The American Association for the Study of Liver Disease, currently taking place in Boston, heard final results from US drug giant Merck & Co (NYSE: MRK) from two pivotal Phase III studies, HCV RESPOND-2 and HCV SPRINT-2 demonstrated that addition of boceprevir to the combination therapy of Pegintron (peginterferon alfa-2b) and Rebetol (ribavirin) achieved significantly higher sustained virologic response in adult chronic HCV genotype 1 patients, who previously failed treatment, and in adult patients who were new to treatment, compared to control arm.
In primary results, addition of boceprevir significantly increased SVR rates compared to control HCV RESPOND-2, which was conducted at US and international sites, included 403 adult patients who had failed prior therapy, including patients who relapsed or were non-responders to prior treatment with peginterferon and ribavirin. HCV SPRINT-2 was conducted in 1,097 treatment-naïve adult patients at US and international sites who were enrolled in two separate cohorts, one with 938 non-African-American/non-Black patients and the other with 159 African-American/Black patients.
In treatment-failure patients in HCV RESPOND-2, boceprevir increased SVR rates to 59% for the RGT arm (95/162) and 66 percent for the 48-week treatment arm (107/161) compared to 21% for control (17/80). In treatment-naïve patients in HCV SPRINT-2, boceprevir increased SVR rates to 63% for the RGT arm (233/368) and 66 percent for the 48-week treatment arm (242/366), compared to 38% for control (137/363). (All primary endpoints achieved statistical significance of p<0.0001 based on intent-to-treat analyses.)
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