August 11, 2010
Some patients taking an experimental hepatitis C drug plus standard therapy achieved rapid, extended viral responses after a shortened course of therapy, Vertex Pharmaceuticals Inc. reported on Tuesday.
The clinical "ILLUMINATE" trial evaluated whether there would be any benefit to extending therapy from 24 to 48 weeks in patients whose hepatitis C virus (HCV) was already undetectable at weeks four and 12 taking Vertex's telaprevir drug candidate plus standard pegylated interferon and ribavirin therapy.
Vertex said patients who responded so well on telaprevir had better outcomes after 24 weeks than those who continued therapy for 48 weeks. The Phase III trial suggests that telaprevir plus standard therapy could be effective for some patients on just a 24-week regimen, Vertex said.
The trial enrolled 540 patients who took 12 weeks of telaprevir plus pegylated interferon and ribavirin. Rapid and extended viral responders at four and 12 weeks were then treated with standard therapy only for either 12 more weeks or 36 more weeks. Among those taking 12 additional weeks of standard therapy (24 weeks total), 92 percent had undetectable virus, compared with 88 percent of those on the 48-week regimen. A sustained viral response, or undetectable HCV RNA, was determined 24 weeks after completion of treatment.
Vertex said it plans to file for Food and Drug Administration approval of telaprevir in the fourth quarter.
No comments have been made.