Phase 2
Completed N=57
Dutch Acute HCV in HIV Study (DAHHS)
Source: ClinicalTrials.gov NCT01912495 ↗Enrolled (actual)
57
Serious AEs
5.3%
Results posted
Apr 2016
Primary outcomePrimary: Sustained Viral Response(SVR) 12 Weeks of Follow up After the End of All Therapy for the Rapid Viral Response at Week 4(RVR4) Population. — 41 participants
Summary
Prospective open label proof of concept feasibility interventional clinical trial in which 60 acute HCV genotype 1 patients co-infected with HIV will receive 12 weeks of boceprevir in addition to Standard Of Care Peginterferon + Ribavirin if they show a Rapid Viral Responds at week 4.
The primary hypothesis of this study is that the subset of patients with a Rapid Viral Responds after 4 weeks of triple therapy with boceprevir, peginterferon alpha-2b (P) and ribavirin (RVR4) can be successfully treated with a shorter 12-week triple therapy regimen.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sustained Viral Response(SVR) 12 Weeks of Follow up After the End of All Therapy for the Rapid Viral Response at Week 4(RVR4) Population. |
41 | — |
| SECONDARY SVR 12 Weeks After the End of All Therapy in the Entire Study Population (With or Without RVR4). |
49 | — |
| SECONDARY SVR 12 Weeks After End of Therapy in Patients With Already a RVR at Week 1. |
5 | — |
| SECONDARY SVR 12 Weeks After End of Therapy in Patients That Started Therapy ≤12weeks After the Presumed HCV Infection Date Versus Those After 12 Weeks. |
5 | — |
| SECONDARY Alterations of Biomarkers by Therapy Induced Viral Eradication: Viral Sequencing, Mutation Analysis, Gene Expression Analysis, and RNA Analysis. |
— | — |
| SECONDARY Safety: Treatment Related (Serious) Adverse Events ((S)AE) and Treatment Discontinuation for (S)AE. |
3 | — |
Eligibility Criteria
Inclusion Criteria
- Documented recent HCV genotype 1 infection (≤26 weeks old at the time of the baseline visit) according to definition mentioned below.
- Plan to start a Standard Of Care therapy for acute HCV consisting of 24 weeks of Peginterferon + Ribavirin. HCV RNA plasma viral load at screening >1000 IU/ml.
- A previously performed HCV RNA plasma measurement can be used for screening if F1 fibrosis on fibroscan. Inclusion of patients with a chronic well-controlled HBV (HBV-DNA below the limit of detection) with tenofovir, lamivudine or emtricitabine therapy is allowed if fibroscan excludes >F1 fibrosis. Fibroscan reports <2 years old can be used for screening. Fibroscan is not required for other patients at screening.
- HAART was started <4 weeks before baseline visit.
- Inability to switch to a HAART regimen consisting of 2 nucleoside/tide reverse transcriptase inhibitors + Raltegravir (Isentress®) 400mg BID or rilpivirine 25mg QD or atazanavir (Reyataz®) 300mg QD + ritonavir (Norvir®) 100mg QD.
- Patient that virologically failed HAART in the past
Data sourced from ClinicalTrials.gov (NCT01912495). 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.