Efficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Adults With Chronic HCV Infection and Decompensated Cirrhosis

Summary

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) with or without ribavirin (RBV) for 12 weeks in adults with chronic hepatitis C virus (HCV) infection and decompensated cirrhosis.

Timeline

Start

2016-12-26

Primary completion

2018-02-13

Completion

2018-05-08

Outcome

Met primary endpoint

registry analysis (superiority test); SOF/VEL; p <0.001; 2-sided exact 1-sample binomial test NCT02996682 ↗

registry P-value was from the 2-sided exact 1-sample binomial test for the superiority of each treatment group over pre-specified rate of 1%. NCT02996682 ↗

Publications

• Results Takehara T, Kurosaki M, Tanaka Y, Tatsumi T, Ikeda F, Takikawa Y, et al. Sofosbuvir/Velpatasvir with or without Ribavirin for 12 Weeks in HCV-Infected Japanese Subjects with Decompensated Cirrhosis [Presentation]. 54th Annual Meeting of Japan Society of Hepatology; 2018 June 15; Osaka, Japan.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	RBV	Unknown	—	Oral
Subject	SOF/VEL	Unknown	—	Oral

Indications