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

HEPNET ACUTE HCV IV study: 6 weeks LDV/SOF for acute hepatitis C. Open-label. Design. W6. ≥ 18 years Acute HCV genotype 1 infection * HCV RNA > 10 00 IU/ ml No cirrhosis No HBV or HIV co-infection. N = 20. SVR 12.

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

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  1. HEPNET ACUTE HCV IV study: 6 weeks LDV/SOF for acute hepatitis C Open-label • Design W6 ≥ 18 years Acute HCV genotype 1 infection * HCV RNA > 10 00 IU/ml No cirrhosis No HBV or HIV co-infection N = 20 SVR12 * 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 withALT > 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%) Deterding K, Lancet Infect Dis 2017; 17:215-22 HEPNET ACUTE HCV IV

  2. HEPNET ACUTE HCV IV study: 6 weeks LDV/SOF for acute hepatitis C • Baseline characteristics and outcome Deterding K, Lancet Infect Dis 2017; 17:215-22 HEPNET ACUTE HCV IV

  3. HEPNET ACUTE HCV IV study: 6 weeks LDV/SOF for acute hepatitis C • Adverse events, % Deterding K, Lancet Infect Dis 2017; 17:215-22 HEPNET ACUTE HCV IV

  4. HEPNET ACUTE HCV IV study: 6 weeks LDV/SOF for acute hepatitis C • 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 Deterding K, Lancet Infect Dis 2017; 17:215-22 HEPNET ACUTE HCV IV

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