Safety and Efficacy of KW-136 and Sofosbuvir for Treatment of Chronic Hepatitis C

Summary

This study aimed to evaluate the safety and efficacy of KW-136, an investigational anti-hepatitis C virus (HCV) drug, combined with sofosbuvir for treatment of Chinese adults chronically infected with HCV. Thirty (30) non-cirrhotic subjects were medicated with KW-136 30 mg daily, 60 non-cirrhotic subjects with KW-136 60 mg daily, and 30 cirrhotic subjects with KW-136 60 mg daily; all the 120 subjects received sofosbuvir 400 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

2017-02-15

Primary completion

2017-09-17

Completion

2017-11-08

Publications

• Rao H, Song G, Li G, Yang Y, Wu X, Guan Y, Mao Q, Jiang X, Wang C, Zhang Y, Jia J, Guo X, Li C, Ning J, Qin H, Pan H, Wei L. Safety and efficacy of coblopasvir and sofosbuvir in patients with genotypes 1, 2, 3 and 6 HCV infections without or with compensated cirrhosis. J Viral Hepat. 2020 Jan;27(1):45-51. doi: 10.1111/jvh.13208. Epub 2019 Oct 2.

Drugs

Indications