HEPNET ACUTE HCV IV

HEPNET ACUTE HCV IV study: 6 weeks LDV/SOF for acute hepatitis C

Deterding K, Lancet Infect Dis 2017; 17:215-22

Anti-HCV
Ledipasvir
Sofosbuvir
Genotype
1a
1b
Special population
Acute HCV infection

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Design


* Documented seroconversion to HCV antibody positivity within the 4 months before screening, or known or suspected exposure to HCV within the 4 months before screening with ALT > 10 x ULN at screening or within a 4-week period before screening

Objective

  • SVR12 (HCV RNA < 15 UI/ ml), power of 80% to conclude efficacy if the true response rate is > 98% (lower margin of the 95 % CI > 80%)

Baseline characteristics and outcome

Adverse events, %

Summary

  • A short course of 6 weeks with an interferon-free and ribavirin-free therapy consisting of LDV/SOF fixed drug combination resulted in a SVR12 of 100% in patients with acute HCV genotype 1
  • Rapid improvement of symptoms and biochemical abnormalities of acute hepatitis
  • Very good tolerance