A Triple Combination Therapy Study of Boceprevir, Pegasys and Copegus in Previously Untreated Patients With Genotype 1 Chronic Hepatitis C

• Sustained virological response 24 weeks after treatment end [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
• Level of hepatitis C virus RNA [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
• End of treatment response [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
• Virological Relapse rate [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
• Safety: incidence of adverse events [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]

This open-label, multicenter, treatment response guided study will evaluate the sustained virological response and safety of the triple combination therapy boceprevir, Pegasys (peginterferon alfa-2a) and Copegus (Ribavirin) in previously untreated patients with genotype 1 chronic hepatitis C. In the lead-in phase, patients will receive a dual combination therapy of Pegasys and Copegus for 4 weeks. In the following triple combination therapy phase, 800 mg boceprevir, 180 mcg Pegasys and 1000-1200 mg Copegus will be administered for 24, 32 or 44 weeks; the duration depending on the patient's treatment response. The anticipated time on study treatment is up to 48 weeks.

• Drug: boceprevir
  800 mg three times daily for 24, 32 or 44 weeks
• Drug: peginterferon alfa-2a [Pegasys]
  180 mcg subcutaneously once a week for 24, 32 or 44 weeks
• Drug: ribavirin (Copegus]
  1000 mg or 1200 mg orally once a day for 24, 32 or 44 weeks
• Drug: peginterferon alfa-2a [Pegasys]
  180 mcg subcutaneously once a week for 4 weeks
• Drug: ribavirin (Copegus]
  1000 mg or 1200 mg orally once a day for 4 weeks

• Experimental: Dual Combination Therapy
  Interventions:

  • Drug: peginterferon alfa-2a [Pegasys]
  • Drug: ribavirin (Copegus]
• Experimental: Triple Combination Therapy
  Interventions:

  • Drug: boceprevir
  • Drug: peginterferon alfa-2a [Pegasys]
  • Drug: ribavirin (Copegus]

Inclusion Criteria:

• Adult patients >/=18 years of age
• Chronic liver disease consistent with chronic hepatitis C, genotype 1 infection
• Serum HCV RNA quantifiable at screening
• Patients who have not been previously treated with pegylated interferon (IFN), standard IFN, RBV or any direct acting anti-viral agent
• Compensated liver disease (Child-Pugh Grade A clinical classification for patients with cirrhosis: total score </=6)
• Negative urine or blood pregnancy test (for women of childbearing potential)

Exclusion Criteria:

• Women with ongoing pregnancy or breast feeding
• Male partners of women who are pregnant
• Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment </=6 months prior to the first dose of study drug
• Any investigational drug </=6 weeks prior to the first dose of study drug
• History or other evidence of decompensated liver disease
• History or other evidence of a medical condition associated with chronic liver disease other than chronic hepatitis C
• Signs or symptoms of hepatocellular carcinoma
• Co-infection with HCV genotypes other than genotype 1
• Co-infection with hepatitis A, hepatitis B, and/or human immunodeficiency virus (HIV)
• Any patient with an increased risk for anemia
• History of severe psychiatric disease
• History of immunologically mediated, chronic pulmonary, or severe cardiac disease
• Current diseases that are not adequately controlled