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.
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Abbreviations
- AE:
-
Adverse events
- BMI:
-
Body mass index
- CI:
-
Confidence interval
- CHC:
-
Chronic hepatitis C
- DAA:
-
Direct-acting antivirals
- DCV:
-
Daclatasvir
- ECG:
-
Electrocardiography
- ELRIAH:
-
Egyptian Liver Research Institute and Hospital
- HCV:
-
Hepatitis C virus
- HIV:
-
Human immunodeficiency virus
- IFN:
-
Interferon
- IQR:
-
Inter-quartile range
- kPa:
-
Kilo Pascals
- LLOQ:
-
Lower limit of quantification
- NS5A:
-
Non-structural protein 5A
- PegIFNα:
-
Pegylated interferon alpha
- RBV:
-
Ribavirin
- RNA:
-
Ribonucleic acid
- SD:
-
Standard deviation
- SOF:
-
Sofosbuvir
- SPSS:
-
Statistical package for social sciences
- SVR:
-
Sustained virologic response
- SVR12:
-
Sustained virologic response after 12 weeks
- ULN:
-
Upper limit of normal
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Acknowledgements
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.
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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.
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Shiha, G., Soliman, R., ElBasiony, M. et al. Sofosbuvir plus Daclatasvir with or without ribavirin for treatment of chronic HCV genotype 4 patients: real-life experience. Hepatol Int 12, 339–347 (2018). https://doi.org/10.1007/s12072-018-9861-2
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DOI: https://doi.org/10.1007/s12072-018-9861-2