Vertex Hep-C Drug Shows Promise

Side Effects

Telaprevir's ability to greatly increase the percentage of patients who achieve RVR bodes well for the experimental drug. But this efficacy may not come without costs. Through 12 weeks of treatment, 11% of telaprevir patients discontinued the study, vs. 3% of patients in the placebo arm. The most common reason for telaprevir patients to stop using the drug was rash, reported by seven patients. Patients also reported gastrointestinal problems and anemia.

While doctors at the Barcelona meeting said the telaprevir rash was manageable and treatable, anecdotal patient reports have suggested the rash is severe and a significant obstacle to completing treatment.

Michael Partridge, a Vertex spokesman, says the overall dropout rate so far in the Prove 1 study was relatively low. He said the rash reported may not be distinguishable from rash often reported in patients taking ribavirin but added that the company and its researchers continue to monitor it.

As I discussed in a previous column, many investors were anxiously awaiting the results of a particular arm (Arm D) of the PROVE 1 study that gave patients telaprevir plus standard therapy for a relatively short 12 weeks. Researchers then stopped treatment for these patients altogether but followed them to determine what happened to the hepatitis C virus in their systems.