Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Adults With Chronic HCV Infection and Compensated Cirrhosis

Phase 3 Completed 37 enrolled Gilead Sciences

NaSingle-groupOpen-labelTreatment

Summary

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in adults with chronic hepatitis C virus (HCV) infection and compensated cirrhosis.

Timeline

Start: 2019-10-16
Primary completion: 2021-03-26
Completion: 2021-06-25

Outcome

Met primary endpoint

registry NUMBER SOF/VEL: 100.0 (90.5 to 100.0) percentage of participants NCT04112303 ↗

registry analysis (superiority test); SOF/VEL; p <0.001; 2-sided exact 1-sample binomial test NCT04112303 ↗

paper All participants (37/37, 100%) achieved SVR12. PMID 35802063 ↗

Publications

Takehara T, Izumi N, Mochida S, Genda T, Fujiyama S, Notsumata K, Tamori A, Suzuki F, Suri V, Mercier RC, Matsuda T, Matsuda K, Kato N, Chayama K, Kumada H. Sofosbuvir-velpatasvir in adults with hepatitis C virus infection and compensated cirrhosis in Japan. Hepatol Res. 2022 Oct;52(10):833-840. doi: 10.1111/hepr.13810. Epub 2022 Aug 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sofosbuvir	Small molecule	400 mg	Oral
Subject	velpatasvir	Other / unclassified	100 mg	Oral