Safety and Efficacy of Generic Sofosbuvir and Ribavirin for Treatment-naive Genotype 2 Chronic Hepatitis C

Summary

This study aimed to evaluate the safety and efficacy of generic sofosbuvir, an investigational anti-hepatitis C virus (HCV) drug, combined with weight-adjusted ribavirin for treatment-naive Chinese adults chronically infected with genotype 2 HCV, the second most prevalent genotype in China. One hundred and thirty-two (132) subjects, including one hundred and twenty (120) non-cirrhotics and twelve (12) compensatory cirrhotics, were medicated with sofosbuvir 400 mg daily combined with weight-adjusted ribavirin 1000-1200 mg daily. The treatment course lasted 12 successive weeks and thereafter all the study participants entered into a 12-week treatment-free follow-up period.

Timeline

Start

2016-08-05

Primary completion

2017-03-18

Completion

2017-03-30

Drugs

Indications