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

2018; Elsevier BV; Volume: 75; Linguagem: Inglês

10.1016/j.ijid.2018.07.025

1878-3511

Mai Abozeid, Ayman Alsebaey, Eman Abdelsameea, Warda Othman, Mostafa Elhelbawy, Amr Rgab, M.D. REEM A. EL-HADIDY NEVEEN M. EL-FAYOMY, Tamer Samir Abdel-Ghafar, Mervat Abdelkareem, Alyaa Sabry, Marwa Fekry, Nashwa Shebl, Eman Rewisha, Imam Waked,

Liver Disease and Transplantation

Highlights•Chronic hepatitis C is a major health problem. DAAs made a revolution in HCV treatment.•Brand DAAs are highly effective but costly. Generic DAAs are cheaper, effective and affordable by low-middle income countries.•This report compares the efficacy of brand and generic DAAs.AbstractBackgroundDirect 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.AimTo compare efficacy of brand and generic DAAs used in the national treatment program in Egypt.MethodsHCV 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.ResultsMost 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.ConclusionGeneric and brand DAAs are equally effective for achieving SVR and improving aminotransferases.