Grazoprevir (MK-5172) + Elbasvir (MK-8742) for the treatment of ACUTE hepatitis C genotype 1/4. The Dutch Acute HCV in HIV Study (DAHHS-2) - DAHHS 2

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 71 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•1. Acute HCV genotype 1 or 4 infection (<=26 weeks old at the baseline visit) according to definition mentioned in the protocol

•;1. If HIV+: Not on cART and a CD4 <500 at the time of screening
•2. If HIV+: Patients on cART for >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.If HIV+: 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.

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