N/A
Completed N=4,100
An Observational Study on Dual And Triple Therapies Based on Peginterferon Alfa (e.g. Pegasys) in Patients With Chronic Hepatitis C
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT01447446 ↗
Enrolled (actual)
4,100
Serious AEs
9.8%
Results posted
Mar 2017
Primary outcomePrimary: Percentage of Participants With Sustained Virological Response at 24 Weeks Post Completion of the Treatment Period (SVR24) — 52.1; 49.4; 46.6; 50.5 percentage of participants
Summary
This prospective, multicenter, observational cohort study will evaluate the efficacy and safety of pegylated interferon alfa (peginterferon alfa) (e.g. Pegasys) plus ribavirin and treatment regimens containing direct-acting antivirals in participants with chronic hepatitis C who are treatment-naïve or treatment-experienced and HIV HCV co-infected. Data will be collected from participants receiving treatment according to current Summary of Product Characteristics (SPC) and local labeling for the duration of their treatment and a 24-week follow-up.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virological Response at 24 Weeks Post Completion of the Treatment Period (SVR24) |
52.1; 49.4; 46.6; 50.5; 57.7; 47.7 | — |
| PRIMARY Percentage of Participants With Sustained Virological Response at 12 Weeks Post Completion of the Treatment Period (SVR12) |
54.3; 51.0; 50.0; 53.8; 62.0; 57.0 | — |
| SECONDARY Virological Response at Various on Treatment Time Points and End of Treatment (EOT) |
39.5; 40.1; 9.9; 9.7; 49.8; 51.2 | — |
| SECONDARY Virological Relapse After End of Treatment |
18.4; 19.7; 21.0; 20.6; 13.8; 7.5 | — |
| SECONDARY Virological Breakthrough |
5.4; 4.8; 8.7; 15.9; 15.0; 21.6 | — |
| SECONDARY Percentage of Participants With Sustained Virological Response (SVR) in Participants With Dose Reductions or Treatment Interruptions |
37.1; 27.3; 20.7; 14.3; 35.4; 44.4 | — |
| SECONDARY Percentage of Participants With Very Rapid Virological Response, Rapid Virological Response, Complete Early Virological Response and Partial Early Virological Response (pEVR) During First 12 Weeks |
— | — |
| SECONDARY Percentage of Participants Achieving Extended (Rapid) Virological Response (eRVR) |
37.7; 32.3; 45.6; 47.7 | — |
| SECONDARY Duration of Overall Treatment |
34.2; 31.3; 35.2; 35.3; 33.2; 31.2 | — |
| SECONDARY Percentage of Participants Treated According to Label/Summary of Product Characteristics (SPC) |
— | — |
| SECONDARY Percentage of Participants Who Discontinued Treatment With PEG-IFN and Ribavirin (RBV) |
5.7; 8.3; 9.2; 9.7; 9.9; 11.6 | — |
| SECONDARY Percentage of Participants Who Discontinued Treatment With Direct-Acting Anti-viral (DAA) |
6.8; 7.5; 1.7; 4.7; 2.1; 1.1 | — |
| SECONDARY Percentage of Participants With Concomitant Medical Condition at Baseline |
48.1; 50.4; 65.8; 68.8; 67.2; 41.9 | — |
| SECONDARY Percentage of Participants With Adverse Events (AE) |
60.3; 65.7; 76.7; 88.2; 90.7; 87.2 | — |
Eligibility Criteria
Inclusion Criteria
- Adult (according to local legislation) participants
- Chronic hepatitis C (HCV)
- Naive or treatment experienced, HIV-HCV co-infected or HCV mono-infected
- Receiving treatment for HCV with pegylated interferons plus ribavirin or regimens containing direct-acting antivirals (DAA) according to standard of care and in line with current SPC/local labeling
Exclusion Criteria
- Contraindications according to SPC/local labeling
- Treatment started >4 weeks before entering study
Data sourced from ClinicalTrials.gov (NCT01447446). 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.