Hepatitis C HIV
Conditions
Interventions
Treatment with boceprevir, P + R
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Documented recent HCV genotype 1 infection (1000 IU/ml. 4. On HAART at the time of baseline visit
Exclusion criteria
Exclusion criteria: 1. Disallowed co-medication that cannot be stopped or replaced: Several potentially life-threatening drug-drug interactions (DDI) are possible when boceprevir is combined with other drugs. Therefore ALL co-medication, including over-the-counter drugs should be checked for potential DDI with DDI table in the Dutch summary of product characteristics (SPC, appendix A). If the comedication is not mentioned in the SPC DDI table, www.HCV-druginteractions.org should be used. ;2. Contraindications for the use of full dose of peginterferon alfa-2b or ribavirin: neutrophils 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained viral response (SVR) 12 weeks after the end of therapy in the RVR week 4 population (RVR4). SVR at week 12 and RVR at week 4 is defined as HCV RNA below the limit of detection with the TaqMan 2.0 assay (Roche Diagnostics). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. SVR 12 weeks after the end of all therapy in the entire study population (with or without RVR at week 4). 2. SVR 12 weeks after end of therapy in patients with already a RVR at week 1. 3. SVR 12 weeks after end of therapy in patients starting therapy | — |
Countries
Netherlands
Outcome results
None listed