Dutch Acute HCV in HIV Study (DAHHS-2): Grazoprevir/Elbasvir for Acute HCV
Status:
Completed
Trial end date:
2019-01-11
Target enrollment:
Participant gender:
Summary
New and recently EMA/FDA approved direct acting antiviral (DAA) combination therapies cure
95% or more of the patients chronically infected with HCV genotype 1 and 4. Grazoprevir
(MK-5172) and elbasvir (MK-8742) combination therapy is such a, albeit not yet EMA/FDA
approved combination DAA therapy.
It is likely that the synergistic effect of the host's immune response and antiviral therapy
when given during the first 6 months of HCV infection makes antiviral therapy during acute
HCV infection more effective. In this study the investigators would like to document that
treatment of acute HCV with grazoprevir (MK-5172), elbasvir (MK-8742) is effective and can
ben shortened from 12 to 8 weeks for HCV genotype 1 and 4 infection without substantial loss
in efficacy.
Study design and intervention:
Prospective open label interventional clinical trial in which 80 acute HCV genotype 1 or 4
patients co-infected with HIV will receive 8 weeks of grazoprevir and elbasvir (a once-daily
combination tablet).
Study population:
80 Adult HIV positive patients with an acute HCV genotype 1 or 4 infection from 10 HIV
treatment centers in the Netherlands and Belgium will be included.
Primary endpoint: Sustained viral response (SVR) 12 weeks after the end of therapy in ITT
study population (=genotype 1 and 4).