A Phase III Study of TMC435 in Genotype 1, Hepatitis C-infected Participants Who Failed to Respond to Previous IFN-based Therapy
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of TMC435 in combination
      with peginterferon alfa-2a (PegIFNα-2a) and ribavirin in genotype 1 hepatitis C virus
      (HCV)-infected participants who failed to respond to previous interferon (IFN)-based therapy
      in Japan.
    

Detailed description: 
      This is a randomized (study drug assigned by chance), 2-arm, open-label study to evaluate the
      efficacy and safety of TMC435 (also referred to as jnj-38733214-aaa) in combination with the
      standard of care (SoC) therapy consisting of peginterferon alfa-2a (PegIFNα-2a ) and
      ribavirin (RBV) administered according to the manufacturer's prescribing information in
      adult, genotype 1 hepatitis C virus (HCV)-infected participants who failed to respond to
      previous interferon (IFN)-based therapy in Japan. The study objective is to evaluate the
      efficacy of TMC435 by the proportion of participants with undetectable HCV ribonucleic acid
      (RNA). Participants will receive 12 weeks of treatment with TMC435 (100 mg) once daily plus
      PegIFNα-2a (P) and RBV P) followed by 12 or 36 weeks of treatment with PR OR participants
      will receive 24 weeks of treatment with TMC435 (100 mg) once daily plus PR followed by 24
      weeks of treatment with PR. TMC435 is a 100-mg capsule and will be taken orally (via the
      mouth). Treatment with PR will last 24 or 48 weeks: Pegylated interferon is supplied as a
      vial containing 1.0 mL solution with 180 mcg PegIFNα-2a and will be injected by a syringe
      under the skin once weekly. Ribavirin is given as 200-mg tablets (daily dose: 600-1000 mg
      based on body weight), and taken orally by mouth two times a day after meals. Participants
      will receive oral capsules of TMC435 (100 mg) once daily up to Week 12 or 24.
    

Intervention name(s): TMC435; Peginterferon alfa-2a (PegIFNα-2a ); Ribavirin (RBV)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100-mg capsule taken by mouth once daily for 12 or 24 weeks.; PegIFNα-2a (PEGASYS) will be administered according to the manufacturer's prescribing information as 180 mcg once weekly injected subcutaneous (under the skin) for up to 24-48 weeks.; RBV (COPEGUS) will be administered according to the manufacturer's prescribing information. If body weight is > 80 kg the total daily dose of RBV will be 1000 mg, taken by mouth as 400 mg (2 tablets of 200 mg) after breakfast and 600 mg (3 tablets of 200 mg) after supper. If body weight is > 60 kg to <=80 kg the total daily dose will be 800 mg, taken by mouth as 400 mg (2 tablets of 200 mg per intake) after breakfast and supper. If body weight is <=60 kg the total daily dose of RBV will be 600 mg, taken by mouth as 200 mg (1 tablet of 200 mg) after breakfast and 400 mg (2 tablets of 200 mg) after supper. Total duration of RBV will be 24-48 weeks.
Other intervention name(s): PEGASYS; COPEGUS
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a; Simeprevir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C, Chronic; Hepatitis C; Hepatitis C virus; Interferon Alfa-2a; Ribavirin; Viral RNA