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Background Chronic hepatitis C virus infection is one of the most important health problems in Egypt. Since November 2015, generic sofosbuvir (SOF) with daclatasvir (DCV)±ribavirin (RBV) became the standard treatment in all National Committee for Control of Viral Hepatitis centers. Yet, the long-term efficacy, safety, and late complications of generic direct-acting antiviral drugs have not been studied. Aims Evaluation of the efficacy and safety of generic DCV-containing regimens in the treatment of chronic hepatitis C patients after 72 weeks of close follow-up. Patients and methods A total of 150 chronic hepatitis C virus patients were classified into easy-to-treat group (naïve patients with no evidence of cirrhosis) and difficult-to-treat group (treatment experienced or have any evidence of cirrhosis) and treated for 12 weeks with generic medications: DCV 60 mg and SOF 400 mg±RBV in easy and difficult-to-treat groups, respectively. A close follow-up of up to 72 weeks was done to assess the efficacy and safety of the generic drugs. Results Overall sustained virologic response (SVR12) was 94.0%, while the end of treatment response rate was 94.7%. SVR12 rates in easy-to-treat and difficult-to-treat groups were 97.06 and 91.46%, respectively. Multivariate analysis revealed that absence of cirrhosis, higher baseline albumin, lower baseline international normalized ratio, higher baseline platelet count, lower baseline alpha-fetoprotein, normal splenic size, and naivety to previous antiviral therapy were associated with SVR12. PCR after 72 weeks for those who achieve SVR12 is still undetectable. Three cases died during the follow-up period and were related to their advanced liver disease. No serious adverse events were reported. Conclusion Generic DCV, SOF±RBV regimen is safe and effective for treatment of chronic hepatitis C with minimal adverse events and SVR12 is efficient to predict persistent viral clearance. |
