Common TitleC-EDGE Coinfection
Official Title Efficacy and Safety of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Patients with Hepatitis C Virus and HIV Co-Infection (C-EDGE CO-INFECTION): a Non-Randomised, Open-Label Trial
Purpose / DescriptionIn this prospective single-arm, open-label clinical trial, 218 patients with chronic hepatitis C genotype 1, 4, or 6 and HIV coinfection received the fixed-dose combination of elbasvir-grazoprevir once daily for 12 weeks. Nearly all (97%) patients were on antiretroviral therapy with HIV viral suppression and the median CD4 cell count was 568 cells/mm3; 86% had genotype 1a or 1b infection and 35 (16%) had compensated cirrhosis. The overall SVR12 rate was 96% by primary analysis, with the breakdown by genotype showing 96.5% for genotype 1a, 95.5% for genotype 1b and 96.4% for genotype 4. All cirrhotic patients achieved an SVR12. When patients who did not achieve an SVR12 due to treatment discontinuation or reinfection were excluded, the overall SVR12 rate was 97%.
Phase Phase III
ClinicalTrials.gov NCT02105662
Treatments
Elbasvir-Grazoprevir

Elbasvir-Grazoprevir
Tradename:ZepatierOther Names:EBR-GZRClass:FDA-ApprovedFunding
IndustryMerck Sharp & Dohme Corp.