Sofosbuvir plus Daclatasvir with or without ribavirin for treatment of chronic HCV genotype 4 patients: real-life experience
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New regimens involving direct-acting antiviral agents have recently been approved for the treatment of HCV. Our aim was to assess the efficacy and safety of 12 or 24 weeks of Sofosbuvir 400 mg plus Daclatasvir 60 mg, with or without ribavirin (800–1000 mg) in treating chronic hepatitis C genotype 4 patients.
This is an open-label observational study that describes the effect of 12 week or 24 weeks of daily oral Sofosbuvir (SOF) 400 mg plus Daclatasvir (DCV) 60 mg with or without ribavirin (RBV) with dose adjustment if indicated. It included the first 1168 patients that fulfilled the inclusion and exclusion criteria and treated in the Egyptian Liver Research Institute and Hospital, Mansoura, Egypt.
Sustained viral response after 12 weeks of end of treatment (SVR12) was achieved in 96.6% (95% CI 95.1–98.2%) of the patients receiving 12 weeks of DCV + SOF treatment, in 95.7% (95% CI 93.6–97.8%) of the patients receiving 12 weeks of DCV + SOF + RBV, in 93.3% (95% CI 90.0–96.6%) of those receiving 24 weeks of DCV + SOF, and in 92.2% (95% CI 85.4–98.9%) of patients receiving 24 weeks of DCV + SOF + RBV treatment. SVR12 rate was significantly higher in patients with no cirrhosis receiving DCV + SOF only for 12 weeks or 24 weeks (97.4 and 97.4%, respectively) than in patients with cirrhosis (91.7 and 88.9%, respectively). The most common adverse events were fatigue, headache, insomnia, and anemia. No treatment-related serious adverse events or death were reported in the studied groups.
Treatment with SOF (400 mg) plus DCV (60 mg), with or without RBV (800–1000 mg) for 12 or 24 weeks, was effective and well tolerated in chronic hepatitis C genotype 4 patients. SVR rates were higher for patients with no cirrhosis. Addition of RBV has benefit only in treatment-experienced group receiving 24 weeks.
KeywordsChronic hepatitis C Treatment Daclatasvir Sofosbuvir Ribavirin Cirrhosis Genotype 4 DAAs
Body mass index
Chronic hepatitis C
Egyptian Liver Research Institute and Hospital
Hepatitis C virus
Human immunodeficiency virus
Lower limit of quantification
Non-structural protein 5A
Pegylated interferon alpha
Statistical package for social sciences
Sustained virologic response
Sustained virologic response after 12 weeks
Upper limit of normal
The authors thank the patients that allowed the use of their data in this report and the treating physicians for their time and contributions to this work.
GS was involved in design, interpretation, and drafting of the manuscript. RS, ME, and AAH were involved in data acquisition and interpretation. NNHM was involved in data analysis and interpretation. All authors critically reviewed and revised the manuscript for content and approved the final draft for publication.
Compliance with Ethical Standards
Conflict of interest
The authors do not have any disclosures to report.
None to declare.
- 13.Welzel TM, Petersen J, Herzer K, Ferenci P, Gschwantler M, Wedemeyer H, et al. Daclatasvir plus sofosbuvir, with or without ribavirin, achieved high sustained virological response rates in patients with HCV infection and advanced liver disease in a real-world cohort. Gut 2016;65(12):2060CrossRefGoogle Scholar
- 15.Lacombe K, Fontaine H, Dhiver C, Metivier S, Rosenthal E, Antonini T, et al. Real-world efficacy of daclatasvir and sofosbuvir, with and without ribavirin, in HIV/HCV co-infected patients with advanced liver disease in a French early-access cohort. J Acquir Immune Defic Syndr 2017;75(1):97CrossRefPubMedPubMedCentralGoogle Scholar
- 17.Ministry of Health and Population, Egypt. Plan of Action for the Prevention, Care and Treatment of Viral Hepatitis, Egypt 2014–2018Google Scholar
- 21.Shiha G, Waked I, Soliman RE, Abdelrazek W, Hassany M, Fouad R, et al. Ledipasivir/Sofosbuvir in Egyptian Patients with chronic genotype 4 HCV infection. Presented in AASLD Meeting, Nov. 11–15, 2016, Boston, MAGoogle Scholar
- 22.Waked I, Shiha G, Qaqish RB, Esmat G, Yosry A, Hassany M, et al. Ombitasvir, paritaprevir, and ritonavir plus ribavirin for chronic hepatitis C virus genotype 4 infection in Egyptian patients with or without compensated cirrhosis (AGATE-II): a multicentre, phase 3, partly randomised open-label trial. Lancet Gastroenterol Hepatol 2016;1(1):36–44CrossRefPubMedGoogle Scholar