Daclatasvir, sofosbuvir, and ribavirin for hepatitis C virus genotype 3 and advanced liver disease: A randomized

Vincent Leroy1, Peter Angus2, Jean-Pierre Bronowicki3

  • 1Clinique Universitaire d'Hepato-Gastroentérologie, Pôle Digidune, CHU de Grenoble and Unité INSERM/Université Grenoble Alpes U823, IAPC Institut Albert Bonniot, Grenoble, France.

Insights

Hepatitis C genotype 3 patients with advanced liver disease achieved high sustained virological response (SVR12) using daclatasvir-sofosbuvir-ribavirin. Treatment duration of 12 or 16 weeks showed similar efficacy and good tolerability.

Area of Science:

  • Hepatology
  • Virology
  • Pharmacology

Background:

  • Hepatitis C virus (HCV) genotype 3 infection with advanced liver disease requires effective therapies.
  • Previous studies showed high efficacy of daclatasvir (DCV) and sofosbuvir (SOF) in noncirrhotic patients.

Purpose of the Study:

  • To evaluate the efficacy and tolerability of DCV-SOF plus ribavirin (RBV) in patients with HCV genotype 3 and advanced liver disease.
  • To compare the outcomes of 12-week versus 16-week treatment durations.

Main Methods:

  • Phase III ALLY-3+ study enrolled 50 treatment-naïve or experienced patients with advanced fibrosis or compensated cirrhosis.
  • Patients received open-label DCV-SOF with weight-based RBV for 12 or 16 weeks.
  • Primary endpoint was sustained virological response at post-treatment week 12 (SVR12).

Main Results:

  • Overall SVR12 was 90% (45/50), with 88% for the 12-week group and 92% for the 16-week group.
  • All patients with advanced fibrosis achieved SVR12.
  • SVR12 in patients with cirrhosis was 86% overall, with high rates in both treatment durations and across treatment experience groups.

Conclusions:

  • The combination of DCV-SOF-RBV demonstrated high efficacy and was well tolerated in genotype 3 HCV patients with advanced liver disease.
  • Both 12 and 16 weeks of treatment resulted in similar high SVR12 rates.
  • Treatment outcomes were consistent regardless of prior treatment experience.
Abstract

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