Sofosbuvir plus velpatasvir for 8 weeks in patients with acute hepatitis C: The HepNet acute HCV-V study.

Abstract

Background & Aims:

EASL guidelines recommend 8 weeks of treatment with sofosbuvir plus velpatasvir (SOF/VEL) for the treatment of acute or recently acquired HCV infection, but only 6- and 12-week data are available. Therefore, the aim of this study was to evaluate the safety and efficacy of a shortened 8-week SOF/VEL treatment for acute HCV monoinfection.

Methods:

In this investigator-initiated, prospective, multicentre, single-arm study, we recruited 20 adult patients with acute HCV monoinfection from nine centers in Germany. Patients received SOF/VEL (400/100 mg) as a fixed-dose combination tablet once daily for 8 weeks. The primary efficacy endpoint was the proportion of patients with sustained virological response 12 weeks after the end of treatment (SVR12).

Results:

The median HCV RNA viral load at baseline was 104,307 IU/ml; the distribution of HCV genotypes was as follows: GT1a/1b/2/3/4: n = 12/1/1/3/3. Thirteen (65%) of the 20 patients were taking medication for HIV pre-exposure prophylaxis. SVR12 was achieved in all patients who complied with the study protocol (n = 18/18 [100%], per protocol analysis), but the primary endpoint was not met in the intention-to-treat analysis (n = 18/20 [90%]) because two patients were lost to follow-up. One serious adverse event (unrelated to study drug) occurred during 12 weeks of post-treatment follow-up.

Conclusions:

The 8-week treatment with SOF/VEL was well tolerated and highly effective in all adherent patients with acute HCV monoinfection. Early treatment of hepatitis C might effectively prevent the spread of HCV in high-risk groups.

Clinical Trial Number:

NCT03818308.

Impact and implications:

The HepNet acute HCV-V study (NCT03818308), an investigator-initiated, single-arm, multicenter pilot study, demonstrates the efficacy and safety of 8 weeks of daily treatment with the fixed-dose combination sofosbuvir/velpatasvir (400/100 mg) in patients with acute hepatitis C virus (HCV) infection. All patients who completed therapy and were followed-up achieved sustained virologic response. Thus, early treatment with SOF/VEL which might effectively prevent the spread of HCV in high-risk groups can be recommended for patients with acute HCV monoinfection.

• Authors: Benjamin Maasoumy, Patrick Ingiliz, Christoph D Spinner, Christiane Cordes, Hans-Jürgen Stellbrink, Julian Schulze Zur Wiesch, Stephan M Schneeweiß, Katja Deterding, Tobias Müller, Julia Kahlhöfer, Petra Dörge, Maria von Karpowitz, Michael P Manns, Heiner Wedemeyer, Markus Cornberg, HepNet Acute HCV-V Study Group
• Journal: JHEP reports : innovation in hepatology (JHEP Rep) Vol. 5 Issue 3 Pg. 100650 (Mar 2023) ISSN: 2589-5559 [Electronic] Netherlands
• PMID: 36852107 (Publication Type: Journal Article)
• Copyright: © 2022 The Author(s).