Phase 4
N=165
A Triple Combination Therapy Study of Boceprevir, Pegasys and Copegus in Previously Untreated Patients With Genotype 1 Chronic Hepatitis C
Hepatitis C, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT01591460 ↗Enrolled (actual)
165
Serious AEs
9.1%
Results posted
Aug 2015
Primary outcome: Primary: Percentage of Participants With Sustained Virological Response (SVR) at 12 Weeks After End of Treatment (EOT) — 81; 70; 75; 88 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- boceprevir (Drug); peginterferon alfa-2a [Pegasys] (Drug); ribavirin (Copegus] (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virological Response (SVR) at 12 Weeks After End of Treatment (EOT) |
81; 70; 75; 88; 95; 32 | — |
| SECONDARY Percentage of Participants With SVR at 24 Weeks After EOT |
80; 70; 71; 88; 95; 32 | — |
| SECONDARY HCV RNA Levels |
6.29; 6.34; 6.40; 6.46; 6.18; 6.34 | — |
| SECONDARY Percentage of Participants With Virological Response |
4; 0; 0; 0; 6; 5 | — |
| SECONDARY Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA |
12; 5; 0; 0; 19; 16 | — |
| SECONDARY Percentage of Participants With Virological Relapse Following EOT Response |
7; 13; 5; 9; 4; 25 | — |
| SECONDARY Percentage of Participants With Virological Breakthrough Following On-Treatment Response |
3; 0; 0; 4; 0; 23 | — |
| SECONDARY Percentage of Participants With Virological Rebound Following On-Treatment Decline in HCV RNA |
6; 5; 17; 4; 0; 22 | — |
| SECONDARY Percentage of Participants With Treatment Discontinued Based Upon Elevated (Week 12) or Detectable (Week 24) HCV RNA |
4; 10; 13; 0; 0; 11 | — |
| SECONDARY Duration of Treatment With PEG-IFN, RBV, and Boceprevir |
28.0; 48.0; 48.0; 48.0; 28.0; 26.0 | — |
| SECONDARY Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason |
52; 60; 54; 46; 42; 84 | — |
| SECONDARY Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir |
8; 25; 25; 0; 0; 0.7 | — |
| SECONDARY Number of Participants With a Safety-Related Dose Modification |
113 | — |
| SECONDARY Time to Safety-Related Dose Modification |
12.1 | — |
| SECONDARY Percentage of Participants Using Concomitant Hematopoietic Stimulants During Treatment and Follow-Up |
6 | — |
| SECONDARY Percentage of Participants With a Concomitant Disease Prior to or During the Study |
53; 18; 8; 6; 5 | — |
| SECONDARY Percentage of Participants Using Concomitant Medications During Treatment and Follow-Up |
79; 29; 22; 19; 19; 17 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01591460). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.