A Study of Debio 025 (Alisporivir) Combined With Peg-IFNα2a and Ribavirin in Treatment naïve Chronic Hepatitis C Genotype 1 Patients

Inclusion Criteria

• •Males or females aged ≥ 18 and ≤ 65 years.
• •Body mass index (BMI) ≥ 18 and ≤ 32 kg/m\^2.
• •Hepatitis B surface antigen (HbsAg) negative and HIV-1 negative.
• •Serological diagnosis of chronic hepatitis C viral infection genotype 1 for \> 6 months.
• •Chronic liver disease consistent with chronic hepatitis C infection on a biopsy or FibroScan® obtained within the past 24 months (36 months for patients with incomplete/transition to cirrhosis).
• •Previously untreated for hepatitis C virus (HCV) infection (approved or investigational drug).
• •Plasma HCV RNA level lower limit ≥ 100 IU/ml assessed by quantitative polymerase chain reaction (qPCR) or equivalent; no upper limit.
• •Neutrophil count ≥ 1500/µL; hemoglobin (Hb) ≥ 12g/dL for females and ≥ 13g/dL for males; platelets ≥ 90,000/µL.
• •Patients with incomplete/transition to cirrhosis on biopsy or an elasticity score between 9.5 and 14 kPa on FibroScan must have an abdominal ultrasound (US), computed tomographic (CT) scan, or magnetic resonance imaging (MRI) scan without evidence of hepatocellular carcinoma (within 2 months prior to randomisation) and a serum alpha-foetoprotein (AFP) \< 100 ng/mL.
• •Aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) \< 5 times the upper limit of normal.
• •Normal or compensated liver function and absence of complicated portal hypertension as documented by the following:
• •* No history of bleeding oesophageal varices;
• •* Absence of ascites;
• •* Absence of encephalopathy;
• •* Albumin ≥ 35 g/L;
• •* Total bilirubin ≤ 1.8 mg/dL (≤ 30 µmol/L);
• •* Prothrombin (INR ≤ 1.5).
• •Creatinine clearance \> 50 mL/min.
• •Thyroid stimulating hormone (TSH) within normal range;
• •All patients should be informed about Debio 025 and ribavirin foetotoxicity:
• •* Females may participate if they are surgically sterile or post-menopausal. Pre-menopausal females may participate if they use 2 reliable contraceptive methods (oral contraceptive + barrier method). The contraceptive regimen must be maintained during the treatment period and for 4 months after the last Debio 025 or ribavirin dose.
• •* Male patients must be surgically sterile or use 2 reliable contraceptive methods (oral contraceptive + barrier method). The contraceptive regimen must be maintained during the treatment period and for 7 months after the last Debio 025 or ribavirin dose.
• •Signed informed consent before any study procedures.
• •Negative pregnancy test within one week of first investigational product administration for female patients of child bearing potential.