Short Duration Versus Standard Response-Guided Therapy With Boceprevir Combined With PegIntron and Ribavirin in Previously Untreated Non-Cirrhotic Asian Participants With Chronic HCV Genotype 1 (MK-3034-107)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Intervention: Boceprevir; Peg-interferon alfa-2b; Ribavirin
Intervention description: 800 mg three times daily orally; 1.5 mcg/kg weekly subcutaneously; 800-1400 mg twice-daily divided orally based on body weight
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 257.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to estimate the difference in the efficacy between a 16-week
      treatment regimen of boceprevir (BOC) in combination with peg-intron alpha 2b (P) plus
      ribavirin (R) (BOC + PR) and a 28-week treatment regimen of BOC + PR in previously untreated
      participants with chronic hepatitis C (CHC) genotype 1 in Asia who achieve undetectable
      hepatitis C virus ribonucleic acid (HCV RNA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  weigh ≥ 40 kg and ≤ 125 kg

          -  have CHC genotype 1 infection

          -  has had a liver biopsy or non-invasive liver fibrosis test that shows no evidence of
             cirrhosis and hepatocellular carcinoma

          -  must agree that the participant and the participant's partner will each use acceptable
             methods of contraception for at least 2 weeks prior to Day 1 and continue until at
             least 6 months after last dose of study medication, or longer if dictated by local
             regulations (for a female participant who is of childbearing potential or male
             participant with female sexual partner who is of childbearing potential)

        Exclusion Criteria:

          -  participates in any other interventional clinical trial within 30 days of the
             screening visit in this trial or intends to participate in another interventional
             clinical trial during participation in this trial

          -  is co-infected with human immunodeficiency virus (HIV) or hepatitis B virus

          -  has evidence or history of chronic hepatitis not caused by HCV, including but not
             limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune
             hepatitis

          -  has evidence of decompensated liver disease including, but not limited to, a history
             or presence of clinical ascites, bleeding varices, or hepatic encephalopathy

          -  has evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC

          -  has evidence of active or suspected malignancy, or a history of malignancy, within the
             last 5 years

          -  has been previously treated with an interferon or ribavirin regimen or HCV direct
             acting anti-viral regimen, or treated for hepatitis C with any investigational
             medication

          -  taking/plans to take significant inducers of inhibitors of Cytochrome P450 3A4
             (CYP3A4) substrates 2 weeks prior to start of study medications, or herbal
             supplements, including but not limited to St. John's Wort 2 weeks prior to start of
             study medications (Day 1)

          -  has pre-existing psychiatric condition(s)

          -  has a clinical diagnosis of substance abuse

          -  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

          -  is pregnant or nursing (for female participant) or female partner intends to become
             pregnant (for male participant)