Merck's grazoprevir/elbasvir combo shows high cure rates, including for people with cirrhosis and HIV/HCV co-infection

Published: November 13, 2014

Liz Highleyman
Original Article: 

An all-oral regimen of grazoprevir (MK-5172) and elbasvir (MK-8742), taken with or without ribavirin for 12 weeks, demonstrated high sustained virological response (SVR) rates for treatment-naive and treatment-experienced people with genotype 1 hepatitis C virus (HCV), including people with liver cirrhosis and HIV and HCV co-infection, researchers reported on Tuesday at the American Association for the Study of Liver Diseases (AASLD) Liver Meeting in Boston, USA. However, pushing treatment duration with this combination plus sofosbuvir down to 4 or 6 weeks raised the risk of treatment failure.

The phase 2 C-WORTHY trial evaluated Merck’s investigational HCV protease inhibitor grazoprevir plus NS5A inhibitor elbasvir, taken with or without ribavirin. After Part A saw good outcomes for previously untreated people with genotype 1 hepatitis C and no liver cirrhosis, the study was expanded to include more people with traditional predictors of poor treatment response.

Overall, the trial included:
•    65 treatment-naive patients without cirrhosis in Part A, all treated for 12 weeks
    •    94 treatment-naive patients without cirrhosis in Part B, treated for 8 or 12 weeks
    •    59 patients with HIV and HCV co-infection, without cirrhosis, all treated for 12 weeks
    •    123 treatment-naive patients with cirrhosis, treated for 12 or 18 weeks
    •    130 prior null responders, with or without cirrhosis, treated for 12 or 18 weeks

Mark Sulkowski from Johns Hopkins reported final combined results from the 218 patients with HCV mono-infection and HIV/HCV co-infection without cirrhosis in both Part and A and Part B.

Half of the participants with HCV mono-infection and 80% of the participants with HIV/HCV co-infection were men, most were white and the mean ages were 49 and 45 years, respectively. Three-quarters had harder-to-treat HCV genotype 1a and most had unfavourable IL28B gene variants. More than 90% had absent-to-mild liver fibrosis while 8% had advanced fibrosis (stage F3).

The participants with HIV and HCV co-infection were required to be on stable antiretroviral therapy containing raltegravir (Isentress), which was shown not to interact with the HCV drugs. They had CD4 cell counts above 300 cells/mm3 (median 626 cells/mm3) and undetectable HIV viral load for at least six months.

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