MK-5172/MK8742 in HCV Subjects on Opiate Substitution Therapy
Research type
Research Study
Full title
A Phase III Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Treatment-Naïve Subjects with Chronic HCV GT1, GT4, GT5, and GT6 Infection who are on Opiate Substitution Therapy.
IRAS ID
153165
Contact name
Ashley Brown
Contact email
Sponsor organisation
Merck Sharp & Dohme Limited
Eudract number
2014-000343-32
Research summary
Chronic Hepatitis C virus (HCV) is a leading cause of liver disease. Three quarters of infected people will develop long term infection which can lead to severe liver damage and the need for liver transplantation. The risk of infection with HCV is high amongst patients who inject drugs, accounting for 50-80% of new HCV infections.
Recent advances in HCV treatment has led to the approval of several medicines, known as direct acting antivirals (DAA). Since the effectiveness of treatments for patients with HCV vary according to hepatitis C genotypes (HCV with a slightly different genetic make-up) and prior treatments, DAAs need to be used in combination with licenced drugs called pegylated interferon and ribavirin (PR). Although DAAs + PR are effective, many patients cannot tolerate the side effects of PR or the length of treatment and thus removal of PR from the backbone of DAA therapy, together with decreasing the length of treatment would be a significant advantage.
MK5172 and MK8742 are two DAAs developed by Merck for the treatment of HCV which together and in combination with PR or ribavirin alone have been shown to rapidly clear the HCV virus from the blood after 12 weeks of treatment in patients with HCV genotype 1.
This study aims to test the effectiveness and safety of MK5172A, a fixed dose combination tablet (FDC) comprising of MK5172 and MK8742 taken for 12 weeks in patients infected with HCV genotype 1, 4, 5 & 6, who are taking an opiate substitute for their iv drug addiction. Patients must be naive to HCV treatment and may also have HIV infection.
About 200 patients will take part in this study. The study will be test the efficacy of MK5172A as determined by virus levels in the blood 12 weeks after completing treatment.
The study will take place at 3 UK hospitals.REC name
London - London Bridge Research Ethics Committee
REC reference
14/LO/0665
Date of REC Opinion
17 Jul 2014
REC opinion
Further Information Favourable Opinion