acute hepatitis c
Conditions
Interventions
Day 1-56: All patients will receive grazoprevir/elbasvir fixed dose combination
oral tablet consisting of 100/50mg per tablet.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Acute HCV genotype 1 or 4 infection (
Exclusion criteria
Exclusion criteria: Exclusion criteria:;1. If HIV+: Not on cART and a CD4 6 months with a HIV viral load >400 copies 3.Disallowed co-medication that cannot be stopped or replaced: Therefore ALL co-medication, including over-the-counter drugs should be checked for potential drug-drug interactions using the investigators brochure (appendix A). In particular, care should be taken for patients that are taking >10mg atorvastatin or >5mg rosuvastatin per day and the dose should be reduced to the lowest dose available (10mg for atorvastatin and 5 for rosuvastatin). Alternatively a switch to pravastatin may be preferred. When in doubt about drug-drug interactions, contact the coordinating investigator. 4.History of liver cirrhosis of any etiology. Inclusion of patients with a chronic well-controlled HBV (HBV-DNA F1 fibrosis. Fibroscan reports
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study endpoint SVR 12 weeks after the end of all therapy in the ITT population | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study endpoints 1. SVR12 in all genotype 1 infected patients in the mITT. 2. SVR12 in genotype 4 infected patients (ITT and mITT) 3. SVR12 in all patients included (=genotype 1 and 4, ITT and mITT) 4. SVR12 in RVR2 and RVR4 (mITT) 5. SVR12 in all patients (=genotype 1+4) according to IL28 genotype (*) 6. SVR24 (mITT and ITT)(%) 7. Cost-effectivity of treatment during the acute phase of HCV in comparison with treatment 12 months later for chronic HCV or treatment only at a certain level of liver fibrosis. 8. SVR12 in genotype 1a infected patients with no NS5a polymorphisms at positions 28/30/31 or 93 versus SVR12 in patients with 1 or more of these polymorphisms (*) The reason to include this analysis as a secondary endpoint is that despite the fact that no interferon is used, IL28 genotype may impact the SVR rates because it determines the spontaneous cure rates of acute HCV. Therefore, a favorable IL28 genotype may work synergistically with DAA and increase SVR rates. (%) The SVR12 endpoint was only thoroughly validated for the treatment of chronic HCV. Therefore, we prefer to include SVR24 as a secondary endpoint, to confirm that SVR12 is also a reliable predictor of SVR24 in acute HCV therapy | — |
Countries
Netherlands
Outcome results
None listed