A Phase III Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Treatment-Naive Subjects With Chronic HCV GT1, GT4, and GT6 Infection Who Are Co-Infected With HIV
Phase of Trial: Phase III
Latest Information Update: 28 Jan 2016
At a glance
- Drugs Elbasvir/grazoprevir (Primary)
- Indications Hepatitis C
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms C-EDGE CO-INFXN; C-EDGE COINFECTION
- Sponsors Merck Sharp & Dohme
- 28 Jan 2016 In January 2016, the US FDA approved elbasvir and grazoprevir (Zepatier) with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adult patients, according to an FDA media release.
- 18 Dec 2015 According to Merck & Co media release, the Committee for Medicinal Products for Human Use (CHMP) of the EMA has advised the company that the MAA for grazoprevir/elbasvir will be reviewed on a standard timetable instead of accelerated timeline.
- 14 Nov 2015 Results of integrated analysis of patients with compensated liver cirrhosis (Child-Pugh class A) from this and 5 other phase II and III trials will be presented at The Liver Meeting 2015, according to a Merck & Co media release.