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Vertex reports positive safety results from hepatitis trial

Vertex Pharmaceuticals has reported positive results from an interim safety analysis from an ongoing phase IIb trial of the investigational inhibitor telaprevir for hepatitis C.

“Chronic hepatitis C infection is a major public health problem, and Vertex's goal is to increase the success rate of hepatitis C treatment with short-duration therapy,” said Joshua Boger, president and CEO of Vertex.

The primary objective of the trial is to assess the proportion of patients in each study arm who achieve a sustained viral response, defined as undetectable hepatitis C virus (HCV) RNA 24 weeks after the completion of dosing.

Of the patients in the telaprevir groups, 88% demonstrated undetectable HCV RNA compared to 52% of patients in the control arm. In the telaprevir dosing arms, the incidence of treatment discontinuations due to adverse events was 9% and the incidence of serious adverse events was 3%.

The most common adverse events were similar in type between the two groups and were characteristic of the known side effects of interferon and ribavirin. Vertex earned a $15 million milestone payment from Janssen Pharmaceutica, based on these results.