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Hepatol Int. 2018 Jul;12(4):339-347. doi: 10.1007/s12072-018-9861-2. Epub 2018 Apr 16.

Sofosbuvir plus Daclatasvir with or without ribavirin for treatment of chronic HCV genotype 4 patients: real-life experience.

Author information

1
Egyptian Liver Research Institute and Hospital (ELRIAH), Mansoura-Damietta Road, Mansoura, Dakahlia, Egypt. g_shiha@hotmail.com.
2
Hepatology and Gastroenterology Unit, Internal Medicine Department, Faculty of Medicine, Mansoura University, Mansoura, Egypt. g_shiha@hotmail.com.
3
Egyptian Liver Research Institute and Hospital (ELRIAH), Mansoura-Damietta Road, Mansoura, Dakahlia, Egypt.
4
Tropical Medicine Department, Faculty of Medicine, Port Said University, Port Said, Egypt.
5
Hepatology and Gastroenterology Unit, Internal Medicine Department, Faculty of Medicine, Mansoura University, Mansoura, Egypt.
6
Biostatistics and Cancer Epidemiology Department, South Egypt Cancer Institute, Assiut University, Assuit, Egypt.

Abstract

INTRODUCTION:

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.

METHODS:

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.

RESULTS:

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.

CONCLUSION:

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.

KEYWORDS:

Chronic hepatitis C; Cirrhosis; DAAs; Daclatasvir; Genotype 4; Ribavirin; Sofosbuvir; Treatment

PMID:
29663115
DOI:
10.1007/s12072-018-9861-2
[Indexed for MEDLINE]

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