Acute HCV genotype 1 infection * No HBV or HIV co-infection

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Presentation transcript:

Acute HCV genotype 1 infection * No HBV or HIV co-infection 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 LDV/SOF 90/400 mg qd 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 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%) HEPNET ACUTE HCV IV Deterding K, Lancet Infect Dis 2017; 17:215-22

Baseline characteristics and outcome HEPNET ACUTE HCV IV study: 6 weeks LDV/SOF for acute hepatitis C Baseline characteristics and outcome LDV/SOF N = 20 Age, years, mean 46 Male, % 60 Risk factor, % Sexual transmission Medical procedures or needlestick injury Nail treatment Unspecified 55 25 5 15 Genotype 1a / 1b, % 55 / 45 HCV RNA, log10 IU/ml, median 4.04 ALAT, median U/L 225 IFNL3 genotype (IFNL4), % CC CT TT 60 30 10 Symptomatic acute HCV infection, % 95 SVR12 (95% CI) 100% (83.89-100) HEPNET ACUTE HCV IV Deterding K, Lancet Infect Dis 2017; 17:215-22

HEPNET ACUTE HCV IV study: 6 weeks LDV/SOF for acute hepatitis C Adverse events, % LDV/SOF 6 weeks N = 20 Gastro-intestinal symptoms 20 Fatigue 15 Hair loss Headache 10 Abdominal pain Skin reaction Mental problems Sleeping disorders 5 Mouth burn Spleen pain Eye twitch HEPNET ACUTE HCV IV Deterding K, Lancet Infect Dis 2017; 17:215-22

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 HEPNET ACUTE HCV IV Deterding K, Lancet Infect Dis 2017; 17:215-22