MK-5172 with PEG-IFN/Ribavirin, Effective, Safe

Manns MP. Gastroenterology. 2014;147:366-376. 

The protease inhibitor MK-5172 in combination with pegylated interferon and ribavirin was safe and effective for the treatment of patients with hepatitis C virus without cirrhosis.

Treatment-naive patients with chronic HCV genotype 1 (n=332) without cirrhosis were randomly assigned MK-5172 (Merck) 100 mg (n=66), 200 mg (n=68), 400 mg (n=67) or 800 mg (n=65) in combination with pegylated interferon (PEG-IFN) and ribavirin (RBV) once daily for 12 or 24 weeks. Based on treatment response at 4 weeks, some patients received an additional 12 or 36 weeks of PEG-IFN/RBV. A control group (n=66) assigned boceprevir (Victrelis, Merck) and PEG-IFN/RBV, dosed according to US product instructions, was also studied.

 

At 24 weeks, the study drug plus PEG-IFN/RBV was highly effective (see Table). Ninety-one percent of patients assigned the 100-mg dose 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 the patients treated with the study drug, 10.5% experienced a serious adverse event. Adverse events included headache, nausea and fatigue. Overall, MK-5172 with PEG-IFN/RBV was well tolerated, and the rate of patients discontinuing therapy due to an adverse event was lower than observed in the control group.

Disclosure: See the study for a full list of the researchers’ relevant financial disclosures.