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Milošević I, Filipović A, Beronja B, Mitrović N, Ružić M, Simić J, Knežević N, Pete M, Todorović N, Nikolić N. Optimizing Hepatitis C Treatment Monitoring: Is Sustained Virologic Response at 4 Weeks Becoming the New Standard? Microorganisms 2024; 12:2050. [PMID: 39458359 PMCID: PMC11509943 DOI: 10.3390/microorganisms12102050] [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: 09/19/2024] [Revised: 10/05/2024] [Accepted: 10/08/2024] [Indexed: 10/28/2024] Open
Abstract
This study, conducted at two university-based infectious disease clinics, included 216 patients with chronic hepatitis C. The primary objective was to assess the positive and negative predictive values, sensitivity, and specificity of achieving a sustained virological response (SVR) at 4 weeks compared to 12 weeks post-therapy. The results demonstrated a maximum sensitivity of 100% for achieving SVR at 12 weeks after reaching SVR at 4 weeks for all analyzed genotypes, except for genotype 1b treated with EBR/GZR therapy, where the specificity was 75%. Additionally, younger age and less advanced liver fibrosis were identified as independent predictors of achieving a sustained virological response at both 4 and 12 weeks. The significant normalization of various biochemical parameters was observed after treatment, indicating an overall improvement in liver function. This study suggests that shortening the monitoring period to 4 weeks might be effective for younger patients without significant fibrosis, potentially reducing loss to follow-up, which is a critical issue in HCV treatment. These findings align with the "test and treat" approach. Further research is needed to confirm these findings and incorporate them into official guidelines, which could simplify and enhance the effectiveness of HCV treatment protocols, aiding global efforts to eliminate HCV as a public health issue by 2030.
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Affiliation(s)
- Ivana Milošević
- Clinic for Infectious and Tropical Diseases, University Clinical Center of Serbia, Bulevar Oslobođenja 16, 11000 Belgrade, Serbia; (A.F.); (N.M.); (J.S.); (N.K.); (N.T.)
- Faculty of Medicine, University of Belgrade, Dr Subotica 8, 11000 Belgrade, Serbia;
| | - Ana Filipović
- Clinic for Infectious and Tropical Diseases, University Clinical Center of Serbia, Bulevar Oslobođenja 16, 11000 Belgrade, Serbia; (A.F.); (N.M.); (J.S.); (N.K.); (N.T.)
| | - Branko Beronja
- Faculty of Medicine, University of Belgrade, Dr Subotica 8, 11000 Belgrade, Serbia;
| | - Nikola Mitrović
- Clinic for Infectious and Tropical Diseases, University Clinical Center of Serbia, Bulevar Oslobođenja 16, 11000 Belgrade, Serbia; (A.F.); (N.M.); (J.S.); (N.K.); (N.T.)
- Faculty of Medicine, University of Belgrade, Dr Subotica 8, 11000 Belgrade, Serbia;
| | - Maja Ružić
- Faculty of Medicine, Clinic for Infectious Diseases, University Clinical Centre of Vojvodina, University of Novi Sad, 21000 Novi Sad, Serbia; (M.R.); (M.P.)
| | - Jelena Simić
- Clinic for Infectious and Tropical Diseases, University Clinical Center of Serbia, Bulevar Oslobođenja 16, 11000 Belgrade, Serbia; (A.F.); (N.M.); (J.S.); (N.K.); (N.T.)
| | - Nataša Knežević
- Clinic for Infectious and Tropical Diseases, University Clinical Center of Serbia, Bulevar Oslobođenja 16, 11000 Belgrade, Serbia; (A.F.); (N.M.); (J.S.); (N.K.); (N.T.)
| | - Maria Pete
- Faculty of Medicine, Clinic for Infectious Diseases, University Clinical Centre of Vojvodina, University of Novi Sad, 21000 Novi Sad, Serbia; (M.R.); (M.P.)
| | - Nevena Todorović
- Clinic for Infectious and Tropical Diseases, University Clinical Center of Serbia, Bulevar Oslobođenja 16, 11000 Belgrade, Serbia; (A.F.); (N.M.); (J.S.); (N.K.); (N.T.)
| | - Nataša Nikolić
- Clinic for Infectious and Tropical Diseases, University Clinical Center of Serbia, Bulevar Oslobođenja 16, 11000 Belgrade, Serbia; (A.F.); (N.M.); (J.S.); (N.K.); (N.T.)
- Faculty of Medicine, University of Belgrade, Dr Subotica 8, 11000 Belgrade, Serbia;
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Genowska A, Zarębska-Michaluk D, Dobrowolska K, Kanecki K, Goryński P, Tyszko P, Lewtak K, Rzymski P, Flisiak R. Trends in Hospitalizations of Patients with Hepatitis C Virus in Poland between 2012 and 2022. J Clin Med 2024; 13:5618. [PMID: 39337105 PMCID: PMC11433470 DOI: 10.3390/jcm13185618] [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: 09/03/2024] [Revised: 09/13/2024] [Accepted: 09/20/2024] [Indexed: 09/30/2024] Open
Abstract
Background: Analyzing hospitalizations of patients with hepatitis C virus (HCV) infection is essential for an effective action plan to eliminate hepatitis C as a public health threat. This study aimed to explore trends in hospitalizations of patients with HCV infection and factors related to these hospitalizations. Methods: This 11-year retrospective study (2012-2022) explored trends in hospitalizations of patients with HCV infection in Poland based on data from the Nationwide General Hospital Morbidity Study. Results: The mean age of individuals was 55 years, with hospitalization rates among men and women of 15.5 and 13.7 per 100,000 population, respectively. Hospitalizations were 1.8-fold higher among urban residents. The most frequent comorbidities were digestive (24%) and cardiovascular (18%) diseases. During the studied period, the hospitalization rates significantly decreased from 31.9 per 100,000 in 2012 to 5.0 per 100,000 in 2022, with stays requiring 0-3, 4-7, and ≥8 days becoming 8-fold, 6-fold, and 4-fold less frequent, respectively. The flattening of hospitalizations was apparent across all age groups, including children. Conclusions: While significant progress has been made in managing HCV in Poland, continued efforts are required to eliminate disparities in care and to sustain the momentum toward HCV elimination, particularly through enhanced political commitment and the implementation of comprehensive national screening programs.
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Affiliation(s)
- Agnieszka Genowska
- Department of Public Health, Medical University of Bialystok, 15-295 Bialystok, Poland;
| | - Dorota Zarębska-Michaluk
- Department of Infectious Diseases and Allergology, Jan Kochanowski University, 25-317 Kielce, Poland;
| | | | - Krzysztof Kanecki
- Department of Social Medicine and Public Health, Medical University of Warsaw, 02-091 Warsaw, Poland; (K.K.); (P.T.); (K.L.)
| | - Paweł Goryński
- Department of Population Health Monitoring and Analysis, National Institute of Public Health NIH-National Research Institute, 00-791 Warsaw, Poland;
| | - Piotr Tyszko
- Department of Social Medicine and Public Health, Medical University of Warsaw, 02-091 Warsaw, Poland; (K.K.); (P.T.); (K.L.)
- Institute of Rural Health, 20-090 Lublin, Poland
| | - Katarzyna Lewtak
- Department of Social Medicine and Public Health, Medical University of Warsaw, 02-091 Warsaw, Poland; (K.K.); (P.T.); (K.L.)
| | - Piotr Rzymski
- Department of Environmental Medicine, Poznan University of Medical Sciences, 60-806 Poznan, Poland;
| | - Robert Flisiak
- Department of Infectious Diseases and Hepatology, Medical University of Bialystok, 15-540 Bialystok, Poland;
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Eleje GU, Loto OM, Usman HA, Onubogu CU, Fiebai PO, Akaba GO, Rabiu A, Mbachu II, Chibuzor MT, Chukwuanukwu RC, Joe-Ikechebelu NN, Igbodike EP, Egeonu RO, Oppah IC, Ogwaluonye UC, Nwankwo CH, Kalu SO, Chigbo CG, Ogbuagu CN, Chukwurah SN, Uzochukwu CE, Ahmed A, Jibuaku CH, Inuyomi SO, Adesoji BA, Anyang UI, Emeka EA, Igue OE, Okoro OD, Aja PO, Chidozie CP, Ibrahim HS, Aliyu FE, Ugwuoroko HC, Numan AI, Omoruyi SA, Umeononihu OS, Okoro CC, Nwaeju IK, Onwuegbuna AA, Eleje LI, Ikwuka DC, Umeh EO, Nweje SI, Ajuba IC, Ugwu AO, Ebubedike UR, Malachy DE, Okafor CG, Obiegbu NP, Ugwu EO, Yakasai IA, Ezechi OC, Ikechebelu JI. A Systematic Review and Meta-Analysis of the Prevalence of Triplex Infections (Combined Human Immunodeficiency Virus, Hepatitis B Virus, and Hepatitis C Virus) among Pregnant Women in Nigeria. Obstet Gynecol Int 2023; 2023:3551297. [PMID: 37492627 PMCID: PMC10365920 DOI: 10.1155/2023/3551297] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/08/2023] [Revised: 04/10/2023] [Accepted: 06/24/2023] [Indexed: 07/27/2023] Open
Abstract
Objective We systematically identified the prevalence of triplex infections (combined human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV)) in pregnancy. Methods To gather information on the frequency of triplex infections, we searched the databases of PubMed, CINAHL, and Google Scholar. Without regard to language, we utilized search terms that covered HIV, HBV, HCV, and pregnancy. Pregnant women with triplex infections of HIV, HBV, and HCV were included in studies that also examined the prevalence of triplex infections. Review Manager 5.4.1 was employed to conduct the meta-analysis. Critical appraisal and bias tool risk data were provided as percentages with 95% confidence intervals (95% CIs), and I2 was used as the statistical measure of heterogeneity. The checklist was created by Hoy and colleagues. The study protocol was registered on PROSPERO, under the registration number CRD42020202583. Results Eight studies involving 5314 women were included. We identified one ongoing study. Pooled prevalence of triplex infections was 0.03% (95% CI: 0.02-0.04%) according to meta-analysis. Subgroup analysis demonstrated a significantly high prevalence of 0.08% (95% CI: 0.06-0.10%; 3863 women) in HIV-positive population than 0.00% (95% CI:-0.00-0.00; 1451 women; P < 0.001) in general obstetric population. Moreover, there was a significant difference in the pooled prevalence between studies published between 2001 and 2010 and between 2011 and 2021 (0.14% (95% CI: 0.12 to 0.16 versus 0.03% (95% CI: 0.02 to 0.04%; P < 0.001))) and participants recruited in the period between 2001 and 2011 and between 2012 and 2021 (0.13% (95% CI: 0.05 to 0.21; p=0.002 versus 0.00% (95% CI: -0.00 to 0.00%; p=1.00))), respectively. Conclusion The combined prevalence of prenatal triplex infections was 0.03%, with rates notably higher among the group of pregnant women who were HIV-positive and during the recruitment period that took place before 2012. This prevalence still necessitates screening for these infections as necessary.
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Affiliation(s)
- George Uchenna Eleje
- Department of Obstetrics and Gynecology, Nnamdi Azikiwe University, Awka, Nigeria
- Department of Obstetrics and Gynecology, Nnamdi Azikiwe University Teaching Hospital, PMB 5025, Nnewi, Anambra State, Nigeria
| | - Olabisi Morebise Loto
- Department of Obstetrics and Gynecology, Obafemi Awolowo University, Ile-Ife, Nigeria
- Department of Obstetrics and Gynecology, Obafemi Awolowo University Teaching Hospital Complex, Ile-Ife, Nigeria
| | - Hadiza Abdullahi Usman
- Department of Obstetrics and Gynecology, University of Maiduguri, Maiduguri, Nigeria
- Department of Obstetrics and Gynecology, University of Maiduguri Teaching Hospital, Maiduguri, Nigeria
| | | | - Preye Owen Fiebai
- Department of Obstetrics and Gynecology, University of Port Harcourt, Port Harcourt, Nigeria
- Department of Obstetrics and Gynecology, University of Port Harcourt Teaching Hospital, Port Harcourt, Nigeria
| | - Godwin Otuodichinma Akaba
- Department of Obstetrics and Gynecology, University of Abuja, Abuja, Nigeria
- Department of Obstetrics and Gynecology, University of Abuja Teaching Hospital, Abuja, Nigeria
| | - Ayyuba Rabiu
- Department of Obstetrics and Gynecology, Bayero University, Kano, Nigeria
- Department of Obstetrics and Gynecology, Aminu Kano Teaching Hospital, Kano, Nigeria
| | - Ikechukwu Innocent Mbachu
- Department of Obstetrics and Gynecology, Nnamdi Azikiwe University, Awka, Nigeria
- Department of Obstetrics and Gynecology, Nnamdi Azikiwe University Teaching Hospital, PMB 5025, Nnewi, Anambra State, Nigeria
| | - Moriam Taiwo Chibuzor
- Cochrane Nigeria, Institute of Tropical Diseases Research and Prevention, University of Calabar Teaching Hospital, Calabar, Nigeria
| | | | - Ngozi Nneka Joe-Ikechebelu
- Department of Community Medicine and Primary Health Care, Faculty of Medicine, Chukwuemeka Odumegwu Ojukwu University, Amaku, Awka, Nigeria
- Department of Community Medicine and Primary Health Care, Faculty of Medicine, Chukwuemeka Odumegwu Ojukwu University Teaching Hospital, Amaku, Awka, Nigeria
| | - Emeka Philip Igbodike
- Department of Obstetrics and Gynecology, Havana Specialist Hospital, Surulere Lagos, Nigeria
| | - Richard Obinwanne Egeonu
- Department of Obstetrics and Gynecology, Nnamdi Azikiwe University Teaching Hospital, PMB 5025, Nnewi, Anambra State, Nigeria
| | - Ijeoma Chioma Oppah
- Department of Obstetrics and Gynecology, University of Port Harcourt Teaching Hospital, Port Harcourt, Nigeria
| | | | | | - Stephen Okoroafor Kalu
- HIV Care Laboratory, HIV Care Department, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria
| | | | | | - Shirley Nneka Chukwurah
- Gastroenterology Unit, Department of Medicine, Faculty of Medicine, Nnamdi Azikiwe University, Awka, Nigeria
| | | | - Aishat Ahmed
- Department of Obstetrics and Gynecology, University of Abuja Teaching Hospital, Abuja, Nigeria
| | | | | | - Bukola Abimbola Adesoji
- Department of Nursing, Obafemi Awolowo University Teaching Hospital Complex, Ile-Ife, Nigeria
| | - Ubong Inyang Anyang
- Department of Obstetrics and Gynecology, University of Abuja Teaching Hospital, Abuja, Nigeria
| | - Ekene Agatha Emeka
- Department of Family Medicine, Faculty of Medicine, Nnamdi Azikiwe University, Awka, Nigeria
| | - Odion Emmanuel Igue
- Department of Physiological Sciences, Obafemi Awolowo University, Ile-Ife, Nigeria
| | - Ogbonna Dennis Okoro
- Department of Parasitology & Entomology, Faculty of Veterinary Medicine, University of Maiduguri Borno State, Maiduguri, Nigeria
| | - Prince Ogbonnia Aja
- Immunology Unit, Department of Medical Laboratory Science, Nnamdi Azikiwe University, Awka, Nigeria
| | | | - Hadiza Sani Ibrahim
- Department of Obstetrics and Gynecology, Aminu Kano Teaching Hospital, Kano, Nigeria
| | - Fatima Ele Aliyu
- Department of Obstetrics and Gynecology, Aminu Kano Teaching Hospital, Kano, Nigeria
| | - Harrison Chiro Ugwuoroko
- Department of Obstetrics and Gynecology, Nnamdi Azikiwe University Teaching Hospital, PMB 5025, Nnewi, Anambra State, Nigeria
| | - Aisha Ismaila Numan
- Department of Obstetrics and Gynecology, University of Maiduguri Teaching Hospital, Maiduguri, Nigeria
| | - Solace Amechi Omoruyi
- Department of Obstetrics and Gynecology, University of Port Harcourt Teaching Hospital, Port Harcourt, Nigeria
| | - Osita Samuel Umeononihu
- Department of Obstetrics and Gynecology, Nnamdi Azikiwe University, Awka, Nigeria
- Department of Obstetrics and Gynecology, Nnamdi Azikiwe University Teaching Hospital, PMB 5025, Nnewi, Anambra State, Nigeria
| | - Chukwuemeka Chukwubuikem Okoro
- Department of Obstetrics and Gynecology, Nnamdi Azikiwe University Teaching Hospital, PMB 5025, Nnewi, Anambra State, Nigeria
| | - Ifeanyi Kingsley Nwaeju
- Department of Obstetrics and Gynecology, Nnamdi Azikiwe University Teaching Hospital, PMB 5025, Nnewi, Anambra State, Nigeria
| | | | - Lydia Ijeoma Eleje
- Measurement Evaluation and Research Unit, Department of Educational Foundations, Nnamdi Azikiwe University, Awka, Nigeria
| | | | - Eric Okechukwu Umeh
- Department of Radiology, Faculty of Medicine, Nnamdi Azikiwe University, Awka, Nigeria
| | | | - Ifeoma Clara Ajuba
- Department of Hematology, Faculty of Medicine, Nnamdi Azikiwe University, Awka, Nigeria
| | - Angela Ogechukwu Ugwu
- Department of Hematology & Immunology, College of Medicine, University of Nigeria, Ituku-Ozalla, Enugu State, Nigeria
| | | | | | - Chigozie Geoffrey Okafor
- Department of Obstetrics and Gynecology, Nnamdi Azikiwe University Teaching Hospital, PMB 5025, Nnewi, Anambra State, Nigeria
| | - Nnaedozie Paul Obiegbu
- Department of Obstetrics and Gynecology, Nnamdi Azikiwe University Teaching Hospital, PMB 5025, Nnewi, Anambra State, Nigeria
| | - Emmanuel Onyebuchi Ugwu
- Department of Obstetrics and Gynecology, College of Medicine, University of Nigeria Enugu Campus, Enugu, Nigeria
| | - Ibrahim Adamu Yakasai
- Department of Obstetrics and Gynecology, Bayero University, Kano, Nigeria
- Department of Obstetrics and Gynecology, Aminu Kano Teaching Hospital, Kano, Nigeria
| | | | - Joseph Ifeanyichukwu Ikechebelu
- Department of Obstetrics and Gynecology, Nnamdi Azikiwe University, Awka, Nigeria
- Department of Obstetrics and Gynecology, Nnamdi Azikiwe University Teaching Hospital, PMB 5025, Nnewi, Anambra State, Nigeria
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Pugliese N, Calvaruso V, Masarone M, D'Ambrosio R, Battistella S, Licata A, Persico M, Anolli MP, Distefano M, Petta S, Russo FP, Di Marco V, Aghemo A. Glecaprevir/Pibrentasvir is safe and effective in Italian patients with chronic hepatitis C aged 75 years or older: A multicentre study. Liver Int 2023; 43:1440-1445. [PMID: 37122194 DOI: 10.1111/liv.15599] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/03/2023] [Revised: 04/03/2023] [Accepted: 04/17/2023] [Indexed: 05/02/2023]
Abstract
BACKGROUND Glecaprevir and Pibrentasvir (G/P) determine high rates of sustained virological response (SVR) with optimal safety profile in patients with chronic hepatitis C virus (HCV) infection. The efficacy and safety of G/P in Caucasian patients aged 75 years and older have not been widely analysed. METHODS This is a retrospective multicentre real-world study enrolling all consecutive patients 75 years and older who received G/P between October 2017 and January 2022 at five referral centres in Italy. SVR was analysed by intention-to-treat (ITT) and per-protocol analyses (PP). RESULTS A total of 570 patients met the inclusion criteria and were analysed: mean age was 80 (75-97) years, 356 (62%) were females, 52% (298/570) had HCV-1, 44% (252/570) had HCV-2 and 137 (24%) patients had liver cirrhosis. Four hundred and sixty-three (81%) patients were taking at least one concomitant drug, with 144 (25%) taking ≥5 concomitant drugs. G/P was given for 8 weeks in 488 patients (86%). During treatment, 48 patients (8%) reported side effects, with 10 (2%) patients discontinuing treatment prematurely. Two patients developed treatment-unrelated serious adverse events. Overall, the SVR rate was 97.9% (558/570) by ITT analysis and 99.6% (558/560) by PP analysis. SVR rates remained consistently high among subgroup analysis stratified by genotype, treatment duration, fibrosis stage and concomitant medications. CONCLUSIONS Treatment with G/P achieved 97.9% SVR rates in HCV patients older than 75 years of age. Safety was optimal with only 2% of patients discontinuing early.
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Affiliation(s)
- Nicola Pugliese
- Division of Internal Medicine and Hepatology, Department of Gastroenterology, IRCCS Humanitas Research Hospital, Rozzano, Italy
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy
| | - Vincenza Calvaruso
- Section of Gastroenterology and Hepatology, PROMISE, University of Palermo, Palermo, Italy
| | - Mario Masarone
- Internal Medicine and Hepatology Unit, Department of Medicine, Surgery and Dentistry, "Scuola Medica Salernitana", University of Salerno, Salerno, Italy
| | - Roberta D'Ambrosio
- Division of Gastroenterology and Hepatology, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy
| | - Sara Battistella
- Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy
- Gastroenterology and Multivisceral Transplant Unit, Azienda Ospedale-Università di Padova, Padua, Italy
| | - Anna Licata
- Internal Medicine Unit, Department of Health Promotion Sciences Maternal and Infantile Care, Internal Medicine and Medical Specialties (PROMISE), University of Palermo, Palermo, Italy
| | - Marcello Persico
- Internal Medicine and Hepatology Unit, Department of Medicine, Surgery and Dentistry, "Scuola Medica Salernitana", University of Salerno, Salerno, Italy
| | - Maria Paola Anolli
- Division of Gastroenterology and Hepatology, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy
| | - Marco Distefano
- UOC Malattie Infettive, Ospedale Umberto I di Siracusa, ASP Siracusa, Siracusa, Italy
| | - Salvatore Petta
- Section of Gastroenterology and Hepatology, PROMISE, University of Palermo, Palermo, Italy
| | - Francesco Paolo Russo
- Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy
- Gastroenterology and Multivisceral Transplant Unit, Azienda Ospedale-Università di Padova, Padua, Italy
| | - Vito Di Marco
- Section of Gastroenterology and Hepatology, PROMISE, University of Palermo, Palermo, Italy
| | - Alessio Aghemo
- Division of Internal Medicine and Hepatology, Department of Gastroenterology, IRCCS Humanitas Research Hospital, Rozzano, Italy
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy
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Genowska A, Zarębska-Michaluk D, Strukcinskiene B, Razbadauskas A, Moniuszko-Malinowska A, Jurgaitis J, Flisiak R. Changing Epidemiological Patterns of Infection and Mortality Due to Hepatitis C Virus in Poland. J Clin Med 2023; 12:3922. [PMID: 37373617 DOI: 10.3390/jcm12123922] [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: 04/04/2023] [Revised: 05/10/2023] [Accepted: 06/06/2023] [Indexed: 06/29/2023] Open
Abstract
INTRODUCTION Limited information is available on trends in hepatitis C virus (HCV) infection, particularly in Central Europe. To address this knowledge gap, we analyzed HCV epidemiology in Poland, considering socio-demographic characteristics, changing patterns over time, and the impact of the COVID-19 pandemic. MATERIAL AND METHODS We examined HCV cases (diagnosis and deaths) reported by national registries and used joinpoint analysis to estimate time trajectories. RESULTS Between 2009 and 2021, there were changes in the trends of HCV, shifting from positive to negative in Poland. Among men, there was a significant increase initially in diagnosis rate of HCV in rural areas (annual percent change, APC2009-2016 +11.50%) and urban areas (APC2009-2016 +11.44%) by 2016. In subsequent years until 2019, the trend changed direction, but the reduction was weak (Ptrend > 0.05) in rural areas (-8.66%) and urban areas (-13.63%). During the COVID-19 pandemic, the diagnosis rate of HCV dramatically decreased in rural areas (APC2019-2021 -41.47%) and urban areas (APC2019-2021 -40.88%). Among women, changes in the diagnosis rate of HCV were less pronounced. In rural areas, there was a significant increase (APC2009-2015 +20.53%) followed by no significant change, whereas changes occurred later in urban areas (APC2017-2021 -33.58%). Trend changes in total mortality due to HCV were mainly among men, with a significant decrease in rural (-17.17%) and urban (-21.55%) areas from 2014/2015. CONCLUSIONS The COVID-19 pandemic reduced HCV diagnosis rates in Poland, especially for diagnosed cases. However, further monitoring of HCV trends is necessary, along with national screening programs and improved linkage to care.
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Affiliation(s)
- Agnieszka Genowska
- Department of Public Health, Medical University of Bialystok, 15-295 Bialystok, Poland
| | - Dorota Zarębska-Michaluk
- Department of Infectious Diseases and Allergology, Jan Kochanowski University, 25-317 Kielce, Poland
| | | | | | - Anna Moniuszko-Malinowska
- Department of Infectious Diseases and Neuroinfections, Medical University of Bialystok, 15-540 Bialystok, Poland
| | - Jonas Jurgaitis
- Faculty of Health Sciences, Klaipeda University, LT-92294 Klaipeda, Lithuania
| | - Robert Flisiak
- Department of Infectious Diseases and Hepatology, Medical University of Bialystok, 15-540 Bialystok, Poland
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6
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Brzdęk M, Zarębska-Michaluk D, Rzymski P, Lorenc B, Kazek A, Tudrujek-Zdunek M, Janocha-Litwin J, Mazur W, Dybowska D, Berak H, Parfieniuk-Kowerda A, Klapaczyński J, Sitko M, Sobala-Szczygieł B, Piekarska A, Flisiak R. Changes in characteristics of patients with hepatitis C virus-related cirrhosis from the beginning of the interferon-free era. World J Gastroenterol 2023; 29:2015-2033. [PMID: 37155527 PMCID: PMC10122793 DOI: 10.3748/wjg.v29.i13.2015] [Citation(s) in RCA: 8] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/21/2022] [Revised: 01/16/2023] [Accepted: 03/20/2023] [Indexed: 04/06/2023] Open
Abstract
BACKGROUND Nearly 290000 patients with chronic hepatitis C die annually from the most severe complications of the disease. One of them is liver cirrhosis, which occurs in about 20% of patients chronically infected with the hepatitis C virus (HCV). Direct-acting antivirals (DAAs), which replaced interferon (IFN)-based regimens, significantly improved the prognosis of this group of patients, increasing HCV eradication rates and tolerability of therapy. Our study is the first to assess changes in patient profile, effectiveness, and safety in the HCV-infected cirrhotic population in the IFN-free era.
AIM To document changes in patient characteristics and treatment regimens along with their effectiveness and safety profile over the years.
METHODS The studied patients were selected from 14801 chronically HCV-infected individuals who started IFN-free therapy between July 2015 and December 2021 in 22 Polish hepatology centers. The retrospective analysis was conducted in real-world clinical practice based on the EpiTer-2 multicenter database. The measure of treatment effectiveness was the percentage of sustained virologic response (SVR) calculated after excluding patients lost to follow-up. Safety data collected during therapy and the 12-wk post-treatment period included information on adverse events, including serious ones, deaths, and treatment course.
RESULTS The studied population (n = 3577) was balanced in terms of gender in 2015-2017, while the following years showed the dominance of men. The decline in the median age from 60 in 2015-2016 to 57 years in 2021 was accompanied by a decrease in the percentage of patients with comorbidities and comedications. Treatment-experienced patients dominated in 2015-2016, while treatment-naive individuals gained an advantage in 2017 and reached 93.2% in 2021. Genotype (GT)-specific options were more prevalent in treatment in 2015-2018 and were supplanted by pangenotypic combinations in subsequent years. The effectiveness of the therapy was comparable regardless of the period analyzed, and patients achieved an overall response rate of 95%, with an SVR range of 72.9%-100% for the different therapeutic regimens. Male gender, GT3 infection, and prior treatment failure were identified as independent negative predictors of therapeutic success.
CONCLUSION We have documented changes in the profile of HCV-infected cirrhotic patients over the years of accessibility to changing DAA regimens, confirming the high effectiveness of IFN-free therapy in all analyzed periods.
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Affiliation(s)
- Michał Brzdęk
- Department of Infectious Diseases, Jan Kochanowski University, Kielce 25-317, Poland
| | | | - Piotr Rzymski
- Department of Environmental Medicine, Poznan University of Medical Sciences, Poznań 60-806, Poland
- Integrated Science Association, Universal Scientific Education and Research Network, Poznań 60-806, Poland
| | - Beata Lorenc
- Pomeranian Center of Infectious Diseases, Medical University Gdańsk, Gdańsk 80-214, Poland
| | | | | | - Justyna Janocha-Litwin
- Department of Infectious Diseases and Hepatology, Medical University Wrocław, Wrocław 50-367, Poland
| | - Włodzimierz Mazur
- Clinical Department of Infectious Diseases, Clinical University of Silesia in Katowice, Chorzów 41-500, Poland
| | - Dorota Dybowska
- Department of Infectious Diseases and Hepatology, Faculty of Medicine, Nicolaus Copernicus University, Bydgoszcz 85-030, Poland
| | - Hanna Berak
- Daily Department, Hospital for Infectious Diseases in Warsaw, Warszawa 01-201, Poland
| | - Anna Parfieniuk-Kowerda
- Department of Infectious Diseases and Hepatology, Medical University of Białystok, Białystok 15-089, Poland
| | - Jakub Klapaczyński
- Department of Internal Medicine and Hepatology, Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warszawa 00-241, Poland
| | - Marek Sitko
- Department of Infectious and Tropical Diseases, Jagiellonian University, Kraków 31-088, Poland
| | - Barbara Sobala-Szczygieł
- Department of Infectious Diseases, Medical University of Silesia in Katowice, Bytom 41-902, Poland
| | - Anna Piekarska
- Department of Infectious Diseases and Hepatology, Medical University of Łódź, Łódź 90-419, Poland
| | - Robert Flisiak
- Department of Infectious Diseases and Hepatology, Medical University of Białystok, Białystok 15-089, Poland
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Burgui C, San Miguel R, Goñi-Esarte S, Juanbeltz R, Úriz-Otano JI, Reparaz J, Sarobe M, Zozaya JM, Castilla J. Effectiveness of hepatitis C antiviral treatment and feasibility of hepatitis C elimination goal. Postgrad Med 2022; 135:352-360. [PMID: 36305320 DOI: 10.1080/00325481.2022.2141499] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/06/2022]
Abstract
OBJECTIVES Second-generation direct-acting antivirals (DAAs) have shown high efficacy in the treatment of chronic hepatitis C virus (HCV) infections in clinical trials. This study aimed to estimate the effectiveness in real-life conditions and their capacity to eliminate HCV infection in the general population. METHODS In this observational cohort study, patients with active HCV infection who commenced DAA treatment between 2015 and 2020 in Navarre, Spain, were studied. Sustained virological response (SVR), defined as an undetectable viral load 12 weeks after the end of treatment, was evaluated until the end of 2021. RESULTS Of a total 1366 HCV-infected patients that commenced treatment, 19.3% (n = 263) were HIV-coinfected. After the first DAA treatment, SVR was achieved in 96.6% (n = 1320/1366) of patients and in 97.7% (95% confidence interval [CI] 96.6%-98.3%) of those who completed treatment (per-protocol analysis; n = 1320/1351). SVR was achieved in 97.9% (n = 1066/1089) and 96.9% (n = 254/262) of mono-infected and HIV-coinfected patients, respectively. Thirty-one patients had virological failure due to non-response (n = 19), poor compliance (n = 9), and with adverse events (n = 3). Of 27 patients that received a second treatment, 24 attained SVR (one after a third treatment), two died, and one that did not achieve SVR declined a third treatment. Three patients were re-infected, re-treated, and achieved SVR. At the end of the study, 1344 patients (98.4%, 95% CI 97.6%-98.9%) had achieved SVR, and only 1.8% needed more than one course of treatment. All patients who completed the treatment and were followed-up achieved SVR. CONCLUSION With DAAs, SVR was achieved in all patients with active HCV infection who completed follow-up, and a second course of treatment was only necessary in a small proportion of patients. Adherence to treatment is essential for HCV infection elimination.
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Affiliation(s)
- Cristina Burgui
- Instituto de Salud Pública de Navarra, Pamplona, Spain
- CIBER Epidemiología y Salud Pública (CIBERESP), Spain
- Instituto de Investigación Sanitaria de Navarra (IdiSNA), Pamplona, Spain
| | - Ramón San Miguel
- Instituto de Investigación Sanitaria de Navarra (IdiSNA), Pamplona, Spain
- Servicio de Farmacia Hospitalaria, Hospital Universitario de Navarra, Pamplona, Spain
| | - Silvia Goñi-Esarte
- Servicio de Digestivo, Hospital Universitario de Navarra, Pamplona, Spain
| | - Regina Juanbeltz
- CIBER Epidemiología y Salud Pública (CIBERESP), Spain
- Instituto de Investigación Sanitaria de Navarra (IdiSNA), Pamplona, Spain
- Servicio de Farmacia Hospitalaria, Hospital Universitario de Navarra, Pamplona, Spain
| | - Juan Isidro Úriz-Otano
- Instituto de Investigación Sanitaria de Navarra (IdiSNA), Pamplona, Spain
- Servicio de Digestivo, Hospital Universitario de Navarra, Pamplona, Spain
| | - Jesús Reparaz
- Instituto de Investigación Sanitaria de Navarra (IdiSNA), Pamplona, Spain
- Servicio de Medicina Interna, Hospital Universitario de Navarra, Pamplona, Spain
| | - Maite Sarobe
- Instituto de Investigación Sanitaria de Navarra (IdiSNA), Pamplona, Spain
- Servicio de Farmacia Hospitalaria, Hospital Universitario de Navarra, Pamplona, Spain
| | - José Manuel Zozaya
- Instituto de Investigación Sanitaria de Navarra (IdiSNA), Pamplona, Spain
- Servicio de Digestivo, Hospital Universitario de Navarra, Pamplona, Spain
| | - Jesús Castilla
- Instituto de Salud Pública de Navarra, Pamplona, Spain
- CIBER Epidemiología y Salud Pública (CIBERESP), Spain
- Instituto de Investigación Sanitaria de Navarra (IdiSNA), Pamplona, Spain
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8
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Molecular Epidemiology and Baseline Resistance of Hepatitis C Virus to Direct Acting Antivirals in Croatia. Pathogens 2022; 11:pathogens11070808. [PMID: 35890052 PMCID: PMC9323280 DOI: 10.3390/pathogens11070808] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/23/2022] [Revised: 07/15/2022] [Accepted: 07/18/2022] [Indexed: 02/04/2023] Open
Abstract
Molecular epidemiology of hepatitis C virus (HCV) is exceptionally complex due to the highly diverse HCV genome. Genetic diversity, transmission dynamics, and epidemic history of the most common HCV genotypes were inferred by population sequencing of the HCV NS3, NS5A, and NS5B region followed by phylogenetic and phylodynamic analysis. The results of this research suggest high overall prevalence of baseline NS3 resistance associate substitutions (RAS) (33.0%), moderate prevalence of NS5A RAS (13.7%), and low prevalence of nucleoside inhibitor NS5B RAS (8.3%). Prevalence of RAS significantly differed according to HCV genotype, with the highest prevalence of baseline resistance to NS3 inhibitors and NS5A inhibitors observed in HCV subtype 1a (68.8%) and subtype 1b (21.3%), respectively. Phylogenetic tree reconstructions showed two distinct clades within the subtype 1a, clade I (62.4%) and clade II (37.6%). NS3 RAS were preferentially associated with clade I. Phylogenetic analysis demonstrated that 27 (9.0%) HCV sequences had a presumed epidemiological link with another sequence and classified into 13 transmission pairs or clusters which were predominantly comprised of subtype 3a viruses and commonly detected among intravenous drug users (IDU). Phylodynamic analyses highlighted an exponential increase in subtype 1a and 3a effective population size in the late 20th century, which is a period associated with an explosive increase in the number of IDU in Croatia.
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HCV Elimination in Central Europe with Particular Emphasis on Microelimination in Prisons. Viruses 2022; 14:v14030482. [PMID: 35336889 PMCID: PMC8952509 DOI: 10.3390/v14030482] [Citation(s) in RCA: 13] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/29/2021] [Revised: 02/13/2022] [Accepted: 02/25/2022] [Indexed: 11/16/2022] Open
Abstract
In 2016, the WHO announced a plan to eliminate viral hepatitis as a public health threat by 2030. In this narrative review, experts from Bulgaria, Croatia, the Czech Republic, Hungary, Latvia, Lithuania, Poland and Slovakia assessed the feasibility of achieving the WHO 2030 target for HCV infections in Central Europe. They focused mainly on HCV micro-elimination in prisons, where the highest incidence of HCV infections is usually observed, and the impact of the COVID-19 pandemic on the detection and treatment of HCV infections. According to the presented estimates, almost 400,000 people remain infected with HCV in the analyzed countries. Interferon-free therapies are available ad libitum, but the number of patients treated annually in the last two years has halved compared to 2017–2019, mainly due to the COVID-19 pandemic. None of the countries analyzed had implemented a national HCV screening program or a prison screening program. The main reason is a lack of will at governmental and prison levels. None of the countries analyzed see any chance of meeting the WHO targets for removing viral hepatitis from the public threat list by 2030, unless barriers such as a lack of political will and a lack of screening programs are removed quickly.
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10
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Romagnoli D. Elimination of hepatitis C virus infection in Europe: targeting the obstacles. EXPLORATION OF MEDICINE 2022:71-76. [DOI: 10.37349/emed.2022.00075] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/23/2021] [Accepted: 12/29/2021] [Indexed: 01/03/2025] Open
Affiliation(s)
- Dante Romagnoli
- Gastroenterology Unit, Polyclinic, Azienda Ospedaliero-Universitaria di Modena, 41124 Modena, Italy
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11
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Grgurevic I, Bozin T, Mikus M, Kukla M, O’Beirne J. Hepatocellular Carcinoma in Non-Alcoholic Fatty Liver Disease: From Epidemiology to Diagnostic Approach. Cancers (Basel) 2021; 13:5844. [PMID: 34830997 PMCID: PMC8616369 DOI: 10.3390/cancers13225844] [Citation(s) in RCA: 33] [Impact Index Per Article: 8.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/03/2021] [Revised: 11/14/2021] [Accepted: 11/17/2021] [Indexed: 12/12/2022] Open
Abstract
Non-alcoholic fatty liver disease (NAFLD) is becoming the leading cause of liver morbidity worldwide and, as such, represents the pathogenic background for the increasing incidence of hepatocellular carcinoma (HCC). The annual incidence of NAFLD-related HCC is expected to increase by 45-130% by 2030. Diabetes mellitus is the most important risk factor for HCC development in NAFLD, with the risk further increased when associated with other metabolic traits, such as obesity, arterial hypertension and dyslipidemia. The highest risk of HCC exists in patients with advanced fibrosis or cirrhosis, although 20-50% of HCC cases arise in NAFLD patients with an absence of cirrhosis. This calls for further investigation of the pathogenic mechanisms that are involved in hepatocarcinogenesis, including genetics, metabolomics, the influence of the gut microbiota and immunological responses. Early identification of patients with or at risk of NAFLD is of utmost importance to improve outcomes. As NAFLD is highly prevalent in the community, the identification of cases should rely upon simple demographic and clinical characteristics. Once identified, these patients should then be evaluated for the presence of advanced fibrosis or cirrhosis and subsequently enter HCC surveillance programs if appropriate. A significant problem is the early recognition of non-cirrhotic NAFLD patients who will develop HCC, where new biomarkers and scores are potential solutions to tackle this issue.
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Affiliation(s)
- Ivica Grgurevic
- Department of Gastroenterology, Hepatology and Clinical Nutrition, University Hospital Dubrava, 10 000 Zagreb, Croatia;
- Faculty of Pharmacy and Biochemistry, School of Medicine, University of Zagreb, 10 000 Zagreb, Croatia
| | - Tonci Bozin
- Department of Gastroenterology, Hepatology and Clinical Nutrition, University Hospital Dubrava, 10 000 Zagreb, Croatia;
| | - Mislav Mikus
- Department of Obstetrics and Gynecology, University Hospital Centre Zagreb, 10 000 Zagreb, Croatia;
| | - Michal Kukla
- Department of Internal Medicine and Geriatrics, Faculty of Medicine, Jagiellonian University Medical College, 30688 Cracow, Poland;
| | - James O’Beirne
- Department of Hepatology, University of the Sunshine Coast, Sunshine Coast 4556, Australia;
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