High efficacy of generic and brand direct acting antivirals in treatment of chronic hepatitis C

Abstract

Background: Direct acting antivirals (DAAs) are highly effective for treatment of hepatitis C (HCV) but brand products are priced beyond the means of most low and middle income countries (LMICs). Although a few DAAs are offered at reduced prices in access programs, they are still beyond affordability in limited resource settings with a large HCV infected population. Cheap generics might fill this economic need, but studies comparing their clinical efficacy to that of original products are limited. Aim: To compare efficacy of brand and generic DAAs used in the national treatment program in Egypt. Methods: HCV treatment eligible patients (n = 971) were enrolled. They were treated with 12 weeks of either sofosbuvir-daclatasvir (SOF-DCV) or SOF-ledipasvir (SOF-LDV). Ribavirin (RBV) was added to patients with cirrhosis and to SOF experienced patients. Patients with cirrhosis who were RBV intolerant were treated for 24 weeks without RBV. Results: Most patients were males (61.4%), treatment naïve (88.6%), without cirrhosis (61.7%), and the mean age was 51.3 ± 11.31 years. Baseline characteristics were not different in patients treated with brand or generic medications regarding age, liver tests, creatinine, platelets, MELD score, baseline HCV-RNA and transient elastography. Overall sustained virologic response (SVR) rate was 98.1%, which was similar for generic and brand drugs (98.2% vs. 98.1%; p = 1), and similar with both regimens used (SOF-DCV ± RBV: brand: 98.1%, generic 97.8%; p = 0.729, SOF-LDV ± RBV: brand 98.2%, generic 100%; p = 0.729). AST and ALT decreased significantly with initiation of therapy with both generic and original drugs. Conclusion: Generic and brand DAAs are equally effective for achieving SVR and improving aminotransferases. Keywords: HCV, Direct acting antivirals, Generic, Brand, Sofosbuvir, Ledipasvir, Daclatasvir, Sustained virological response