. SwipeRx, a digital network with more than 30,000 pharmacy professionals in Vietnam, was leveraged to raise awareness about the benefits of COVID-19 rapid antigen tests (Ag-RDTs) that meet quality assurance standards for self-use and were registered with the Vietnamese regulatory authority. The campaigns also included information on local suppliers of Humasis and Flowflex self-test products, offering favorable pricing terms for SwipeRx users. In addition, offline pharmacy training and point-of-sale materials were provided to encourage dispensing, counseling, and restocking of at least one locally registered self-use Ag-RDT for COVID-19. After nine months of engagement between 2022 and 2023, a digital survey was conducted among 331 retail pharmacies to assess the impact on knowledge and practices related to COVID-19 self-tests. Pharmacy professionals who received SwipeRx training reported greater confidence and knowledge in stocking, dispensing, and counseling clients on the proper use of COVID-19 self-tests. These trained professionals were also more capable of distinguishing between COVID-19 Ag-RDTs approved for self-use and those approved for professional use. By the end of the nine months, 70 (92%) of trained pharmacy professionals stocked at least one quality-assured self-test for COVID-19, compared to just 38 (29%) of untrained professionals. These findings demonstrate that digital pharmacy networks can rapidly facilitate market introduction and access to new diagnostic products. Future initiatives should prioritize continuous price negotiations with manufacturers and distributors, focusing on optimizing pricing, credit, and delivery terms for community pharmacies. Additionally, combining digital and offline training with community demand-generating activities could facilitate greater pharmacy uptake of Ag-RDTs and other prioritized public health products.
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Affiliation(s)
- Tien Ho
- Public Health Division, SwipeRx, Ho Chi Minh City, Vietnam
| | | | | | | | - Anabel Gomez
- Market Access Division, FIND, Geneva, Switzerland
| | - Michael Gallo
- Public Health Division, SwipeRx, Singapore, Singapore
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Pan Z, Xu L, Fan Z, Ren F. CRIPSR-Cas for hepatitis virus: a systematic review and meta-analysis of diagnostic test accuracy studies. Front Microbiol 2025; 16:1509890. [PMID: 40099180 PMCID: PMC11912011 DOI: 10.3389/fmicb.2025.1509890] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/29/2024] [Accepted: 02/05/2025] [Indexed: 03/19/2025] Open
Abstract
Background and aims Hepatitis viruses pose a significant global health challenge, necessitating accurate and efficient diagnostic methods. The CRISPR-Cas system, renowned for gene editing, shows potential tool in virus detection. This systematic review and meta-analysis aims to evaluate the diagnostic accuracy of CRISPR-Cas-based tests for hepatitis viruses, aiming to provide evidence for their effectiveness in clinical settings. Methods Studies from Web of Science, PubMed, and CNKI were analyzed. A bivariate random-effects model was employed to compute pooled estimates for sensitivity, specificity, and the area under the summary receiver operating characteristic (SROC) curve. Additionally, the methodological quality of the studies was evaluated using the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) tool. Results Following a rigorous screening process, 14 studies meeting our inclusion criteria were selected from an initial pool of 657 studies. The pooled sensitivity and specificity of the CRISPR-Cas system in hepatitis virus detection showed high sensitivity (0.99, 95% CI: 0.95-1.00) and specificity (0.99, 95% CI: 0.93-1.00) with SROC area 1.00 (95% CI: 0.99-1.00). However, considering the notable heterogeneity among the included studies, subgroup analyses and meta-regression were conducted. These analyses revealed that the type of hepatitis virus detected and the format of the final result presentation could be potential sources of this heterogeneity. Conclusion This systematic review and meta-analysis demonstrates the high diagnostic accuracy of CRISPR-Cas system in detecting hepatitis viruses. However, conclusions are limited by study number and quality. Therefore, more high-quality data are still needed to support this conclusion.
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Affiliation(s)
| | | | | | - Feng Ren
- Beijing Institute of Hepatology, Beijing Youan Hospital, Capital Medical University, Beijing, China
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Bagheri S, Fard GB, Talkhi N, Rashidi Zadeh D, Mobarra N, Mousavinezhad S, Khamse FM, Hosseini Bafghi M. Laboratory Biochemical and Hematological Parameters: Early Predictive Biomarkers for Diagnosing Hepatitis C Virus Infection. J Clin Lab Anal 2024; 38:e25127. [PMID: 39569979 DOI: 10.1002/jcla.25127] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/28/2024] [Revised: 10/20/2024] [Accepted: 11/09/2024] [Indexed: 11/22/2024] Open
Abstract
BACKGROUND Hepatitis C virus (HCV) infection is a worldwide concern, causing liver damage and necessitating early detection to prevent its spread. Studies indicate that evaluating changes in biochemical and hematological parameters, which serve as suitable predictors of inflammation, can be a reasonable method for diagnosing hepatitis C infection. METHODS This study analyzed 100 samples from high-risk patients positively identified via quantitative real-time PCR (qPCR). Anti-HCV titers, biochemical and inflammatory tests, and complete blood cell counts (CBCs) were performed for these individuals. Additionally, 100 HCV-negative individuals with normal laboratory results were selected as the control group. Receiver operating characteristic (ROC) curves were plotted to determine the cutoff values of the laboratory parameters. RESULTS According to the findings, the age, average white blood cell (WBC) count, platelet-to-lymphocyte ratio (PLR), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), lactate dehydrogenase (LDH), total bilirubin (TBIL), direct bilirubin (DBIL), alkaline phosphatase (ALP), serum glutamic-pyruvic transaminase (SGPT), and ferritin levels were significantly higher in HCV patients. On the other hand, red blood cell (RBC) counts, neutrophils, lymphocytes, hemoglobin-to-platelet ratio (HPR), and iron (Fe) levels were significantly lower in the case group compared to those in the control group (p < 0.05). Furthermore, the ROC curve analysis revealed that lymphocyte count, neutrophil count, and PLR were very strong predictors for hepatitis C infection (p < 0.0001, AUC = 1). CONCLUSION The study highlights significant biochemical and hematological differences between HCV patients and healthy subjects. These biomarkers are crucial for early diagnosis, potentially preventing liver damage and reducing HCV transmission.
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Affiliation(s)
- Saeede Bagheri
- Department of Laboratory Sciences, School of Paramedical and Rehabilitation Sciences, Mashhad University of Medical Sciences, Mashhad, Iran
| | - Ghazaleh Behrouzian Fard
- Department of Laboratory Sciences, School of Paramedical and Rehabilitation Sciences, Mashhad University of Medical Sciences, Mashhad, Iran
| | - Nasrin Talkhi
- Department of Biostatistics, School of Allied Medical Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran
| | - Davoud Rashidi Zadeh
- Department of Microbiology, Faculty of Basic Sciences, Mashhad Branch, Islamic Azad University, Mashhad, Iran
| | - Naser Mobarra
- Department of Laboratory Sciences, School of Paramedical and Rehabilitation Sciences, Mashhad University of Medical Sciences, Mashhad, Iran
| | - Seyedmahdi Mousavinezhad
- Department of Laboratory Sciences, School of Paramedical Sciences, Sabzevar University of Medical Sciences, Sabzevar, Iran
| | - Fatemeh Mirzaeian Khamse
- Department of Laboratory Sciences, School of Paramedical and Rehabilitation Sciences, Mashhad University of Medical Sciences, Mashhad, Iran
| | - Mahdi Hosseini Bafghi
- Department of Laboratory Sciences, School of Paramedical and Rehabilitation Sciences, Mashhad University of Medical Sciences, Mashhad, Iran
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Ceesay A, Drammeh S, Ndow G, Jallow AOA, Nyang H, Bittaye B, Mendy FS, Secka O, D’Alessandro U, Shimakawa Y, Vo-Quang E, Testoni B, Thursz M, Lemoine M, Chemin I. Real-Life Diagnostic Accuracy and Clinical Utility of Hepatitis B Virus (HBV) Nucleic Acid Testing Using the GeneXpert Point-of-Care Test System from Fresh Plasma and Dry Blood Spot Samples in The Gambia. Microorganisms 2024; 12:2273. [PMID: 39597662 PMCID: PMC11596281 DOI: 10.3390/microorganisms12112273] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/09/2024] [Revised: 10/30/2024] [Accepted: 10/30/2024] [Indexed: 11/29/2024] Open
Abstract
The GeneXpert HBV Viral Load test is a simplified tool to scale up screening and HBV monitoring in resource-limited settings, where HBV is endemic and where molecular techniques to quantify HBV DNA are expensive and scarce. However, the accuracy of field diagnostics compared to gold standard assays in HBV-endemic African countries has not been well understood. We aim to validate the diagnostic performance of the GeneXpert HBV Viral Load test in freshly collected and stored plasma and dried blood spot (DBS) samples to assess turn-around-time (TAT) for sample processing and treatment initiation, to map GeneXpert machines and to determine limitations to its use in The Gambia. Freshly collected paired plasma and DBS samples (n = 56) were analyzed by the GeneXpert test. Similarly, stored plasma and DBS samples (n = 306, n = 91) were analyzed using the GeneXpert HBV test, in-house qPCR and COBAS TaqMan Roche. The correlation between freshly collected plasma and DBS is r = 0.88 with a mean bias of -1.4. The GeneXpert HBV test had the highest quantifiable HBV DNA viremia of 81.4% (n = 249/306), and the lowest was detected by in-house qPCR at 37.9% (n = 116/306) for stored plasma samples. Bland-Altman plots show strong correlation between GeneXpert and COBAS TaqMan and between GeneXpert and in-house qPCR with a mean bias of +0.316 and -1.173 log10 IU/mL, respectively. However, paired stored plasma and DBS samples had a lower mean bias of 1.831 log10 IU/mL, which is almost significant (95% limits of agreement: 0.66-3.001). Patients (n = 3) were enrolled in the study within a TAT of 6 days. The GeneXpert HBV test displayed excellent diagnostic accuracy by detecting HBV viremia in less than 10 IU/mL.
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Affiliation(s)
- Amie Ceesay
- Disease Control and Elimination, Medical Research Council Unit, The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, Banjul P.O. Box 273, The Gambia or (A.C.); (S.D.); (G.N.); (A.O.A.J.); (H.N.); (B.B.); (F.S.M.); (O.S.); (U.D.); (E.V.-Q.)
- Cancer Research Center of Lyon, INSERM U1052, CNRS UMR 5286, 69008 Lyon, France;
- School of Arts and Sciences, University of The Gambia, Serrekunda, Banjul P.O. Box 3530, The Gambia
| | - Sainabou Drammeh
- Disease Control and Elimination, Medical Research Council Unit, The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, Banjul P.O. Box 273, The Gambia or (A.C.); (S.D.); (G.N.); (A.O.A.J.); (H.N.); (B.B.); (F.S.M.); (O.S.); (U.D.); (E.V.-Q.)
| | - Gibril Ndow
- Disease Control and Elimination, Medical Research Council Unit, The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, Banjul P.O. Box 273, The Gambia or (A.C.); (S.D.); (G.N.); (A.O.A.J.); (H.N.); (B.B.); (F.S.M.); (O.S.); (U.D.); (E.V.-Q.)
| | - Alpha Omar A. Jallow
- Disease Control and Elimination, Medical Research Council Unit, The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, Banjul P.O. Box 273, The Gambia or (A.C.); (S.D.); (G.N.); (A.O.A.J.); (H.N.); (B.B.); (F.S.M.); (O.S.); (U.D.); (E.V.-Q.)
| | - Haddy Nyang
- Disease Control and Elimination, Medical Research Council Unit, The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, Banjul P.O. Box 273, The Gambia or (A.C.); (S.D.); (G.N.); (A.O.A.J.); (H.N.); (B.B.); (F.S.M.); (O.S.); (U.D.); (E.V.-Q.)
| | - Baboucarr Bittaye
- Disease Control and Elimination, Medical Research Council Unit, The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, Banjul P.O. Box 273, The Gambia or (A.C.); (S.D.); (G.N.); (A.O.A.J.); (H.N.); (B.B.); (F.S.M.); (O.S.); (U.D.); (E.V.-Q.)
| | - Francis S. Mendy
- Disease Control and Elimination, Medical Research Council Unit, The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, Banjul P.O. Box 273, The Gambia or (A.C.); (S.D.); (G.N.); (A.O.A.J.); (H.N.); (B.B.); (F.S.M.); (O.S.); (U.D.); (E.V.-Q.)
| | - Ousman Secka
- Disease Control and Elimination, Medical Research Council Unit, The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, Banjul P.O. Box 273, The Gambia or (A.C.); (S.D.); (G.N.); (A.O.A.J.); (H.N.); (B.B.); (F.S.M.); (O.S.); (U.D.); (E.V.-Q.)
| | - Umberto D’Alessandro
- Disease Control and Elimination, Medical Research Council Unit, The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, Banjul P.O. Box 273, The Gambia or (A.C.); (S.D.); (G.N.); (A.O.A.J.); (H.N.); (B.B.); (F.S.M.); (O.S.); (U.D.); (E.V.-Q.)
| | - Yusuke Shimakawa
- Unité d’Épidémiologie des Maladies Émergentes, Institut Pasteur, Université Paris Cité, 75015 Paris, France;
| | - Erwan Vo-Quang
- Disease Control and Elimination, Medical Research Council Unit, The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, Banjul P.O. Box 273, The Gambia or (A.C.); (S.D.); (G.N.); (A.O.A.J.); (H.N.); (B.B.); (F.S.M.); (O.S.); (U.D.); (E.V.-Q.)
- Institut Mondor de Recherche Biomédicale (INSERM U955), 94000 Creteil, France
| | - Barbara Testoni
- Cancer Research Center of Lyon, INSERM U1052, CNRS UMR 5286, 69008 Lyon, France;
| | - Mark Thursz
- Division of Digestive Diseases, Section of Hepatology, Department of Metabolism, Digestion and Reproduction, Imperial College London, London W2 1NY, UK;
| | - Maud Lemoine
- Disease Control and Elimination, Medical Research Council Unit, The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, Banjul P.O. Box 273, The Gambia or (A.C.); (S.D.); (G.N.); (A.O.A.J.); (H.N.); (B.B.); (F.S.M.); (O.S.); (U.D.); (E.V.-Q.)
- Division of Digestive Diseases, Section of Hepatology, Department of Metabolism, Digestion and Reproduction, Imperial College London, London W2 1NY, UK;
| | - Isabelle Chemin
- Cancer Research Center of Lyon, INSERM U1052, CNRS UMR 5286, 69008 Lyon, France;
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Domínguez A, Avellón A, Hernando V, Soldevila N, Borràs E, Martínez A, Izquierdo C, Torner N, Pericas C, Rius C, Godoy P. Hepatitis B Virus-Related Cirrhosis and Hepatocellular Carcinoma Hospital Discharge Rates from 2005 to 2021 in Spain: Impact of Universal Vaccination. Vaccines (Basel) 2024; 12:1254. [PMID: 39591157 PMCID: PMC11598889 DOI: 10.3390/vaccines12111254] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/05/2024] [Revised: 10/25/2024] [Accepted: 11/01/2024] [Indexed: 11/28/2024] Open
Abstract
Background: The main consequences of chronic hepatitis B virus (HBV) infections are cirrhosis and hepatocellular carcinoma (HCC), both associated with frequent hospitalization. The aim of this study was to analyze the impact of universal HBV vaccination in Spain on chronic HBV-related hospital discharges from 2005 to 2021. Methods: Using data from the Minimum Basic Data Set of the Spanish National Health System, we calculated the hospital discharge rate ratio (HDRR) and 95% confidence interval (CI) values for chronic HBV-related discharges between 2005 and 2021. For comparative purposes, we calculated the HDRR and 95% confidence interval (CI) values for the early (2005-2013) and later (2014-2021) periods and the vaccinated compared with unvaccinated cohorts for the 20-39 age group. Results: The hospital discharge rate per 1,000,000 people was 3.08 in 2005 and 4.50 in 2021 for HCC, and 4.81 in 2005 and 1.92 in 2021 for cirrhosis. Comparing the early and later periods, values were higher for HCC (HDRR 1.13; 95% CI: 1.06-1.20) and lower for cirrhosis (HDRR 0.56; 95% CI: 0.51-0.60). The rate for the 20-39 age group was lower for the vaccinated compared with the unvaccinated cohorts overall (HDRR 0.53; 95% CI: 0.45-0.62), for HCC (HDRR 0.66; 95% CI: 0.53-0.82), and for cirrhosis (HDRR 0.41; 95% CI: 0.33-0.53). Conclusions: This study describes the important impact, after 25 years, of universal HBV vaccination in Spain: cirrhosis hospital discharge rate was reduced, and the vaccinated cohorts, compared with the unvaccinated cohorts in the 20-39 age group, had a lower hospital discharge rate of both HCC and cirrhosis.
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Affiliation(s)
- Angela Domínguez
- Department of Medicine, Universidad de Barcelona, 08036 Barcelona, Spain; (A.D.); (E.B.); (N.T.); (C.P.)
- CIBER Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III, 28029 Madrid, Spain; (A.A.); (A.M.); (C.R.); (P.G.)
| | - Ana Avellón
- CIBER Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III, 28029 Madrid, Spain; (A.A.); (A.M.); (C.R.); (P.G.)
- Hepatitis Unit, National Centre of Microbiology, Instituto de Salud Carlos III, 28222 Madrid, Spain
| | - Victoria Hernando
- Centro Nacional de Epidemiología, Instituto de Salud Carlos III, 28029 Madrid, Spain;
- CIBER Enfermedades Infecciosas (CIBERINFEC), Instituto de Salud Carlos III, 28029 Madrid, Spain
| | - Núria Soldevila
- Department of Medicine, Universidad de Barcelona, 08036 Barcelona, Spain; (A.D.); (E.B.); (N.T.); (C.P.)
- CIBER Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III, 28029 Madrid, Spain; (A.A.); (A.M.); (C.R.); (P.G.)
| | - Eva Borràs
- Department of Medicine, Universidad de Barcelona, 08036 Barcelona, Spain; (A.D.); (E.B.); (N.T.); (C.P.)
- CIBER Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III, 28029 Madrid, Spain; (A.A.); (A.M.); (C.R.); (P.G.)
- Agència de Salut Pública de Catalunya, 08005 Barcelona, Spain;
| | - Ana Martínez
- CIBER Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III, 28029 Madrid, Spain; (A.A.); (A.M.); (C.R.); (P.G.)
- Agència de Salut Pública de Catalunya, 08005 Barcelona, Spain;
| | | | - Núria Torner
- Department of Medicine, Universidad de Barcelona, 08036 Barcelona, Spain; (A.D.); (E.B.); (N.T.); (C.P.)
- CIBER Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III, 28029 Madrid, Spain; (A.A.); (A.M.); (C.R.); (P.G.)
| | - Carles Pericas
- Department of Medicine, Universidad de Barcelona, 08036 Barcelona, Spain; (A.D.); (E.B.); (N.T.); (C.P.)
- Agència de Salut Pública de Barcelona, 08023 Barcelona, Spain
- Institut de Recerca de l’Hospital de la Santa Creu i Sant Pau (IRB Sant Pau), 08041 Barcelona, Spain
| | - Cristina Rius
- CIBER Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III, 28029 Madrid, Spain; (A.A.); (A.M.); (C.R.); (P.G.)
- Agència de Salut Pública de Barcelona, 08023 Barcelona, Spain
- Institut de Recerca de l’Hospital de la Santa Creu i Sant Pau (IRB Sant Pau), 08041 Barcelona, Spain
- Department MELIS-UPF, Universitat Pompeu Fabra, 08002 Barcelona, Spain
| | - Pere Godoy
- CIBER Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III, 28029 Madrid, Spain; (A.A.); (A.M.); (C.R.); (P.G.)
- Institut de Recerca Biomédica de Lleida (IRBLleida), 25006 Lleida, Spain
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Shahni SN, Albogami S, Azmi I, Pattnaik B, Chaudhuri R, Dev K, Iqbal J, Sharma A, Ahmad T. Dual Detection of Hepatitis B and C Viruses Using CRISPR-Cas Systems and Lateral Flow Assay. J Nucleic Acids 2024; 2024:8819834. [PMID: 39399398 PMCID: PMC11470818 DOI: 10.1155/2024/8819834] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/25/2024] [Accepted: 07/25/2024] [Indexed: 10/15/2024] Open
Abstract
The development of sensitive and specific diagnostic tools for hepatitis B virus (HBV) and hepatitis C virus (HCV) remains crucial for effective disease management and control. In this study, we utilized CRISPR-Cas12 and CRISPR-Cas13 systems for the detection of HBV (DNA virus) and HCV (RNA virus), respectively. We designed and tested multiple guide RNAs (gRNAs) targeting both viruses, confirming successful cleavage of target sequences through gel electrophoresis and a fluorescent reporter assay. Using optimized gRNAs, we developed a lateral flow assay (LFA) for sensitive detection of HBV and HCV, demonstrating a concentration-dependent signal increase. Importantly, no cross-reactivity was observed with other viral targets. To further enhance sensitivity, we employed a dual-enzyme approach, combining Cas12 and Cas13 in a single reaction, which significantly improved detection limits for both viruses. Finally, we developed a dual antigen detection LFA strip capable of simultaneously detecting both HBV and HCV in a single sample. This approach holds promise for point-of-care (POC) diagnostics where the specific viral infection is unknown. This study addresses the current limitations in CRISPR-Cas based diagnostics, namely, the need for ultrasensitive detection methods and the ability to detect multiple antigens using a single test strip. Our findings demonstrate the feasibility of using CRISPR-Cas systems for highly sensitive and specific detection of HBV and HCV, paving the way for potential POC application.
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Affiliation(s)
- Syeda Najidah Shahni
- Multidisciplinary Centre for Advanced Research and Studies, Jamia Millia Islamia, New Delhi, India
| | - Sarah Albogami
- Department of Biotechnology, College of Science, Taif University, Taif, Saudi Arabia
| | - Iqbal Azmi
- Multidisciplinary Centre for Advanced Research and Studies, Jamia Millia Islamia, New Delhi, India
| | - Bijay Pattnaik
- Department Of Pulmanary Medicine and Sleep Disorders, All India Institute of Medical Sciences, New Delhi, India
| | - Rituparna Chaudhuri
- Molecular and Cellular Neuroscience, Neurovirology Section, National Brain Research Centre (NBRC), Gurugram 122052, India
| | - Kapil Dev
- Department of Biotechnology, Jamia Millia Islamia, New Delhi, India
| | - Jawed Iqbal
- Multidisciplinary Centre for Advanced Research and Studies, Jamia Millia Islamia, New Delhi, India
| | - Amit Sharma
- Multidisciplinary Centre for Advanced Research and Studies, Jamia Millia Islamia, New Delhi, India
| | - Tanveer Ahmad
- Multidisciplinary Centre for Advanced Research and Studies, Jamia Millia Islamia, New Delhi, India
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Jain RK, Shrivastava R, Jain SK, Chaurasia D, Jain A, Jain S, Ahirwar KK, Perumal N. Seropositivity and coinfection of hepatitis B and hepatitis C viruses in Central India: A hospital-based study. J Family Med Prim Care 2024; 13:4413-4418. [PMID: 39629376 PMCID: PMC11610833 DOI: 10.4103/jfmpc.jfmpc_202_24] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/08/2024] [Revised: 04/20/2024] [Accepted: 04/27/2024] [Indexed: 12/07/2024] Open
Abstract
Background Hepatitis B virus (HBV) and Hepatitis C virus (HCV) show similarity in the transmission, distribution, hepatotropism, and leading to chronic asymptomatic infection. Coinfection of HBV and HCV can lead to more severe liver disease and an increased risk for progression to hepatocellular carcinoma (HCC). Most of the people with chronic infection are unaware of their HBV and HCV infections, hence facilitating these to go undiagnosed until these viruses have caused serious liver damage and they act as a potential source of infection for the community at large. Therefore, the present study aimed to find the prevalence of HBV and HCV along with incidences of coinfection of HBV and HCV in patients seeking hospital care in central India. Methods A five-year hospital-based study was carried out at the tertiary care hospital in Central India from 2018 to 2022. A total of 72402 patients attending the outdoor patients and admitted indoor patients who were advised for HBV and HCV for screening before any invasive/surgical procedure and patients who presented with symptoms of acute or chronic liver disease were included in this study. Screening was done by immunochromatography-based card test followed by the confirmation of all samples by enzyme immunoassay. Results Seroprevalence of HBV and HCV was found to be 3.71% and 1.91%, respectively. Coinfection with HBV/HCV was seen in 0.13% of the individuals. The overall prevalence of HBV, HCV, and HBV-HCV coinfection was significantly higher in the male population as compared to females. Conclusion The study findings of seroprevalence of HBV and HCV among the hospital-based population will help to get a baseline understanding of the disease burden in central India. The HBV/HCV coinfection rate also raises serious concerns owing to its high prevalence rate among the younger age.
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Affiliation(s)
- Rajeev K. Jain
- State Virology Laboratory, Gandhi Medical College, Bhopal, Madhya Pradesh, India
| | - Rakesh Shrivastava
- Department of Microbiology, Gandhi Medical College, Bhopal, Madhya Pradesh, India
| | - Shailendra K. Jain
- Department of Gastroenterology, Gandhi Medical College, Bhopal, Madhya Pradesh, India
| | - Deepti Chaurasia
- Department of Microbiology, Gandhi Medical College, Bhopal, Madhya Pradesh, India
| | - Anamika Jain
- State Virology Laboratory, Gandhi Medical College, Bhopal, Madhya Pradesh, India
| | - Swati Jain
- Model Treatment Centre, National Viral Hepatitis Control Program, Gandhi Medical College, Bhopal, Madhya Pradesh, India
| | - Kamlesh K. Ahirwar
- State Virology Laboratory, Gandhi Medical College, Bhopal, Madhya Pradesh, India
| | - Nagaraj Perumal
- State Virology Laboratory, Gandhi Medical College, Bhopal, Madhya Pradesh, India
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Mazzilli S, Aslam MK, Akhtar J, Miazek M, Wailly Y, Hamid S, Shilton S, Donchuk D, de Glanville WA, Isaakidis P. Usability and acceptability of self-testing for hepatitis C virus exposure in a high-prevalence urban informal settlement in Karachi, Pakistan. BMC Infect Dis 2024; 24:1054. [PMID: 39333922 PMCID: PMC11428378 DOI: 10.1186/s12879-024-09925-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/02/2024] [Accepted: 09/12/2024] [Indexed: 09/30/2024] Open
Abstract
BACKGROUND Hepatitis C virus (HCV) antibody self-testing (HCVST) may help expand screening access and support HCV elimination efforts. Despite potential benefits, HCVST is not currently implemented in Pakistan. This study aimed to assess the usability and acceptability of HCVST in a high HCV prevalence informal settlement in Karachi, Pakistan. METHODS We performed a cross-sectional study in a hepatitis C clinic from April through June 2023. Participants were invited to perform a saliva-based HCVST (OraSure Technologies, USA) while following pictorial instructions. A study member evaluated test performance using a standardized checklist and provided verbal support if a step could not be completed. Perceived usability and acceptability were assessed using a semi-structured questionnaire. The HCVST was considered successful if the participant was able to complete all steps and correctly interpret test results. Overall concordance and positive and negative agreement were estimated in comparison with the HCVST result read by the study member (inter-reader concordance and agreement) and result of a second rapid HCV test (Abbott Diagnostics Korea Inc, South Korea) performed by a trained user (inter-operator concordance and agreement). RESULTS The study included 295 participants of which 97 (32%) were illiterate. In total, 280 (95%, 95% CI 92-97%) HCVSTs were successful. Overall, 38 (13%) people performed the HCVST without verbal assistance, 67 (23%) needed verbal assistance in one step, 190 (64%) in two or more. Assistance was most often needed in managing the test buffer and test reading times. The inter-reader concordance was 96% and inter-operator concordance 93%. Inter-reader and inter-operator positive percent agreement were 84 and 70%, respectively. All participants reported they would use HCVST again and would recommend it to friends and family. CONCLUSION Saliva-based HCVST was very well accepted in this clinic-based setting. However, many people requested verbal support in several steps, highlighting the need for clear instructions for use and test devices that are simple to use, particularly in low literacy settings. Moderately low positive percent agreement with the results of a rapid test performed by a trained user highlights potential uncertainty in the accuracy of HCVST in the hands of lay users.
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Affiliation(s)
- Sara Mazzilli
- Scuola Normale Superiore, Pisa, Italy
- Médecins Sans Frontières, Operational Centre Brussels (MSF OCB), Karachi, Pakistan
| | - Muhammad K Aslam
- Médecins Sans Frontières, Operational Centre Brussels (MSF OCB), Karachi, Pakistan.
| | - Javed Akhtar
- Médecins Sans Frontières, Operational Centre Brussels (MSF OCB), Karachi, Pakistan
| | - Marta Miazek
- Médecins Sans Frontières, Operational Centre Brussels (MSF OCB), Brussels, Belgium
| | - Yves Wailly
- Médecins Sans Frontières, Operational Centre Brussels (MSF OCB), Brussels, Belgium
| | - Saeed Hamid
- Department of Medicine and Director of the Clinical Trials Unitat , The Aga Khan University, Karachi, Pakistan
| | | | - Dimitri Donchuk
- Médecins Sans Frontières, Southern Africa Medical Unit (SAMU), Johannesburg, South Africa
| | - William A de Glanville
- Médecins Sans Frontières, Operational Centre Brussels (MSF OCB), Karachi, Pakistan
- School of Biodiversity, College of Medical, Veterinary and Life Sciences, One Health and Veterinary Medicine, University of Glasgow, Glasgow, UK
| | - Petros Isaakidis
- Médecins Sans Frontières, Southern Africa Medical Unit (SAMU), Johannesburg, South Africa
- Clinical and Molecular Epidemiology Unit, Department of Hygiene and Epidemiology, University of Ioannina School of Medicine, Ioannina, Greece
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9
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Campusano C, Kanner R, McDonell C, Morris M, Duarte M, Price JC. High prevalence of hepatitis B virus susceptibility among persons undergoing community-based hepatitis C virus treatment. Harm Reduct J 2024; 21:25. [PMID: 38281942 PMCID: PMC10823661 DOI: 10.1186/s12954-024-00942-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/03/2023] [Accepted: 01/21/2024] [Indexed: 01/30/2024] Open
Abstract
BACKGROUND Due to shared modes of transmission, coinfection with hepatitis B virus (HBV) and hepatitis C virus (HCV) is common, and HBV vaccination is recommended for all persons with HCV who remain susceptible to HBV. To identify potential gaps in HBV vaccination among this high-risk population, we aimed to determine the patterns of HBV susceptibility in persons undergoing community-based HCV treatment. METHODS We performed a cross-sectional study within two community-based HCV treatment programs in an urban US setting. Participants were identified for HCV screening and confirmatory testing via street-outreach recruitment directed at persons experiencing homelessness and currently using drugs. Participants were excluded if HBsAg was reactive. Cohort characteristics were obtained via intake surveys and descriptive analysis was performed by exposure status. RESULTS Among 150 participants without chronic HBV receiving community-based HCV treatment, 43% had evidence of prior HBV infection, 26% were immune from vaccination, and 31% were non-immune. Among the subset of the cohort reporting current injection drug use (IDU) (N = 100), 31% (n = 10) of those aged 24-40 and 47% (n = 23) of those aged 41-57 remained susceptible to HBV infection. By contrast only two participants aged 58-74 were HBV non-immune (11%), with 84% immune due to prior exposure. CONCLUSIONS Our data reflect a high prevalence of HBV susceptibility among persons undergoing community-based HCV treatment. Although younger patients were more likely to be immune due to vaccination, a high proportion remained non-immune to HBV, particularly among those reporting current IDU. Our data reflect a gap in HBV vaccination among younger persons with HCV and suggest a potential role for co-localizing HBV vaccination with community-based HCV screening and treatment.
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Affiliation(s)
- Catherine Campusano
- Department of Medicine, School of Medicine, University of California, San Francisco, CA, USA.
- Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
| | - Rachel Kanner
- Department of Medicine, School of Medicine, University of California, San Francisco, CA, USA
| | - Claire McDonell
- Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA
| | - Meghan Morris
- Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA
| | - Maria Duarte
- Department of Medicine, School of Medicine, University of California, San Francisco, CA, USA
| | - Jennifer C Price
- Department of Medicine, School of Medicine, University of California, San Francisco, CA, USA
- Liver Center, University of California San Francisco, San Francisco, CA, USA
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10
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Chan HK, Sem X, Ivanova Reipold E, Pannir Selvam SBA, Salleh NA, Mohamad Gani AHB, Fajardo E, Shilton S, Abu Hassan MR. Usability and acceptability of oral fluid- and blood-based hepatitis C virus self-testing among the general population and men who have sex with men in Malaysia. PLOS GLOBAL PUBLIC HEALTH 2024; 4:e0001770. [PMID: 38170720 PMCID: PMC10763960 DOI: 10.1371/journal.pgph.0001770] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 03/25/2023] [Accepted: 11/20/2023] [Indexed: 01/05/2024]
Abstract
Hepatitis C self-testing (HCVST) is emerging as an additional strategy that could help to expand access to HCV testing. We conducted a study to assess the usability and acceptability of two types of HCVST, oral fluid- and blood-based, among the general population and men who have sex with men (MSM) in Malaysia. An observational study was conducted in three primary care centres in Malaysia. Participants who were layman users performed the oral fluid- and blood-based HCVST sequentially. Usability was assessed by calculating the rate of errors observed, the rate of difficulties faced by participants as well as inter-reader (self-test interpreted by self-tester vs interpreted by trained user) and inter-operator concordances (self-test vs test performed by trained user). The acceptability of HCV self-testing was assessed using an interviewer-administered semi-structured questionnaire. Participants were also required to read contrived test results which included "positive", "negative", and "invalid". There was a total of 200 participants (100 general population, 100 MSM; mean age 33.6 ± 14.0 years). We found a high acceptability of oral fluid- and blood-based HCVST across both general population and MSM. User errors, related to timekeeping and reading within stipulated time, were common. However, the majority of the participants were still able to obtain and interpret results correctly, including that of contrived results, although there was substantial difficulty interpreting weak positive results. The high acceptability of HCVST among the participants did not appreciably change after they had experienced both tests, with 97.0% of all participants indicating they would be willing to use HCVST again and 98.5% of them indicating they would recommend it to people they knew. There was no significant difference between the general population and MSM in these aspects. Our study demonstrates that both oral fluid- and blood-based HCVST are highly acceptable among both the general population and MSM. Both populations also showed comparable ability to conduct the tests and interpret the results. Overall, this study suggests that HCVST could be introduced as an addition to existing HCV testing services in Malaysia. Further studies are needed to establish the optimal positioning of self-testing alongside facility-based testing to expand access to HCV diagnosis in the country.
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Affiliation(s)
- Huan-Keat Chan
- Clinical Research Centre, Hospital Sultanah Bahiyah, Alor Setar, Malaysia
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11
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Ferrasi AC, Lima SVG, Galvani AF, Delafiori J, Dias-Audibert FL, Catharino RR, Silva GF, Praxedes RR, Santos DB, Almeida DTDM, Lima EO. Metabolomics in chronic hepatitis C: Decoding fibrosis grading and underlying pathways. World J Hepatol 2023; 15:1237-1249. [DOI: 10.4254/wjh.v15.i11.1237] [Citation(s) in RCA: 4] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/22/2023] [Revised: 09/22/2023] [Accepted: 10/23/2023] [Indexed: 11/24/2023] Open
Abstract
BACKGROUND Chronic Hepatitis C (CHC) affects 71 million people globally and leads to liver issues such as fibrosis, cirrhosis, cancer, and death. A better understanding and prognosis of liver involvement are vital to reduce morbidity and mortality. The accurate identification of the fibrosis stage is crucial for making treatment decisions and predicting outcomes. Tests used to grade fibrosis include histological analysis and imaging but have limitations. Blood markers such as molecular biomarkers can offer valuable insights into fibrosis.
AIM To identify potential biomarkers that might stratify these lesions and add information about the molecular mechanisms involved in the disease.
METHODS Plasma samples were collected from 46 patients with hepatitis C and classified into fibrosis grades F1 (n = 13), F2 (n = 12), F3 (n = 6), and F4 (n = 15). To ensure that the identified biomarkers were exclusive to liver lesions (CHC fibrosis), healthy volunteer participants (n = 50) were also included. An untargeted metabolomic technique was used to analyze the plasma metabolites using mass spectrometry and database verification. Statistical analyses were performed to identify differential biomarkers among groups.
RESULTS Six differential metabolites were identified in each grade of fibrosis. This six-metabolite profile was able to establish a clustering tendency in patients with the same grade of fibrosis; thus, they showed greater efficiency in discriminating grades.
CONCLUSION This study suggests that some of the observed biomarkers, once validated, have the potential to be applied as prognostic biomarkers. Furthermore, it suggests that liquid biopsy analyses of plasma metabolites are a good source of molecular biomarkers capable of stratifying patients with CHC according to fibrosis grade.
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Affiliation(s)
| | | | - Aline Faria Galvani
- Department of Internal Medicine, Sao Paulo State University, Botucatu 18618-686, Brazil
| | - Jeany Delafiori
- Innovare Biomarkers Laboratory, University of Campinas, Campinas 13083-877, Brazil
| | | | | | - Giovanni Faria Silva
- Department of Internal Medicine, Sao Paulo State University, Botucatu 18618-686, Brazil
| | | | | | | | - Estela Oliveira Lima
- Department of Internal Medicine, Sao Paulo State University, Botucatu 18618-686, Brazil
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12
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Luxenburger H, Thimme R. SARS-CoV-2 and the liver: clinical and immunological features in chronic liver disease. Gut 2023; 72:1783-1794. [PMID: 37316169 PMCID: PMC10423489 DOI: 10.1136/gutjnl-2023-329623] [Citation(s) in RCA: 14] [Impact Index Per Article: 7.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/12/2023] [Accepted: 05/24/2023] [Indexed: 06/16/2023]
Abstract
SARS-CoV-2 infection may affect the liver in healthy individuals but also influences the course of COVID-19 in patients with chronic liver disease (CLD). As described in healthy individuals, a strong SARS-CoV-2-specific adaptive immune response is important for the outcome of COVID-19, however, knowledge on the adaptive immune response in CLD is limited.Here, we review the clinical and immunological features of SARS-CoV-2 infection in individuals with CLD. Acute liver injury occurs in many cases of SARS-CoV-2 infection and may be induced by multiple factors, such as cytokines, direct viral infection or toxic effects of COVID-19 drugs. In individuals with CLD, SARS-CoV-2 infection may have a more severe course and promote decompensation and particularly in patients with cirrhosis. Compared with healthy individuals, the SARS-CoV-2-specific adaptive immune responses is impaired in patients with CLD after both, natural infection and vaccination but improves at least partially after booster vaccination.Following SARS-CoV-2 vaccination, rare cases of acute vaccine-induced liver injury and the development of autoimmune-like hepatitis have been reported. However, the concomitant elevation of liver enzymes is reversible under steroid treatment.
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Affiliation(s)
- Hendrik Luxenburger
- Department of Medicine II (Gastroenterology, Hepatology, Endocrinology and Infectious Diseases), Freiburg University Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany
| | - Robert Thimme
- Department of Medicine II (Gastroenterology, Hepatology, Endocrinology and Infectious Diseases), Freiburg University Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany
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13
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Pandey P, Roy A, Bhadoria AS. National viral hepatitis control program in India: Call for update. J Family Med Prim Care 2023; 12:1755-1758. [PMID: 38024898 PMCID: PMC10657081 DOI: 10.4103/jfmpc.jfmpc_1455_23] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/02/2023] [Revised: 09/07/2023] [Accepted: 09/08/2023] [Indexed: 12/01/2023] Open
Abstract
Viral hepatitis is a serious yet manageable and preventable public health menace that infects about 3 million of people and leads to 1.1 million deaths worldwide every year. An acute episode of viral hepatitis usually subsides on its own, however, if not intervened timely, chronic infection puts people at risk of cirrhosis, liver cancer, and eventually death. In 2015, the global community allied to tackle viral hepatitis, as a result of which combating viral hepatitis target was included in the sustainable development goals (SDGs), and the World Health Organisation (WHO) constituted the first-ever global health sector strategy on viral hepatitis for 2016 to 2021 which is also renewed recently. Conforming to the global commitment, India launched the National Viral Hepatitis Control Program in the year 2018 with the aim to eliminate viral hepatitis as a public health threat by the year 2030. In the Subsequent years, WHO and various other international societies have released updated recommendations with respect to vaccination, prevention of mother-to-child transmission, strategies to increase testing uptake including self-testing, newer diagnostics including point of care and reflex testing approaches, simplified treatment algorithms, expanded treatment eligibility criteria, and simplified service delivery models. With the program being in its fifth year of implementation, there is a need to revamp the operational guidelines based on various global evidence-based advancements in order to attain the ambitious elimination goal by 2030.
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Affiliation(s)
- Pragya Pandey
- Department of Community and Family Medicine, All India Institute of Medical Sciences (AIIMS), Rishikesh, Uttarkhand, India
| | - Akash Roy
- Department of Hepatology, Institute of Gastrosciences and Liver Transplantation, Apollo Multispeciality Hospitals, Kolkata, West Bengal, India
| | - Ajeet Singh Bhadoria
- Department of Community and Family Medicine, All India Institute of Medical Sciences (AIIMS), Rishikesh, Uttarkhand, India
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14
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Howell J, Seaman C, Wallace J, Xiao Y, Scott N, Davies J, de Santis T, Adda D, El-Sayed M, Feld JJ, Gane E, Lacombe K, Lesi O, Mohamed R, Silva M, Tu T, Revill P, Hellard ME. Pathway to global elimination of hepatitis B: HBV cure is just the first step. Hepatology 2023; 78:976-990. [PMID: 37125643 PMCID: PMC10442143 DOI: 10.1097/hep.0000000000000430] [Citation(s) in RCA: 17] [Impact Index Per Article: 8.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/24/2022] [Revised: 02/04/2023] [Accepted: 02/10/2023] [Indexed: 05/02/2023]
Abstract
Hepatitis B (HBV) is a major cause of global morbidity and mortality, and the leading cause of liver cancer worldwide. Significant advances have recently been made toward the development of a finite HBV treatment that achieves permanent loss of HBsAg and HBV DNA (so-called "HBV cure"), which could provide the means to eliminate HBV as a public health threat. However, the HBV cure is just one step toward achieving WHO HBV elimination targets by 2030, and much work must be done now to prepare for the successful implementation of the HBV cure. In this review, we describe the required steps to rapidly scale-up future HBV cure equitably. We present key actions required for successful HBV cure implementation, integrated within the World Health Organization (WHO) Global Health Sector Strategy (GHSS) 2022-2030 framework. Finally, we highlight what can be done now to progress toward the 2030 HBV elimination targets using available tools to ensure that we are preparing, but not waiting, for the cure.
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Affiliation(s)
- Jessica Howell
- Disease Elimination, Burnet Institute, Melbourne, Victoria, Australia
- Department Gastroenterology, St Vincent’s Hospital, Melbourne, Victoria, Australia
- Department Medicine, University of Melbourne, Melbourne, Victoria, Australia
- Department Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
| | - Chris Seaman
- Disease Elimination, Burnet Institute, Melbourne, Victoria, Australia
- Department Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
| | - Jack Wallace
- Disease Elimination, Burnet Institute, Melbourne, Victoria, Australia
| | - Yinzong Xiao
- Disease Elimination, Burnet Institute, Melbourne, Victoria, Australia
| | - Nick Scott
- Disease Elimination, Burnet Institute, Melbourne, Victoria, Australia
| | - Jane Davies
- Department Global Health and Infectious diseases, Menzies School of Public Health, Darwin, Northern Territory, Australia
| | - Teresa de Santis
- Department Global Health and Infectious diseases, Menzies School of Public Health, Darwin, Northern Territory, Australia
| | | | - Manal El-Sayed
- Department Paediatrics, Ain Shams University, Cairo, Egypt
| | - Jordan J. Feld
- Toronto Centre for Liver Disease, University Health Network, University of Toronto, Toronto, Ontario, Canada
| | - Edward Gane
- Department Medicine, University of Auckland, Auckland, New Zealand
| | - Karine Lacombe
- Sorbonne Université, IPLESP, Saint-Antoine Hospital, AP-HP, Paris, France
| | - Olufunmilayo Lesi
- Global HIV, Hepatitis, and STI Programme, World Health Organisation, Geneva, Switzerland
| | - Rosmawati Mohamed
- Department of Medicine, University of Malaya, Kuala Lumpur, Malaysia
| | - Marcelo Silva
- Department Hepatology and Liver Transplantation, Austral University Hospital, Buenos Aires, Argentina
| | - Thomas Tu
- Storr Liver Centre, The Westmead Institute for Medical Research, The University of Sydney and Westmead Hospital, Sydney, New South Wales, Australia
- University of Sydney Institute for Infectious Diseases, University of Sydney, Sydney, New South Wales, Australia
| | - Peter Revill
- Victorian Infectious Diseases Reference Laboratory (VIDRL), Royal Melbourne Hospital at the Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia
| | - Margaret E. Hellard
- Disease Elimination, Burnet Institute, Melbourne, Victoria, Australia
- Department Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
- Department Infectious Diseases, Alfred Hospital, Melbourne, Victoria, Australia
- Department Infectious Diseases, School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia
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15
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Wang C, Zhao P, Weideman AM, Xu W, Ong JJ, Jamil MS, Yang B, Tucker JD. Expanding hepatitis C virus test uptake using self-testing among men who have sex with men in China: two parallel randomized controlled trials. BMC Med 2023; 21:279. [PMID: 37507702 PMCID: PMC10386771 DOI: 10.1186/s12916-023-02981-w] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/25/2022] [Accepted: 07/17/2023] [Indexed: 07/30/2023] Open
Abstract
BACKGROUND HCV self-testing (HCVST) may be an effective strategy to address low rates of HCV test uptake among men who have sex with men (MSM). We evaluated the effectiveness and cost of providing HCVST to increase HCV test uptake among MSM in China. METHODS Two parallel, unmasked, individual-level randomized controlled trials were conducted. HIV-negative MSM and MSM living with HIV were enrolled from 22 cities in China. Men in both trials were randomly assigned (1:1) into standard-of-care (SOC) or HCVST arms. The primary outcome was the proportion of participants who tested for HCV during the trial period. Intervention effects were estimated using multiply imputed data in the main analysis. Costs were measured using a micro-costing approach. RESULTS A total of 84 men who were HIV-negative (trial 1) and 84 men living with HIV were enrolled (trial 2). Overall, the proportion of individuals who underwent HCV testing during the trial period was higher in the HCVST arm compared to SOC in trial 1 (estimated risk difference (RD): 71.1%, 95% CI: 54.6 to 87.7%) and trial 2 (estimated RD: 62.9%, 95% CI: 45.7 to 80.1%). Over half (58.6%, 34/58) of HCV self-testers reported the self-test was their first HCV test. The cost per person tested in trial 1 was $654.52 for SOC and $49.83 for HCVST, and in trial 2 was $438.67 for SOC and $53.33 for HCVST. CONCLUSIONS Compared to the standard of care, providing HCVST significantly increased the proportion of MSM testing for HCV in China, and was cheaper per person tested. TRIAL REGISTRATION Chinese Clinical Trial Registry. REGISTRATION NUMBER ChiCTR2100048379.
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Affiliation(s)
- Cheng Wang
- Dermatology Hospital of Southern Medical University, Guangzhou, China.
- Southern Medical University Institute for Global Health, Guangzhou, China.
- Guangdong Provincial Center for Skin Diseases and STIs Control, Guangzhou, China.
| | - Peizhen Zhao
- Dermatology Hospital of Southern Medical University, Guangzhou, China
- Southern Medical University Institute for Global Health, Guangzhou, China
- Guangdong Provincial Center for Skin Diseases and STIs Control, Guangzhou, China
| | - Ann Marie Weideman
- Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, USA
- Center for AIDS Research Biostatistics Core, University of North Carolina at Chapel Hill, Chapel Hill, USA
| | - Wenqian Xu
- Dermatology Hospital of Southern Medical University, Guangzhou, China
- Southern Medical University Institute for Global Health, Guangzhou, China
- Guangdong Provincial Center for Skin Diseases and STIs Control, Guangzhou, China
- School of Public Health, Southern Medical University, Guangzhou, China
| | - Jason J Ong
- Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK
- Central Clinical School, Monash University, Melbourne, VIC, Australia
| | - Muhammad S Jamil
- Global HIV, Hepatitis and STIs Programmes, World Health Organization, Geneva, Switzerland
| | - Bin Yang
- Dermatology Hospital of Southern Medical University, Guangzhou, China
- Southern Medical University Institute for Global Health, Guangzhou, China
- Guangdong Provincial Center for Skin Diseases and STIs Control, Guangzhou, China
| | - Joseph D Tucker
- Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK
- University of North Carolina Project-China, Guangzhou, China
- Institute for Global Health and Infectious Diseases, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, USA
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16
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Baliashvili D, Blumberg HM, Gandhi NR, Averhoff F, Benkeser D, Shadaker S, Gvinjilia L, Turdziladze A, Tukvadze N, Chincharauli M, Butsashvili M, Sharvadze L, Tsertsvadze T, Zarkua J, Kempker RR. Hepatitis C care cascade among patients with and without tuberculosis: Nationwide observational cohort study in the country of Georgia, 2015-2020. PLoS Med 2023; 20:e1004121. [PMID: 37141386 PMCID: PMC10194957 DOI: 10.1371/journal.pmed.1004121] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/03/2022] [Revised: 05/18/2023] [Accepted: 04/13/2023] [Indexed: 05/06/2023] Open
Abstract
BACKGROUND The Eastern European country of Georgia initiated a nationwide hepatitis C virus (HCV) elimination program in 2015 to address a high burden of infection. Screening for HCV infection through antibody testing was integrated into multiple existing programs, including the National Tuberculosis Program (NTP). We sought to compare the hepatitis C care cascade among patients with and without tuberculosis (TB) diagnosis in Georgia between 2015 and 2019 and to identify factors associated with loss to follow-up (LTFU) in hepatitis C care among patients with TB. METHODS AND FINDINGS Using national ID numbers, we merged databases of the HCV elimination program, NTP, and national death registry from January 1, 2015 to September 30, 2020. The study population included 11,985 adults (aged ≥18 years) diagnosed with active TB from January 1, 2015 through December 31, 2019, and 1,849,820 adults tested for HCV antibodies between January 1, 2015 and September 30, 2020, who were not diagnosed with TB during that time. We estimated the proportion of patients with and without TB who were LTFU at each step of the HCV care cascade and explored temporal changes. Among 11,985 patients with active TB, 9,065 (76%) patients without prior hepatitis C treatment were tested for HCV antibodies, of which 1,665 (18%) had a positive result; LTFU from hepatitis C care was common, with 316 of 1,557 (20%) patients with a positive antibody test not undergoing viremia testing and 443 of 1,025 (43%) patients with viremia not starting treatment for hepatitis C. Overall, among persons with confirmed viremic HCV infection, due to LTFU at various stages of the care cascade only 28% of patients with TB had a documented cure from HCV infection, compared to 55% among patients without TB. LTFU after positive antibody testing substantially decreased in the last 3 years, from 32% among patients diagnosed with TB in 2017 to 12% among those diagnosed in 2019. After a positive HCV antibody test, patients without TB had viremia testing sooner than patients with TB (hazards ratio [HR] = 1.46, 95% confidence intervals [CI] [1.39, 1.54], p < 0.001). After a positive viremia test, patients without TB started hepatitis C treatment sooner than patients with TB (HR = 2.05, 95% CI [1.87, 2.25], p < 0.001). In the risk factor analysis adjusted for age, sex, and case definition (new versus previously treated), multidrug-resistant (MDR) TB was associated with an increased risk of LTFU after a positive HCV antibody test (adjusted risk ratio [aRR] = 1.41, 95% CI [1.12, 1.76], p = 0.003). The main limitation of this study was that due to the reliance on existing electronic databases, we were unable to account for the impact of all confounding factors in some of the analyses. CONCLUSIONS LTFU from hepatitis C care after a positive antibody or viremia test was high and more common among patients with TB than in those without TB. Better integration of TB and hepatitis C care systems can potentially reduce LTFU and improve patient outcomes both in Georgia and other countries that are initiating or scaling up their nationwide hepatitis C control efforts and striving to provide personalized TB treatment.
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Affiliation(s)
- Davit Baliashvili
- Department of Epidemiology, Emory University Rollins School of Public Health, Atlanta, Georgia, United States of America
| | - Henry M. Blumberg
- Department of Epidemiology, Emory University Rollins School of Public Health, Atlanta, Georgia, United States of America
- Department of Global Health, Emory University Rollins School of Public Health, Atlanta, Georgia, United States of America
- Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, United States of America
| | - Neel R. Gandhi
- Department of Epidemiology, Emory University Rollins School of Public Health, Atlanta, Georgia, United States of America
- Department of Global Health, Emory University Rollins School of Public Health, Atlanta, Georgia, United States of America
- Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, United States of America
| | - Francisco Averhoff
- Department of Family and Preventive Medicine, Emory University School of Medicine, Atlanta, Georgia, United States of America
| | - David Benkeser
- Department of Biostatistics and Bioinformatics, Emory University Rollins School of Public Health, Atlanta, Georgia, United States of America
| | - Shaun Shadaker
- Division of Viral Hepatitis, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America
| | - Lia Gvinjilia
- Eastern Europe and Central Asia Regional Office, Centers for Disease Control and Prevention, Tbilisi, Georgia
| | | | - Nestani Tukvadze
- National Center for Tuberculosis and Lung Diseases, Tbilisi, Georgia
| | | | | | - Lali Sharvadze
- Clinic “Hepa”, Tbilisi, Georgia
- The University of Georgia, Tbilisi, Georgia
| | - Tengiz Tsertsvadze
- Infectious Diseases, AIDS and Clinical Immunology Research Center, Tbilisi, Georgia
| | | | - Russell R. Kempker
- Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, United States of America
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17
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Howell J, Van H, Pham MD, Sawhney R, Li F, Bhat P, Lubel J, Kemp W, Bloom S, Majumdar A, McCaughan GW, Hall S, Spelman T, Doyle JS, Hellard M, Visvanathan K, Thompson A, Drummer HE, Anderson D. Validation of a novel point-of-care test for alanine aminotransferase measurement: A pilot cohort study. Liver Int 2023; 43:989-999. [PMID: 36719055 DOI: 10.1111/liv.15531] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/28/2022] [Revised: 01/15/2023] [Accepted: 01/23/2023] [Indexed: 02/01/2023]
Abstract
BACKGROUND Alanine aminotransferase (ALT) measurement is essential for evaluation of liver disease. We validated a novel rapid point-of-care (POC) test for ALT1 against laboratory ALT. METHODS Stored plasma samples from adults with chronic liver disease (Test cohort n = 240; Validation cohort n = 491) were analysed using the BioPoint® antigen immunoassay POC ALT1 lateral flow test, which provides quantitative ALT results (Axxin handheld reader) or semi-quantitative results (visual read, cut off 40 IU/ml). The accuracy of POC ALT1 to detect ALT > 40 IU/L was determined by ROC analysis. In patients with chronic hepatitis B, treatment eligibility (EASL criteria) was determined using POC ALT1 and compared to laboratory ALT. RESULTS POC ALT1 test had good accuracy for laboratory ALT > 40 IU/L: AUROC 0.93 (95% CI: 0.89-0.96) in the Test cohort and AUROC 0.92 (95% CI: 0.88-0.95) in the Validation cohort. POC ALT1 cut off of 0.8 for ALT > 40 IU/L maximised sensitivity (97%) and specificity (71%) in the Test cohort (42% laboratory ALT > 40 IU/L) and yielded PPV 84% and NPV 91% in the Validation cohort (19% laboratory ALT > 40 IU/L). Semi-quantitative POC ALT1 had good accuracy for laboratory ALT in the Validation cohort (AUROC 0.85, 95% CI: 0.81-0.99; sensitivity 77% and specificity 93%). Combined with HBV DNA and transient elastography, both quantitative and semi-quantitative POC ALT1 tests had good accuracy for excluding hepatitis B treatment needs (sensitivity 96%, specificity 78% and NPV 99%). CONCLUSION The POC ALT1 test had good accuracy for elevated ALT levels and for determining treatment eligibility among people with chronic hepatitis B.
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Affiliation(s)
- Jessica Howell
- Burnet Institute, Melbourne, Australia
- St Vincent's Hospital and University of Melbourne, Melbourne, Australia
| | - Huy Van
- Burnet Institute, Melbourne, Australia
| | - Minh D Pham
- Burnet Institute, Melbourne, Australia
- School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia
| | - Rohit Sawhney
- St Vincent's Hospital and University of Melbourne, Melbourne, Australia
- Department of Gastroenterology, Eastern Health, Box Hill, Victoria, Australia
- Department of Medicine, Monash University, Melbourne, Australia
| | - Fan Li
- Burnet Institute, Melbourne, Australia
| | | | - John Lubel
- Central Clinical School, Monash University, Melbourne, Australia
| | - William Kemp
- Central Clinical School, Monash University, Melbourne, Australia
| | - Stephen Bloom
- Department of Gastroenterology, Eastern Health, Box Hill, Victoria, Australia
- Department of Medicine, Monash University, Melbourne, Australia
| | - Avik Majumdar
- A.W.Morrow Gastroenterology and Liver Centre, Royal Prince Alfred Hospital, University of Sydney, Sydney, Australia
| | - Geoffrey W McCaughan
- A.W.Morrow Gastroenterology and Liver Centre, Royal Prince Alfred Hospital, University of Sydney, Sydney, Australia
- Centenary Institute, Sydney, Australia
| | - Samuel Hall
- St Vincent's Hospital and University of Melbourne, Melbourne, Australia
| | | | - Joseph S Doyle
- Burnet Institute, Melbourne, Australia
- Department of Infectious Diseases, The Alfred and Monash University, Melbourne, Australia
| | - Margaret Hellard
- Burnet Institute, Melbourne, Australia
- Department of Infectious Diseases, The Alfred and Monash University, Melbourne, Australia
| | - Kumar Visvanathan
- St Vincent's Hospital and University of Melbourne, Melbourne, Australia
| | | | - Heidi E Drummer
- Burnet Institute, Melbourne, Australia
- Department of Microbiology, Monash University, Clayton, Victoria, Australia
- Department of Microbiology at The Peter Doherty Institute for Infection and Immunity, The University of Melbourne, Parkville, Australia
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18
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Howell J, Van H, Pham MD, Sawhney R, Li F, Bhat P, Lubel J, Kemp W, Bloom S, Majumdar A, McCaughan G, Spelman T, Doyle JS, Hellard M, Visvanathan K, Thompson A, Anderson D. A novel point-of-care test for cirrhosis based on dimeric to monomeric IgA ratio in blood: a pilot cohort study. Hepatol Commun 2023; 7:e0106. [PMID: 36995999 PMCID: PMC10069834 DOI: 10.1097/hc9.0000000000000106] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/14/2022] [Accepted: 12/19/2022] [Indexed: 03/31/2023] Open
Abstract
BACKGROUND AND AIMS Dimeric IgA to monomeric IgA ratio (dIgA ratio) is a biomarker of gut mucosal leakage in liver cirrhosis. We evaluated the diagnostic performance of a novel point-of-care (POC) dIgA ratio test for cirrhosis. METHODS Plasma samples from people with chronic liver disease were analyzed using the BioPoint POC dIgA ratio antigen immunoassay lateral flow test. Cirrhosis was defined by Fibroscan>12.5 kPa, clinical evidence of cirrhosis or liver histopathology. POC dIgA test diagnostic accuracy was determined in a test cohort using receiver operating characteristic curve analysis; optimal cutoffs for sensitivity and specificity were then applied to a validation cohort. RESULTS A total of 1478 plasma samples from 866 patients with chronic liver disease were included (test cohort n = 260, validation cohort n = 606). In all, 32% had cirrhosis; 44% Child-Pugh A, 26% Child-Pugh B, and 29% Child-Pugh C. Median POC dIgA ratio was higher in cirrhosis (0.9) compared with no cirrhosis (0.4, p < 0.001), and in Child-Pugh class B/C compared with A cirrhosis (1.4 Child-Pugh B/C vs. 0.6 Child-Pugh A, p < 0.001). POC dIgA ratio test had good diagnostic accuracy for liver cirrhosis in the test cohort (area under the receiver operating characteristic curve=0.80); a dIgA ratio cutoff of 0.6 had a sensitivity of 74% and specificity of 86%. POC dIgA test accuracy was moderate in the validation cohort (area under the receiver operating characteristic curve=0.75; positive predictive value 64%, negative predictive value 83%). Using a dual cutoff approach, 79% of cirrhosis cases were correctly diagnosed and further testing was avoided in 57%. CONCLUSIONS POC dIgA ratio test had moderate accuracy for cirrhosis. Further studies evaluating the accuracy of POC dIgA ratio testing for cirrhosis screening are warranted.
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Affiliation(s)
- Jessica Howell
- Burnet Institute, Melbourne, Victoria, Australia
- St Vincent’s Hospital and University of Melbourne, Melbourne, Victoria, Australia
- School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
| | - Huy Van
- Burnet Institute, Melbourne, Victoria, Australia
| | - Minh D. Pham
- Burnet Institute, Melbourne, Victoria, Australia
- School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
| | - Rohit Sawhney
- St Vincent’s Hospital and University of Melbourne, Melbourne, Victoria, Australia
- Eastern Health, Box Hill, Victoria, Australia
| | - Fan Li
- Burnet Institute, Melbourne, Victoria, Australia
| | | | - John Lubel
- Department of Gastroenterology, The Alfred Hospital and Monash Central Clinical School, Melbourne, Victoria, Australia
| | - William Kemp
- Department of Gastroenterology, The Alfred Hospital and Monash Central Clinical School, Melbourne, Victoria, Australia
| | | | - Avik Majumdar
- Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
| | - Geoff McCaughan
- Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
- Centenary Institute, Sydney, New South Wales, Australia
| | | | - Joseph S. Doyle
- Burnet Institute, Melbourne, Victoria, Australia
- Department of Infectious Diseases, The Alfred and Monash University, Melbourne, Victoria, Australia
| | - Margaret Hellard
- Burnet Institute, Melbourne, Victoria, Australia
- School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
- Department of Infectious Diseases, The Alfred and Monash University, Melbourne, Victoria, Australia
| | - Kumar Visvanathan
- St Vincent’s Hospital and University of Melbourne, Melbourne, Victoria, Australia
| | - Alexander Thompson
- St Vincent’s Hospital and University of Melbourne, Melbourne, Victoria, Australia
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19
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Accelerating point-of-care HCV viral load testing. Lancet Gastroenterol Hepatol 2023; 8:203-204. [PMID: 36706774 DOI: 10.1016/s2468-1253(22)00381-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/24/2022] [Accepted: 10/26/2022] [Indexed: 01/26/2023]
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20
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Trickey A, Fajardo E, Alemu D, Artenie AA, Easterbrook P. Impact of hepatitis C virus point-of-care RNA viral load testing compared with laboratory-based testing on uptake of RNA testing and treatment, and turnaround times: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol 2023; 8:253-270. [PMID: 36706775 PMCID: PMC11810864 DOI: 10.1016/s2468-1253(22)00346-6] [Citation(s) in RCA: 40] [Impact Index Per Article: 20.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/13/2022] [Revised: 10/06/2022] [Accepted: 10/12/2022] [Indexed: 01/26/2023]
Abstract
BACKGROUND Point-of-care (POC) hepatitis C virus (HCV) RNA nucleic acid test viral load assays are being used increasingly as an alternative to centralised, laboratory-based standard-of-care (SOC) viral load assays to reduce loss to follow-up. We aimed to evaluate the impact of using POC compared with SOC approaches on uptake of HCV RNA viral load testing and treatment, and turnaround times from testing to treatment along the HCV care cascade. METHODS We searched PubMed, Embase, and Web of Science for studies published in English between Jan 1, 2016, and April 13, 2022. We additionally searched for accepted conference abstracts (2016-20) not identified in the main search. The contacts directory of the WHO Global Hepatitis Programme was also used to solicit additional studies on use of POC RNA assays. We included studies if they evaluated use of POC HCV RNA viral load with or without a comparator laboratory-based SOC assay, and had data on uptake of viral load testing and treatment, and turnaround times between these steps in cascade. We excluded studies with a sample size of ten or fewer participants. The POC studies were categorised according to whether the POC assay was based onsite at the clinic, in a mobile unit, or in a laboratory. Studies using the POC assay or comparator SOC assays were further stratified according to four models of care: whether HCV testing and treatment initiation were performed in the same or different site, and on the same or a different visit. The comparator was centralised, laboratory-based HCV RNA SOC assays. For turnaround times, we calculated the weighted median of medians with 95% CIs. We analysed viral load testing and treatment uptake using random-effects meta-analysis. The quality of evidence was rated using the GRADE framework. This study is registered with PROSPERO, CRD42020218239. FINDINGS We included 45 studies with 64 within-study arms: 28 studies were in people who inject drugs, were homeless, or both; four were in people incarcerated in prison; nine were in the general or mixed (ie, includes high-risk groups) populations; and four were in people living with HIV. All were observational studies. The pooled median turnaround times between HCV antibody test and treatment initiation was shorter with onsite POC assays (19 days [95% CI 14-53], ten arms) than with either laboratory-based POC assays (64 days [64-64], one arm) or laboratory-based SOC assays (67 days [50-67], two arms). Treatment uptake was higher with onsite POC assays (77% [95% CI 72-83], 34 arms) or mobile POC assays (81% [60-97], five arms) than with SOC assays (53% [31-75], 12 arms); onsite and mobile POC assay vs SOC assay p=0·029). For POC and SOC arms, higher RNA viral load testing uptake was seen with the same-site models for testing and treatment than with different-site models (all within-category p≤0·0001). For onsite and mobile POC arms, there was higher treatment uptake for same-site than different-site models (within-category p<0·0001). Four studies had direct within-study POC versus SOC comparisons for RNA viral load testing uptake (pooled relative risk 1·11 [95% CI 0·89-1·38]), and there were ten studies on treatment uptake (1·32 [1·06-1·64]). Overall, the quality of evidence was rated as low. INTERPRETATION Compared with use of laboratory-based SOC HCV viral load testing, the use of POC assays was associated with reduced time from antibody test to treatment initiation and increased treatment uptake. The effect of POC viral load testing is greatest when positioned within a simplified care model in which testing and treatment are provided at the same site, and, where possible, on the same day. POC HCV RNA viral load testing is now recommended in WHO guidelines as an alternative strategy to laboratory-based viral load testing. FUNDING Unitaid.
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Affiliation(s)
- Adam Trickey
- Population Health Sciences, University of Bristol, Bristol, UK
| | - Emmanuel Fajardo
- Department of Global HIV, Hepatitis and STI Programmes, World Health Organization, Geneva, Switzerland
| | - Daniel Alemu
- Department of Global HIV, Hepatitis and STI Programmes, World Health Organization, Geneva, Switzerland
| | | | - Philippa Easterbrook
- Department of Global HIV, Hepatitis and STI Programmes, World Health Organization, Geneva, Switzerland.
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21
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Duah E, Mathebula EM, Mashamba-Thompson T. Quality Assurance for Hepatitis C Virus Point-of-Care Diagnostics in Sub-Saharan Africa. Diagnostics (Basel) 2023; 13:684. [PMID: 36832172 PMCID: PMC9955859 DOI: 10.3390/diagnostics13040684] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/01/2022] [Revised: 02/06/2023] [Accepted: 02/10/2023] [Indexed: 02/15/2023] Open
Abstract
As part of a multinational study to evaluate the Bioline Hepatitis C virus (HCV) point-of-care (POC) testing in sub-Saharan Africa (SSA), this narrative review summarises regulatory standards and quality indicators for validating and approving HCV clinical diagnostics. In addition, this review also provides a summary of their diagnostic evaluations using the REASSURED criteria as the benchmark and its implications on the WHO HCV elimination goals 2030.
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Affiliation(s)
- Evans Duah
- Faculty of Health Science, School of Health Systems and Public Health, University of Pretoria, Pretoria 0002, South Africa
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22
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Crespo J, Cabezas J, Aguilera A, Berenguer M, Buti M, Forns X, García F, García-Samaniego J, Hernández-Guerra M, Jorquera F, Lazarus JV, Lens S, Martró E, Pineda JA, Prieto M, Rodríguez-Frías F, Rodríguez M, Serra MÁ, Turnes J, Domínguez-Hernández R, Casado MÁ, Calleja JL. Recommendations for the integral diagnosis of chronic viral hepatitis in a single analytical extraction. GASTROENTEROLOGIA Y HEPATOLOGIA 2023; 46:150-162. [PMID: 36257502 DOI: 10.1016/j.gastrohep.2022.09.009] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 07/29/2022] [Revised: 09/08/2022] [Accepted: 09/28/2022] [Indexed: 11/11/2022]
Abstract
The Spanish Society of Digestive Pathology (SEPD), the Spanish Association for the Study of the Liver (AEEH), the Spanish Society of Infections and Clinical Microbiology (SEIMC) and its Viral Hepatitis Study Group (GEHEP), and with the endorsement of the Alliance for the Elimination of Viral Hepatitis in Spain (AEHVE), have agreed on a document to carry out a comprehensive diagnosis of viral hepatitis (B, C and D), from a single blood sample; that is, a comprehensive diagnosis, in the hospital and/or at the point of care of the patient. We propose an algorithm, so that the positive result in a viral hepatitis serology (B, C and D), as well as human immunodeficiency virus (HIV), would trigger the analysis of the rest of the virus, including the viral load when necessary, in the same blood draw. In addition, we make two additional recommendations. First, the need to rule out a previous hepatitis A virus (VHA) infection, to proceed with its vaccination in cases where IgG-type studies against this virus are negative and the vaccine is indicated. Second, the determination of the HIV serology. Finally, in case of a positive result for any of the viruses analyzed, there must be an automated alerts and initiate epidemiological monitoring.
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Affiliation(s)
- Javier Crespo
- Servicio de Gastroenterología y Hepatología, Grupo de Investigación Clínica y Traslacional en Enfermedades Digestivas, Instituto de Investigación Valdecilla (IDIVAL), Hospital Universitario Marqués de Valdecilla, Santander, España.
| | - Joaquín Cabezas
- Servicio de Gastroenterología y Hepatología, Grupo de Investigación Clínica y Traslacional en Enfermedades Digestivas, Instituto de Investigación Valdecilla (IDIVAL), Hospital Universitario Marqués de Valdecilla, Santander, España
| | - Antonio Aguilera
- Servicio de Microbiología, Hospital Clínico Universitario de Santiago de Compostela, Departamento de Microbioloxía y Parasitoloxía, Universidade de Santiago de Compostela, A Coruña, España
| | - Marina Berenguer
- Unidad de Hepatología y Trasplante Hepático y CIBEREHD, Hospital Universitario y Politécnico La Fe; IIS La Fe y Universidad de Valencia, Valencia, España
| | - María Buti
- Servicio de Hepatología, Hospital Universitario Valle Hebrón y CIBEREHD del Instituto Carlos III, Barcelona, España
| | - Xavier Forns
- Servicio de Hepatología, Hospital Clínic, Universidad de Barcelona, IDIBAPS, CIBEREHD, Barcelona, España
| | - Federico García
- Servicio de Microbiología, Hospital Universitario Clínico San Cecilio, Instituto de Investigación IBS, Ciber de Enfermedades Infecciosas (CIBERINFEC), Granada, España
| | | | - Manuel Hernández-Guerra
- Servicio de Aparato Digestivo, Hospital Universitario de Canarias, Universidad de La Laguna, Tenerife, España
| | - Francisco Jorquera
- Servicio de Aparato Digestivo, Complejo Asistencial Universitario de León, IBIOMED y CIBEREHD, León, España
| | - Jeffrey V Lazarus
- Instituto de Salud Global de Barcelona (ISGlobal), Hospital Clínic, Universidad de Barcelona, Barcelona, España
| | - Sabela Lens
- Servicio de Hepatología, Hospital Clínic de Barcelona, IDIBAPS, CIBEREHD, Universidad de Barcelona, Barcelona, España
| | - Elisa Martró
- Servicio de Microbiología, Laboratori Clínic Metropolitana Nord (LCMN), Hospital Universitario Germans Trias i Pujol, Institut d'Investigació Germans Trias i Pujol (IGTP), Badalona (Barcelona), España, Consorcio de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III, Madrid, España
| | - Juan Antonio Pineda
- Departamento de Medicina, Universidad de Sevilla, Hospital Universitario de Valme, Ciber de Enfermedades Infecciosas (CIBERINFEC), Sevilla, España
| | - Martín Prieto
- Unidad de Hepatología y Trasplante Hepático, Hospital Universitario y Politécnico La Fe, Valencia, CIBEREHD, Instituto de Salud Carlos III, Madrid, España
| | - Francisco Rodríguez-Frías
- Servicios de Microbiología y Bioquímica, Laboratorios Clínicos Hospital Universitario Vall d'Hebron, CIBEREHD, Instituto de investigación Vall d'Hebron (VHIR), Barcelona, España
| | - Manuel Rodríguez
- Sección de Hepatología, Servicio de Digestivo, Hospital Universitario Central de Asturias, Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), Universidad de Oviedo, Oviedo, España
| | - Miguel Ángel Serra
- Catedrático Jubilado de Medicina, Universidad de Valencia, Valencia, España
| | - Juan Turnes
- Servicio de Digestivo, Hospital Universitario de Pontevedra, Pontevedra, España
| | | | | | - José Luis Calleja
- Servicio de Gastroenterología y Hepatología, Hospital Universitario Puerta de Hierro, Instituto de Investigación Puerta de Hierro Majadahonda (IDIPHIM), Universidad Autónoma de Madrid, Madrid, España
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23
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Screening of Occult Hepatitis B and C Virus Infection in Working Children, Tehran, Iran. ARCHIVES OF PEDIATRIC INFECTIOUS DISEASES 2022. [DOI: 10.5812/pedinfect-118763] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
Background: Working children are susceptible to infection with various infectious microorganisms. Unfortunately, the difficulties of working children are growing at a remarkable speed worldwide. Objectives: The aim of this research was to determine the prevalence of hepatitis B virus (HBV) and hepatitis C virus (HCV) infection, as well as to evaluate the level of anemia, calcium, and phosphorus in working children. Methods: This cross-sectional research was performed on 370 Iranian and Afghan working children from February 2018 to May 2019. Hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B core antibody (HBcAb), and anti-HCV Ab were evaluated using an enzyme-linked immunosorbent assay (ELISA). Furthermore, HCV-RNA and genomic HBV-DNA in the plasma and peripheral blood mononuclear cell (PBMC) specimens of the participants were investigated. The restriction fragment length polymorphism (RFLP) method was used to determine the genotype of HCV, and sequencing was performed to confirm. Results: The mean age of the participants was 10.1 ± 2.1 years (range, 6 - 15 years), and 229 (61.9%) were male. None of the studied children had any detectable HBV-DNA in the plasma and PBMC. The HCV genome was not detected in the plasma of the children, but HCV-RNA was assessed in the PBMC sample of 1 child (0.3%). Therefore, one of the children had occult HCV infection (OCI). The genotype of HCV in this child was subtype 1a. Furthermore, HBsAb was detected in Iranian (41.5%) and Afghan children (40.0%), and 2 (0.54%) of the working children were HBsAg positive. In 3 participants (0.8%), a positive HBcAb test result was noted. Conclusions: The prevalence of HCV and HBV infection in working children in Iran is extremely rare. However, there is a possibility of the presence of OCI in these children.
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Said ZNA, El-Sayed MH. Challenge of managing hepatitis B virus and hepatitis C virus infections in resource-limited settings. World J Hepatol 2022; 14:1333-1343. [PMID: 36158908 PMCID: PMC9376770 DOI: 10.4254/wjh.v14.i7.1333] [Citation(s) in RCA: 17] [Impact Index Per Article: 5.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/07/2021] [Revised: 01/30/2022] [Accepted: 06/13/2022] [Indexed: 02/06/2023] Open
Abstract
The global burden of hepatitis B virus (HBV) and hepatitis C virus (HCV) infections and coinfection represents a major public health concern, particularly in resource-limited settings. Elimination of HCV by 2030 has become foreseeable, with effective direct-acting antiviral oral therapies and the availability of affordable generics in low-and-middle-income countries (LMICs). However, access to oral nucleos(t)ide therapy for HBV remains critical and is limited outside the existing global HIV program platforms despite affordable prices. Prevention of mother-to-child transmission of HBV through scaling up of birth dose implementation in LMICs is essential to achieve the 2030 elimination goal. Most individuals living with HBV and/or HCV in resource-limited settings are unaware of their infection, and with improved access to medications, the most significant barrier remains access to affordable diagnostics and preventive strategies. The coronavirus disease 2019 pandemic interrupted hepatitis elimination programs, albeit offered opportunities for improved diagnostic capacities and raised political awareness of the critical need for strengthening health care services and universal health coverage. This review underpins the HBV and HCV management challenges in resource-limited settings, highlighting the current status and suggested future elimination strategies in some of these countries. Global efforts should continue to improve awareness and political commitment. Financial resources should be secured to access and implement comprehensive strategies for diagnosis and linkage to care in resource-constrained settings to fulfill the 2030 elimination goal.
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Affiliation(s)
- Zeinab Nabil Ahmed Said
- Department of Microbiology & Immunology, Faculty of Medicine for Girls Al-Azhar University, Cairo, Egypt.
| | - Manal Hamdy El-Sayed
- Department of Pediatrics, Faculty of Medicine, Ain Shams University, Cairo, Egypt
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25
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Fajardo E, Watson V, Kumwenda M, Usharidze D, Gogochashvili S, Kakhaberi D, Giguashvili A, Johnson CC, Jamil MS, Dacombe R, Stvilia K, Easterbrook P, Ivanova Reipold E. Usability and acceptability of oral-based HCV self-testing among key populations: a mixed-methods evaluation in Tbilisi, Georgia. BMC Infect Dis 2022; 22:510. [PMID: 35641908 PMCID: PMC9154030 DOI: 10.1186/s12879-022-07484-2] [Citation(s) in RCA: 12] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/31/2021] [Accepted: 05/18/2022] [Indexed: 01/09/2023] Open
Abstract
BACKGROUND Hepatitis C virus self-testing (HCVST) is an additional approach that may expand access to HCV testing. We conducted a mixed-methods cross-sectional observational study to assess the usability and acceptability of HCVST among people who inject drugs (PWID), men who have sex with men (MSM) and transgender (TG) people in Tbilisi, Georgia. METHODS The study was conducted from December 2019 to June 2020 among PWID at one harm reduction site and among MSM/TG at one community-based organization. We used a convergent parallel mixed-methods design. Usability was assessed by observing errors made and difficulties faced by participants. Acceptability was assessed using an interviewer-administered semi-structured questionnaire. A subset of participants participated in cognitive and in-depth interviews. RESULTS A total of 90 PWID, 84 MSM and 6 TG were observed performing HCVST. PWID were older (median age 35 vs 24) and had a lower level of education compared to MSM/TG (27% vs 59%). The proportion of participants who completed all steps successfully without assistance was 60% among PWID and 80% among MSM/TG. The most common error was in sample collection and this was observed more often among PWID than MSM/TG (21% vs 6%; p = 0.002). More PWID requested assistance during HCVST compared to MSM/TG (22% vs 8%; p = 0.011). Acceptability was high in both groups (98% vs 96%; p = 0.407). Inter-reader agreement was 97% among PWID and 99% among MSM/TG. Qualitative data from cognitive (n = 20) and in-depth interviews (n = 20) was consistent with the quantitative data confirming a high usability and acceptability. CONCLUSIONS HCVST was highly acceptable among key populations in Georgia of relatively high educational level, and most participants performed HCVST correctly. A significant difference in usability was observed among PWID compared to MSM/TG, indicating that PWID may benefit from improved messaging and education as well as options to receive direct assistance when self-testing for HCV.
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Affiliation(s)
- Emmanuel Fajardo
- grid.452485.a0000 0001 1507 3147The Foundation for Innovative New Diagnostics (FIND), Campus Biotech, Chemin des Mines 9, 1202 Geneva, Switzerland
| | - Victoria Watson
- grid.48004.380000 0004 1936 9764Liverpool School of Tropical Medicine (LSTM), Liverpool, UK
| | - Moses Kumwenda
- grid.419393.50000 0004 8340 2442Malawi Liverpool Wellcome Trust Clinical Research Programme (MLW), Blantyre, Malawi ,grid.10595.380000 0001 2113 2211College of Medicine, University of Malawi (CoM), Blantyre, Malawi
| | | | | | - David Kakhaberi
- Community-Based Organization Equality Movement, Tbilisi, Georgia
| | - Ana Giguashvili
- National Centre for Disease Control and Public Health of Georgia, Tbilisi, Georgia
| | - Cheryl C. Johnson
- grid.3575.40000000121633745Department of Global HIV, Hepatitis and STI Programmes, World Health Organization, Geneva, Switzerland
| | - Muhammad S. Jamil
- grid.3575.40000000121633745Department of Global HIV, Hepatitis and STI Programmes, World Health Organization, Geneva, Switzerland
| | - Russell Dacombe
- grid.48004.380000 0004 1936 9764Liverpool School of Tropical Medicine (LSTM), Liverpool, UK
| | - Ketevan Stvilia
- National Centre for Disease Control and Public Health of Georgia, Tbilisi, Georgia
| | - Philippa Easterbrook
- grid.3575.40000000121633745Department of Global HIV, Hepatitis and STI Programmes, World Health Organization, Geneva, Switzerland
| | - Elena Ivanova Reipold
- grid.452485.a0000 0001 1507 3147The Foundation for Innovative New Diagnostics (FIND), Campus Biotech, Chemin des Mines 9, 1202 Geneva, Switzerland
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26
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Xu W, Reipold EI, Zhao P, Tang W, Tucker JD, Ong JJ, Wang J, Easterbrook P, Johnson CC, Jamil MS, Wang C. HCV Self-Testing to Expand Testing: A Pilot Among Men Who Have Sex With Men in China. Front Public Health 2022; 10:903747. [PMID: 35712303 PMCID: PMC9194083 DOI: 10.3389/fpubh.2022.903747] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/24/2022] [Accepted: 05/11/2022] [Indexed: 11/23/2022] Open
Abstract
Background Hepatitis C virus self-testing (HCVST) may increase test uptake especially among marginalized key populations such as men who have sex with men (MSM). We conducted an observational study to assess the usability, acceptability and feasibility of HCVST among MSM in China. Methods An observational study with convenience sampling was performed among MSM in Guangzhou, China in 2019. The OraQuick® HCV Rapid Antibody Test kits were used in this study. Participants performed all 12 HCVST steps and interpreted the results in the presence of a trained observer. Usability was defined as the number and percentage of participants who completed all testing steps correctly without assistance and interpreted the results correctly. Inter-reader concordance was calculated as the percentage agreement between the results interpreted by the participant and those interpreted by a trained staff member. The same process was used to estimate inter-operator agreement between the self-testing and professional use test results. Acceptability was assessed using an interviewer-administered semi-structured questionnaire. Results Among 100 participants with median age 27 (interquartile range 23-30) years, 4% reported prior history of HCV testing, 41% reported using blood-based HIV self-testing in the past, 54% (95%CI: 43.7-64.0%) completed all self-testing steps correctly without assistance and interpreted the results correctly. Both the inter-reader and inter-operator concordance were excellent at 97% (95%CI: 91.5-99.4%) and 98% (95%CI: 93.0-99.8%), respectively. The majority rated the HCVST process as very easy (52%, 95%CI: 41.8-62.1%) or easy (41%, 95%CI: 31.3-51.3%), 76% (95%CI: 66.4-84.0%) were willing to use HCVST again, and 75% (95%CI: 65.3-83.1%) would recommend it to their family and friends. Conclusions Our findings demonstrate that oral fluid HCVST has high usability and acceptability among Chinese MSM. More implementation research is needed to plan how best to position and scale-up HCVST alongside other facility-and community-based testing approaches and ensure data linkage into health systems.
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Affiliation(s)
- Wenqian Xu
- School of Public Health, Southern Medical University, Guangzhou, China
- Dermatology Hospital of Southern Medical University, Guangzhou, China
- Southern Medical University Institute for Global Health, Guangzhou, China
- Guangdong Provincial Center for Skin Diseases and STIs Control, Guangzhou, China
| | | | - Peizhen Zhao
- Dermatology Hospital of Southern Medical University, Guangzhou, China
- Southern Medical University Institute for Global Health, Guangzhou, China
- Guangdong Provincial Center for Skin Diseases and STIs Control, Guangzhou, China
| | - Weiming Tang
- Dermatology Hospital of Southern Medical University, Guangzhou, China
- Southern Medical University Institute for Global Health, Guangzhou, China
- Guangdong Provincial Center for Skin Diseases and STIs Control, Guangzhou, China
- University of North Carolina Project-China, Guangzhou, China
| | - Joseph D. Tucker
- Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom
- School of Medicine, Institute for Global Health and Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States
| | - Jason J. Ong
- Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom
- Central Clinical School, Monash University, Melbourne, VIC, Australia
| | - Jinshen Wang
- School of Public Health, Southern Medical University, Guangzhou, China
- Dermatology Hospital of Southern Medical University, Guangzhou, China
- Southern Medical University Institute for Global Health, Guangzhou, China
- Guangdong Provincial Center for Skin Diseases and STIs Control, Guangzhou, China
| | - Philippa Easterbrook
- Department of Global HIV, Hepatitis, and STI Programmes, World Health Organization, Geneva, Switzerland
| | - Cheryl Case Johnson
- Department of Global HIV, Hepatitis, and STI Programmes, World Health Organization, Geneva, Switzerland
| | - Muhammad S. Jamil
- Department of Global HIV, Hepatitis, and STI Programmes, World Health Organization, Geneva, Switzerland
| | - Cheng Wang
- School of Public Health, Southern Medical University, Guangzhou, China
- Dermatology Hospital of Southern Medical University, Guangzhou, China
- Southern Medical University Institute for Global Health, Guangzhou, China
- Guangdong Provincial Center for Skin Diseases and STIs Control, Guangzhou, China
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27
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Stockdale AJ, Kreuels B, Shawa IT, Meiring JE, Thindwa D, Silungwe NM, Chetcuti K, Joekes E, Mbewe M, Mbale B, Patel P, Kachala R, Patel PD, Malewa J, Finch P, Davis C, Shah R, Tong L, da Silva Filipe A, Thomson EC, Geretti AM, Gordon MA. A clinical and molecular epidemiological survey of hepatitis C in Blantyre, Malawi, suggests a historic mechanism of transmission. J Viral Hepat 2022; 29:252-262. [PMID: 35075742 PMCID: PMC9305194 DOI: 10.1111/jvh.13646] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/13/2021] [Accepted: 01/06/2022] [Indexed: 12/09/2022]
Abstract
Hepatitis C virus (HCV) is a leading cause of liver disease worldwide. There are no previous representative community HCV prevalence studies from Southern Africa, and limited genotypic data. Epidemiological data are required to inform an effective public health response. We conducted a household census-based random sampling serological survey, and a prospective hospital-based study of patients with cirrhosis and hepatocellular carcinoma (HCC) in Blantyre, Malawi. We tested participants with an HCV antigen/antibody ELISA (Monolisa, Bio-Rad), confirmed with PCR (GeneXpert, Cepheid) and used line immunoassay (Inno-LIA, Fujiribio) for RNA-negative participants. We did target-enrichment whole-genome HCV sequencing (NextSeq, Illumina). Among 96,386 censused individuals, we randomly selected 1661 people aged ≥16 years. Population-standardized HCV RNA prevalence was 0.2% (95% CI 0.1-0.5). Among 236 patients with cirrhosis and HCC, HCV RNA prevalence was 1.9% and 5.0%, respectively. Mapping showed that HCV RNA+ patients were from peri-urban areas surrounding Blantyre. Community and hospital HCV RNA+ participants were older than comparator HCV RNA-negative populations (median 53 vs 30 years for community, p = 0.01 and 68 vs 40 years for cirrhosis/HCC, p < 0.001). Endemic HCV genotypes (n = 10) were 4v (50%), 4r (30%) and 4w (10%). In this first census-based community serological study in Southern Africa, HCV was uncommon in the general population, was centred on peri-urban regions and was attributable for <5% of liver disease. HCV infection was observed only among older people, suggesting a historic mechanism of transmission. Genotype 4r, which has been associated with treatment failure with ledipasvir and daclatasvir, is endemic.
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Affiliation(s)
- Alexander J Stockdale
- Malawi-Liverpool-Wellcome Trust Programme, Blantyre, Malawi.,Institute of Infection, Veterinary and Ecological Sciences, University of Liverpool, Liverpool, UK
| | - Benno Kreuels
- Department of Tropical Medicine, Bernhard Nocht Institute for Tropical Medicine and 1st Department of Medicine, University Medical Centre, Hamburg-Eppendorf, Hamburg, Germany.,Kamuzu University of Health Sciences, Blantyre, Malawi
| | - Isaac T Shawa
- Malawi-Liverpool-Wellcome Trust Programme, Blantyre, Malawi.,Kamuzu University of Health Sciences, Blantyre, Malawi
| | - James E Meiring
- Malawi-Liverpool-Wellcome Trust Programme, Blantyre, Malawi.,Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK
| | - Deus Thindwa
- Malawi-Liverpool-Wellcome Trust Programme, Blantyre, Malawi.,Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK
| | | | - Karen Chetcuti
- Malawi-Liverpool-Wellcome Trust Programme, Blantyre, Malawi.,Kamuzu University of Health Sciences, Blantyre, Malawi
| | | | - Maurice Mbewe
- Malawi-Liverpool-Wellcome Trust Programme, Blantyre, Malawi
| | | | | | - Rabson Kachala
- Malawi Ministry of Health, Capitol Hill, Lilongwe, Malawi
| | | | - Jane Malewa
- Kamuzu University of Health Sciences, Blantyre, Malawi.,Department of Medicine, Queen Elizabeth Central Hospital, Blantyre, Malawi
| | - Peter Finch
- Kamuzu University of Health Sciences, Blantyre, Malawi.,Department of Medicine, Queen Elizabeth Central Hospital, Blantyre, Malawi
| | - Chris Davis
- MRC - University of Glasgow Centre for Virus Research, University of Glasgow, Glasgow, UK
| | - Rajiv Shah
- MRC - University of Glasgow Centre for Virus Research, University of Glasgow, Glasgow, UK
| | - Lily Tong
- MRC - University of Glasgow Centre for Virus Research, University of Glasgow, Glasgow, UK
| | - Ana da Silva Filipe
- MRC - University of Glasgow Centre for Virus Research, University of Glasgow, Glasgow, UK
| | - Emma C Thomson
- MRC - University of Glasgow Centre for Virus Research, University of Glasgow, Glasgow, UK
| | - Anna Maria Geretti
- Department of Infectious Diseases, Fondazione PTV, Faculty of Medicine, University of Rome Tor Vergata, Rome, Italy
| | - Melita A Gordon
- Malawi-Liverpool-Wellcome Trust Programme, Blantyre, Malawi.,Institute of Infection, Veterinary and Ecological Sciences, University of Liverpool, Liverpool, UK.,Kamuzu University of Health Sciences, Blantyre, Malawi
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28
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Walters F, Burwell G, Mitchell JJ, Ali MM, Daghigh Ahmadi E, Mostert AB, Jenkins CA, Rozhko S, Kazakova O, Guy OJ. A Rapid Graphene Sensor Platform for the Detection of Viral Proteins in Low Volume Samples. ADVANCED NANOBIOMED RESEARCH 2022. [DOI: 10.1002/anbr.202100140] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/18/2022] Open
Affiliation(s)
- Ffion Walters
- Centre for NanoHealth, School of Engineering and Applied Sciences Swansea University Swansea SA2 8PP UK
| | - Gregory Burwell
- Department of Physics, School of Biosciences, Geography and Physics Swansea University Swansea SA2 8PP UK
| | - Jacob John Mitchell
- Centre for NanoHealth, School of Engineering and Applied Sciences Swansea University Swansea SA2 8PP UK
- SPTS Technologies Ltd, R&D and Product department Ringland Way Newport NP18 2TA UK
| | - Muhammad Munem Ali
- Centre for NanoHealth, School of Engineering and Applied Sciences Swansea University Swansea SA2 8PP UK
| | - Ehsaneh Daghigh Ahmadi
- Centre for NanoHealth, School of Engineering and Applied Sciences Swansea University Swansea SA2 8PP UK
| | - A. Bernardus Mostert
- Department of Chemistry, School of Engineering and Applied Sciences Swansea University Swansea SA2 8PP UK
| | | | - Sergiy Rozhko
- National Physical Laboratory Quantum Metrology Institute Teddington Middlesex TW11 0LW UK
| | - Olga Kazakova
- National Physical Laboratory Quantum Metrology Institute Teddington Middlesex TW11 0LW UK
| | - Owen J. Guy
- Centre for NanoHealth, School of Engineering and Applied Sciences Swansea University Swansea SA2 8PP UK
- Department of Chemistry, School of Engineering and Applied Sciences Swansea University Swansea SA2 8PP UK
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29
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Kamali I, Shumbusho F, Barnhart DA, Nyirahabihirwe F, Gakuru JDLP, Dusingizimana W, Nizeyumuremyi E, Habinshuti P, Walker S, Makuza JD, Serumondo J, Nshogoza Rwibasira G, Ndahimana JD. Time to complete hepatitis C cascade of care among patients identified during mass screening campaigns in rural Rwanda: a retrospective cohort study. BMC Infect Dis 2022; 22:272. [PMID: 35313817 PMCID: PMC8935096 DOI: 10.1186/s12879-022-07271-z] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/23/2021] [Accepted: 03/14/2022] [Indexed: 12/18/2022] Open
Abstract
Background Since the discovery of direct-acting antivirals, treatment for hepatitis C virus (HCV) is increasingly accessible in low-resource settings, but quality of care in these settings is not known. We described progression through the cascade of care among individuals who screened positive for HCV antibodies during a mass screening campaign in Kirehe and Kayonza, two rural Rwandan districts, in September 2019. Methods This retrospective cohort study used routine clinical data to assess proportions of participants completing each stage of the cascade of care, including: (a) screening positive on rapid diagnostic test; (b) return of initial viral load results; (c) detectable viral load; (d) treatment assessment; (e) treatment initiation; (f) return of sustained virological response (SVR12) results; and (g) achieving SVR12. We proposed three indicators to assess timely care provision and used medians and interquartile ranges (IQR) to describe the time to complete the cascade of care. Results Overall, 666 participants screened HCV positive, among them, 452 (68.1%) were female and median age was 61 years (IQR: 47, 70). Viral load results were returned for 537 (80.6%) participants of whom 448 (83.4%) had detectable viral loads. Of these, 398 (88.8%) were assessed for treatment, 394 (99%) were initiated, but only 222 (56.3%) had results returned for SVR12. Among those with SVR12 results, 208 (93.7%) achieved SVR12. When assessing timely care provision, we found 65.9% (95% CI: 62.0, 69.7) of initial viral load results were returned ≤ 30 days of screening; 45% (95% CI: 40.1, 49.8) of people with detectable viral load completed treatment assessment ≤ 90 days of initial viral load results; and 12.5% (95% CI: 9.2, 16.3) of SVR12 results were returned ≤ 210 days of treatment initiation among those who initiated treatment. The overall median time from screening to SVR12 assessment was 437 days. Conclusion Despite high rates of SVR12 among those who completed all stages of the cascade of care, we identified gaps and delays in the treatment cascade. Improving communication between viral load testing hubs and health facilities could reduce the turn-around time for viral load testing, and actively monitor timeliness of care provision could improve quality of HCV care.
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Affiliation(s)
| | | | - Dale A Barnhart
- Partners In Health / Inshuti Mu Buzima, Rwinkwavu, Rwanda.,Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA, USA
| | | | | | | | | | | | | | - Jean Damascene Makuza
- STIs and OBBI Division, Rwanda Biomedical Centre, HIV/AIDS, Kigali, Rwanda.,School of Population and Public Health, University of British Columbia, Vancouver, BC, Canada.,British Columbia Center for Disease Control, Vancouver, BC, Canada
| | - Janvier Serumondo
- STIs and OBBI Division, Rwanda Biomedical Centre, HIV/AIDS, Kigali, Rwanda
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30
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Gupta A, Ramachandran K, Paul D, Gupta E. Evaluation of three different rapid card tests for the detection of hepatitis B surface antigen. Trop Doct 2022; 52:307-310. [PMID: 35072566 DOI: 10.1177/00494755211069712] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
Rapid diagnostic card tests are crucial steps on the road to hepatitis B elimination and should be incorporated into diagnostic algorithms. However, all commercial rapid diagnostic card tests are not equal and require evaluation before clinical use. Thus, we aimed to compare the performance characteristics of three different rapid diagnostic card tests with chemiluminescence-based assay (CLIA) for the detection of hepatitis B surface antigen.We concluded rapid diagnostic card tests can be used to identify patients with high signal/cut-off ratio on CLIA, but patients with signal/cut-off ratio <200 may be missed. Rapid diagnostic card tests may help pave the way for decentralised testing, but should be used only after evaluation in the community.
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Affiliation(s)
- Akshita Gupta
- Department of Clinical Virology, 80402Institute of Liver and Biliary Sciences, New Delhi, India
| | - Krithiga Ramachandran
- Department of Clinical Virology, 80402Institute of Liver and Biliary Sciences, New Delhi, India
| | - Diptanu Paul
- Department of Clinical Virology, 80402Institute of Liver and Biliary Sciences, New Delhi, India
| | - Ekta Gupta
- Department of Clinical Virology, 80402Institute of Liver and Biliary Sciences, New Delhi, India
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31
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Sintusek P, Thanapirom K, Komolmit P, Poovorawan Y. Eliminating viral hepatitis in children after liver transplants: How to reach the goal by 2030. World J Gastroenterol 2022; 28:290-309. [PMID: 35110951 PMCID: PMC8771616 DOI: 10.3748/wjg.v28.i3.290] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/03/2021] [Revised: 08/12/2021] [Accepted: 01/06/2022] [Indexed: 02/06/2023] Open
Abstract
Viral hepatitis infections are a great burden in children who have received liver transplant. Hepatotropic viruses can cause liver inflammation that can develop into liver graft fibrosis and cirrhosis over the long term. Immunological reactions due to viral hepatitis infections are associated with or can mimic graft rejection, rendering the condition difficult to manage. Prevention strategies using vaccinations are agreeable to patients, safe, cost-effective and practical. Hence, strategies to eliminate viral hepatitis A and B focus mainly on immunization programmes for children who have received a liver transplant. Although a vaccine has been developed to prevent hepatitis C and E viruses, its use is not licensed worldwide. Consequently, eliminating hepatitis C and E viruses mainly involves early detection in children with suspected cases and effective treatment with antiviral therapy. Good hygiene and sanitation are also important to prevent hepatitis A and E infections. Donor blood products and liver grafts should be screened for hepatitis B, C and E in children who are undergoing liver transplantation. Future research on early detection of viral hepatitis infections should include molecular techniques for detecting hepatitis B and E. Moreover, novel antiviral drugs for eradicating viral hepatitis that are highly effective and safe are needed for children who have undergone liver transplantation.
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Affiliation(s)
- Palittiya Sintusek
- The Thai Pediatric Gastroenterology, Hepatology and Immunology (TPGHAI) Research Unit, Chulalongkorn University, Bangkok 10330, Thailand
- Division of Gastroenterology, Department of Pediatrics, Faculty of Medicine, King Chulalongkorn Memorial Hospital, Chulalongkorn University, Bangkok 10330, Thailand
| | - Kessarin Thanapirom
- Division of Gastroenterology, Department of Medicine, Liver Fibrosis and Cirrhosis Research Unit, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok 10330, Thailand
- Center of Excellence in Liver Diseases, King Chulalongkorn Memorial Hospital, Chulalongkorn University, Bangkok 10330, Thailand
| | - Piyawat Komolmit
- Division of Gastroenterology, Department of Medicine, Liver Fibrosis and Cirrhosis Research Unit, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok 10330, Thailand
- Center of Excellence in Liver Diseases, King Chulalongkorn Memorial Hospital, Chulalongkorn University, Bangkok 10330, Thailand
| | - Yong Poovorawan
- Center of Excellence in Clinical Virology, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand
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32
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Shenge JA, Osiowy C. Rapid Diagnostics for Hepatitis B and C Viruses in Low- and Middle-Income Countries. FRONTIERS IN VIROLOGY 2021; 1. [DOI: 10.3389/fviro.2021.742722] [Citation(s) in RCA: 10] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/05/2025]
Abstract
The global health challenge posed by hepatitis B virus (HBV) and hepatitis C virus (HCV) persists, especially in low-and-middle-income countries (LMICs), where underdiagnosis of these viral infections remains a barrier to the elimination target of 2030. HBV and HCV infections are responsible for most liver-related mortality worldwide. Infected individuals are often unaware of their condition and as a result, continue to transmit these viruses. Although conventional diagnostic tests exist, in LMIC they are largely inaccessible due to high costs or a lack of trained personnel, resulting in poor linkage to care and increased infections. Timely and accurate diagnosis is needed to achieve elimination of hepatitis B and C by the year 2030 as set out by the World Health Organization Global Health Sector Strategy. In this review rapid diagnostic tests allowing for quick and cost-effective screening and diagnosis of HBV and HCV, are discussed, as are their features, including suitability, reliability, and applicability in LMIC, particularly those within Africa.
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33
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Mahamat G, Kenmoe S, Akazong EW, Ebogo-Belobo JT, Mbaga DS, Bowo-Ngandji A, Foe-Essomba JR, Amougou-Atsama M, Monamele CG, Mbongue Mikangue CA, Kame-Ngasse GI, Magoudjou-Pekam JN, Zemnou-Tepap C, Meta-Djomsi D, Maïdadi-Foudi M, Touangnou-Chamda SA, Daha-Tchoffo AG, Selly-Ngaloumo AA, Nayang-Mundo RA, Yéngué JF, Taya-Fokou JB, Fokou LKM, Kenfack-Momo R, Tchami Ngongang D, Atembeh Noura E, Tazokong HR, Demeni Emoh CP, Kengne-Ndé C, Bigna JJ, Boyomo O, Njouom R. Global prevalence of hepatitis B virus serological markers among healthcare workers: A systematic review and meta-analysis. World J Hepatol 2021; 13:1190-1202. [PMID: 34630885 PMCID: PMC8473496 DOI: 10.4254/wjh.v13.i9.1190] [Citation(s) in RCA: 15] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/24/2021] [Revised: 06/29/2021] [Accepted: 08/03/2021] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND The hepatitis B virus (HBV) infection is a global public health concern that affects about 2 billion people and causes 1 million people deaths yearly. HBV is a blood-borne disease and healthcare workers (HCWs) are a high-risk group because of occupational hazard to patients' blood. Different regions of the world show a highly variable proportion of HCWs infected and/or immunized against HBV. Global data on serologic markers of HBV infection and immunization in HCWs are very important to improve strategies for HBV control. AIM To determine the worldwide prevalence of HBV serological markers among HCWs. METHODS In this systematic review and meta-analyses, we searched PubMed and Excerpta Medica Database (Embase) to identify studies published between 1970 and 2019 on the prevalence of HBV serological markers in HCWs worldwide. We also manually searched for references of relevant articles. Four independent investigators selected studies and included those on the prevalence of each of the HBV serological markers including hepatitis B surface antigen (HBsAg), hepatitis e antigen (HBeAg), immunoglobulin M anti-HBc, and anti-HBs. Methodological quality of eligible studies was assessed and random-effect model meta-analysis resulted in the pooled prevalence of HBV serological markers HBV infection in HCWs. Heterogeneity (I²) was assessed using the χ² test on Cochran's Q statistic and H parameters. Heterogeneity' sources were explored through subgroup and metaregression analyses. This study is registered with PROSPERO, number CRD42019137144. RESULTS We reviewed 14059 references, out of which 227 studies corresponding to 448 prevalence data among HCWs (224936 HCWs recruited from 1964 to 2019 in 71 countries) were included in this meta-analysis. The pooled seroprevalences of current HBsAg, current HBeAg, and acute HBV infection among HCWs were 2.3% [95% confidence interval (CI): 1.9-2.7], 0.2% (95%CI: 0.0-1.7), and 5.3% (95%CI: 1.4-11.2), respectively. The pooled seroprevalences of total immunity against HBV and immunity acquired by natural HBV infection in HCWs were 56.6% (95%CI: 48.7-63.4) and 9.2% (95%CI: 6.8-11.8), respectively. HBV infection was more prevalent in HCWs in low-income countries, particularly in Africa. The highest immunization rates against HBV in HCWs were recorded in urban areas and in high-income countries including Europe, the Eastern Mediterranean and the Western Pacific. CONCLUSION New strategies are needed to improve awareness, training, screening, vaccination, post-exposure management and treatment of HBV infection in HCWs, and particularly in low-income regions.
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Affiliation(s)
- Gadji Mahamat
- Department of Microbiology, The University of Yaounde I, Yaoundé 00237, Cameroon
| | - Sebastien Kenmoe
- Virology Department, Centre Pasteur of Cameroon, Yaoundé 00237, Cameroon
| | - Etheline W Akazong
- Department of Biochemistry, University of Dschang, Dschang 00237, Cameroon
| | - Jean Thierry Ebogo-Belobo
- Medical Research Centre, Institute of Medical Research and Medicinal Plants Studies, Yaoundé 00237, Cameroon
| | - Donatien Serge Mbaga
- Department of Microbiology, The University of Yaounde I, Yaoundé 00237, Cameroon
| | - Arnol Bowo-Ngandji
- Department of Microbiology, The University of Yaounde I, Yaoundé 00237, Cameroon
| | | | - Marie Amougou-Atsama
- Centre de Recherche sur les Maladies Émergentes et Re-Emergentes, Institut de Recherches Médicales et d'Etudes des Plantes Médicinales, Yaoundé 00237, Cameroon
| | | | | | - Ginette Irma Kame-Ngasse
- Medical Research Centre, Institute of Medical Research and Medicinal Plants Studies, Yaoundé 00237, Cameroon
| | | | - Cromwel Zemnou-Tepap
- Department of Biochemistry, The University of Yaounde I, Yaoundé 00237, Cameroon
| | - Dowbiss Meta-Djomsi
- Centre de Recherche sur les Maladies Émergentes et Re-Emergentes, Institut de Recherches Médicales et d'Etudes des Plantes Médicinales, Yaoundé 00237, Cameroon
| | - Martin Maïdadi-Foudi
- Centre de Recherche sur les Maladies Émergentes et Re-Emergentes, Institut de Recherches Médicales et d'Etudes des Plantes Médicinales, Yaoundé 00237, Cameroon
| | | | | | | | | | | | | | - Lorraine K M Fokou
- Department of Biochemistry, The University of Yaounde I, Yaoundé 00237, Cameroon
| | - Raoul Kenfack-Momo
- Department of Biochemistry, The University of Yaounde I, Yaoundé 00237, Cameroon
| | | | - Efietngab Atembeh Noura
- Medical Research Centre, Institute of Medical Research and Medicinal Plants Studies, Yaoundé 00237, Cameroon
| | - Hervé Raoul Tazokong
- Department of Microbiology, The University of Yaounde I, Yaoundé 00237, Cameroon
| | | | - Cyprien Kengne-Ndé
- Evaluation and Research Unit, National AIDS Control Committee, Yaoundé 00237, Cameroon
| | - Jean Joel Bigna
- Department of Epidemiology and Public Health, Centre Pasteur of Cameroon, Yaoundé 00237, Cameroon
| | - Onana Boyomo
- Department of Microbiology, The University of Yaounde I, Yaoundé 00237, Cameroon
| | - Richard Njouom
- Virology Department, Centre Pasteur of Cameroon, Yaoundé 00237, Cameroon.
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Aguilera A, Alados JC, Alonso R, Eiros JM, García F. Current position of viral load versus hepatitis C core antigen testing. Enferm Infecc Microbiol Clin 2021; 38 Suppl 1:12-18. [PMID: 32111360 DOI: 10.1016/j.eimc.2020.02.003] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/20/2022]
Abstract
Quantification of hepatitis C virus (HCV) RNA (viral load) is the most widely used marker to diagnose and confirm active HCV infection. The HCV core antigen forms part of the internal structure of the virus and, like HCV RNA, its detection also indicates viral replication and presents certain advantages over viral load testing such as its lower cost, the greater stability of the target, the possibility of working with the same primary tube as that used for HCV serology, and the rapidity of obtaining results, since there is no need to work in batches, unlike the situation with most viral load platforms. Although the core antigen has lower analytical sensitivity than HCV RNA for the detection of low viremia levels, several studies and guidelines have already shown their utility in the identification of patients with active HCV infection. This article summarises current platforms for viral load determination, including point-of-care systems, and also reviews the indications attributed to this marker by the main HCV treatment guidelines. The article also reviews the characteristics of HCV core antigen, the available platforms for its determination, its correlation with viral load determination, and the indications for this marker in the distinct guidelines.
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Affiliation(s)
- Antonio Aguilera
- Servicio de Microbiología, Complejo Hospitalario Universitario de Santiago de Compostela y Departamento de Microbiología de la Universidad de Santiago de Compostela, Santiago de Compostela, A Coruña, España
| | - Juan Carlos Alados
- Servicio de Microbiología, Hospital Universitario de Jerez, Jerez, Cádiz, España
| | - Roberto Alonso
- Servicio de Microbiología, Hospital Universitario Gregorio Marañón, Madrid, España
| | - José María Eiros
- Servicio de Microbiología, Hospital Universitario Río Hortega, Valladolid, España
| | - Federico García
- Servicio de Microbiología, Hospital Universitario San Cecilio, Granada, España; Instituto de Investigación Biosanitaria Ibs.Granada, Granada, España.
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Abid A, Uddin M, Muhammad T, Awan S, Applegate T, Dore GJ, Cloherty G, Hamid S. Evaluation of Hepatitis C Virus Core Antigen Assay in a Resource-Limited Setting in Pakistan. Diagnostics (Basel) 2021; 11:diagnostics11081354. [PMID: 34441289 PMCID: PMC8394911 DOI: 10.3390/diagnostics11081354] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/08/2021] [Revised: 07/11/2021] [Accepted: 07/12/2021] [Indexed: 01/20/2023] Open
Abstract
The diagnosis of Hepatitis C virus (HCV) infection can be challenging due to its cost and a lack of access to centralized testing. There is an urgent need to develop simplified HCV testing algorithms. The aim of this study was to evaluate the performance characteristics of a Hepatitis C core antigen (HCVcAg) assay in a decentralized, resource-limited setting. This is a descriptive cross-sectional study from a highly endemic area of Karachi, Pakistan. Between October 2019 and July 2020, subjects aged 12 years and above who screened positive for HCV antibodies were simultaneously tested for HCV RNA (Xpert HCV Viral Load, GeneXpert® IV, Cepheid, France) and HCVcAg (ARCHITECT HCV Ag assay, Abbott® Diagnostics) to confirm active HCV infection. An Abbott ARCHITECT® i1000SR Immunoassay Analyser was installed at a local district hospital as a point-of-care (POC) facility for HCVcAg testing, while samples for HCV RNA were tested in a central lab. Two hundred individuals (mean age 46.4 ± 14.5 years, 71.5% females), who screened positive for HCV antibody, were included in the study. HCV RNA was detected in 128 (64.0%) while HCVcAg was reactive in 119 (59.5%) cases. Performance of the Immunoassay Analyser was excellent with a higher throughput and quicker readout value compared to the GeneXpert System. The sensitivity and specificity of HCVcAg (≥10 fmol/L) at HCV RNA thresholds of ≥12 was 99.1% (95% CI: 95–100%) and 87.6% (95%CI: 78.4–94%). A strong agreement was observed between the HCVcAg assay and HCV RNA. The ARCHITECT HCV Ag assay showed high sensitivity and specificity compared to HCV RNA in a decentralized, resource-limited setting. It can therefore be used as a confirmatory test in HCV elimination programs, particularly for low-income countries such as Pakistan.
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Affiliation(s)
- Adeel Abid
- Department of Medicine, Aga Khan University, Stadium Road, Karachi 74800, Pakistan; (A.A.); (M.U.); (T.M.); (S.A.)
| | - Murad Uddin
- Department of Medicine, Aga Khan University, Stadium Road, Karachi 74800, Pakistan; (A.A.); (M.U.); (T.M.); (S.A.)
| | - Taj Muhammad
- Department of Medicine, Aga Khan University, Stadium Road, Karachi 74800, Pakistan; (A.A.); (M.U.); (T.M.); (S.A.)
| | - Safia Awan
- Department of Medicine, Aga Khan University, Stadium Road, Karachi 74800, Pakistan; (A.A.); (M.U.); (T.M.); (S.A.)
| | - Tanya Applegate
- Kirby Institute, Viral Hepatitis Clinical Research Program, UNSW Sydney, Sydney, NSW 2052, Australia; (T.A.); (G.J.D.)
| | - Gregory J. Dore
- Kirby Institute, Viral Hepatitis Clinical Research Program, UNSW Sydney, Sydney, NSW 2052, Australia; (T.A.); (G.J.D.)
| | | | - Saeed Hamid
- Department of Medicine, Aga Khan University, Stadium Road, Karachi 74800, Pakistan; (A.A.); (M.U.); (T.M.); (S.A.)
- Correspondence:
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Martínez-Pérez GZ, Nikitin DS, Bessonova A, Fajardo E, Bessonov S, Shilton S. Values and preferences for hepatitis C self-testing among people who inject drugs in Kyrgyzstan. BMC Infect Dis 2021; 21:609. [PMID: 34171990 PMCID: PMC8233180 DOI: 10.1186/s12879-021-06332-z] [Citation(s) in RCA: 13] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/16/2021] [Accepted: 06/09/2021] [Indexed: 12/21/2022] Open
Abstract
BACKGROUND The prevalence of hepatitis C virus (HCV) among people who inject drugs (PWID) continues to be a major public-health burden in this highly stigmatised population. To halt transmission of HCV, rapid HCV self-testing kits represent an innovative approach that could enable PWID to know their HCV status and seek treatment. As no HCV test has yet been licenced for self-administration, it is crucial to obtain knowledge around the factors that may deter or foster delivery of HCV self-testing among PWID in resource-constrained countries. METHODS A qualitative study to assess values and preferences relating to HCV self-testing was conducted in mid-2020 among PWID in the Bishkek and Chui regions of Kyrgyzstan. Forty-seven PWID participated in 15 individual interviews, two group interviews (n = 12) and one participatory action-research session (n = 20). Responses were analysed using a thematic analysis approach with 4 predefined themes: awareness of HCV and current HCV testing experiences, and acceptability and service delivery preferences for HCV self-testing. Informants' insights were analysed using a thematic analysis approach. This research received local ethics approval. RESULTS Awareness of HCV is low and currently PWID prefer community-based HCV testing due to stigma encountered in other healthcare settings. HCV self-testing would be accepted and appreciated by PWID. Acceptability may increase if HCV self-testing: was delivered in pharmacies or by harm reduction associations; was free of charge; was oral rather than blood-based; included instructions with images and clear information on the test's accuracy; and was distributed alongside pre- and post-testing counselling with linkage to confirmatory testing support. CONCLUSIONS HCV self-testing could increase awareness of and more frequent testing for HCV infection among PWID in Kyrgyzstan. It is recommended that peer-driven associations are involved in the delivery of any HCV self-testing. Furthermore, efforts should be maximised to end discrimination against PWID at the healthcare institutions responsible for confirmatory HCV testing and treatment provision.
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Affiliation(s)
- Guillermo Z Martínez-Pérez
- Department of Physiatrics and Nursing, University of Zaragoza, Calle Domingo Miral s/n, 50009, Zaragoza, Spain
| | - Danil S Nikitin
- Global Research Institute Foundation (GLORI), 125 Suyumbaev Street apt 21, 720011, Bishkek, Kyrgyzstan
| | - Alla Bessonova
- Kyrgyz Network of Harm Reduction (KNHR), 21 Yug-2 Microdistrict apt 55, 720052, Bishkek, Kyrgyzstan
| | - Emmanuel Fajardo
- Foundation for Innovative New Diagnostics, Chemin des Mines 9, 1202, Geneva, Switzerland
| | - Sergei Bessonov
- Kyrgyz Network of Harm Reduction (KNHR), 21 Yug-2 Microdistrict apt 55, 720052, Bishkek, Kyrgyzstan
| | - Sonjelle Shilton
- Foundation for Innovative New Diagnostics, Chemin des Mines 9, 1202, Geneva, Switzerland.
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Burgui C, Martín C, Juanbeltz R, San Miguel R, Martínez-Baz I, Zozaya JM, Castilla J. Recapture of patients with an incomplete diagnosis of hepatitis C virus infection. REVISTA ESPANOLA DE ENFERMEDADES DIGESTIVAS 2021; 112:525-531. [PMID: 32515981 DOI: 10.17235/reed.2020.6944/2020] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/20/2022]
Abstract
BACKGROUND hepatitis C virus (HCV) antibody tests have been performed since the 90s, although HCV-RNA (viral load) determination was not always performed. Some of these patients may be actively infected and not be aware of it. Here, we describe a procedure to capture these subjects and complete their diagnosis. METHODS the historical laboratory results of Navarra were reviewed and individuals who were positive for antibodies against HCV (anti-HCV) and had not undergone HCV-RNA testing were identified. In September 2018, each general practitioner (GP) was informed about their patients and given precise instructions for completing the diagnosis. The procedure was assessed until December 2019. RESULTS two hundred and eighty-nine anti-HCV positive patients were detected for whom active infection had not been discarded. Two were HIV-positive and six had already died. GPs were asked to assess the remaining 281 subjects. By the end of 2019, a new blood test had been performed in 187 (67 %) patients, 5 % decided not to do it, 4 % were living outside of Navarra, 3 % could not be contacted and the GP considered that it was not justified in 2 % of cases. Thus, 19 % remained to be contacted. From the 187 assessed patients, active infection was confirmed in 52 (28 %) individuals, 40 % were false positives and HCV-RNA was undetectable in 31 %. Regarding the 52 actively infected subjects, 34 had already initiated antiviral therapy and three were hospitalized due to decompensated cirrhosis, from which one patient died. CONCLUSIONS the strategy to recapture individuals with an incomplete HCV infection diagnosis was effective to detect active infections and subsequent initiation of antiviral therapy.
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Affiliation(s)
- Cristina Burgui
- Epidemiología, Instituto de Salud Pública de Navarra, España
| | - Carmen Martín
- Microbiología Clínica, Complejo Hospitalario de Navarra
| | | | | | - Iván Martínez-Baz
- Salud Pública, Instituto de Salud Pública de Navarra (IdiSNA), España
| | | | - Jesús Castilla
- Epidemiología, Instituto de Salud Pública y Laboral de Navarra, España
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Reipold EI, Farahat A, Elbeeh A, Soliman R, Aza EB, Jamil MS, Johnson CC, Shiha G, Easterbrook P. Usability and acceptability of self-testing for hepatitis C virus infection among the general population in the Nile Delta region of Egypt. BMC Public Health 2021; 21:1188. [PMID: 34158006 PMCID: PMC8218412 DOI: 10.1186/s12889-021-11169-x] [Citation(s) in RCA: 15] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/25/2021] [Accepted: 05/28/2021] [Indexed: 12/24/2022] Open
Abstract
BACKGROUND Self-testing for hepatitis C virus antibodies (HCVST) may be an additional strategy to expand access to hepatitis C virus (HCV) testing and support elimination efforts. We conducted a study to assess the usability and acceptability of HCVST among the general population in a semi-rural, high-HCV prevalence region in Egypt. METHODS An observational study was conducted in two hospitals in the Nile Delta region. A trained provider gave an in-person demonstration on how to use the oral fluid HCVST followed by observation of the participant performing the test. Usability was assessed by observing errors made and difficulties faced by participants. Acceptability of HCV self-testing was assessed using an interviewer-administered semi-structured questionnaire. RESULTS Of 116 participants enrolled, 17 (14.6%) had received no formal education. The majority (72%) of participants completed all testing steps without any assistance and interpreted the test results correctly. Agreement between participant-reported HCVST results and interpretation by a trained user was 86%, with a Cohen's kappa of 0.6. Agreement between participant-reported HCVST results and provider-administered oral fluid HCV rapid test results was 97.2%, with a Cohen's kappa of 0.75. The majority of participants rated the HCVST process as easy (53%) or very easy (44%), and 96% indicated they would be willing to use HCVST again and recommend it to their family and friends. CONCLUSION Our study demonstrates the high usability and acceptability of oral fluid HCVST in a general population. Further studies are needed to establish the optimal positioning of self-testing alongside facility-based testing to expand access to HCV diagnosis in both general and high-risk populations.
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Affiliation(s)
| | - Ahmed Farahat
- Egyptian Liver Research Institute and Hospital (ELRIAH), Mansoura, Egypt
| | - Amira Elbeeh
- Association of Liver Patient Care (ALPC), Mansoura, Egypt
| | - Reham Soliman
- Egyptian Liver Research Institute and Hospital (ELRIAH), Mansoura, Egypt
- Tropical Medicine Department, Port Said University, Port Said, Egypt
| | | | - Muhammad S Jamil
- Department of Global HIV, Hepatitis and STI Programmes, World Health Organization, Geneva, Switzerland
| | - Cheryl Case Johnson
- Department of Global HIV, Hepatitis and STI Programmes, World Health Organization, Geneva, Switzerland
| | - Gamal Shiha
- Egyptian Liver Research Institute and Hospital (ELRIAH), Mansoura, Egypt
- Internal Medicine Department, Mansoura University, Mansoura, Egypt
| | - Philippa Easterbrook
- Department of Global HIV, Hepatitis and STI Programmes, World Health Organization, Geneva, Switzerland
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Jaquet A, Boni SP, Boidy K, Tine J, Tchounga B, Touré SA, Koffi JJ, Dial C, Monnereau A, Diomande I, Tanon A, Seydi M, Dabis F, Diop S, Koffi G. Chronic viral hepatitis, HIV infection and Non-Hodgkin lymphomas in West Africa, a case-control study. Int J Cancer 2021; 149:1536-1543. [PMID: 34124779 DOI: 10.1002/ijc.33709] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/14/2021] [Revised: 05/17/2021] [Accepted: 05/28/2021] [Indexed: 12/09/2022]
Abstract
Non-Hodgkin lymphomas (NHL) are underestimated causes of cancer in West Africa where chronic viral hepatitis and HIV are endemic. While the association with HIV infection has already been characterized, limited information is available on the association between chronic viral hepatitis and NHL in sub-Saharan Africa. A case-control study was conducted in referral hospitals of Abidjan (Cote d'Ivoire) and Dakar (Senegal). Cases of NHL were matched with controls on age, gender and participating site. The diagnosis of NHL relied on local pathological examination completed with immunohistochemistry. HIV, HBV and HCV serology tests were systematically performed. A conditional logistic regression model estimated the associations by the Odds Ratio (OR) with their 95% confidence interval (CI). A total of 117 NHL cases (Abidjan n = 97, Dakar n = 20) and their 234 matched controls were enrolled. Cases were predominantly men (68.4%) and had a median age of 50 years (IQR 37-57). While Diffuse Large B-cell lymphoma were the most reported morphological type (n = 35) among mature B-cell NHL, the proportion mature T-cell NHL (30%) was high. The prevalence figures of HBV, HCV and HIV infection were 12.8%, 7.7% and 14.5%, respectively among cases of NHL. In multivariate analysis, HBV, HCV and HIV were independently associated with NHL with OR of 2.23 (CI 1.05-4.75), 4.82 (CI 1.52-15.29) and 3.32 (CI 1.54-7.16), respectively. Chronic viral hepatitis B and C were significantly associated with NHL in West Africa. Timely preventive measures against HBV infection and access to curative anti-HCV treatment might prevent a significant number of NHL.
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Affiliation(s)
- Antoine Jaquet
- University of Bordeaux, Inserm, French National Research Institute for Sustainable Development (IRD), Bordeaux, France
| | - Simon P Boni
- Programme National de Lutte Contre le Cancer (PNLCa), Abidjan, Côte d'Ivoire.,Programme PACCI/Site ANRS Abidjan, Abidjan, Côte d'Ivoire
| | - Kouakou Boidy
- Service d'hématologie, Centre Hospitalier Universitaire de Yopougon, Abidjan, Côte d'Ivoire
| | - Judicaël Tine
- Service des Maladies Infectieuses et Tropicales, Centre Hospitalier National Universitaire de Fann, Dakar, Senegal
| | - Boris Tchounga
- Programme PACCI/Site ANRS Abidjan, Abidjan, Côte d'Ivoire.,Elizabeth Glaser Pediatric AIDS Foundation, Yaoundé, Cameroon
| | - Sokhna A Touré
- Service d'hématologie, Centre National de Transfusion Sanguine, Dakar, Senegal
| | | | - Cherif Dial
- Service Anatomopathologie, Hôpital de Grand Yoff, Dakar, Senegal
| | - Alain Monnereau
- University of Bordeaux, Inserm, French National Research Institute for Sustainable Development (IRD), Bordeaux, France
| | - Isidore Diomande
- Service Anatomopathologie, Centre Hospitalier Universitaire Cocody, Abidjan, Côte d'Ivoire
| | - Aristophane Tanon
- Service des Maladies Infectieuses et Tropicales, Centre Hospitalier Universitaire de Treichville, Abidjan, Côte d'Ivoire
| | - Moussa Seydi
- Service des Maladies Infectieuses et Tropicales, Centre Hospitalier National Universitaire de Fann, Dakar, Senegal
| | - François Dabis
- University of Bordeaux, Inserm, French National Research Institute for Sustainable Development (IRD), Bordeaux, France
| | - Saliou Diop
- Service d'hématologie, Centre National de Transfusion Sanguine, Dakar, Senegal
| | - Gustave Koffi
- Service d'hématologie, Centre Hospitalier Universitaire de Yopougon, Abidjan, Côte d'Ivoire
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Non-pharmacologic direct cost of a simplified strategy with glecaprevir/pibrentasvir for 8 weeks in naïve non-cirrhotic patients with hepatitis C implemented in clinical practice. The Just SIMPLE Study. GASTROENTEROLOGIA Y HEPATOLOGIA 2021; 45:342-349. [PMID: 34129903 DOI: 10.1016/j.gastrohep.2021.05.015] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 03/03/2021] [Revised: 04/23/2021] [Accepted: 05/25/2021] [Indexed: 11/23/2022]
Abstract
BACKGROUND AND OBJECTIVE The emergence of highly tolerable, effective, and shorter duration direct-acting antivirals (DAAs) regimens offers the opportunity to simplify hepatitis C virus management but medical costs are unknown. Thus, we aimed to determine the direct medical costs associated with a combo-simplified strategy (one-step diagnosis and low monitoring) to manage HCV infection within an 8-week glecaprevir/pibrentasvir (GLE/PIB) regimen in clinical practice in Spain. PATIENTS AND METHODS Healthcare resources and clinical data were collected retrospectively from medical charts of 101 eligible patients at 11 hospitals. Participants were adult, treatment naïve subjects with HCV infection without cirrhosis in whom a combo-simplified strategy with GLE/PIB for 8 weeks were programmed between Apr-2018 and Nov-2018. RESULTS The GLE/PIB effectiveness was 100% (CI95%: 96.2-100%) in the mITT population and 94.1% (CI95%: 87.5-97.8%) in the ITT population. Three subjects discontinued the combo-simplified strategy prematurely, none of them due to safety reasons. Five subjects reported 8 adverse events, all of mild-moderate intensity. Combo-simplified strategy mean direct costs were 754.35±103.60€ compared to 1689.42€ and 2007.89€ of a theoretical 12-week treatment with 4 or 5 monitoring visits, respectively; and 1370.95€ and 1689.42€ of a theoretical 8-week with 3 or 4 monitoring visits, respectively. Only 4.9% of the subjects used unexpected health care resources. CONCLUSIONS 8-week treatment with GLE/PIB combined with a combo simplified strategy in real-life offers substantial cost savings without affecting the effectiveness and safety compared to traditional approaches.
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Forns X, Feld JJ, Dylla DE, Pol S, Chayama K, Hou J, Heo J, Lampertico P, Brown A, Bondin M, Tatsch F, Burroughs M, Marcinak J, Zhang Z, Emmett A, Gordon SC, Jacobson IM. Safety of Patients with Hepatitis C Virus Treated with Glecaprevir/Pibrentasvir from Clinical Trials and Real-World Cohorts. Adv Ther 2021; 38:3409-3426. [PMID: 34021887 PMCID: PMC8189955 DOI: 10.1007/s12325-021-01753-3] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/09/2021] [Accepted: 04/18/2021] [Indexed: 12/24/2022]
Abstract
INTRODUCTION More than 70 million people are estimated to be infected with hepatitis C virus (HCV) globally. If left untreated, HCV infection can lead to complications such as extensive liver fibrosis, cirrhosis, and hepatocellular carcinoma (HCC). Evolution of treatments has resulted in highly effective and well-tolerated all-oral direct-acting antivirals. The pangenotypic regimen of glecaprevir/pibrentasvir is approved for treating HCV for patients without cirrhosis or with compensated cirrhosis (CC). Guidelines have evolved to simplify treatment to enable non-specialists to manage and treat HCV-infected patients. Simultaneously, such treatment algorithms provide guidance on the pretreatment identification of small subsets of patients who may require specialist treatment and long-term follow-up for advanced liver disease, including those at risk of developing HCC. This study describes the safety profile of glecaprevir/pibrentasvir in patients identified using previously described noninvasive laboratory measures who may be eligible for treatment by non-liver specialists. METHODS This post hoc analysis of glecaprevir/pibrentasvir in patients, identified by noninvasive laboratory measures, intended to exclude patients with advanced liver disease and severe renal impairment, who can be managed within non-liver specialist settings. Patients were included from clinical trials and real-world studies of glecaprevir/pibrentasvir for HCV treatment. Baseline demographics, clinical characteristics, and safety assessments, including adverse events and laboratory abnormalities, were summarized. RESULTS Data across these large-scale studies confirm that glecaprevir/pibrentasvir is well tolerated across different patient populations, with fewer than 0.1% of patients experiencing a serious adverse event related to treatment drugs, and few patients developing HCC during or after treatment. CONCLUSION The safety profile of glecaprevir/pibrentasvir enhances the confidence of non-liver specialists to treat the majority of HCV-infected patients, and provides an opportunity to expand the treater pool, potentially increasing diagnosis and treatment rates for HCV, contributing to elimination of HCV.
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Affiliation(s)
- Xavier Forns
- Liver Unit, Hospital Clinic de Barcelona, IDIBAPS and CIBEREHD, University of Barcelona, Barcelona, Spain.
| | - Jordan J Feld
- Toronto Centre for Liver Disease, University Health Network, University of Toronto, Toronto, ON, Canada
| | | | - Stanislas Pol
- Liver Unit, Cochin Hospital, APHP, Inserm U-1223, Institut Pasteur, Université de Paris, Paris, France
| | - Kazuaki Chayama
- Department of Gastroenterology and Metabolism, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan
| | - Jinlin Hou
- Department of Infectious Diseases, State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Viral Hepatitis Research, Nanfang Hospital, Southern Medical University, Guangzhou, China
| | - Jeong Heo
- Department of Internal Medicine, College of Medicine, Pusan National University and Medical Research Institute, Busan, Republic of Korea
| | - Pietro Lampertico
- Division of Gastroenterology and Hepatology, CRC "A.M. and A. Migliavacca" Center for Liver Disease, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy
- Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy
| | - Ashley Brown
- Imperial College Healthcare NHS Trust, London, UK
| | | | | | | | | | | | | | - Stuart C Gordon
- Division of Gastroenterology and Hepatology, Henry Ford Health System and Wayne State University School of Medicine, Detroit, MI, USA
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Duarte G, Pezzuto P, Barros TD, Mosimann G, Martinez-Espinosa FE. Brazilian Protocol for Sexually Transmitted Infections 2020: viral hepatitis. Rev Soc Bras Med Trop 2021; 54:e2020834. [PMID: 33729415 PMCID: PMC8210490 DOI: 10.1590/0037-8682-834-2020] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/01/2021] [Accepted: 03/10/2021] [Indexed: 12/09/2022] Open
Abstract
This article discusses viral hepatitis, a theme addressed by the Clinical Protocol and Therapeutic Guidelines to Comprehensive Care for People with Sexually Transmitted Infections and, more precisely, by the Clinical Protocols and Therapeutic Guidelines for Hepatitis B and Hepatitis C and Coinfections, published by the Brazilian Ministry of Health. Besides the broad spectrum of health impairment, hepatitis A, B, and C viruses also present different transmission forms, whether parenteral, sexual, vertical, or fecal-oral. Among the strategies suggested for the control of viral hepatitis, in addition to behavioral measures, are expanded diagnosis, early vaccination against hepatitis A and hepatitis B viruses, and access to available therapeutic resources. Considering vertical transmission of the hepatitis B and hepatitis C viruses, screening for pregnant women with chronic hepatitis B and C is an essential perinatal health strategy, indicating with precision those who can benefit from the prophylactic interventions. Viral hepatitis A, B, and C are responsible for more than 1.34 million deaths worldwide every year, from which 66% are the result of hepatitis B, 30% of hepatitis C, and 4% of hepatitis A.
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Affiliation(s)
- Geraldo Duarte
- Universidade de São Paulo, Faculdade de Medicina de Ribeirão Preto, Ribeirão Preto, SP, Brasil
| | - Paula Pezzuto
- Ministério da Saúde, Secretaria de Vigilância em Saúde, Brasília, DF, Brasil
| | - Tiago Dahrug Barros
- Ministério da Saúde, Secretaria de Vigilância em Saúde, Brasília, DF, Brasil
| | - Gláucio Mosimann
- Ministério da Saúde, Secretaria de Vigilância em Saúde, Brasília, DF, Brasil
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Bajis S, Applegate TL, Grebely J, Matthews GV, Dore GJ. Novel Hepatitic C Virus (HCV) Diagnosis and Treatment Delivery Systems: Facilitating HCV Elimination by Thinking Outside the Clinic. J Infect Dis 2021; 222:S758-S772. [PMID: 33245354 DOI: 10.1093/infdis/jiaa366] [Citation(s) in RCA: 14] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/13/2022] Open
Abstract
The World Health Organization has set a goal to eliminate hepatitis C virus (HCV) infection as public health threat by 2030. Although the advent of highly effective and tolerable direct-acting antiviral therapy has paved the way for HCV elimination, most people with HCV infection remain undiagnosed and untreated globally, with striking disparities between high-income and low- to middle-income countries. Novel decentralized and cost-effective "test-and-treat" strategies are critically needed to identify the millions of people unaware of their status and link them to treatment.
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Affiliation(s)
- Sahar Bajis
- The Kirby Institute, UNSW Sydney, Sydney, New South Wales, Australia
| | - Tanya L Applegate
- The Kirby Institute, UNSW Sydney, Sydney, New South Wales, Australia
| | - Jason Grebely
- The Kirby Institute, UNSW Sydney, Sydney, New South Wales, Australia
| | - Gail V Matthews
- The Kirby Institute, UNSW Sydney, Sydney, New South Wales, Australia
| | - Gregory J Dore
- The Kirby Institute, UNSW Sydney, Sydney, New South Wales, Australia
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Duarte G, Pezzuto P, Barros TD, Mosimann Junior G, Martínez-Espinosa FE. [Brazilian Protocol for Sexually Transmitted Infections 2020: viral hepatitis]. ACTA ACUST UNITED AC 2021; 30:e2020834. [PMID: 33729415 DOI: 10.1590/s1679-4974202100016.esp1] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/08/2020] [Accepted: 10/03/2020] [Indexed: 01/01/2023]
Abstract
This article discusses viral hepatitis, a theme addressed by the Clinical Protocol and Therapeutic Guidelines to Comprehensive Care for People with Sexually Transmitted Infections and, more precisely, by the Clinical Protocols and Therapeutic Guidelines for Hepatitis B and Hepatitis C and Coinfections, published by the Brazilian Ministry of Health. Besides the broad spectrum of health impairment, hepatitis A, B and C viruses also present different forms of transmission, whether parenteral, sexual, vertical or oral. Among the strategies suggested for the control of viral hepatitis, in addition to behavioral measures, are expanded diagnosis, early vaccination against hepatitis A and hepatitis B viruses, and access to available therapeutic resources. Considering vertical transmission of the hepatitis B and hepatitis C viruses, screening for pregnant women with chronic hepatitis B and C is an important perinatal health strategy, indicating with precision those who can benefit from the prophylactic interventions.
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Affiliation(s)
- Geraldo Duarte
- Universidade de São Paulo, Faculdade de Medicina de Ribeirão Preto, Ribeirão Preto, SP, Brasil
| | - Paula Pezzuto
- Ministério da Saúde, Secretaria de Vigilância em Saúde, Brasília, DF, Brasil
| | - Tiago Dahrug Barros
- Ministério da Saúde, Secretaria de Vigilância em Saúde, Brasília, DF, Brasil
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Howell J, Pedrana A, Schroeder SE, Scott N, Aufegger L, Atun R, Baptista-Leite R, Hirnschall G, ‘t Hoen E, Hutchinson SJ, Lazarus JV, Olufunmilayo L, Peck R, Sharma M, Sohn AH, Thompson A, Thursz M, Wilson D, Hellard M. A global investment framework for the elimination of hepatitis B. J Hepatol 2021; 74:535-549. [PMID: 32971137 PMCID: PMC7505744 DOI: 10.1016/j.jhep.2020.09.013] [Citation(s) in RCA: 45] [Impact Index Per Article: 11.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/30/2020] [Revised: 08/28/2020] [Accepted: 09/14/2020] [Indexed: 12/16/2022]
Abstract
BACKGROUND & AIMS More than 292 million people are living with hepatitis B worldwide and are at risk of death from cirrhosis and liver cancer. The World Health Organization (WHO) has set global targets for the elimination of viral hepatitis as a public health threat by 2030. However, current levels of global investment in viral hepatitis elimination programmes are insufficient to achieve these goals. METHODS To catalyse political commitment and to encourage domestic and international financing, we used published modelling data and key stakeholder interviews to develop an investment framework to demonstrate the return on investment for viral hepatitis elimination. RESULTS The framework utilises a public health approach to identify evidence-based national activities that reduce viral hepatitis-related morbidity and mortality, as well as international activities and critical enablers that allow countries to achieve maximum impact on health outcomes from their investments - in the context of the WHO's 2030 viral elimination targets. CONCLUSION Focusing on hepatitis B, this health policy paper employs the investment framework to estimate the substantial economic benefits of investing in the elimination of hepatitis B and demonstrates how such investments could be cost saving by 2030. LAY SUMMARY Hepatitis B infection is a major cause of death from liver disease and liver cancer globally. To reduce deaths from hepatitis B infection, we need more people to be tested and treated for hepatitis B. In this paper, we outline a framework of activities to reduce hepatitis B-related deaths and discuss ways in which governments could pay for them.
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Affiliation(s)
- Jessica Howell
- Disease Elimination Programme, Burnet Institute, Melbourne, Australia; School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia; Department of Medicine, University of Melbourne, Melbourne, Australia; Department of Gastroenterology, St Vincent's Hospital Melbourne, Australia.
| | - Alisa Pedrana
- Disease Elimination Programme, Burnet Institute, Melbourne, Australia,School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia
| | - Sophia E. Schroeder
- Disease Elimination Programme, Burnet Institute, Melbourne, Australia,School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia
| | - Nick Scott
- Disease Elimination Programme, Burnet Institute, Melbourne, Australia,School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia
| | | | - Rifat Atun
- Harvard T H Chan School of Public Health, Harvard University, Boston, MA, USA
| | - Ricardo Baptista-Leite
- Universidade Catolica Portuguesa, Lisbon, Portugal,Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands
| | - Gottfried Hirnschall
- Strategic Information, Global Hepatitis Programme, World Health Organization,Formerly Department of HIV and Global Hepatitis Programme, World Health Organization
| | - Ellen ‘t Hoen
- Global Health Unit, University Medical Centre, Groningen, the Netherlands,Medicines Law & Policy, Amsterdam, The Netherlands
| | - Sharon J. Hutchinson
- School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK,Health Protection Scotland, Meridian Court, Cadogan St, Glasgow, UK
| | - Jeffrey V. Lazarus
- Barcelona Institute for Global Health (ISGlobal), Hospital Clinic, University of Barcelona, Barcelona, Spain
| | - Lesi Olufunmilayo
- Department of Medicine, Medicine, College of Medicine, University of Lagos, Nigeria
| | | | - Manik Sharma
- Division of Gastroenterology and Hepatology, Hamad General Hospital, Hamad Medical Corporation, Doha, Qatar
| | - Annette H. Sohn
- TREAT Asia/amfAR, Foundation for AIDS Research, Bangkok, Thailand
| | - Alexander Thompson
- Department of Medicine, University of Melbourne, Melbourne, Australia,Department of Gastroenterology, St Vincent's Hospital Melbourne, Australia
| | - Mark Thursz
- Department of Hepatology, Imperial College London, London, UK
| | - David Wilson
- Disease Elimination Programme, Burnet Institute, Melbourne, Australia,School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia
| | - Margaret Hellard
- Disease Elimination Programme, Burnet Institute, Melbourne, Australia,School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia,Department of Infectious Diseases, The Alfred and Monash University, Australia
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46
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Prabdial‐Sing N, Gaelejwe L, Makhathini L, Thaver J, Manamela MJ, Malfeld S, Spearman CW, Sonderup M, Scheibe A, Young K, Hausler H, Puren AJ. The performance of hepatitis C virus (HCV) antibody point-of-care tests on oral fluid or whole blood and dried blood spot testing for HCV serology and viral load among individuals at higher risk for HCV in South Africa. Health Sci Rep 2021; 4:e229. [PMID: 33614978 PMCID: PMC7876859 DOI: 10.1002/hsr2.229] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/09/2020] [Revised: 11/10/2020] [Accepted: 12/04/2020] [Indexed: 12/14/2022] Open
Abstract
BACKGROUND AND AIMS To enhance screening and diagnosis in those at-risk of hepatitis C virus (HCV), efficient and improved sampling and testing is required. We investigated the performance of point-of-care (POC) tests and dried blood spots (DBS) for HCV antibody and HCV RNA quantification in individuals at higher risk for HCV (people who use and inject drugs, sex workers and men who have sex with men) in seven South African cities. METHODS Samples were screened on the OraQuick HCV POC test (471 whole blood and 218 oral fluid); 218 whole blood and DBS paired samples were evaluated on the ARCHITECT HCV antibody (Abbott) and HCV viral load (COBAS Ampliprep/COBAS TaqMan version 2) assays. For HCV RNA quantification, 107 dB were analyzed with and without normalization coefficients. RESULTS POC on either whole blood or oral fluid showed an overall sensitivity of 98.5% (95% CI 97.4-99.5), specificity of 98.2% (95% CI 98.8-100) and accuracy of 98.4% (95% CI 96.5-99.3). On the antibody immunoassay, DBS showed a sensitivity of 96.0% (95% CI 93.4-98.6), specificity of 97% (95% CI 94.8-99.3) and accuracy of 96.3% (95% CI 93.8-98.8). A strong correlation (R 2 = 0.90) between viral load measurements for DBS and plasma samples was observed. After normalization, DBS viral load results showed an improved bias from 0.5 to 0.16 log10 IU/mL. CONCLUSION The POC test performed sufficiently well to be used for HCV screening in at-risk populations. DBS for diagnosis and quantification was accurate and should be considered as an alternative sample to test. POC and DBS can help scale up hepatitis services in the country, in light of our elimination goals.
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Affiliation(s)
- Nishi Prabdial‐Sing
- Centre for Vaccines and ImmunologyNational Institute for Communicable DiseasesJohannesburgSouth Africa
- Faculty of Health SciencesUniversity of WitwatersrandJohannesburgSouth Africa
| | - Lucinda Gaelejwe
- Centre for Vaccines and ImmunologyNational Institute for Communicable DiseasesJohannesburgSouth Africa
- Faculty of Health SciencesUniversity of WitwatersrandJohannesburgSouth Africa
| | - Lillian Makhathini
- Centre for Vaccines and ImmunologyNational Institute for Communicable DiseasesJohannesburgSouth Africa
| | - Jayendrie Thaver
- Centre for Vaccines and ImmunologyNational Institute for Communicable DiseasesJohannesburgSouth Africa
| | - Morubula Jack Manamela
- Centre for Vaccines and ImmunologyNational Institute for Communicable DiseasesJohannesburgSouth Africa
| | - Susan Malfeld
- Centre for Vaccines and ImmunologyNational Institute for Communicable DiseasesJohannesburgSouth Africa
| | - C. Wendy Spearman
- Division of Hepatology, Department of Medicine, Faculty of Health SciencesUniversity of Cape TownCape TownSouth Africa
| | - Mark Sonderup
- Division of Hepatology, Department of Medicine, Faculty of Health SciencesUniversity of Cape TownCape TownSouth Africa
| | - Andrew Scheibe
- TB HIV CareCape TownSouth Africa
- Department of Family MedicineUniversity of PretoriaPretoriaSouth Africa
| | | | | | - Adrian J. Puren
- Centre for Vaccines and ImmunologyNational Institute for Communicable DiseasesJohannesburgSouth Africa
- Faculty of Health SciencesUniversity of WitwatersrandJohannesburgSouth Africa
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Kumar S, Nehra M, Khurana S, Dilbaghi N, Kumar V, Kaushik A, Kim KH. Aspects of Point-of-Care Diagnostics for Personalized Health Wellness. Int J Nanomedicine 2021; 16:383-402. [PMID: 33488077 PMCID: PMC7814661 DOI: 10.2147/ijn.s267212] [Citation(s) in RCA: 28] [Impact Index Per Article: 7.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/11/2020] [Accepted: 09/24/2020] [Indexed: 12/24/2022] Open
Abstract
Advancements in analytical diagnostic systems for point-of-care (POC) application have gained considerable attention because of their rapid operation at the site required to manage severe diseases, even in a personalized manner. The POC diagnostic devices offer easy operation, fast analytical outcome, and affordable cost, which promote their advanced research and versatile adoptability. Keeping advantages in view, considerable efforts are being made to design and develop smart sensing components such as miniaturized transduction, interdigitated electrodes-based sensing chips, selective detection at low level, portable packaging, and sustainable durability to promote POC diagnostics according to the needs of patient care. Such effective diagnostics systems are in demand, which creates the challenge to make them more efficient in every aspect to generate a desired bio-informatic needed for better health access and management. Keeping advantages and scope in view, this mini review focuses on practical scenarios associated with miniaturized analytical diagnostic devices at POC application for targeted disease diagnostics smartly and efficiently. Moreover, advancements in technologies, such as smartphone-based operation, paper-based sensing assays, and lab-on-a-chip (LOC) which made POC more sensitive, informative, and suitable for major infectious disease diagnosis, are the main focus here. Besides, POC diagnostics based on automated patient sample integration with a sensing platform is continuously improving therapeutics interventions against specific infectious disease. This review also discussed challenges associated with state-of-the-art technology along with future research opportunities to design and develop next generation POC diagnostic systems needed to manage infectious diseases in a personalized manner.
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Affiliation(s)
- Sandeep Kumar
- Department of Bio and Nano Technology, Guru Jambheshwar University of Science and Technology, Hisar, Haryana 125001, India
| | - Monika Nehra
- Department of Bio and Nano Technology, Guru Jambheshwar University of Science and Technology, Hisar, Haryana 125001, India
| | - Sakina Khurana
- Department of Bio and Nano Technology, Guru Jambheshwar University of Science and Technology, Hisar, Haryana 125001, India
| | - Neeraj Dilbaghi
- Department of Bio and Nano Technology, Guru Jambheshwar University of Science and Technology, Hisar, Haryana 125001, India
| | - Vanish Kumar
- National Agri-Food Biotechnology Institute (NABI), Mohali, Punjab, India
| | - Ajeet Kaushik
- NanoBioTech Laboratory, Department of Natural Sciences, Division of Sciences, Art, & Mathematics, Florida Polytechnic University, Lakeland, FL, 33805-8531, USA
| | - Ki-Hyun Kim
- Department of Civil & Environmental Engineering, Hanyang University, Seoul 04763, Republic of Korea
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48
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Dunn D, Price H, Vudriko T, Kityo C, Musoro G, Hakim J, Gilks C, Kaleebu P, Pillay D, Gilson R. New Insights on Long-Term Hepatitis B Virus Responses in HIV-Hepatitis B virus Co-infected Patients: Implications for Antiretroviral Management in Hepatitis B virus-Endemic Settings. J Acquir Immune Defic Syndr 2021; 86:98-103. [PMID: 33306565 DOI: 10.1097/qai.0000000000002517] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/15/2023]
Abstract
BACKGROUND WHO treatment guidelines recommend tenofovir plus lamivudine or emtricitabine as the nucleoside reverse transcriptase inhibitor backbone in first-line regimens for HIV-infected adults. Lamivudine alone is not recommended, because of the risk of hepatitis B virus (HBV) resistance. We studied HBV responses in a large cohort of co-infected patients in a resource-limited setting. SETTING Clinical centers in Uganda and Zimbabwe. METHODS DART was a randomized trial of monitoring practices in HIV-infected adults starting antiretroviral therapy. Baseline samples were tested retrospectively for HBV serological markers and HBV DNA. Longitudinal HBV DNA testing at 48 weeks and the last available sample before HBV-relevant modification of antiretroviral therapy was performed on patients with detectable HBV DNA at baseline. RESULTS Two hundred twenty-four hepatitis B surface antigen-positive patients were followed for up to 4.8 years. Of the drugs with anti-HBV activity, 166 were prescribed lamivudine-tenofovir and 58 lamivudine alone. Ninety-eight percent (96/98) patients with baseline HBV DNA <6 log10 IU/mL achieved viral suppression at 48 weeks (HBV DNA <48 IU/mL), regardless of regimen, compared with 50%(26/52) for HBV DNA >6 log10 IU/mL. Of the 83 patients suppressed at 48 weeks and with follow-up data, only 7(8%) experienced viral rebound (range 200-3460 IU/mL). Of the 20 patients not suppressed at 48 weeks and with follow-up data, HBV DNA levels generally declined with lamivudine-tenofovir, but increased with lamivudine alone. Alanine transaminase flares were not observed in any patient who experienced viral rebound. CONCLUSIONS The suppressive effect of lamivudine alone was highly durable (up to 5 years) in HIV-HBV co-infected patients with baseline HBV DNA <6 log10 IU/mL. It may be feasible to develop stratified approaches using lamivudine as the only drug with anti-HBV activity.
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Affiliation(s)
- David Dunn
- Institute for Global Health, University College London, London, United Kingdom
- MRC Clinical Trials Unit, University College London, London, United Kingdom
| | - Huw Price
- Institute for Global Health, University College London, London, United Kingdom
| | - Tobias Vudriko
- MRC/UVRI & London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda
| | - Cissy Kityo
- Joint Clinical Research Centre, Kampala, Uganda
| | - Godfrey Musoro
- University of Zimbabwe Clinical Research Centre, Harare, Zimbabwe
| | - James Hakim
- University of Zimbabwe Clinical Research Centre, Harare, Zimbabwe
| | - Charles Gilks
- School of Public Health, University of Queensland, Brisbane, Australia; and
| | - Pontiano Kaleebu
- MRC/UVRI & London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda
| | - Deenan Pillay
- Division of Infection and Immunity, University College London, London, United Kingdom
| | - Richard Gilson
- Institute for Global Health, University College London, London, United Kingdom
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Lim HJ, Saha T, Tey BT, Tan WS, Ooi CW. Quartz crystal microbalance-based biosensors as rapid diagnostic devices for infectious diseases. Biosens Bioelectron 2020; 168:112513. [PMID: 32889395 PMCID: PMC7443316 DOI: 10.1016/j.bios.2020.112513] [Citation(s) in RCA: 90] [Impact Index Per Article: 18.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/19/2020] [Revised: 07/30/2020] [Accepted: 08/11/2020] [Indexed: 12/18/2022]
Abstract
Infectious diseases are the ever-present threats to public health and the global economy. Accurate and timely diagnosis is crucial to impede the progression of a disease and break the chain of transmission. Conventional diagnostic techniques are typically time-consuming and costly, making them inefficient for early diagnosis of infections and inconvenient for use at the point of care. Developments of sensitive, rapid, and affordable diagnostic methods are necessary to improve the clinical management of infectious diseases. Quartz crystal microbalance (QCM) systems have emerged as a robust biosensing platform due to their label-free mechanism, which allows the detection and quantification of a wide range of biomolecules. The high sensitivity and short detection time offered by QCM-based biosensors are attractive for the early detection of infections and the routine monitoring of disease progression. Herein, the strategies employed in QCM-based biosensors for the detection of infectious diseases are extensively reviewed, with a focus on prevalent diseases for which improved diagnostic techniques are in high demand. The challenges to the clinical application of QCM-based biosensors are highlighted, along with an outline of the future scope of research in QCM-based diagnostics.
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Affiliation(s)
- Hui Jean Lim
- Chemical Engineering Discipline, School of Engineering, Monash University Malaysia, Jalan Lagoon Selatan, 47500, Bandar Sunway, Selangor, Malaysia
| | - Tridib Saha
- Electrical and Computer Systems Engineering Discipline, School of Engineering, Monash University Malaysia, Jalan Lagoon Selatan, 47500, Bandar Sunway, Selangor, Malaysia
| | - Beng Ti Tey
- Chemical Engineering Discipline, School of Engineering, Monash University Malaysia, Jalan Lagoon Selatan, 47500, Bandar Sunway, Selangor, Malaysia; Advanced Engineering Platform, Monash University Malaysia, Jalan Lagoon Selatan, 47500, Bandar Sunway, Selangor, Malaysia
| | - Wen Siang Tan
- Department of Microbiology, Faculty of Biotechnology and Biomolecular Sciences, Universiti Putra Malaysia, 43400, UPM Serdang, Selangor, Malaysia; Laboratory of Vaccine and Biomolecules, Institute of Bioscience, Universiti Putra Malaysia, 43400, UPM Serdang, Selangor, Malaysia
| | - Chien Wei Ooi
- Chemical Engineering Discipline, School of Engineering, Monash University Malaysia, Jalan Lagoon Selatan, 47500, Bandar Sunway, Selangor, Malaysia; Tropical Medicine and Biology Platform, School of Science, Monash University Malaysia, Jalan Lagoon Selatan, 47500, Bandar Sunway, Selangor, Malaysia.
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50
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Stasi C, Silvestri C, Voller F. Update on Hepatitis C Epidemiology: Unaware and Untreated Infected Population Could Be the Key to Elimination. SN COMPREHENSIVE CLINICAL MEDICINE 2020; 2:2808-2815. [PMID: 33103061 PMCID: PMC7568689 DOI: 10.1007/s42399-020-00588-3] [Citation(s) in RCA: 45] [Impact Index Per Article: 9.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Accepted: 10/11/2020] [Indexed: 02/07/2023]
Abstract
Globally, the World Health Organization (WHO) estimates that 71 million people have chronic hepatitis C virus (HCV) infection. A significant number of these will develop cirrhosis or liver cancer. Currently, during the COVID-19 outbreak, a high mortality rate has been found in patients with COVID-19 and cirrhosis. New direct-acting antiviral agents can cure more than 90% of HCV-infected patients. The new WHO strategy has introduced global goals against viral hepatitis, including a 30% reduction in new HCV cases and a 10% reduction in mortality by 2020. HCV transmission has changed considerably, reflecting both the evolution of medicine and health and social changes. The HCV is usually spread through blood-to-blood contact. After the discovery of HCV in 1989, antibody screening has drastically decreased the incidence of post-transfusion hepatitis. Nowadays, routine blood donor screening by nucleic acid amplification testing for the presence of HCV RNA has been introduced in many countries. It is conceivable that HCV screening could be offered to people born between 1946 and 1964 in the developed world and to people at high risk for HCV infection such as those who have received blood transfusions, blood products or organ donations before the 1990s, prisoners, health care workers, drug users and infants born to HCV-infected women. To achieve HCV elimination, health programmes should include improvement to access to health care services, increased screening and new projects to identify a submerged portion of patients with HCV infection. Submerged people with HCV infection are both people who are unaware of their condition and people diagnosed with HCV but not yet treated. Based on these premises, this review will examine and discuss the epidemiological changes in contracting HCV, highlighting the ways in which to identify a submerged portion of patients with HCV infection.
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Affiliation(s)
- Cristina Stasi
- Observatory of Epidemiology, Regional Health Agency of Tuscany, 50141 Florence, Italy
- Department of Experimental and Clinical Medicine, University of Florence, 50134 Florence, Italy
| | - Caterina Silvestri
- Observatory of Epidemiology, Regional Health Agency of Tuscany, 50141 Florence, Italy
| | - Fabio Voller
- Observatory of Epidemiology, Regional Health Agency of Tuscany, 50141 Florence, Italy
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