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Elbaz T, Al-Naamani K, Abosheaishaa H, Alswat K, El-Kassas M. Leading Role of Sofosbuvir/Daclatasvir in Achieving Hepatitis C Elimination in Egypt. J Viral Hepat 2025; 32:e70032. [PMID: 40433912 DOI: 10.1111/jvh.70032] [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: 12/04/2024] [Revised: 01/09/2025] [Accepted: 05/03/2025] [Indexed: 05/29/2025]
Abstract
Chronic hepatitis C virus (HCV) management has historically been challenging, particularly in Egypt, the country with the highest global disease prevalence. The introduction of direct-acting antivirals (DAAs) has revolutionised treatment, providing high rates of sustained virologic response (SVR) with fewer adverse events compared to previous therapies. In Egypt, the locally produced generics of sofosbuvir/daclatasvir (SOF/DAC) have been integral to the national HCV elimination programme, treating millions effectively and affordably, demonstrating similar efficacy and safety to brand-name drugs. Although not currently present in most international guidelines, this cost-effective regimen offers a viable option for large-scale elimination programmes similar to Egypt's successful experience. This review synthesises real-world Egyptian data and highlights the efficacy and safety of the SOF/DAC combination in various population groups. High sustained virological response (SVR) rates were observed across diverse patient populations, including those with advanced liver disease. However, limitations regarding long-term follow-up, especially HCC surveillance, were identified, underscoring the need for further research. Additionally, the review underscores the success of local Egyptian pharmaceutical policies in reducing treatment costs and securing access for all infected individuals. The Egyptian experience offers valuable insights into the potential for replicating its success, particularly in other high-burden regions.
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Affiliation(s)
- Tamer Elbaz
- Endemic Hepatology and Gastroenterology Department, Faculty of Medicine, Cairo University, Cairo, Egypt
- Hepatology and Gastroenterology Department, Faculty of Medicine, New Giza University, Cairo, Egypt
| | - Khalid Al-Naamani
- Department of Medicine, Division of Gastroenterology and Hepatology, The Medical City for Military and Security Services, Muscat, Oman
| | - Hazem Abosheaishaa
- Internal Medicine, Icahn School of Medicine at Mount Sinai, New York City Health and Hospitals, Queens Hospital Center, New York, New York, USA
| | - Khalid Alswat
- Liver Disease Research Center, College of Medicine, King Saud University, Riyadh, Saudi Arabia
| | - Mohamed El-Kassas
- Endemic Medicine Department, Faculty of Medicine, Helwan University, Cairo, Egypt
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Behery ME, Elghwab A, Tabll AA, Elsayed EH, Abdelrazek MA. Serum collagen IV as a predictor for response to direct-acting antivirals hepatitis C therapy. J Immunoassay Immunochem 2024; 45:539-548. [PMID: 39402774 DOI: 10.1080/15321819.2024.2415882] [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] [Indexed: 11/12/2024]
Abstract
Althoughchronic hepatitis C (CHC) therapies based on direct-acting antiviral (DAA) agents safely improved treatment effectiveness, some cases do not obtain sustained virological response (SVR) and, thus, evaluating factors that may be related to treatment failure is very important. We aimed to evaluate the association of baseline serum collagen IV with DAA treatment failure in Egyptian patients with CHC. A total of 175 CHC patients (100 responders and 75non-responders tosofosbuvir/daclatasvir) were included. Collagen IV was assessed using sensitive chemiluminescent immunoassay. There was distinctly higher (P < 0.0001) collagen IV in non-responders compared to responder patients as the median (interquartile range) were 19.02 (13.4-25.2) vs.9.7 (7.2-12.3) µg/L, respectively. Collagen IV has a good ability for distinguishing nonresponders from responder patients (AUC = 0.890) with sensitivity of 92%, specificity 72%, PPV 71.1%, NPV 92.3% and accuracy of 80.6%. Collagen IV was correlated (p < 0.05) with decreased albumin (r=-0.266), elevated APRI (r = 0.288), and elevated FIB-4 (r = 0.281) scores. In conclusion,these findings suggested the remarkable role of baseline collagen IV in the prediction of HCV DAAs treatment response. Thus, however further studies are needed, its measurement may improve treatment duration and the disease control.
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Affiliation(s)
- Mohammed El Behery
- Chemistry Department, Faculty of Science, Port Said University, Port Said, Egypt
| | - AhmedI Elghwab
- Chemistry Department, Faculty of Science, Port Said University, Port Said, Egypt
| | - Ashraf A Tabll
- Microbial Biotechnology Department, Biotechnology Research Institute, National Research Centre, Giza, Egypt
| | - Elsherbiny H Elsayed
- Chemistry Department, Faculty of Science, Port Said University, Port Said, Egypt
| | - Mohamed A Abdelrazek
- Sherbin Central Hospital, Ministry of Health and Population, Shirbin, Egypt
- Research and Development Department, Biotechnology Research Center, New Damietta, Egypt
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Shousha HI, Abdelghafour R, Dabees H, AbdelRazek W, Said M. Three regimens for re-treatment failure of Sofosbuvir-based therapy for chronic hepatitis-C genotype-4: a cohort study. Rev Inst Med Trop Sao Paulo 2022; 64:e50. [PMID: 36074445 PMCID: PMC9448256 DOI: 10.1590/s1678-9946202264050] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/15/2021] [Accepted: 03/30/2022] [Indexed: 12/24/2022] Open
Abstract
Despite the high sustained virologic response (SVR) rates of direct-acting antiviral (DAAs) therapy, a small number of patients does not eradicate the virus, and these patients represent a challenge. This study aims to compare the outcomes of three second-line regimens for DAAs-experienced patients with chronic hepatitis C (CHC). This prospective observational study was conducted at the Damanhur Viral Hepatitis Center from January 2017 to February 2020. We included patients with CHC who did not achieve SVR after the complete course of Sofosbuvir/Daclatasvir±Ribavirin (SOF/DAC±RBV). The primary endpoint was SVR-12 after re-treatment. This study included 360 patients (with a mean age of 51.53±11.38 years). Approximately 51.1% of the patients were males, and 65.5% had liver cirrhosis. All patients of group 1 (45 patients) received SOF/VEL/VOX over 12-weeks; SVR-12 was achieved in 44 patients (97.8%). Group 2 (28 patients) received SOF/DAC/RBV over 24-weeks; (one patient was lost during follow-ups and one patient discontinued treatment due to hepatic decompensation). SVR-12 was achieved in 25 patients (96.2%). Group 3 (287 patients) received SOF/Ombitasvir/Paritaprevir/Ritonavir/RBV) over 12-weeks. Eight patients were lost during follow-ups, and one patient discontinued treatment due to grade 4 adverse events. SVR-12 was achieved in 276 patients (99.3%). There was no difference between the groups regarding their age, gender distribution, baseline viral load or comorbidities. Adverse events (thrombocytopenia, anemia, hyperbilirubinaemia and prolonged INR) were significantly higher in group 3, while group 1 did not experience any. The three studied retreatment regimens can be used for DAAs treatment-experienced patients considering availability. The SOF/VEL/VOX combination had the least adverse events.
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Affiliation(s)
- Hend Ibrahim Shousha
- Cairo University, Faculty of Medicine, Endemic Medicine and Hepato-Gastroenterology Department, Cairo, Egypt
| | | | - Hosam Dabees
- National Medical Institute of Damanhour, Damanhour, Egypt
| | - Wael AbdelRazek
- Menofia University, National Liver Institute, Menofia, Egypt
| | - Mohamed Said
- Cairo University, Faculty of Medicine, Endemic Medicine and Hepato-Gastroenterology Department, Cairo, Egypt
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Interleukin 28B Polymorphism as a Predictor of Sustained Virological Response to Sofosbuvir-Based Therapy for Hepatitis C Virus Patients. Trop Med Infect Dis 2022; 7:tropicalmed7090230. [PMID: 36136642 PMCID: PMC9501239 DOI: 10.3390/tropicalmed7090230] [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: 08/01/2022] [Revised: 08/28/2022] [Accepted: 09/01/2022] [Indexed: 11/17/2022] Open
Abstract
In various genome-wide correlation studies, interleukin (IL)28B gene polymorphism has been strongly correlated with both the therapeutic and spontaneous mediated clearance of hepatitis C virus (HCV). Therefore, this study aimed to evaluate the genotype and allele frequency distributions of IL28B (rs12979860) in patients with chronic hepatitis C and assess the IL28B polymorphisms as predictors of sustained virological response to SOF-based therapy for HCV in Egyptian patients. This retrospective case-control study was conducted on 54 chronic HCV patients who completed treatment with SOF/DCV ± RBV for 12 weeks and responded to treatment with SVR12 (the responder group) as a control group, and 54 chronic HCV patients who completed treatment with SOF/DCV ± RBV for 12 weeks and did not respond to treatment and failed to achieve SVR12 (the non-responder group) as a case group. The CC genotype frequency of IL-28B (rs12979860) was greater in the responder group (51.9%). In contrast, the TT genotype frequency was higher in the non-responder group (48.1%) (p < 0.001), and the T allele significantly increased the risk of non-responses by 3.13 fold. Therefore IL-28B (rs12979860) SNP could be used as a genetic predictor of sustained virological response to SOF+DCV ± RBV-based HCV treatment in Egyptian patients.
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Hassnine AA, Soliman W, Elsayed AM, Higazi MM, Saied M, Abdelraheem EM. Effect of direct-acting antiviral drugs on portal circulation hemodynamics in cirrhotic patients infected with HCV. EGYPTIAN LIVER JOURNAL 2022. [DOI: 10.1186/s43066-022-00181-4] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/10/2022] Open
Abstract
Abstract
Background
Liver cirrhosis (LC) is the most common cause of portal hypertension. In chronic hepatitis C patients who are treated with direct-acting antiviral therapy (DAAS), the progression of cirrhosis can be reversed with treatment. Portal hypertension is also expected to improve with a virological response.
Aim
To evaluate the effect of direct-acting antiviral therapy on portal circulation hemodynamics in cirrhotic patients infected with HCV.
Methods
This study included 78 consecutive patients with chronic HCV-related liver disease. They were treated by a sofosbuvir-based regimen in combination with daclatasavir. All patients were subjected to routine investigations (complete blood count, liver and renal function tests), hepatitis B surface antigen, α feto protein, PCR of HCV RNA, imaging (abdominal ultrasound and colored Doppler and duplex examination for the assessment portal hypertension) before starting treatment and after 1 year.
Results
There was a significant improvement in Doppler parameters such as portal vein (PV) diameter, PV velocity, PV cross-sectional area, portal congestive index, splenic vein diameter, and spleen span; the decrease in portal pressure occur in about 55% of the patients; several factors are associated with non-response as a history of bilharziasis, patients from a rural area, presence of splenomegaly and varices, low HB level, low platelet count, and high level of fibrosis.
Conclusion
Sustained virological response to direct-acting antiviral therapy is associated with a reduction in portal pressure in patients with liver cirrhosis and clinically significant portal hypertension.
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El Raziky M, Hamdy S, Hamada Y, Abdelaziz NM, Hassany M, Doss W, Zakaria Z. Efficacy and safety of sofosbuvir and daclatasvir in patients with chronic hepatitis C virus induced cirrhosis with Child-Pugh class B. EGYPTIAN LIVER JOURNAL 2022. [DOI: 10.1186/s43066-022-00174-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/10/2022] Open
Abstract
Abstract
Background
This study aimed to evaluate the efficacy, safety and tolerability of SOF/DCV ± RBV in a cohort of Egyptian patients with chronic hepatitis C (CHC)-induced cirrhosis with decompensation (class B7–B9).
Results
After excluding the 9 patients who withdrew, SVR12 rate according to per protocol analysis was 82.9% (92/111), non-response and relapse rates were 2.7% (3/111) for each, 4 patients died secondary to hematemesis, and 8.1% stopped therapy due to worsening of Child’s class. SVR12 rate was significantly higher among patients with higher baseline WBCs count and lower among patients with Child-Pugh class B9. All treatment intolerant patients had ascites in pre-treatment assessment (P = 0.02). There was a significant decline in the levels of hemoglobin, ALT and AST, and serum bilirubin (P < 0.001) and a significant increase in albumin level (P < 0.001) at the end of treatment when compared to their pre-treatment levels. Follow-up of the three HCC did not show evidence of tumor recurrence.
Conclusions
The SOF/DCV combination ± ribavirin is an effective and safe regimen for patients with CHC induced cirrhosis with mild decompensation. Treatment did not increase the risk of HCC recurrence.
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Abdel-Razik A, Shabana W, El Nakib AM, Abdelsalam M, Abdelwahab A, Hasan AS, Elzehery R, Elhelaly R, Fathy AA, Mostafa SA, El-Wakeel N, Moemen D, Eldars W, Yassen AH. De Novo Hepatocellular Carcinoma in Hepatitis C-Related Cirrhosis: Are Advanced Glycation End Products a Key Driver? Front Cell Infect Microbiol 2021; 11:662431. [PMID: 34660332 PMCID: PMC8517490 DOI: 10.3389/fcimb.2021.662431] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/01/2021] [Accepted: 08/23/2021] [Indexed: 11/23/2022] Open
Abstract
Background and Purpose The advanced glycation end products (AGEs) have been implicated in different diseases’ pathogenesis, but their role in hepatocellular carcinoma (HCC) is still a matter of debate. This study aims to investigate the association of AGEs with HCC development in patients with hepatitis C-related cirrhosis. Methods Only 153 of the 181 non-diabetic patients with cirrhosis were consecutively involved in this pilot cohort prospective study, along with 34 healthy control participants. Demographic characteristics, biochemical parameters, clinical data, and AGEs levels in all subjects at the starting point and every year after that for two years were assessed. Multivariable Cox regression analysis was used to settle variables that could predict HCC development within this period. Results HCC developed in 13 (8.5%) patients. Univariate Cox regression analysis reported that body mass index (P=0.013), homeostatic model assessment-insulin resistance (P=0.006), alpha-fetoprotein (P <0.001), and AGEs levels (P <0.001) were related to HCC development. After adjusting multiple confounders, the multivariable Cox regression model has revealed that AFP and AGEs were the powerful parameters related to the HCC occurrence (all P<0.05). AGEs at a cutoff value of more than 79.6 ng/ml had 100% sensitivity, 96.4% specificity, and 0.999 area under the curve (all P<0.001), using the receiver operating characteristic curve, for prediction of HCC development. Conclusion This work suggests that AGEs are associated with an increased incidence of HCC, particularly in cirrhosis, which is encouraging in decreasing the risk of HCC in these patients.
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Affiliation(s)
- Ahmed Abdel-Razik
- Tropical Medicine Department, Faculty of Medicine, Mansoura University, Mansoura City, Egypt
| | - Walaa Shabana
- Tropical Medicine Department, Faculty of Medicine, Mansoura University, Mansoura City, Egypt
| | - Ahmed Mohamed El Nakib
- Tropical Medicine Department, Faculty of Medicine, Mansoura University, Mansoura City, Egypt
| | - Mostafa Abdelsalam
- Nephrology and Dialysis Unit, Internal Medicine Department, Faculty of Medicine, Mansoura University, Mansoura City, Egypt
| | - Ahmed Abdelwahab
- Nephrology and Dialysis Unit, Internal Medicine Department, Faculty of Medicine, Mansoura University, Mansoura City, Egypt
| | - Ahmad S Hasan
- Clinical Pathology Department, Faculty of Medicine, Mansoura University, Mansoura City, Egypt
| | - Rasha Elzehery
- Clinical Pathology Department, Faculty of Medicine, Mansoura University, Mansoura City, Egypt
| | - Rania Elhelaly
- Clinical Pathology Department, Faculty of Medicine, Mansoura University, Mansoura City, Egypt
| | - Aya Ahmed Fathy
- Public Health and Community Department, Faculty of Medicine, Mansoura University, Mansoura City, Egypt
| | - Sally Abdallah Mostafa
- Medical Biochemistry and Molecular Biology Department, Faculty of Medicine, Mansoura University, Mansoura City, Egypt
| | - Niveen El-Wakeel
- Medical Microbiology and Immunology Department, Faculty of Medicine, Mansoura University, Mansoura City, Egypt
| | - Dalia Moemen
- Medical Microbiology and Immunology Department, Faculty of Medicine, Mansoura University, Mansoura City, Egypt
| | - Waleed Eldars
- Medical Microbiology and Immunology Department, Faculty of Medicine, Mansoura University, Mansoura City, Egypt
| | - Ahmed H Yassen
- Tropical Medicine Department, Faculty of Medicine, Mansoura University, Mansoura City, Egypt
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Effectiveness of Direct-Acting Antivirals in Treatment of Elderly Egyptian Chronic Hepatitis C Patients. GASTROENTEROLOGY INSIGHTS 2021. [DOI: 10.3390/gastroent12030031] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/20/2022] Open
Abstract
Background: Hepatitis C virus treatment has dramatically improved by direct-acting antiviral (DAA) therapy. The aim of this study was to assess the efficacy and safety of DAA in elderly Egyptian chronic hepatitis C (CHC) patients. Methods: The study was carried out on 327 CHC elderly patients >60 years; patients were divided into 3 age subgroups (<65, 65–75 and >75 years) on DAA therapy for 12 weeks. Ninety-one patients (27.8%) were treated with dual therapy, 234 patients (71.6%) with triple therapy and 2 patients (0.6%) with quadrable therapy. Results: All patients achieved end-of-treatment virological response (100%). ALT levels normalized during therapy. The follow-up rate of sustained virological response at 12 weeks after the end of treatment (SVR12) was 100%. One hundred and two patients had missed SVR12 data due to being lost tofollow-up. Two hundred twenty-two adverse events were reported (67.8%), including anemia in 30 patients (9.1%), leucopenia in 129 patients (39.4%) and thrombocytopenia in 63 patients (19.2%). No serious side effects led to discontinuation of therapy. No hepatic decompensation was observed, and no patients died. Conclusion: Age does not influence the success of DAA treatment and all DAA regimens are well tolerated, safe and highly efficacious, even in those aged 75 years or older.
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Nagaty A, Helmy SH, Abd El-Wahab EW. Sofosbuvir-/Daclatasvir-based therapy for chronic HCV and HCV/hepatitis B virus coinfected patients in Egypt. Trans R Soc Trop Med Hyg 2021; 114:200-212. [PMID: 31722032 DOI: 10.1093/trstmh/trz079] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/04/2019] [Revised: 03/25/2019] [Accepted: 07/11/2019] [Indexed: 12/18/2022] Open
Abstract
BACKGROUND Dramatic advances in hepatitis C virus (HCV) treatment were witnessed with the introduction of direct-acting antivirals (DAAs). Generic DAAs with remarkable efficacy and good safety profiles are currently manufactured by local pharmaceutical companies in Egypt. METHODS In the real-world setting, of a total of 367 patients chronically infected with HCV, 289 (277 treatment-naïve and 12 treatment-experienced) patients were enrolled. Approximately 15% of the patients were coinfected with hepatitis B virus (HBV). Patients were treated with sofosbuvir+daclatasvir with or without ribavirin for 12 or 24 wk as the standard of care. HBV DNA levels were monitored throughout the study. RESULTS A sustained virologic response at 12 wk (SVR12) was achieved in 98.3% of the patients. All non-responders were treatment-naïve and the response rate among treatment-experienced patients was 100.0%. Elevated α-fetoprotein and treatment with sofosbuvir+daclatasvir+ribavirin for 6 mo were predictors of non-response (OR [95% CI] = 1.06 [1.02 to 1.1] and 15.9 [1.8 to 136.2]; p<0.05, respectively). No HBV reactivation was noticed throughout the treatment and follow-up periods in HCV/HBV coinfected patients. CONCLUSION The present real-world findings add to the evidence for the efficacy of generic DAAs for the treatment of patients infected with HCV. HBV reactivation is unlikely to occur in those coinfected with HBV. Although liver cirrhosis affected the outcome, pretreatment liver chemistry did not seem to correlate with the results of treatment.
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Affiliation(s)
- Ahmed Nagaty
- Consultant of Hepatogastroentrology and Infectious Diseases, Ministry of Health and Population, 21568 Alexandria, Egypt
| | - Sherine Ha Helmy
- Medical Consultant, R&D Project Innovations, Pharco Pharamaceutical Corporation, 679 El Horreya Road, 21569 Alexandria, Egypt
| | - Ekram W Abd El-Wahab
- Tropical Health Department, High Institute of Public Health, Alexandria University, 165 El Horreya Road, 21561 Alexandria, Egypt
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Li J, Casey JL, Greenwald ZR, Yasseen III AS, Dickie M, Feld JJ, Cooper CL, Crawley AM. The 9th Canadian Symposium on Hepatitis C Virus: Advances in HCV research and treatment towards elimination. CANADIAN LIVER JOURNAL 2021; 4:59-71. [PMID: 35991475 PMCID: PMC9203168 DOI: 10.3138/canlivj-2020-0026] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/07/2020] [Accepted: 08/09/2020] [Indexed: 08/31/2024]
Abstract
Hepatitis C virus (HCV) elimination has evolved into a coordinated global effort. Canada, with more than 250,000 chronically infected individuals, is among the countries leading this effort. The 9th Canadian Symposium on HCV, held in February 2020, thus established and addressed its theme, 'advances in HCV research and treatment towards elimination', by gathering together basic scientists, clinicians, epidemiologists, social scientists, and community members interested in HCV research in Canada. Plenary sessions showcased topical research from prominent international and national researchers, complemented by select abstract presentations. This event was hosted by the Canadian Network on Hepatitis C (CanHepC), with support from the Public Health Agency of Canada and the Canadian Institutes of Health Research and in partnership with the Canadian Liver Meeting. CanHepC has an established record in HCV research by its members and in its advocacy activities to address the care, treatment, diagnosis, and immediate and long-term needs of those affected by HCV infection. Many challenges remain in tackling chronic HCV infection, such as the need for a vaccine; difficult-to-treat populations and unknown aspects of patient subgroups, including pregnant women and children; vulnerable people; and issues distinct to Indigenous peoples. There is also increasing concern about long-term clinical outcomes after successful treatment, with the rise in comorbidities such as diabetes, cardiovascular disease, and fatty liver disease and the remaining risk for hepatocellular carcinoma in cirrhotic individuals. The symposium addressed these topics in highlighting research advances that will collectively play an important role in eliminating HCV and minimizing subsequent health challenges.
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Affiliation(s)
- Jiafeng Li
- Department of Biochemistry, Microbiology and Immunology, University of Ottawa, Ottawa, Ontario, Canada
- Chronic Disease Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
- Centre for Infection, Immunity and Inflammation, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada
| | - Julia L Casey
- Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada
- Toronto General Hospital Research Institute, University Health Network, Toronto, Ontario, Canada
| | - Zoë R Greenwald
- Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada
| | - Abdool S Yasseen III
- Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada
| | - Melisa Dickie
- Knowledge Exchange Division, Community AIDS Treatment Information Exchange, Toronto, Ontario, Canada
| | - Jordan J Feld
- Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada
- Toronto General Hospital Research Institute, University Health Network, Toronto, Ontario, Canada
- Toronto Centre for Liver Disease, Toronto General Hospital, Toronto, Ontario, Canada
| | - Curtis L Cooper
- Centre for Infection, Immunity and Inflammation, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada
- Division of Infectious Diseases, The Ottawa Hospital, Ottawa, Ontario, Canada
- School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada
- Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
| | - Angela M Crawley
- Department of Biochemistry, Microbiology and Immunology, University of Ottawa, Ottawa, Ontario, Canada
- Chronic Disease Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
- Centre for Infection, Immunity and Inflammation, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada
- Department of Biology, Carleton University, Ottawa, Ontario, Canada
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Elsayed A, M Abdelraheem E, Hassan H, Abbas A, Hassnine A. Efficacy of antiviral therapy in patients with post-hepatitis C liver cirrhosis: is hyperuricaemia a potential adverse effect? BMJ Open Gastroenterol 2020; 7:e000533. [PMID: 33310750 PMCID: PMC7735097 DOI: 10.1136/bmjgast-2020-000533] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/29/2020] [Revised: 10/06/2020] [Accepted: 11/18/2020] [Indexed: 12/12/2022] Open
Abstract
UNLABELLED Hepatitis C virus (HCV) related liver cirrhosis is considered a major health problem; sofosbuvir (SOF)/ledipasvir (LDV) and SOF/daclatsvir (DACLA) are very promising direct antiviral agents (DAAS) especially in treating HCV genotype 4 which is the main genotype in Egypt. Uric acid elevation was reported in many systemic diseases and might be elevated during direct antiviral therapy. The aim is to evaluate efficacy and safety of SOF/LDV and SOF/DACLA plus ribavirin in treating HCV related child A liver cirrhosis and assess hyperuricaemia as a potential adverse effect to this regimen. METHODS This prospective observatinal study included 128 HCV naive child A cirrhotic patients divided into two groups (77 patients were treated with SOF 400 mg, DACLA 60 mg and ribavirin 600 mg and 51 patients were treated with SOF 400 mg, LDV 90 mg and ribavirin 600 mg) for 12 weeks, during the treatment complete blood count, creatinine, bilirubin, alanine transaminase, aspartate transaminase and serum uric acid were monitored, HCV RNA quantitative PCR at 12 weeks after the end of treatment was done. RESULTS Response to treatment in SOF/LDV (sof/led) group is about (98%), response to treatment in SOF/DACLA (sof/dacla) group is about (96%). Hyperuricaemia was noticed in 17.6% of patients received sof/led and in 15.5% of those received sof/dacla. CONCLUSION SOF+LDV and SOF+DACLA plus ribavirin regimens are highly effective in treating chronic HCV patients with compensated liver cirrhosis. Hyperuricaemia is considered a potential adverse effect to DAAS containing ribavirin and may lead to serious side effects such as renal impairment.
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Affiliation(s)
- Amr Elsayed
- Gasteroentrology and Tropical Diseases, Minia University Faculty of Medicine, El Minia, Egypt
| | - Ehab M Abdelraheem
- Gasteroentrology and Tropical Diseases, Minia University Faculty of Medicine, El Minia, Egypt
| | - Hatem Hassan
- Department of Internal Medicine, Minia University Faculty of Medicine, El Minia, Egypt
| | - Abbas Abbas
- Department of Biochemistry and Molecular Biology, Cairo University Kasr Alainy Faculty of Medicine, Cairo, Egypt
| | - Alshymaa Hassnine
- Gasteroentrology and Tropical Diseases, Minia University Faculty of Medicine, El Minia, Egypt
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12
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Abdel-Razik A, Mousa N, Zakaria S, Abdelsalam M, Eissa M, Abd El-Ghany MI, Hasan AS, Elhelaly R, Elzehery R, El-Wakeel N, Eldars W. Advanced Glycation End Products as a Predictor of Diabetes Mellitus in Chronic Hepatitis C-Related Cirrhosis. Front Med (Lausanne) 2020; 7:588519. [PMID: 33195350 PMCID: PMC7649387 DOI: 10.3389/fmed.2020.588519] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/29/2020] [Accepted: 09/25/2020] [Indexed: 12/16/2022] Open
Abstract
Background and Aims: Advanced glycation end products (AGEs) were found to be involved in the pathogenesis of various disorders. Chronic hepatitis C virus infection is the major cause of liver cirrhosis development and glucose metabolism alteration. We aimed to explore the association of AGEs with the development of diabetes mellitus (DM) in patients with cirrhosis in this study. Methods: Only 144 of the 165 non-diabetic patients with cirrhosis were consecutively included in this prospective cohort pilot study, in addition to 72 healthy control subjects. Clinical data and biochemical parameters including basal insulin secretion and insulin sensitivity indices together with AGEs were evaluated in all participants at baseline and every 1 year thereafter for 2 years. Multivariable Cox regression analysis was used to determine the parameters that could predict the development of DM within this period. Results: DM developed in 14 (10%) patients only. Univariate Cox regression analysis showed that AGEs (P = 0.004), Homeostatic Model Assessment-Insulin Resistance (HOMA-IR) (P = 0.018), HOMA-β (P = 0.015), and age (P = 0.012) were associated with DM. After adjusting multiple confounders, the multivariable Cox regression model showed that AGEs, HOMA-IR, and age were the strongest variables associated with DM (all P < 0.05). Using the receiver operating characteristic curve, AGEs at a cutoff value of more than 82.4 ng/ml had 99.23% specificity, 100% sensitivity, and 0.992 area under the curve (AUC) (all P < 0.001) for DM prediction. Conclusion: Our study suggests that AGEs are related to increased incidence of DM, especially in patients with cirrhosis, which is very promising in lowering the risk of DM in these patients.
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Affiliation(s)
- Ahmed Abdel-Razik
- Tropical Medicine Department, Faculty of Medicine, Mansoura University, Mansoura, Egypt
| | - Nasser Mousa
- Tropical Medicine Department, Faculty of Medicine, Mansoura University, Mansoura, Egypt
| | - Sahar Zakaria
- Tropical Medicine Department, Faculty of Medicine, Mansoura University, Mansoura, Egypt
| | - Mostafa Abdelsalam
- Nephrology and Dialysis Unit, Internal Medicine Department, Faculty of Medicine, Mansoura University, Mansoura, Egypt
| | - Mohamed Eissa
- Internal Medicine Department, Faculty of Medicine, Mansoura University, Mansoura, Egypt
| | - Mohammed I. Abd El-Ghany
- Endocrinology and Diabetes Unit, Internal Medicine Department, Faculty of Medicine, Mansoura University, Mansoura, Egypt
| | - Ahmad S. Hasan
- Clinical Pathology Department, Faculty of Medicine, Mansoura University, Mansoura, Egypt
| | - Rania Elhelaly
- Clinical Pathology Department, Faculty of Medicine, Mansoura University, Mansoura, Egypt
| | - Rasha Elzehery
- Clinical Pathology Department, Faculty of Medicine, Mansoura University, Mansoura, Egypt
| | - Niveen El-Wakeel
- Medical Microbiology and Immunology Department, Faculty of Medicine, Mansoura University, Mansoura, Egypt
| | - Waleed Eldars
- Medical Microbiology and Immunology Department, Faculty of Medicine, Mansoura University, Mansoura, Egypt
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Li J, Wu DB, Jiang W, Chen XB, Xiao GB, Wang YH, Wang ML, Tao YC, Chen EQ. Efficacy and safety of sofosbuvir-based pangenotypic direct-acting antiviral agents for chronic hepatitis C patients without genotype determination: Real-world experience of a retrospective study. Medicine (Baltimore) 2020; 99:e22726. [PMID: 33120769 PMCID: PMC7581131 DOI: 10.1097/md.0000000000022726] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/30/2020] [Revised: 08/16/2020] [Accepted: 09/15/2020] [Indexed: 02/07/2023] Open
Abstract
Several new, pangenotypic direct-acting antiviral agents (DAAs) have been approved, may reduce the need for genotyping to guide therapy decisions for patients with chronic hepatitis C (CHC).This study aimed to investigate the efficacy and safety of Sofosbuvir (SOF)-based pangenotypic DAAs therapy for CHC patients without genotype (GT determination in the real-world practice.This retrospective cohort study included treatment-naïve CHC patients without GT determination, who received SOF-based DAAs therapy, including 400 mg SOF plus 60 mg daclatasvir (DCV) daily or 400 mg SOF plus 100 mg velpatasvir (VEL) daily for 12 or 24 weeks. Clinical and laboratory data, including sustained virologic response (SVR), were obtained at baseline, end of treatment (EOT), 12 weeks after EOT, and 48 weeks after EOT.A total of 95 CHC patients, including 30 (31.58%) had liver cirrhosis were enrolled. SVR rates after 12 weeks of treatment (SVR12) was 96.84% (92/95), including 96.20% (76/79) of patients receiving SOF plus DCV and 100% (16/16) of patients receiving SOF plus VEL. For 92 patients achieving an SVR12, no virological relapse was observed at 48 weeks after EOT. Furthermore, serum evaluation of liver fibrosis aspartate aminotransferase-to-platelet ratio index and Fibrosis-4 score were decreased significantly at EOT and 12 weeks after EOT, compared to pre-treatment values (both P < .05). Treatment was well-tolerated by our patients.SOF-based pangenotypic DAAs including SOF plus DCV and SOF plus VEL, were effective and safe for CHC patients without GT determination in this study. This may provide a potential simple strategy for CHC treatment without GT determination.
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Affiliation(s)
- Juan Li
- Department of Infectious Diseases, Pidu District People's Hospital
| | - Dong-Bo Wu
- Center of Infectious Diseases, West China Hospital, Sichuan University, Chengdu
| | - Wei Jiang
- Center of Infectious Diseases, West China Hospital, Sichuan University, Chengdu
| | - Xue-Bin Chen
- Department of Infectious Diseases, People's Hospital of Deyang City
| | - Gui-Bao Xiao
- Department of Infectious Diseases, the First People's Hospital of Ziyang, Sichuan, PR China
| | - Yong-Hong Wang
- Center of Infectious Diseases, West China Hospital, Sichuan University, Chengdu
| | - Meng-Lan Wang
- Center of Infectious Diseases, West China Hospital, Sichuan University, Chengdu
| | - Ya-Chao Tao
- Center of Infectious Diseases, West China Hospital, Sichuan University, Chengdu
| | - En-Qiang Chen
- Center of Infectious Diseases, West China Hospital, Sichuan University, Chengdu
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14
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Wang A, Sun B, Wang M, Shi H, Huang Z, He T, Li Q, Deng J, Fu W, Jiang Y. Predictive value of CONUT score combined with serum CA199 levels in postoperative survival of patients with pancreatic ductal adenocarcinoma: a retrospective study. PeerJ 2020; 8:e8811. [PMID: 32219033 PMCID: PMC7085292 DOI: 10.7717/peerj.8811] [Citation(s) in RCA: 10] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/15/2019] [Accepted: 02/27/2020] [Indexed: 12/11/2022] Open
Abstract
Background The preoperative controlling nutritional status (CONUT) score and serum carbohydrate antigen 199 (CA199) levels are individually correlated with the prognosis of pancreatic ductal adenocarcinoma (PDAC). The objective of this study aimed to investigate the efficacy of CONUT score and CA199 (CONUT-CA199) combination in predicting the prognosis of PDAC patients undergoing radical surgery. Methods We retrospectively analyzed the preoperative CONUT scores and serum CA199 levels of 294 patients with PDAC who underwent radical resection at the Affiliated Hospital of Southwest Medical University between March 2012 and July 2019. Patients were divided into four groups on the basis of their preoperative CONUT scores and serum CA199 levels: CONUTlow/CA199low (1), CONUTlow/CA199high (2), CONUThigh/CA199low (3) and CONUThigh/CA199high (4). The prognostic effects were compared among the groups. Results CONUThigh was more frequent in patients with positive peripancreatic infiltration and Clavien–Dindo classification of ≥IIIa (P < 0.001). Kaplan–Meier analysis revealed obvious difference in overall survival (OS) and recurrence-free survival (RFS) among patients with PDAC having CONUT-CA199 scores of 1, 2, 3 and 4 (P < 0.001). Peripancreatic infiltration, lymph node metastasis, pTNM stage, CONUT score, serum CA199 levels and CONUT-CA199 classification were found to be the independent prognostic factors for OS and RFS in multivariate analyses. In time-dependent receiver operating characteristic (ROC) analyses, the area of the CONUT-CA199 score under the ROC curve (AUC) was higher than that of the preoperative CONUT score or serum CA199 levels for the prediction of OS and RFS. Conclusion CONUT-CA199 classification may be more effective in predicting the postoperative prognosis of PDAC patients.
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Affiliation(s)
- Ankang Wang
- Department of Hepatobiliary Surgery, The Affiliated Hospital of Southwest Medical University, Sichuan, China.,Department of General Surgery, Nanchong Central Hospital, The Second Clinical College of North Sichuan Medical College, Nanchong, Sichuan, China
| | - Bo Sun
- Department of Hepatobiliary Surgery, The Affiliated Hospital of Southwest Medical University, Sichuan, China
| | - Min Wang
- Department of Nutrition, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, China
| | - Hao Shi
- Department of Hepatobiliary Surgery, The Affiliated Hospital of Southwest Medical University, Sichuan, China
| | - Zhiwei Huang
- Department of Hepatobiliary Surgery, The Affiliated Hospital of Southwest Medical University, Sichuan, China
| | - Tao He
- Department of Hepatobiliary Surgery, The Affiliated Hospital of Southwest Medical University, Sichuan, China
| | - Qiu Li
- Department of Hepatobiliary Surgery, The Affiliated Hospital of Southwest Medical University, Sichuan, China
| | - Jiaqi Deng
- Department of Ultrasound, The Affiliated Hospital of Southwest Medical University, Sichuan, China
| | - Wenguang Fu
- Department of Hepatobiliary Surgery, The Affiliated Hospital of Southwest Medical University, Sichuan, China
| | - Yu Jiang
- Department of Hepatobiliary Surgery, The Affiliated Hospital of Southwest Medical University, Sichuan, China
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15
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Charatcharoenwitthaya P, Wongpaitoon V, Komolmit P, Sukeepaisarnjaroen W, Tangkijvanich P, Piratvisuth T, Sanpajit T, Sutthivana C, Bunchorntavakul C, Sobhonslidsuk A, Chonprasertsuk S, Siripipattanamongkol C, Sethasine S, Tanwandee T. Real-world effectiveness and safety of sofosbuvir and nonstructural protein 5A inhibitors for chronic hepatitis C genotype 1, 2, 3, 4, or 6: a multicentre cohort study. BMC Gastroenterol 2020; 20:47. [PMID: 32138687 PMCID: PMC7057522 DOI: 10.1186/s12876-020-01196-0] [Citation(s) in RCA: 13] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Key Words] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/05/2019] [Accepted: 02/17/2020] [Indexed: 02/07/2023] Open
Abstract
Background We investigated real-world effectiveness and safety of sofosbuvir and the nonstructural protein 5A inhibitors in the treatment of patients infected with hepatitis C virus (HCV) genotypes 1, 2, 3, 4, or 6. Methods We analyzed data from 1021 patients with HCV infection (506 with genotype 1; 16 with genotype 2; 314 with genotype 3; 13 with genotype 4; 166 with genotype 6) who received 12 to 24 weeks of daclatasvir plus sofosbuvir (n = 767), ledipasvir/sofosbuvir (n = 197), or sofosbuvir/velpatasvir (n = 57), with or without ribavirin in 12 centers across Thailand to estimate sustained virologic response at post-treatment week 12 (SVR12). Results Overall, SVR12 rate was 98.0% (95% confidence interval [CI], 96.7–98.8%) with daclatasvir plus sofosbuvir, 97.9% (95% CI, 94.8–99.2%) with ledipasvir/sofosbuvir, and 96.5% (95% CI, 88.1–99.0%) with sofosbuvir/velpatasvir. SVR12 was achieved by 99.2% (95% CI, 97.9–99.7%) of subjects with genotype 1 infection, 100% (95% CI, 78.5–100%) of those with genotype 2 infection, 96.7% (95% CI, 94.0–98.2%) of those with genotype 3 infection, 90.9% (95% CI, 62.3–98.4%) of those with genotype 4 infection, and 96.7% (95% CI 92.5–98.6%) of those with genotype 6 infection. Patients with advanced liver disease were at risk of treatment failure. Only four patients discontinued treatment before week 4 due to non-hepatic adverse events. Conclusions In this large cohort of patients with various HCV genotypes managed in the real-world practice setting, daclatasvir plus sofosbuvir, ledipasvir/sofosbuvir, and sofosbuvir/velpatasvir achieved high SVR rates with good safety profile, comparable to those observed in clinical trials.
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Affiliation(s)
| | | | - Piyawat Komolmit
- Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand
| | | | | | | | | | | | | | | | | | | | | | - Tawesak Tanwandee
- Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand
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16
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El-Khayat H, Kamal EM, Mahmoud H, Gomaa A, Ebeid B, Sameh Y, Hasseb A, El Raziky M, El Serafy M, Doss W, Esmat G, Fouad Y, Attia D. Retreatment of chronic hepatitis C virus genotype-4 patients after non-structural protein 5A inhibitors' failure: efficacy and safety of different regimens. Eur J Gastroenterol Hepatol 2020; 32:440-446. [PMID: 31688311 DOI: 10.1097/meg.0000000000001581] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
Abstract
BACKGROUND Nonstructural protein 5A (NS5A) is an important regimen for the treatment of chronic hepatitis C virus (HCV) genotype-4 infected patients. Retreatments for NS5A virologic failure are limited. The aim of this study is to provide real-life data regarding the effectiveness and safety of retreatment with different regimens after NS5A regimen virologic failure in GT4 patients. PATIENTS AND METHODS A total of 524 HCV patients (mean age 48 ± 11 years, 71% males), with virologic failure to sofosbuvir+daclatasvir, n = 450 and sofosbuvir/ledipasvir, n = 74 were included in this study. Patients were retreated with sofosbuvir + ombitasvir/paritaprevir/ritonavir + ribavirin, n = 278 and sofosbuvir + simeprevir + daclatasvir + ribavirin, n = 246. Response was evaluated 12 weeks after the end of treatment (SVR12). RESULTS Overall, SVR12 was 95.2% [95% confidence interval (CI) 93.3%-97.1%]. In sofosbuvir + ombitasvir/paritaprevir/ritonavir + ribavirin and sofosbuvir + simeprevir + daclatasvir + ribavirin, SVR12s were 94.9% (95% CI 92.5%-97.4%) and 95.5% (95% CI 92.8%-98%), respectively. In liver cirrhosis patients, SVR12s were 96.4% (95% CI 90.7%-100%) and 98% (95% CI 94.9%-100%), respectively. Relapse in the sofosbuvir + ombitasvir/paritaprevir/ritonavir + ribavirin was n = 14 patients, and n = 11 patients in sofosbuvir + simeprevir + daclatasvir + ribavirin. Three patients developed hepatic encephalopathy, haematemesis, lower limb oedema, and one patient died in the SOF + OBV/PTV/RTV + RIB. In the sofosbuvir + simeprevir + daclatasvir + ribavirin, three patients developed hepatocellular carcinoma and one patient died. No treatment discontinuation due to anaemia. CONCLUSION Salvage treatment for NS5A-treatment failure is effective and well tolerated in genotype-4 patients, in both noncirrhotic and compensated cirrhotic groups.
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Affiliation(s)
- Hisham El-Khayat
- Department of Gastroenterology, Hepatology and Endemic Medicine, Theodor Bilharz Institute
| | - Enas M Kamal
- Department of Gastroenterology, Hepatology and Endemic Medicine, Faculty of Medicine, Minia University Hospitals, Minya
| | - Hani Mahmoud
- Department of Gastroenterology, Hepatology and Endemic Medicine, Faculty of Medicine, Beni-Suef University, Beni-Suef
| | - Ahmed Gomaa
- Department of Gastroenterology, Hepatology and Endemic Medicine, Faculty of Medicine, Fayoum University, Faiyum
| | - Bassel Ebeid
- Department of Gastroenterology, Hepatology and Endemic Medicine, Faculty of Medicine, Fayoum University, Faiyum
| | - Yehia Sameh
- Department of Gastroenterology, Hepatology and Endemic Medicine, Faculty of Medicine, Beni-Suef University, Beni-Suef
| | - Alaa Hasseb
- Department of Gastroenterology, Hepatology and Endemic Medicine, Faculty of Medicine, Beni-Suef University, Beni-Suef
| | - Maissa El Raziky
- Department of Gastroenterology, Hepatology and Endemic Medicine, Faculty of Medicine, Cairo University
| | - Magdy El Serafy
- National Committee of Viral Hepatitis MOH, Cairo University, Cairo, Egypt
| | - Wahid Doss
- National Committee of Viral Hepatitis MOH, Cairo University, Cairo, Egypt
| | - Gamal Esmat
- National Committee of Viral Hepatitis MOH, Cairo University, Cairo, Egypt
| | - Yasser Fouad
- Department of Gastroenterology, Hepatology and Endemic Medicine, Faculty of Medicine, Minia University Hospitals, Minya
| | - Dina Attia
- Department of Gastroenterology, Hepatology and Endemic Medicine, Faculty of Medicine, Beni-Suef University, Beni-Suef
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Hussein HA, Allam AS, Moaty ASA. Evaluation of Glycated Haemoglobin (HbA1c) Level in Type 2 Diabetic Chronic HCV Non-cirrhotic Treatment-Naïve Egyptian Patients Eradicated with Sofosbuvir Plus Daclatasvir. Curr Diabetes Rev 2020; 16:165-170. [PMID: 31146663 DOI: 10.2174/1573399815666190531091128] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/08/2019] [Revised: 04/13/2019] [Accepted: 05/05/2019] [Indexed: 12/13/2022]
Abstract
UNLABELLED Background /Introduction: A high prevalence of type 2 diabetes mellitus (T2DM) was seen in association with hepatitis C virus infection; moreover, risk of development of T2DM is increased about 11 folds in patients with risk factors for metabolic syndrome in the presence of chronic hepatitis C virus (HCV) infection. There is a few available data on the effect of HCV eradication by the new direct-acting antiviral drugs (DAAs) on the glycemic control; hence the aim of our study is to evaluate the glycated haemoglobin (HbA1c) level changes in type 2 diabetic chronic HCV non cirrhotic treatment-naïve Egyptian patients after eradication with sofosbuvir (SOV) plus daclatasvir (DCV). PATIENTS AND METHODS A prospective observational cross-sectional study, included 128 type 2 diabetic HCV patients with easy to treat criteria (non cirrhotic treatment-naïve patients with the following liver biochemical markers; total serum bilirubin ≤ 1.2 mg/dl, serum albumin ≥ 3.5 g/dl, INR≤ 1.2 and Platelet count≥ 150.000/mm3); according to the protocol of the Egyptian National Committee for Controlling HCV and the guidelines of the European Association for the Study of the Liver. HbA1c was done for all patients enrolled in the study before starting antiviral treatment, at the end of treatment and 3 months (12 weeks) after the end of treatment to patients who achieved sustained virological response (SVR) 12 only. RESULTS According to their antidiabetic medications, patients were classified to Group I: 70 patients taking oral hypoglycemic drugs, Group II: 58 patients taking insulin therapy +/- oral hypoglycemic drugs. Regarding the glycemic profile, a statistically significant decrease of mean HbA1c % values was found in the studied patients (n=128), over the period of the study with p-value < 0.05. For better evaluation of improvement of glycemic control, we used a composite endpoint given by the reduction of HbA1c % (of a minimum of 0.5%). The endpoint was reached to 79% (101 patients) of all studied patients 3 months after the end of treatment. 75.7% (53 patients) reached the endpoint in group I, while 82.75 % (48 patients) of group II reached the endpoint 3 months after the end of treatment. CONCLUSION This study supports the idea that HCV eradication leads to a reduction in HbA1c in patients with diabetes, which could delay the onset and progression of microvascular diabetes complications.
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Affiliation(s)
- Hany Aly Hussein
- Internal Medicine Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt
| | - Ahmed Samir Allam
- Internal Medicine Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt
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18
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Ibrahim Mohammed Ebid AH, Ashraf Ahmed O, Hassan Agwa S, Mohamed Abdel-Motaleb S, Mohamed Elsawy A, Hagag RS. Safety, efficacy and cost of two direct-acting antiviral regimens: A comparative study in chronic hepatitis C Egyptian patients. J Clin Pharm Ther 2019; 45:539-546. [PMID: 31889322 DOI: 10.1111/jcpt.13104] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/29/2019] [Revised: 11/26/2019] [Accepted: 11/29/2019] [Indexed: 12/16/2022]
Abstract
WHAT IS KNOWN AND OBJECTIVE Direct-acting antivirals (DAAs) have become the most widely used treatment of chronic hepatitis C infection. Comparative studies on DAAs regimens approved by the Egyptian Ministry of Health for easy-to-treat genotype 4 (G4) Egyptian patients are still deficient. In this prospective study, we compared the efficacy and cost of two DAA regimens that are used in the treatment of Egyptian chronic hepatitis C virus (HCV) G4. The cost-saving regimen is determined. METHODS Eligible patients were randomized into 2 groups. Group 1 (Gp 1) received sofosbuvir plus daclatasvir, and group 2 (Gp 2) received ombitasvir, paritaprevir and ritonavir plus ribavirin (RBV) for 12 weeks. Data were collected and evaluated at baseline and at weeks 4, 8 and 12. Sustained virologic response 12 weeks after the end of treatment (SVR12 ) was evaluated. Cost-minimization analysis (CMA) was performed. RESULTS AND DISCUSSION Eligibility was achieved in 107 patients, Gp1 included 57 patients, and Gp 2 included 50 patients. Two patients dropped out from Gp 2 due to non-compliance. All patients in the two groups showed negative HCV blood levels at the end of treatment. At the 24th week, 3 relapsers (5.2%) were detected in Gp1 and 2 relapsers (4.1%) were detected in Gp 2. SVR12 was 54/57 (94.7%) and 46/48 (95.8%) for Gp 1 and Gp 2, respectively. After the 12th week of treatment, a significant decrease in aspartate aminotransferase (AST), alanine aminotransferase (ALT) and haemoglobin levels were observed in both groups. Albumin levels declined in Gp 2 only. CMA showed higher cost in Gp 2 than Gp 1, although similar efficacy and safety. WHAT IS NEW AND CONCLUSION The two DAA regimens showed high SVR12 and safety in Egyptian HCV G4 patients. Sofosbuvir plus daclatasvir is the cost-saving regimen.
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Affiliation(s)
| | - Osama Ashraf Ahmed
- Department of Internal Medicine, Faculty of Medicine, Ain Shams University, Cairo, Egypt
| | - Sara Hassan Agwa
- Department of Clinical & Chemical Pathology at MASRI, Faculty of Medicine, Ain Shams University, Cairo, Egypt
| | | | - Amira Mohamed Elsawy
- Department of Pharmacy Practice, Faculty of Pharmacy, Helwan University, Cairo, Egypt
| | - Radwa Samir Hagag
- Department of Pharmacy Practice, Faculty of Pharmacy, Egyptian Russian University, Badr City, Egypt
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19
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Smolders EJ, Jansen AME, Ter Horst PGJ, Rockstroh J, Back DJ, Burger DM. Viral Hepatitis C Therapy: Pharmacokinetic and Pharmacodynamic Considerations: A 2019 Update. Clin Pharmacokinet 2019; 58:1237-1263. [PMID: 31114957 PMCID: PMC6768915 DOI: 10.1007/s40262-019-00774-0] [Citation(s) in RCA: 48] [Impact Index Per Article: 8.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
It has been estimated by the World Health Organization (WHO) that over 71 million people were infected with the hepatitis C virus (HCV) in 2015. Since then, a number of highly effective direct-acting antiviral (DAA) regimens have been licensed for the treatment of chronic HCV infection: sofosbuvir/daclatasvir, sofosbuvir/ledipasvir, elbasvir/grazoprevir, sofosbuvir/velpatasvir, glecaprevir/pibrentasvir, and sofosbuvir/velpatasvir/voxilaprevir. With these treatment regimens, almost all chronic HCV-infected patients, even including prior DAA failures, can be treated effectively and safely. It is therefore likely that further development of DAAs will be limited. In this descriptive review we provide an overview of the clinical pharmacokinetic characteristics of currently available DAAs by describing their absorption, distribution, metabolism, and excretion. Potential drug-drug interactions with the DAAs are briefly discussed. Furthermore, we summarize what is known about the pharmacodynamics of the DAAs in terms of efficacy and safety. We briefly discuss the relationship between the pharmacokinetics of the DAAs and efficacy or toxicity in special populations, such as hard to cure patients and patients with liver cirrhosis, liver transplantation, renal impairment, hepatitis B virus or HIV co-infection, bleeding disorders, and children. The aim of this overview is to educate/update prescribers and pharmacists so that they are able to safely and effectively treat HCV-infected patients even in the presence of underlying co-infections or co-morbidities.
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Affiliation(s)
- Elise J Smolders
- Department of Pharmacy, Isala Hospital, Dokter van Heesweg 2, 8025 AB, Zwolle, The Netherlands.
- Department of Pharmacy, Radboud Institute of Health Sciences (RIHS), Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, The Netherlands.
| | - Anouk M E Jansen
- Department of Pharmacy, Isala Hospital, Dokter van Heesweg 2, 8025 AB, Zwolle, The Netherlands
| | - Peter G J Ter Horst
- Department of Pharmacy, Isala Hospital, Dokter van Heesweg 2, 8025 AB, Zwolle, The Netherlands
| | - Jürgen Rockstroh
- Department of Internal Medicine I, University Hospital Bonn, Bonn, Germany
| | - David J Back
- Department of Clinical and Molecular Pharmacology, University of Liverpool, Liverpool, UK
| | - David M Burger
- Department of Pharmacy, Radboud Institute of Health Sciences (RIHS), Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, The Netherlands
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20
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El-Khayat H, Kamal EM, Yakoot M, Gawad MA, Kamal N, El Shabrawi M, Sameh Y, Haseeb A, Fouad Y, Attia D. Effectiveness of 8-week sofosbuvir/ledipasvir in the adolescent chronic hepatitis C-infected patients. Eur J Gastroenterol Hepatol 2019; 31:1004-1009. [PMID: 30676473 DOI: 10.1097/meg.0000000000001360] [Citation(s) in RCA: 13] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/18/2022]
Abstract
BACKGROUND The sustained virological response (SVR) rate for the 12-week sofosbuvir (SOF)/ledipasvir (LVD) treatment of adolescent genotype-4 patients is high. The aim of this study is to evaluate 8 versus 12-week treatment efficacy and safety in adolescent genotype-4 patients. PATIENTS AND METHODS In total, 157 chronic hepatitis C-infected adolescent patients (mean age 14±2 years, 62% males) were included in this study. All patients received a morning dose of SOF (400 mg)/LVD (90 mg) as a single tablet for 8 and 12 weeks. Laboratory and biochemical monitoring were performed at weeks 4 and 8, end of treatment (8/12) and 12 weeks after the end of treatment (SVR12). RESULTS In total, SVR12 was 98% [95% confidence interval (CI): 96-100] for all treated patients. For patients treated for 12 weeks, SVR12 was 97.6% (95% CI: 96-101) (82/84 patients), and 98.6% (95% CI: 93-101) (72/73) patients for those treated for 8 weeks. For both regimens, no serious adverse effects, treatment discontinuation or cases of death were detected. The main adverse effects for the 8-week patient group were fatigue (2.8%), headache (1.4%), nausea (1.4%) and epigastric tenderness (1.4%). For the 12-week-treated group, adverse events were epigastric tenderness (1.2%), nausea (1.2%), diarrhoea (2.4%) and rash (2.4%). Three patients were lost to follow-up: two were in the 12-week treatment group and one was in the 8-week group. All of them reached end of treatment but were lost before SVR12. No relapsers were observed in either group. CONCLUSION Eight weeks of treatment of SOF/LVD combination is equally effective and safe as 12 weeks in adolescent genotype-4 patients.
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Affiliation(s)
- Hesham El-Khayat
- Department of Gastroenterology, Hepatology and Endemic Medicine, Theodore Bilharz Research Institute
| | - Enas M Kamal
- Department of Gastroenterology, Hepatology and Endemic Medicine, Minia University Hospitals, Minia
| | | | - Manal A Gawad
- Pediatrics and Pediatrics Hepatology Department, Faculty of Medicine, Alexandria University, Alexandria
| | - Naglaa Kamal
- Pediatric and Pediatrics Hepatology Department, Faculty of Medicine, Cairo University, Cairo
| | - Mortada El Shabrawi
- Pediatric and Pediatrics Hepatology Department, Faculty of Medicine, Cairo University, Cairo
| | - Yehia Sameh
- Department of Hepatology, Gastroenterology and Endemic Medicine, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt
| | - Alaa Haseeb
- Department of Hepatology, Gastroenterology and Endemic Medicine, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt
| | - Yasser Fouad
- Department of Gastroenterology, Hepatology and Endemic Medicine, Minia University Hospitals, Minia
| | - Dina Attia
- Department of Hepatology, Gastroenterology and Endemic Medicine, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt
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21
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Lv DD, Wang ML, Chen EQ, Wu DB, Tao YC, Zhang DM, Tang H. A retrospective study of the efficacy of sofosbuvir plus NS5A inhibitors for patients with hepatitis C virus genotype-2 chronic infection. Eur J Gastroenterol Hepatol 2019; 31:382-388. [PMID: 30383554 DOI: 10.1097/meg.0000000000001299] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/05/2023]
Abstract
BACKGROUND A combination of sofosbuvir (SOF)+NS5A inhibitor therapies is the main treatment for patients with hepatitis C virus (HCV) genotype-2 (GT-2) chronic infection, but the data are rarely reported in China. This study aimed to investigate the virological response and liver fibrosis improvement among GT-2 patients receiving SOF+NS5A inhibitors. PATIENTS AND METHODS In this retrospective study, patients who received SOF+NS5A inhibitors between March 2016 and July 2017 were recruited. The treatment duration was 12 weeks and the treatment strategies included SOF+daclatasvir, SOF/ledipasvir, and SOF/velpatasvir. The primary endpoint was a sustained virologic response (serum HCV RNA undetectable) at week 12 after the end of therapy and the secondary endpoint was the improvement in liver stiffness and scores of apartate aminotransferase to platelet ratio index and fibrosis-4. RESULTS A total of 30 GT-2 patients were enrolled, with 13 (43.3%) patients in SOF+daclatasvir, 13 (43.3%) patients in SOF/ledipasvir, and four (13.3%) patients in SOF/velpatasvir. All patients [30/30 (100%)] achieved SVR, irrespective of treatment regimens and degree of liver fibrosis. After the treatment, liver fibrosis scores of apartate aminotransferase to platelet ratio index (2.27±2.14 vs. 0.89±0.77, P=0.003) and fibrosis-4 (1.17±1.22 vs. 0.42±0.25, P=0.013) were both significantly lower than those before treatment. CONCLUSION SOF+NS5A inhibitor therapies may induce an excellent virological response and fibrosis improvement in HCV GT-2-infected patients.
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Affiliation(s)
- Duo-Duo Lv
- Center of Infectious Diseases, West China Hospital of Sichuan University, Chengdu, People's Republic of China
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22
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Abdel Ghaffar TY, El Naghi S, Abdel Gawad M, Helmy S, Abdel Ghaffar A, Yousef M, Moafy M. Safety and efficacy of combined sofosbuvir/daclatasvir treatment of children and adolescents with chronic hepatitis C Genotype 4. J Viral Hepat 2019; 26:263-270. [PMID: 30380158 DOI: 10.1111/jvh.13032] [Citation(s) in RCA: 29] [Impact Index Per Article: 4.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/13/2018] [Accepted: 10/03/2018] [Indexed: 12/16/2022]
Abstract
Direct-acting antivirals have become available for treating chronic HCV (hepatitis C virus) infection in adults and, recently, in children at least 12 years old. Our aim was to investigate the safety and efficacy of combined sofosbuvir (SOF)/daclatasvir (DCV) for HCV Genotype 4 in children aged 8 to 18 years or weighing 17 kg or more. A total of 40 chronic HCV-infected, treatment-naïve children with well compensated livers were recruited from two sites. Patients received combined therapy of SOF (400 mg/d for patients weighing greater than 45 kg; 200 mg/d for patients weighing 17 to 45 kg) and DCV (60 mg/d for patients weighing greater than 45 kg; 30 mg/d for patients weighing 17 to 45 kg) for 12 weeks. They were followed up regularly by clinical examination and laboratory tests during treatment (weekly in the first month then monthly to the end of treatment), every 3 months for 6 months post-treatment, and at 48 weeks post-treatment. In our cohort, which included 45% of children below the age of 12 years (72.5% genotype 4 and 27.5% mixed genotype 4 and 1), end of treatment response (ETR) was 97.5%. Sustained virologic response for weeks 12 and 24 post-treatment (SVR12 and SVR24) were 97.5% and 95%, respectively, on an intention to treat basis, and 100% and 100% for those who completed the study protocol. Observed side effects were mild and none required drug cessation. Combined SOF/DCV was found to be effective and safe for treating HCV Genotype 4-infected children, 8 years of age and above.
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Affiliation(s)
- Tawhida Y Abdel Ghaffar
- Yassin Abdel Ghaffar Charity Center for Liver Disease and Research, Cairo, Egypt.,Department of Pediatrics, Ain Shams University, Cairo, Egypt
| | - Suzan El Naghi
- Yassin Abdel Ghaffar Charity Center for Liver Disease and Research, Cairo, Egypt.,Department of Pediatrics, National Hepatology & Tropical Medicine Research Institute, Cairo, Egypt
| | | | - Sarah Helmy
- Yassin Abdel Ghaffar Charity Center for Liver Disease and Research, Cairo, Egypt
| | | | | | - Mohamad Moafy
- Department of Pediatrics, Ain Shams University, Cairo, Egypt
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23
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Di Biagio A, Taramasso L, Cenderello G. Treatment of hepatitis C virus genotype 4 in the DAA era. Virol J 2018; 15:180. [PMID: 30466446 PMCID: PMC6251143 DOI: 10.1186/s12985-018-1094-4] [Citation(s) in RCA: 15] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/22/2017] [Accepted: 11/13/2018] [Indexed: 02/07/2023] Open
Abstract
The recently approved interferon-free DAA (direct antiviral agents) regimens have shown not only to be effective in terms of sustained virological response (SVR) rates (> 90%) but also well tolerated in most hepatitis C virus (HCV) infected patients. Nevertheless HCV genotypes are different and only a small percentage of trials consider genotype 4 (GT4), which was associated with lower rates of SVR compared with other genotypes before the arrival of the DAA's. In this review, we discuss the efficacy of DAA therapy in GT4 HCV infection with specific reference to more recent studies, including those conducted in a 'field-practice' scenario. Overall, DAA-based regimens appear more effective also in the poorly-explored setting of patients with HCV GT4 infection. Despite an overall limited number of patients was evaluated, favorable results are being derived from studies on ombitasvir/paritaprevir/ritonavir, sofosbuvir and velpatasvir, whether or not in association with voxilaprevir, and with the new combined therapy glecaprevir + pibentasvir.
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Affiliation(s)
- Antonio Di Biagio
- Infectious Diseases Clinic, Policlinico Hospital San Martino, L.go R. Benzi n 10, 16132 Genoa, Italy
| | - Lucia Taramasso
- Department of Health Sciences (DISSAL), University of Genova and Infectious Disease Clinic, Via Pastore n 1, 16136 Genoa, Italy
- Infectious Diseases Unit, Department of Internal Medicine, ‘Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Via Francesco Sforza 35, Milan, Italy
| | - Giovanni Cenderello
- Infectious Disease Unit, EO Ospedali Galliera, via Mura delle Cappuccine n 14, 16128 Genoa, Italy
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24
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Ahmed M. Era of direct acting anti-viral agents for the treatment of hepatitis C. World J Hepatol 2018; 10:670-684. [PMID: 30386460 PMCID: PMC6206157 DOI: 10.4254/wjh.v10.i10.670] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/11/2018] [Revised: 05/15/2018] [Accepted: 05/23/2018] [Indexed: 02/06/2023] Open
Abstract
Hepatitis C infection is universal and the most common indication of liver transplantation in the United States. The period of less effective interferon therapy with intolerable side effects has gone. Now we have stepped into the era of direct acting anti-viral agents (DAAs) against hepatitis C virus. Treatment of hepatitis C is now extremely effective, tolerable and requires a short duration of intake of oral agents. Less monitoring is required with the current therapy and drug-drug interactions are less than the previous regimen. The current treatment options of chronic hepatitis C with various DAAs are discussed in this article.
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Affiliation(s)
- Monjur Ahmed
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Thomas Jefferson University, Philadelphia, PA 19107, United States.
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25
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Omran D, Alboraie M, Zayed RA, Wifi MN, Naguib M, Eltabbakh M, Abdellah M, Sherief AF, Maklad S, Eldemellawy HH, Saad OK, Khamiss DM, El Kassas M. Towards hepatitis C virus elimination: Egyptian experience, achievements and limitations. World J Gastroenterol 2018; 24:4330-4340. [PMID: 30344418 PMCID: PMC6189850 DOI: 10.3748/wjg.v24.i38.4330] [Citation(s) in RCA: 86] [Impact Index Per Article: 12.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/27/2018] [Revised: 09/13/2018] [Accepted: 10/05/2018] [Indexed: 02/06/2023] Open
Abstract
Worldwide, more than one million people die each year from hepatitis C virus (HCV) related diseases, and over 300 million people are chronically infected with hepatitis B or C. Egypt used to be on the top of the countries with heavy HCV burden. Some countries are making advances in elimination of HCV, yet multiple factors preventing progress; remain for the majority. These factors include lack of global funding sources for treatment, late diagnosis, poor data, and inadequate screening. Treatment of HCV in Egypt has become one of the top national priorities since 2007. Egypt started a national treatment program intending to provide cure for Egyptian HCV-infected patients. Mass HCV treatment program had started using Pegylated interferon and ribavirin between 2007 and 2014. Yet, with the development of highly-effective direct acting antivirals (DAAs) for HCV, elimination of viral hepatitis has become a real possibility. The Egyptian National Committee for the Control of Viral Hepatitis did its best to provide Egyptian HCV patients with DAAs. Egypt adopted a strategy that represents a model of care that could help other countries with high HCV prevalence rate in their battle against HCV. This review covers the effects of HCV management in Egyptian real life settings and the outcome of different treatment protocols. Also, it deals with the current and future strategies for HCV prevention and screening as well as the challenges facing HCV elimination and the prospect of future eradication of HCV.
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Affiliation(s)
- Dalia Omran
- Department of Endemic Medicine and Hepatology, Faculty of Medicine, Cairo University, Cairo 11651, Egypt
| | - Mohamed Alboraie
- Department of Internal Medicine, Al-Azhar University, Cairo 11651, Egypt
| | - Rania A Zayed
- Department of Clinical and Chemical Pathology, Faculty of Medicine, Cairo University, Cairo 11651, Egypt
| | - Mohamed-Naguib Wifi
- Department of Internal Medicine, Faculty of Medicine, Cairo University, Cairo 11599, Egypt
| | - Mervat Naguib
- Department of Internal Medicine, Faculty of Medicine, Cairo University, Cairo 11599, Egypt
| | - Mohamed Eltabbakh
- Department of Tropical Medicine, Faculty of Medicine, Ain Shams University, Cairo 11566, Egypt
| | - Mohamed Abdellah
- Department of Internal Medicine, Al-Azhar University, Cairo 11651, Egypt
| | - Ahmed Fouad Sherief
- Department of Tropical Medicine, Faculty of Medicine, Ain Shams University, Cairo 11566, Egypt
| | - Sahar Maklad
- National Hepatology and Tropical Medicine Research Institute, Cairo 11599, Egypt
| | - Heba Hamdy Eldemellawy
- Department of Internal Medicine, Faculty of Medicine, Beni-Suef University, Beni-Suef 62511, Egypt
| | | | - Doaa Mohamed Khamiss
- Department of Clinical and Chemical Pathology, El-monera hospital, Ministry of Health, Cairo 11562, Egypt
| | - Mohamed El Kassas
- Department of Endemic Medicine, Faculty of Medicine, Helwan University, Cairo 11599, Egypt
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26
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Abdel-Moneim A, Aboud A, Abdel-Gabaar M, Zanaty MI, Ramadan M. Efficacy and safety of sofosbuvir plus daclatasvir with or without ribavirin: large real-life results of patients with chronic hepatitis C genotype 4. Hepatol Int 2018; 12:348-355. [PMID: 29754329 DOI: 10.1007/s12072-018-9868-8] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/08/2018] [Accepted: 04/23/2018] [Indexed: 12/13/2022]
Abstract
BACKGROUND AND AIM Clinical studies evaluating the efficacy of daclatasvir (DCV) for treatment of chronic hepatitis C virus (HCV) genotype 4 (GT4) infection are scarce. This study aims to evaluate the efficacy and safety of DCV plus sofosbuvir (SOF) with or without ribavirin (RBV) for treatment of Egyptian patients infected with HCV GT4. METHODS Between April 2016 and March of 2017, a large cohort of 946 patients with chronic HCV GT4 was enrolled for completing the treatment. Patients were classified into two groups: group 1 (easy to treat) was treated with a dual therapy of SOF/DCV daily for 12 weeks and group 2 (difficult to treat) was treated with a triple therapy of SOF/DCV/RBV daily for 12 weeks. Efficacy and safety of the treatments were estimated, and baseline characters associated with sustained virological response at 12 weeks post-treatment (SVR12) were investigated. RESULTS Among the patient's cohort, SVR12 was achieved by 94% (891/946) in the overall patients, by 95% (718/758) in the easy-to-treat group, and by 92% (173/188) in the difficult-to-treat group. The most common adverse events recorded were fatigue, headache, nausea, asthenia, and gastrointestinal troubles. No patient discontinued treatment due to severe adverse events. CONCLUSION The findings from the present study suggested that SOF/DCV (with or without RBV) regimen exhibited high effectiveness, was well tolerated in the treatment of chronic HCV GT 4, and revealed itself as a better option for patients with advanced liver disease, making the eradication of HCV a more realistic target to achieve.
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Affiliation(s)
- Adel Abdel-Moneim
- Molecular Physiology Division, Faculty of Science, Beni-Suef University, Salah Salim St., Beni Suef, 62511, Egypt.
| | - Alaa Aboud
- Tropical Medicine Department, Faculty of Medicine, Beni-Suef University, Beni Suef, Egypt
| | - Mohamed Abdel-Gabaar
- Biochemistry Division, Faculty of Science, Beni-Suef University, Beni Suef, Egypt
| | - Mohamed I Zanaty
- Biotechnology Department, Faculty of Postgraduate Studies for Advanced Science, Beni-Suef University, Beni Suef, Egypt
| | - Mohamed Ramadan
- Biochemistry Division, Faculty of Science, Beni-Suef University, Beni Suef, Egypt
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27
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Sun J, Liang X, Fan R, Hou J. Editorial: sofosbuvir plus daclatasvir for the treatment of hepatitis C-can one size fit all? Aliment Pharmacol Ther 2018; 47:853-854. [PMID: 29446138 DOI: 10.1111/apt.14530] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/08/2022]
Affiliation(s)
- J Sun
- State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Viral Hepatitis Research, Department of Infectious Diseases and Hepatology Unit, Nanfang Hospital, Southern Medical University, Guangzhou, China
| | - X Liang
- State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Viral Hepatitis Research, Department of Infectious Diseases and Hepatology Unit, Nanfang Hospital, Southern Medical University, Guangzhou, China
| | - R Fan
- State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Viral Hepatitis Research, Department of Infectious Diseases and Hepatology Unit, Nanfang Hospital, Southern Medical University, Guangzhou, China
| | - J Hou
- State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Viral Hepatitis Research, Department of Infectious Diseases and Hepatology Unit, Nanfang Hospital, Southern Medical University, Guangzhou, China
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