A Study to Assess the Safety, Tolerability and Efficacy of TMC435 Along With Pegylated Interferon Alpha-2a (Pegasys) and Ribavirin (Copegus) Triple Therapy in Chronic Hepatitis C Genotype-1 Infected Patients Co-infected With Human Immunodeficiency Virus-Type 1
Condition: Hepatitis C Virus Genotype-1
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Acquired Immunodeficiency Syndrome; HIV Infections; Hepatitis; Immunologic Deficiency Syndromes
Intervention: TMC435; Pegylated interferon alpha-2a; Ribavirin
Intervention description: TMC435 150 mg will be administered once daily for 12 weeks along with peginterferon alpha-2a and ribavirin.; Pegylated interferon alpha-2a 180 microgram will be administered as subcutaneous injection of 0.5 mL until 24 to 48 weeks.; Ribavirin 1000 or 1200 mg twice daily will be administered each day until 24 to 48 weeks.
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a; Simeprevir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 109.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hepatitis C virus genotype-1; Human immunodeficiency virus-type 1; HCV-1; HIV-1; TMC435; Pegylated interferon alpha-2a; PegIFNα-2a; Pegasys; Ribavirin; RBV; Copegus

Summary:

      The purpose of this study is to evaluate the safety and tolerability of TMC435 along with
      pegylated interferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) triple therapy in hepatitis C
      virus genotype-1 infected subjects, co-infected with human immunodeficiency virus-type 1, and
      to evaluate the number of patients with sustained virologic response (SVR) at 12 weeks after
      the planned end of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A liver biopsy required within 3 years prior to screening unless the patient has a
             contraindication for a liver biopsy

          -  Patients with bridging fibrosis or cirrhosis and without a liver biopsy result within
             2 years prior screening must have an ultrasound taken within 2 months prior to the
             screening visit or during screening with no findings suspicious for hepatocellular
             carcinoma (HCC)

          -  Genotype-1 hepatitis C virus (HCV) infection

          -  Plasma HCV ribonucleic acid (RNA) of more than 10,000 IU per mL

          -  Documented human immunodeficiency virus-type 1 (HIV-1) infection at least 6 months
             prior to screening

        Exclusion Criteria:

          -  Patient showing evidence of hepatic decompensation (ie, history or current evidence of
             ascites, bleeding varices or hepatic encephalopathy, albumin serum concentration less
             than 3.3 gm per dL, prolonged prothrombin time [PT] expressed as international
             normalized ratio [INR] more than 1.5)

          -  Any liver disease of non-HCV etiology

          -  Co-infection with hepatitis B virus (hepatitis B surface antigen [HBsAg] positive)

          -  An acute HIV-1 infection; or HIV-2 infection

          -  Change in antiretroviral (ARV) regimen within the last 4 weeks prior screening