Safety and Efficacy of Boceprevir/Peginterferon Alfa-2a/Ribavirin in Interleukin-28B CC Allele-Positive Chronic Hepatitis C Virus (HCV) Genotype 1 Participants (P07755)
Safety and Efficacy of Boceprevir/Peginterferon Alfa-2a/Ribavirin in Interleukin-28B CC Allele-Positive Chronic Hepatitis C Virus (HCV) Genotype 1 Participants (P07755)
The primary purpose of this study is to compare the efficacy of two boceprevir
 (BOC)-containing therapeutic regimens in the treatment of naïve participants with chronic
 hepatitis C virus (HCV) genotype 1 who have the IL28B CC allele.

 The regimens differ in the treatment for participants who achieve undetectable HCV
 ribonucleic acid (RNA) at the end of the peginterferon alfa-2a (peg-IFN) plus ribavirin (RBV)
 4 week lead-in. Participants receive either peg-IFN + RBV (Arm 1) or BOC + peg-IFN + RBV (Arm
 2). The hypothesis is that Arm 2 is noninferior to Arm 1 in the proportion of participants
 with undetectable HCV RNA at Follow-Up (FU) Week 24.
Inclusion Criteria:

 -  Is ≥ 40 kg and ≤ 125 kg.

 -  Documented CHC genotype 1 with HCV RNA ≥10,000 International Units (IU)/mL

 -  Has IL-28B CC allele gene

 -  Has had a liver biopsy without evidence of cirrhosis and hepatocellular carcinoma
 (non-invasive fibroscan and Fibrotest can also be used for staging of liver disease).

 Exclusion Criteria:

 -  Co-infection with the human immunodeficiency virus (HIV) or hepatitis B virus
 (Hepatitis B surface antigen [HBsAg] or HIV positive).

 -  Previously treated with an interferon and ribavirin regimen or HCV direct acting
 antiviral regimen.

 -  Treatment for hepatitis C with any investigational medication, or prior treatments
 with herbal remedies with known hepatotoxicity

 -  Receiving any medication(s) within 2 weeks prior to the Day 1 visit that are highly
 dependent on Cytochrome P450 3A4 (CYP3A4/5) for clearance, and for which elevated
 plasma concentrations could be associated with serious and/or life-threatening events

 -  Participation in any other clinical trial within 30 days of the screening visit in
 this trial or intention to participate in another clinical trial during participation
 in this trial.

 -  Evidence of decompensated liver disease or hepatocellular carcinoma (HCC)

 -  Is diabetic and/or hypertensive with significant retinopathy

 -  Has any known medical condition that could interfere with the participation in and
 completion of the trial including immunologically-mediated disease, chronic pulmonary
 disease, or current or history of any clinically significant cardiac
 abnormalities/dysfunction.

 -  Evidence of active or suspected malignancy, or a history of malignancy, within the
 last 5 years

 -  Hemoglobin <12 g/dL for females and <13 g/dL for males

 -  Neutrophils <1,500/mm^3, or <1,200/mm^3 for participants of African descent

 -  Platelets <150,000/mm^3

 -  Direct bilirubin >1.5 x upper limit of normal (ULN) of the laboratory reference range.