This study will assess the safety and efficacy of alisporivir (ALV) and boceprevir (BOC), each in combination with Peginterferon alfa-2a (PEG) and Ribavirin (RBV), in African American participants who have never received treatment for their chronic hepatitis C (HCV) genotype 1 infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
ALV 200 mg soft gel capsules administered orally
BOC 800 mg (4 x 200 mg soft gel capsules) administered orally
PEG 180 μg administered via subcutaneous (s.c.) injection once weekly
Novartis Investigational Site
Beverly Hills, California, United States
Novartis Investigational Site
Baltimore, Maryland, United States
Percentage of Participants That Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events
Time frame: within 48 weeks
Percentage of Participants With Emergence of Resistant Mutations
Time frame: within 48 weeks
Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 24 Weeks After the End of Treatment (SVR24)
SVR24 was defined as hepatitis C virus (HCV) RNA undetectable (by limit of detection) 24 weeks after end of treatment.
Time frame: 24 weeks post-treatment
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RBV 200 mg tablets (weight-based dose: \< 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose