An Efficacy, Safety and Pharmacokinetics Study of Simeprevir, Daclatasvir and Sofosbuvir in Participants With Chronic Hepatitis C Virus Genotype 1 or 4 Infection and Decompensated Liver Disease
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Liver Diseases
Intervention: Simeprevir; Daclatasvir; Sofosbuvir
Intervention description: Simeprevir 150 milligram (mg) capsule orally once daily for 12 weeks; Daclatasvir 60 mg tablet orally once daily for 12 weeks; Sofosbuvir 400 mg tablet orally once daily for 12 weeks
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: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatitis C, Chronic; Simeprevir; Daclatasvir; Sofosbuvir; Decompensated Liver Disease

Summary:

      The purpose of this study is to assess the efficacy of a 12-week regimen containing
      simeprevir, daclatasvir and sofosbuvir in participants with decompensated liver disease (the
      liver function is insufficient) due to genotype 1 or 4 Hepatitis (inflammation of the liver)
      C virus (HCV) infection by assessing sustained virologic response 12-weeks after the end of
      study drug treatment (SVR12).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented chronic Hepatitis C virus (HCV) infection: diagnosis of HCV more than (>) 6
             months before the Screening visit, either by detectable HCV ribonucleic acid (RNA), a
             HCV positive antibody or the presence of histological changes consistent with chronic
             hepatitis

          -  HCV genotype 1 or 4 infection and HCV RNA plasma level >10,000 international unit per
             milliliter (IU/mL) (both determined at screening)

          -  Presence of cirrhosis, which is defined as a FibroScan with a result of >14.5
             kilopascals (kPa) at Screening

          -  HCV treatment-naive participants: participant has not received treatment with any
             approved or investigational drug for the treatment of HCV infection and HCV
             treatment-experienced participants: participant has had at least 1 documented previous
             course of a non-direct-acting antiviral agent (DAA), interferon (IFN)-based HCV
             therapy (with or without Ribavirin [RBV]). Last dose in this previous course should
             have occurred at least 2 months prior to Screening

          -  Decompensated liver disease: Panel 1: Child Pugh A (mild hepatic impairment) with
             evidence of portal hypertension [confirmed by the presence of esophageal varices on
             gastroscopy or hepatic venous pressure gradient (HVPG) greater than or equal to (>=)
             10 millimeter of mercury (mm Hg)], Panel 2: Child-Pugh B (moderate hepatic impairment)
             7 to 9 (extremes included)

        Exclusion Criteria:

          -  Co-infection with any HCV genotype

          -  Co-infection with human immunodeficiency virus (HIV)-1 or -2 (positive HIV-1 or HIV-2
             antibodies test at Screening)

          -  Co-infection with hepatitis B virus (hepatitis B surface antigen [HBsAg] positive)

          -  Any evidence of liver disease of non-HCV etiology. This includes, but is not limited
             to, acute hepatitis A infection, 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

          -  Use of any disallowed therapies before the planned first dose of study drugs