Merck has announced that boceprevir, its chronic hepatitis C virus treatment, has met its primary endpoints in a Phase III trial.
It showed that boceprevir increased the number of patients who achieved sustained virologic response when used in combination with Pegintron and Rebetol.
The trial had two studies: the HCV Respond-2 study, which involved patients who had previously received treated, and HCV Sprint-2 Study, which involved patients who were new to treatment.
The patients in both the studies were divided into three groups, the first of which received 48 weeks of boceprevir treatment plus Pegintron and Rebetol.
The second group received response-guided therapy, where patients with undetectable Hepatitis C were able to stop the treatment at certain points in the studies and continue with Pegintron and Rebetol.
The third group or the control group received the placebo plus Pegintron and Rebetol for 48 weeks.
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The HCV Respond-2 Study showed that 66 % of patients achieved sustained virologic response in the boceprevir 48-week treatment group, 59% in the response-guided therapy group and 21% in the control group.
In the HCV Sprint-2 Study, 66 % of patients achieved sustained virologic response in the boceprevir 48-week treatment group, 63% in the response-guided therapy group and 38% in the control group.
Following the positive results, Merck plans to submit a new drug application for boceprevir to the US Food and Drug Administration.