This article is more than 5 years old. Information may no longer be current.
MK-5172 with PEG-IFN/ribavirin effective, safe when treating HCV
Click Here to Manage Email Alerts
The protease inhibitor MK-5172 in combination with pegylated interferon and ribavirin was safe and effective when treating patients with hepatitis C virus without cirrhosis, according to new study results.
Treatment-naive patients with chronic hepatitis C virus genotype 1 (HCV; n=332) without cirrhosis were randomly assigned 100 mg (n=66), 200 mg (n=68), 400 mg (n=67) or 800 mg (n=65) MK-5172 (Merck) concomitantly with peginterferon and ribavirin (PR) once daily for 12 or 24 weeks. Based on treatment response at 4 weeks, some patients received an additional 12 or 36 weeks of PR. A control group (n=66) receiving boceprevir (Victrelis, Merck) and PR, dosed according to US product instructions, also was included.
At 24 weeks post-treatment, 89% of patients assigned 100 mg MK-5172 with PR achieved sustained virologic response (SVR), as did 93% of the 200-mg group, 91% of the 400-mg group and 86% of the 800 mg group vs. 61% of control patients. Ninety-one percent of patients receiving 100 mg MK-5172 plus PR had undetectable levels of HCV-RNA at 4 weeks and had a shorter duration of therapy.
Twenty-seven patients assigned MK-5172 did not achieve SVR at 24 weeks, including 19 who were lost to follow-up. Of MK-5172-treated patients, 10.5% experienced a serious adverse event, while adverse events included headache, nausea and fatigue. Overall, MK-5172 with PR was well tolerated, and the rate of patients discontinuing therapy due to an adverse event was lower than observed among the control group.
“The high efficacy of MK-5172 plus PR shown in this clinical study and the high barrier to resistance of MK-5172 when combined with MK-8742 in vitro suggest the possibility of high rates of efficacy when MK-5172 is combined with an NS5A inhibitor or another direct-acting antiviral with a different mechanism of action (such as sofosbuvir) in an interferon-free and ribavirin-free regimen in patients chronically infected with HCV,” the researchers wrote.
Disclosure: See the study for a full list of relevant financial disclosures.
Click Here to Manage Email Alerts