Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P07614)

Inclusion Criteria:

- Documented chronic hepatitis C (CHC) genotype 1 infection

- Treatment naïve or failed previous interferon/ribavirin therapy (≥12 uninterrupted
weeks)

- Weigh between 10 kg to 90 kg inclusive at screening and baseline (Day -1).

- Body Mass Index (BMI) from the 5th to the 95th percentile for the participant's age
and gender, inclusive, per tables from the Center for Disease Control and Prevention,
USA

- Use of acceptable methods of contraception for at least 3 months prior to baseline
and continue on study

Exclusion Criteria:

- Co-infection with the human immunodeficiency virus (HIV) or hepatitis B virus (HBsAg
positive).

- Treatment with ribavirin within 90 days, or any interferon-alfa within 30 days

- Discontinued from interferon treatment due to adverse events

- Currently receiving antiviral/immunomodulating therapy for hepatitis C

- Prior treatment with an HCV protease inhibitor

- Prior treatment with any known hepatotoxic agent (including herbal remedies)

- Use of investigational drugs within 30 days of enrollment into study

- Evidence of de-compensated liver disease including, but not limited to, a history or
presence of clinical ascites, bleeding varices, or hepatic encephalopathy.

- Substance abuse (including but not limited to alcohol abuse, illicit drugs,

inhalational drugs, marijuana use, etc) any time prior to entry into the study

- Any surgical or medical condition which might significantly alter the absorption,
distribution, metabolism or excretion of any drug.

- Pregnant or breastfeeding female

- Meeting any of the laboratory exclusion criteria