Vertex Pharmaceuticals (VRTX) has added a fresh haul of solid Phase III data to support its rolling application for telaprevir, a potential blockbuster that some analysts believe is a likely game changer in the market. An overwhelming majority of hepatitis C patients who registered a quick response to a telaprevir-based cocktail were effectively cleared of the virus after 24 weeks, according to researchers, making further treatments unnecessary. And that indicates the new hep C drug could cut the current standard treatment time in half for a large group of patients.
Investigators set out to determine if patients who achieved undetectable levels of the virus after four and 12 weeks of treatment would benefit by going past the 24-week mark and push on to 48 weeks of therapy. But they found that subjects with an extended rapid viral response, or eRVR, had a cure rate of 92 percent at 24 weeks and 88 percent at 48 weeks.
"The viral cure rates seen in (the Phase III Illuminate trial) showed that there was no benefit to extending telaprevir-based therapy to 48 weeks for the majority of people," said Kenneth Sherman, 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 plans to release more late-stage data next month in the lead-up to completing their rolling FDA application by the end of this year. Seeking Alpha says it expects an approval of the drug in early 2011 with a huge market to tap. The market, though, has evidently seen enough positive data to discount any new releases like this. Vertex shares were up a little more than one percent this morning.