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SMV+DCV+SOF in HCV Genotype 1 Decompensated Liver Disease: Open-label Study (IMPACT)

This study evaluates the impact of SMV, DCV, and SOF treatment in HCV genotype 1 patients with decompensated liver disease. The objective is to achieve SVR12 and assess changes in baseline characteristics and scores. The study also examines the pharmacokinetics and safety of the treatment. Long-term outcomes will be evaluated in the 5-year follow-up.

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SMV+DCV+SOF in HCV Genotype 1 Decompensated Liver Disease: Open-label Study (IMPACT)

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  1. IMPACT Study: SMV + DCV + SOF in HCV genotype 1 with decompensated liver disease • Design Open label ≥ 18 years Chronic HCV infection Genotype 1 or 4 HCV RNA > 10 000 IU/ml Treatment-naïve or pre-treated with PEG-IFN ± RBV Cirrhosis (> 14.5 kPa on FibroScan) Portal hypertension or liver decompensation No hepatocellular carcinoma Total bilirubin ≤ 3 x ULN, Platelet ≥ 30,000/mm3, Albumin ≤ 2.5 g/dl, INR ≤ 2.5, eGFR ≥ 30 ml/min No HBV or HIV co-infection W12 N = 19 CP A < 7 + PH SVR12 N = 21 CP B 7-9 CP : Child-Pugh ; PH : portal hypertension Post-treatmentfollow-up of 5 years SMV 150 mg qd + DCV 90 mg qd + SOF 400 mg qd • Objective • SVR12 (HCV RNA < 15 IU/ml), with 2-sided 95% CI, by ITT IMPACT Lawitz E. J Viral Hepat 2017; 24:287-94

  2. IMPACT Study: SMV + DCV + SOF in HCV genotype 1 with decompensated liver disease Baseline characteristics IMPACT Lawitz E. J Viral Hepat 2017; 24:287-94

  3. IMPACT Study: SMV + DCV + SOF in HCV genotype 1 with decompensated liver disease Outcome Change in Child-Pugh score at follow-upW12 Change in MELD score at follow-up W12 8 Baseline CP score Baseline MELD score 5–6 7–9 < 10 ≥ 10-< 15 ≥ 15 3 6 2 4 1 2 0 0 -2 -1 • Decreased, N = 11 • No change, N = 23 • Increased, N = 6 • Decreased, N = 20 • No change, N = 13 • Increased, N = 7 -4 -2 -6 -3 IMPACT Lawitz E. J Viral Hepat 2017; 24:287-94

  4. IMPACT Study: SMV + DCV + SOF in HCV genotype 1 with decompensated liver disease SMV, DCV and SOF pharmacokinetics following administration of SMV + DCV + SOF • Intensive PK analysis performed at Week 2 and Week 8 • Mean SMV exposure: 2.2-fold higher in CP B than CP A • Mean DCV exposure: similar in CP B and CP A (1.2-fold higher in CP B) • Mean SOF exposure: 1.5-fold higher in CP B than CP A • Mean GS-331007 exposure (SOF metabolite): similar in CP B and CP A IMPACT Lawitz E. J Viral Hepat 2017; 24:287-94

  5. IMPACT Study: SMV + DCV + SOF in HCV genotype 1 with decompensated liver disease • Adverse events and laboratory abnormalities, N (%) IMPACT Lawitz E. J Viral Hepat 2017; 24:287-94

  6. IMPACT Study: SMV + DCV + SOF in HCV genotype 1 with decompensated liver disease • Summary • Treatment for 12 weeks with SMV, SOF, and DCV resulted in 100% response rate; all 19 Child-Pugh A patients and all 21 Child-Pugh B patients achieved SVR12 • High virologic response was observed regardless • of Child-Pugh class (<7 or 7–9) • or the presence of resistance-associated variants at baseline • This 3-DAA combination was generally safe and well tolerated • No discontinuations due to adverse events • No deaths • 5-year follow-up will be important in providing long-term outcomes in association with SVR IMPACT Lawitz E. J Viral Hepat 2017; 24:287-94

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