Pharmaceutical Business review

Vertex reports positive safety results from hepatitis trial

“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.