An International, Multicenter, Open-Label Study Evaluating Sustained Virological Response and Safety With Boceprevir in Triple Combination Therapy With Peginterferon Alfa-2a (40KD) and Ribavirin in Treatment-Naïve Patients With Genotype 1 Chronic Hepatitis C
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 165
- Primary Endpoint
- Percentage of Participants With Sustained Virological Response (SVR) at 12 Weeks After End of Treatment (EOT)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Dual Combination Therapy
Intervention: peginterferon alfa-2a [Pegasys] (Drug)
Dual Combination Therapy
Intervention: ribavirin (Copegus] (Drug)
Triple Combination Therapy
Intervention: boceprevir (Drug)
Triple Combination Therapy
Intervention: peginterferon alfa-2a [Pegasys] (Drug)
Triple Combination Therapy
Intervention: ribavirin (Copegus] (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With Sustained Virological Response (SVR) at 12 Weeks After End of Treatment (EOT)
Time Frame: At 12 weeks after EOT (up to 60 weeks)
SVR at 12 weeks after EOT was defined as an undetectable HCV RNA viral load obtained 12 weeks following completion of treatment. HCV RNA viral load was measured using the Roche COBAS TaqMan 2.0 HCV Test, with a lower limit of detection (LOD) of 10 to 15 international units per milliliter (IU/mL). The percentage of participants with SVR was calculated as \[number of participants with undetectable HCV RNA at 12 weeks after EOT divided by the number of participants analyzed\] multiplied by 100.
Secondary Outcomes
- Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA(At Weeks 2, 4, 6, 8, 12, 16, 24, and 28)
- Percentage of Participants With Virological Relapse Following EOT Response(Up to 72 weeks (at 12 and 24 weeks after EOT))
- Number of Participants With a Safety-Related Dose Modification(Up to 48 weeks (from Baseline until EOT))
- Time to Safety-Related Dose Modification(Up to 48 weeks (from Baseline until EOT))
- Percentage of Participants Using Concomitant Hematopoietic Stimulants During Treatment and Follow-Up(Up to 72 weeks (from Baseline until 24 weeks after EOT))
- Percentage of Participants With Virological Rebound Following On-Treatment Decline in HCV RNA(Up to 48 weeks (at Baseline; Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; and EOT))
- Duration of Treatment With PEG-IFN, RBV, and Boceprevir(Up to 48 weeks (from Baseline until EOT))
- Percentage of Participants With Virological Breakthrough Following On-Treatment Response(Up to 48 weeks (at Baseline; Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; and EOT))
- Percentage of Participants With Treatment Discontinued Based Upon Elevated (Week 12) or Detectable (Week 24) HCV RNA(At 12 and 24 weeks)
- Percentage of Participants With SVR at 24 Weeks After EOT(At 24 weeks after EOT (up to 72 weeks))
- Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir(Up to 48 weeks (from Baseline until EOT))
- HCV RNA Levels(At Baseline; Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; EOT; and 12 and 24 weeks after EOT (up to 72 weeks))
- Percentage of Participants With Virological Response(At Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; and EOT (up to 48 weeks))
- Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason(Up to 48 weeks (from Baseline until EOT))
- Percentage of Participants With a Concomitant Disease Prior to or During the Study(Up to 76 weeks (from Screening until 24 weeks after EOT))
- Percentage of Participants Using Concomitant Medications During Treatment and Follow-Up(Up to 72 weeks (from Baseline until 24 weeks after EOT))