Acute Hepatitis C in HIV infected patients
Conditions
Interventions
Product Name: Grazoprevir/Elbasvir
Product Code: MK-5172/Mk-8742
Pharmaceutical Form: Tablet
INN or Proposed INN: mK-8742
Other descriptive name: ELBASVIR
Concentration unit: mg milligram(s)
Concentra
Sponsors
Erasmus MC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. HIV positive 2. Acute HCV genotype 1 or 4 infection (=26 weeks old at the baseline visit) according to definition mentioned above Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. 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 <5 years old can be used for screening. 5. Protease inhibitor based and NNRTI based cART regimens are not allowed. Therefore, the inability to switch to a HAART regimen consisting of 2 nucleoside/tide reverse transcriptase inhibitors and an allowed third agent which can be raltegravir (Isentress®) 400mg BID, dolutegravir (Tivicay) 50mg QD or rilpivirine 25mg QD.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To document that a 8-week treatment of acute HCV with grazoprevir (MK-5172), elbasvir (MK-8742) is effective.;Secondary Objective: To document that treatment of acute HCV with grazoprevir (MK-5172), elbasvir (MK-8742) is safe;Primary end point(s): SVR 12 weeks after the end of all therapy in the ITT population;Timepoint(s) of evaluation of this end point: 12 weeks after therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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) XML File Identifier: rE5Uuvi/Hp5eKOOrB/DfZBLaoJI= Page 12/23 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.;Timepoint(s) of evaluation of this end point: 12 or 24 weeks after end of therapy | — |
Countries
Belgium
Contacts
Public ContactPrincipal investigator
Erasmus MC
Outcome results
None listed