Trial for the Treatment of Acute Hepatitis C for 8 Weeks With Sofosbuvir/Velpatasvir

Phase 2 Completed 20 enrolled Hannover Medical School German Center for Infection Research · collab Gilead Sciences · collab HepNet Study House, German Liverfoundation · collab

NaSingle-groupOpen-labelTreatment

Summary

This is a single arm multicenter pilot study to evaluate the efficacy and safety of treatment with sofosbuvir (SOF)/velpatasvir (VEL) fix dose combination (FDC) in patients with acute hepatitis C virus (HCV) infection.

Timeline

Start: 2019-05-28
Primary completion: 2021-06-08
Completion: 2021-06-08

Outcome

Missed primary endpoint

paper the primary endpoint was not met in the intention-to-treat analysis (n = 18/20 [90%]) because two patients were lost to follow-up. PMID 36852107 ↗

Publications

Maasoumy B, Ingiliz P, Spinner CD, Cordes C, Stellbrink HJ, Schulze Zur Wiesch J, Schneeweiss SM, Deterding K, Muller T, Kahlhofer J, Dorge P, von Karpowitz M, Manns MP, Wedemeyer H, Cornberg M; HepNet Acute HCV-V Study Group. Sofosbuvir plus velpatasvir for 8 weeks in patients with acute hepatitis C: The HepNet acute HCV-V study. JHEP Rep. 2022 Dec 16;5(3):100650. doi: 10.1016/j.jhepr.2022.100650. eCollection 2023 Mar.

Drugs

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