A Study of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin in Participants With Chronic HCV Infection
Condition: Hepatitis C, Chronic; Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy, tolerability, and safety of 12-weeks
      of treatment with TMC435 plus pegylated interferon alfa-2a (PegIFNα-2a) and ribavirin (RBV)
      in previously untreated adult participants with genotype 1 or genotype 4 chronic Hepatitis C
      Virus (HCV) infection.
    

Detailed description: 
      This is a multicenter, international study where all participants will receive triple therapy
      with the following 3 medications: TMC435 also referred to as simeprevir (formerly known as
      TMC435350) which is an investigational medication in development for the treatment of chronic
      hepatitis C virus (HCV) infection, pegylated interferon alfa-2a (PegIFNα-2a), and ribavirin
      (RBV). PegIFNα-2a and RBV are commercially available therapies for HCV infection.
      Participants will receive treatment with TMC435, PegIFNα-2a, and RBV for 12 weeks. If blood
      levels of HCV ribonucleic acid (RNA) monitored at Weeks 2, 4, and 8 are below 25 IU/mL, all
      treatment will be stopped at Week 12. If HCV RNA values are above 25 IU/mL at Weeks 2, 4, or
      8, treatment with PegIFNα-2a and RBV will continue for an additional 12 weeks (up to Week 24)
      unless protocol-specified stopping criteria are met at Week 4 or 12, at which time all
      treatment will be discontinued. The study will be conducted in 3 phases: a screening phase of
      maximum 6 weeks, a treatment phase extending from Day 1 (baseline) up to 12 or 24 weeks
      depending on the response to treatment, and a posttreatment follow-up period of 24 weeks
      after the participant's last planned dose of study drug. The duration of the participation
      (excluding screening phase) for each participant will vary between 36 and 48 weeks, depending
      on the response to treatment. Blood samples for laboratory analysis will be obtained from
      participants at protocol-specified time points during the study and participant safety will
      be monitored throughout the study.
    

Intervention name(s): TMC435; Pegylated interferon alfa-2a (PegIFNα-2a); Ribavirin (RBV)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 150 mg taken orally (by mouth) as a capsule with food once daily for 12 weeks.; 180 mcg administered according to the manufacturer's prescribing information as a 0.5 mL subcutaneous (under the skin) (SC) injection once a week in the morning or evening for up to 24 weeks.; 1000 mg or 1200 mg administered according to the manufacturer's prescribing information for up to 24 weeks. If the participant's baseline body weight is < 75 kg, the total daily dose of RBV will be 1000 mg, administered orally (by mouth) as 400 mg (2 tablets of 200 mg, intake with food) in the morning and 600 mg (3 tablets of 200 mg, intake with food) in the evening. If the baseline body weight is > or = 75 kg, the total daily dose will be 1200 mg, administered as 600 mg in the morning and evening (3 tablets of 200 mg per intake, with food).
Other intervention name(s): Pegasys; Copegus
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a; Simeprevir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C, Chronic; Infection; Triple therapy; TMC435; simeprevir; Pegylated interferon alfa-2a (PegIFNα-2a); ribavirin (RBV); PEGASYS; COPEGUS