N/A
Completed N=991
An Observational Study of Dual and Triple Therapies Based on Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT01604291 ↗
Enrolled (actual)
991
Serious AEs
13.5%
Results posted
Mar 2019
Primary outcomePrimary: Percentage of Participants With Sustained Viral Response (SVR) at Week 24 — 87.2; 94.8; 85.2 Percentage of Participants
Summary
This multi-center, observational study will evaluate the efficacy and safety of dual and triple therapies based on Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis C. Patients receiving treatment with either Pegasys plus ribavirin or Pegasys plus ribavirin plus telaprevir/boceprevir will be observed for the duration of their treatment and for up to 24 weeks of follow-up.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Viral Response (SVR) at Week 24 |
87.2; 94.8; 85.2 | — |
| SECONDARY Comparison of SVR at Week 24 |
86.6; 94.8; 84.5; 100; 100; 83.8 | — |
| SECONDARY Number of Participants With SVR at Week 24 According to the Demographic Characteristics |
316; 33; 198; 20; 513; 44 | 0.9109 |
| SECONDARY Percentage of Participants With Rapid Virologic Response (RVR) at Week 4 |
61.2; 70.9; 21.1 | — |
| SECONDARY Percentage of Participants With Extended RVR |
72.7; 70.7 | — |
| SECONDARY Percentage of Participants With Complete Early Virologic Response (cEVR) |
75.0; 84.9; 62.0 | — |
| SECONDARY Percentage of Participants With End of Treatment Response (EoT) |
86.4; 81.9; 76.6 | — |
| SECONDARY Percentage of Participants With Virologic Relapse |
0.3; 0; 0 | — |
| SECONDARY Treatment Duration |
26.2; 34.8; 36.1; 26.2; 34.8; 36.1 | — |
| SECONDARY Time to First Dose Modification of Peginterferon Alfa-2a |
418.5; 247.6; 328.4 | — |
| SECONDARY Time to First Dose Modification of Ribavirin |
NA; 61.4; 89.4 | — |
| SECONDARY Time to First Dose Modification of Telaprevir/Boceprevir |
124.6; 82.3 | — |
| SECONDARY Percentage of Participants With Adverse Events (AEs) |
68.8; 79.3; 85.9 | — |
| SECONDARY Mean Value of Hemoglobin in Participants With Treatment-Induced Anemia |
9.3; 9.2; 9.5 | — |
| SECONDARY Percentage of Participants With Treatment Regimen for HCV Treatment Induced Anemia |
37; 56.5; 53.6; 2.5; 4.5; 2.3 | — |
| SECONDARY Percentage of Participants Who Had SVR at Week 24 With Dose Modifications |
15.70; 55.56; 0.78 | 0.0463 sig |
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Chronic hepatitis C (all genotypes, naïve or treatment experienced, HCV mono-infected or HCV-HIV co-infected)
- Receiving either dual therapy (Pegasys plus ribavirin) or triple therapy (Pegasys plus ribavirin plus telaprevir/boceprevir)
- No contra-indications to Pegasys and ribavirin therapy or to treatment regimen containing protease inhibitor (telaprevir or boceprevir) as detailed in local Prescribing Information
- Quantitative serum HCV RNA by PCR test before initiation of treatment
Exclusion Criteria
- Hepatitis A/B co-infection
- Evidence of severe illness, active malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
- Pregnant or breast-feeding women
Data sourced from ClinicalTrials.gov (NCT01604291). 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.