Safety and Efficacy of Boceprevir/Peginterferon Alfa-2a/Ribavirin in Interleukin-28B CC Allele-Positive Chronic Hepatitis C Virus (HCV) Genotype 1 Participants (P07755)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: peg-Interferon alfa-2a; Ribavirin; Boceprevir
Intervention description: peg-IFN (180 ug) was taken once weekly via subcutaneous injection.; RBV 200 mg tablets taken by mouth at a total daily dose of 1,000 mg (body weight <75 kilograms [kg]) or 1,200 mg (body weight ≥75 kg) with total daily dose divided into 2 dosings.; Four 200 mg BOC capsules taken three times a day by mouth for a total daily dose of 2,400 mg.
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 737.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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.