Vertex Pharmaceuticals Inc. has announced that a late-stage clinical trial has found that doubling the length of therapy for its hepatitis C drug candidate does not substantially increase the benefit.
Vertex officials said the new data shows that a shorter course of treatment is sufficient, and this may increase adherence to the regimen. The trial assigned certain types of patients randomly to either a 24-week or 48-week treatment schedule and found viral cure rates of 92 percent and 88 percent, respectively.
“The viral cure rates seen in [the clinical trial] showed that there was no benefit to extending telaprevir-based therapy to 48 weeks for the majority of people,” said Dr. Kenneth Sherman, professor of medicine at the University of Cincinnati College of Medicine and the principal investigator of the trial. “Patients who had a rapid response to telaprevir-based regimens at weeks four and 12 had a high likelihood of achieving a cure with 24 weeks of total treatment, which may provide important information to motivate people to continue therapy.”
Vertex said 72 percent of all 540 people treated with the drug, called telaprevir, in the study achieved a viral cure. The company said the safety of the drug remained consistent at the longer treatment period.
The company plans to submit the results of this study, along with two other Phase 3 clinical trials, in its application for approval with the U.S. Food and Drug Administration, which is planned for the fourth quarter of 2010.