A Long Term Follow-up Study of Subjects previously treated with MK5172
Research type
Research Study
Full title
A Long-Term Follow-up Study to Evaluate the Durability of Virologic Response and/or Viral Resistance Patterns of Subjects with Chronic Hepatitis C Who Have Been Previously Treated with MK-5172 in a Prior Clinical Trial.
IRAS ID
128290
Contact name
Fiona Gordon
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp.
Eudract number
2012-002232-85
Research summary
Research Summary
Hepatitis C is a leading cause of liver disease. Three quarters of infected people will develop long term infection which can lead to severe liver damage (cirrhosis), liver cancer or liver failure and the need for liver transplantation.\nCurrently Hepatitis C treatment consists of a lengthy treatment (24 to 48 weeks) with pegylated interferon (pegIFN)and ribavirn (RBV) and is effective in around 50% of patients. Recently, two protease inhibitors have been approved as\ntreatment in combination with pegIFN and RBV for hepatitis C Genotype 1 patients, which has significantly increased response rates up to ~70%. However many patients can not tolerate the side effects of pegIFN or the lengthy duration of\ntreatment - therefore a shorter duration of treatment would be a significant advantage.\nThe experimental drug MK5172 is a very potent protease inhibitor which has been shown to rapidly clear the HCV virus from the blood and could therefore offer an effective shorter duration treatment for HCV. A shorter duration of treatment\nwould lead to fewer side effects suffered by patients and better treatment compliance.\nThe MK5172-017 study is a long-term follow-up study. Whilst enrolled into the MK5172-017 study, patients will not receive any study drugs. In order for subjects to be eligible to participate in the MK5172-017 study, the subject will have had to of received at least one dose of MK-5172 in a previous study. The main objective of the MK-5172-017 study, is to evaluate how long sustained virologic response (SVR) will last after treatment with MK-5172. SVR (also called long-term response) means that there is no detectable level of Hepatitis C Virus in the blood.Summary of Results
Efficacy/Viral Resistance
The following key efficacy results were observed:
Of the 2332 participants who achieved SVR24 in their prior base study, 4 participants experienced virologic relapse approximately 7 months (n=2) and approximately 12 months (n=2) after the last dose of study medication. Ten participants experienced reinfection. In HCV-infected participants who achieved SVR24 in a prior GZR treatment study, SVR was durable in long-term follow-up.
No new NS3 or NS5A RASs were detected following entry into this study.
Treatment-emergent NS5A RASs in HCV GT1-infected participants identified at the time of virologic failure persisted for 144 weeks post-failure.
Treatment-emergent NS5A RASs identified in 5 HCV genotype 4 (GT4)-infected participants at the time of virologic failure persisted in 2 of these participants for 96 weeks post-failure.
Treatment-emergent NS3 RASs were supplanted by the wild-type sequence in most HCVGT1- or GT4-infected participants by 24 weeks post-failure
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
13/EE/0214
Date of REC Opinion
21 Aug 2013
REC opinion
Favourable Opinion