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Study of Sofosbuvir and Ribavirin in Genotype 2 HCV in Japanese Patients

Open-label study on Japanese patients ≥20 years with chronic Genotype 2 HCV infection, evaluating Sofosbuvir and Ribavirin regimen for treatment-naïve or pre-treated individuals with compensated cirrhosis. The study aims to achieve SVR12 with high historical SVR improvement, showing superior efficacy with minimal adverse events.

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Study of Sofosbuvir and Ribavirin in Genotype 2 HCV in Japanese Patients

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  1. Japanese SOF + RBV Study: SOF + RBV in genotype 2 W12 Open-label • Design Japanese patients ≥ 20 years Chronic HCV infection Genotype 2 HCV RNA ≥ 10,000 IU/ml Treatment naïve or pre-treated Compensated cirrhosis* (Child-Pugh A) allowed N = 153 SVR12 * Metavir = 4 or Ishak ≥ 5 or Fibroscan > 12.5 kPa • SOF 400 mg : 1 pill qd • RBV (bid dosing) : 600 mg/day if <60 kg ; 800 mg/day if 60-80 kg ; 1000 mg/day if > 80 kg • Objective • Primary endpoint : SVR12 (HCV RNA < 25 IU/ml) > 18% of historical SVR (69%) in naïve patients without cirrhosis, significance level of 0.05, 80% power Omata M. J Viral Hepatitis 2015;21:762-8 SOF + RBV GT2 Japanese

  2. Japanese SOF + RBV Study: SOF + RBV in genotype 2 Baseline characteristics and patient disposition Omata M. J Viral Hepatitis 2015;21:762-8 SOF + RBV GT2 Japanese

  3. Japanese SOF + RBV Study: SOF + RBV in genotype 2 SVR12 (HCV RNA < 25 IU/ml), % (95% CI) 100 (63-100) 98 (92-100) 96.3 (87-100) 97.6 (92-100)* 95 (87-99) % 89 (52-100) 100 75 50 25 N 90 63 82 8 54 9 0 Naïve Pre- treated Naïve No cirrhosis Naïve with cirrhosis Pre-treated No cirrhosis Pre-treated with cirrhosis * Superior to the adjusted historical control rate of 69% (p < 0.001) 4/5 relapses had RBV dose reduction Omata M. J Viral Hepatitis 2015;21:762-8 SOF + RBV GT2 Japanese

  4. Japanese SOF + RBV Study: SOF + RBV in genotype 2 • Adverse events, n (%) Omata M. J Viral Hepatitis 2015;21:762-8 SOF + RBV GT2 Japanese

  5. Japanese SOF + RBV Study: SOF + RBV in genotype 2 • Summary • 12 weeks of treatment with SOF + RBV resulted in high rates of SVR12 (> 95%) in treatment-naïve and previously treated Japanese patients with chronic genotype 2 HCV infection • In the present study, 22% of patients were aged 65 or older and 11% had cirrhosis • Efficacy similar • Increases in reported adverse events and laboratory abnormalities in patients ≥ 65 years, but these differences did not present a barrier to treatment as no premature discontinuation of study treatment occurred in any patient • Relapse rate was 3%, and none of the subjects who relapsed had S282T or other nucleoside inhibitor resistance-associated variants Omata M. J Viral Hepatitis 2015;21:762-8 SOF + RBV GT2 Japanese

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