Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of Simeprevir, Daclatasvir and Sofosbuvir in Treatment-naive Participants With Chronic Hepatitis C Virus Genotype 1 Infection
Condition: Hepatitis C Virus
MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: Simeprevir 150 mg; Daclatasvir 60 mg; Sofosbuvir 400 mg
Intervention description: Simeprevir 150 mg capsule orally once daily.; Daclatasvir 60 mg tablet orally once daily.; Sofosbuvir 400 mg tablet orally once daily.
Intervention MeSH terms: Sofosbuvir; Simeprevir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hepatitis C virus; Hepatitis C virus genotype 1; Chronic Hepatitis C Virus Genotype 1 Infection; Liver fibrosis; Cirrhosis; Simeprevir; Daclatasvir; Sofosbuvir

Summary:

      The purpose of this study is to evaluate the efficacy of 6 or 8 weeks of treatment regimen
      containing simeprevir (SMV), daclatasvir (DCV) and sofosbuvir (SOF) in treatment-naive (not
      having received treatment with any approved or investigational drug) participants with
      chronic hepatitis (inflammation of the liver) C virus (HCV) genotype 1 infection with early
      stages of liver fibrosis or with cirrhosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HCV genotype 1 infection and HCV RNA plasma level greater than (>) 10,000
             international units per milliliter (IU/mL), both determined at Screening

          -  Participants of Arm A should have evidence of early stages of liver fibrosis, defined
             by a FibroSURE score less than or equal to (<=) 0.48 and aspartate aminotransferase to
             platelet ratio index (APRI) score <=1

          -  Participants of Arm B should have evidence of cirrhosis, defined by a FibroSURE score
             >0.75 and APRI score >2, OR a previous (historical) biopsy documenting a METAVIR score
             F4. In addition, participants should have absence of esophageal varices or presence of
             small (grade 1) esophageal varices determined by upper gastrointestinal endoscopy, and
             absence of findings indicative of hepatocellular carcinoma in an ultrasonography

          -  HCV treatment-naive, defined as not having received treatment with any approved or
             investigational drug for chronic HCV infection

          -  Pegylated interferon (PegIFN) and ribavirin (RBV) eligible, defined as not having any
             contraindication to the use of PegIFN and RBV, in line with the prescribing
             information for each compound

        Exclusion Criteria:

        A. Main Study:

          -  Co-infection with HCV of another genotype than genotype 1 and/or human
             immunodeficiency virus (HIV) type 1 or 2 (positive HIV-1 or HIV 2 antibody test at
             Screening)

          -  Any evidence of liver disease of non-HCV etiology. This includes, but is not limited
             to, acute hepatitis A infection, hepatitis B infection (hepatitis B surface antigen
             positive), drug- or alcohol-related liver disease, autoimmune hepatitis,
             hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, non-alcoholic
             steatohepatitis, primary biliary cirrhosis, or any other non-HCV liver disease
             considered clinically significant by the Investigator

          -  Evidence of clinical hepatic decompensation or presence of grade 2/3 esophageal
             varices

          -  Any of the protocol defined laboratory abnormalities

        B. Sub-study:

          -  Presence of coagulopathy (hemophilia) or hemoglobinopathy (including sickle cell
             disease, thalassemia)

          -  Use of any anti-coagulant (for example, warfarin, heparin) or anti-platelet
             medications within 1 week of the Screening visit

          -  Any of the protocol defined laboratory abnormalities