Final results phase-3 studies of boceprevir

Merck releases results from phase-3 studies of hepatitis C drug
By Alaric DeArment
BOSTON (Nov. 5)

An investigative treatment for hepatitis C got strong results in patients who had failed previous treatments or who were new to treatment, according to results of a late-stage clinical trial program announced this week.

Merck released final results from two phase-3 studies of boceprevir, saying it produced “significantly higher” results compared with patients in the control group. Treatment success was measured by the virus becoming undetectable — also known as sustained virological response, or SVR — with patients receiving the drug achieving SVR rates of 86% to 97%. The company plans to file for approval with the Food and Drug Administration this year.
“We are excited by the results of these pivotal studies,” Merck Research Labs president Peter Kim said in a statement. “In these studies, boceprevir substantially increased success rates compared to standard therapy, both for patients who received 48 weeks of treatment and for patients treated with the response-guided therapy approach, many of whom were able to be treated for 28 to 36 weeks.”

In the studies, a total of 1,500 patients received boceprevir combined with either Rebetol (ribavirin) or Pegintron (peginterferon alfa-2b). In each study, patients were randomly placed in 1-of-3 groups: a response-guided therapy group in which the total duration of treatment was based on early results — meaning patients who had failed to respond to previous treatments could stop after 36 weeks if the virus became undetectable by then, while those receiving treatment for the first time could stop after 24 weeks; a second group who first received Rebetol or Pegintron only for four weeks, followed by that drug combined with boceprevir for another 44 weeks; and a control group of patients who received Pegintron or Rebetol only for 48 weeks.

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