N/A
Completed N=635
An Observational Study of Peginterferon (e.g. Pegasys)-Based Direct Acting Antiviral Triple Therapy in Patients With Chronic Hepatitis C Genotype 1
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT01508130 ↗
Enrolled (actual)
635
Serious AEs
14.6%
Results posted
Feb 2016
Primary outcomePrimary: Time to Premature Treatment Discontinuation Due to Any Reason — 40.0; 40.6 weeks — p=0.6451
Summary
This prospective observational study will evaluate the efficacy and safety of two approved pegylated interferon-based direct acting antiviral triple therapies in patients with chronic hepatitis C genotype 1. Patients receiving pegylated interferon (e.g. Pegasys) and ribavirin plus either telaprevir or boceprivir in accordance with local standard of care and US labeling will be followed for the duration of their treatment and for up to 24 weeks post-treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Premature Treatment Discontinuation Due to Any Reason |
40.0; 40.6 | 0.6451 |
| PRIMARY Number of Participants With Sustained Virologic Response (SVR) at 12 Weeks or Later After Completion of the Treatment Period |
160; 39 | 0.7695 |
| SECONDARY Number of Participants With Virologic Response (VR) |
104; 3; 348; 19; 327; 33 | — |
| SECONDARY Number of Participants With VR by Categories of Very Rapid VR (VRVR), Rapid Virological Response (RVR), VR Week 8, Early Virological Response (cEVR), Partial Virological Response (pEVR), and None of the Above |
104; 3; 252; 16; 28; 56 | — |
| SECONDARY Number of Participants Who Achieved Extended VR, Virologic Breakthrough/Rebound, Virologic Relapse, and Who Were Non-responder |
159; 39; 52; 15; 174; 52 | — |
| SECONDARY Predictors of Sustained Virologic Response by Week |
43; 1; 138; 10; 142; 17 | — |
| SECONDARY Number of Participants With SVR by Subgroups (Demographic and Baseline Factors) |
76; 22; 84; 17; 49; 14 | — |
| SECONDARY Duration of Viral Undetectability During Treatment for Participants With HCV RNA Undetectable During Treatment by Trial Treatment |
22.1; 23.0 | — |
| SECONDARY Time to Premature Treatment Discontinuation Due to Lack of Efficacy |
NA; NA | 0.9156 |
| SECONDARY Time to Premature Treatment Discontinuation Due to Intolerance |
NA; NA | 0.5649 |
| SECONDARY Treatment Duration, as Measure of Extent of Exposure to Study Medication |
26.0; 26.8; 23.2; 34.0; 26.1; 27.6 | — |
| SECONDARY Mean Cumulative Dose, as Measure of Extent of Exposure to Study Medication |
4504.5; 4478.1; 3234.5; 4239.1; 24991.1; 26215.9 | — |
| SECONDARY Percentage of Dose Reduction, as Measure of Extent of Exposure to Study Medication |
102.5; 104.8; 101.2; 111.7; 116.8; 118.2 | — |
| SECONDARY Compliance of Study Treatment |
342; 113; 312; 103; 304; 101 | — |
| SECONDARY Number of Participants Treated With PegIFN, RBV, and TEL as Per the U.S. Label |
190; 75; 8; 58; 25 | — |
| SECONDARY Number of Participants Treated With PegIFN, RBV, and BOC as Per the U.S. Label |
59; 15; 1; 2; 17; 3 | — |
| SECONDARY Number of Participants With Safety-related Dose Reductions |
190; 70 | — |
| SECONDARY Number of Participants With Premature Treatment Discontinuation Due to Adverse Events (AEs) |
80; 28 | — |
| SECONDARY Number of Participants With Any AEs and Serious Adverse Events (SAEs) |
470; 142; 76; 16 | — |
| SECONDARY Change From Baseline in Work Loss And Productivity Outcomes (WPAI) |
14.6; 13.8; 9.3; 19.6; 11.8; 26.8 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Chronic hepatitis C, genotype 1
- Receiving pegylated interferon-based direct acting antiviral therapy (pegylated interferon and ribavirin plus either telaprevir or boceprivir) in accordance with local standard of care and US labeling
Exclusion Criteria
- Contraindications per US labels
Data sourced from ClinicalTrials.gov (NCT01508130). 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. Informational only — not medical advice.