MK-5172/MK-8742 in HCV G1, 4, 6 with Inherited Blood Disorders
Research type
Research Study
Full title
A Phase III Double Blind Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-8742 in Subjects with Chronic HCV GT1, GT4 and GT6 Infection with Inherited Blood Disorders with and without HIV Co-Infection
IRAS ID
161636
Contact name
Graham Foster
Contact email
Eudract number
2014-002356-27
Clinicaltrials.gov Identifier
110,261, IND Number
Research summary
Hepatitis C virus (HCV) is a leading cause of liver disease. Approximately 30–170 million people globally are chronically infected with HCV. It is transmitted by exposure to contaminated blood. Before the virus was discovered, there was no effective screening process to ensure virus-free blood products were used. Consequently, many people became infected from medical interventions. Long-term complications of chronic HCV infection include cirrhosis and end-stage liver disease.
Requirements for blood products as part of medical care have resulted in high rates of HCV infection for patients with inherited blood disorders (IBD). Advances in care for patients with IBD have resulted in patients living longer; therefore HCV related liver complications are becoming more common in these individuals.
There have been six different types of HCV identified (HCV with a slightly different genetic make-up called genotypes). The global distribution of these genotypes (GT) is diverse. HCV GT 1, 2 and 3 have a fairly broad geographical distribution, whereas HCV GT 4, 5 and 6 are generally confined to specific geographical regions.
Recent advances in HCV treatment has led to the approval of several medicines, known as direct acting antivirals (DAA). MK-5172 and MK-8742 are two DAAs in development that work by preventing the virus multiplying. Used in combination as a single tablet, the drug is known as MK-5172A. This double blinded study will look at how effective and safe MK-5172A is at treating patients with HCV GT1, 4 and 6 with different types of IBD. This will include subjects with or without cirrhosis, treatment-naïve or treatment-experienced and with or without HIV co-infection.
About 200 patients will take part in this study. It will last 42.5 or 58.5 weeks depending on what arm the patient is assigned.
The study will take place at 2 UK sites. The study is funded by Merck Sharp & Dohme Limited.
REC name
East of England - Essex Research Ethics Committee
REC reference
14/EE/1120
Date of REC Opinion
8 Oct 2014
REC opinion
Further Information Favourable Opinion