Telaprevir is designed to be taken three times a day in combination with standard drugs, and its ongoing final-stage clinical trials are enrolling patients on that dosing schedule. But the company also wants to know if it might be equally good in a more convenient twice-daily form. The results of this study suggest it could be. Researchers found 76 of 82 patients (93 percent) had their virus completely wiped out in the blood after three months on the usual telaprevir-containing regimen, while more than 80 percent in a comparison group did that well on a twice-daily telaprevir dose. “The question is do we continue to study twice-daily regimens based on what we see? The answer is yes,” says Lewis-Hall.
—Prove 3. Not a lot of news on this one. The Prove 3 study of telaprevir for patients who failed on previous therapy, first released in June, found that 60 of 115 patients (52 percent) who got the Vertex drug along with the standard drugs had no signs of the virus after about three months of follow-up after finishing treatment, the company said. That number is consistent with what Vertex is reporting to doctors at the liver meeting. It notes that 34 of 114 patients (30 percent) in a control group taking the standard meds had undetectable amounts of virus in the blood after they were three-quarters of the way through their nearly yearlong course of treatment. The true test of what’s considered a “clinical cure” is when patients have no sign of virus a full 24 weeks after they finish treatment, and that data isn’t yet available for release at this meeting, Vertex says.
About 16 percent dropped out of the Prove 3 study early because of adverse events, while just four percent of patients in the control group quit, the company says. In the final analysis of the Prove 2 study, which enrolled patients who were new to treatment, about 14 percent dropped out because of adverse events, compared with half that many in the control group.
When looked at altogether, Vertex now has more than 1,000 patients who have been analyzed for the safety of its drug.
Based on my conversation with Vertex’s chief commercial officer, Kurt Graves, heading into the meeting, it doesn’t seem like this data will surprise physicians who have been following the telaprevir story. He sounds like he’ll be keeping an eye on competitors like Schering-Plough’s boceprevir and other types of antivirals in development, like polymerase inhibitors and NS5A inhibitors, which might be combined with telaprevir. We’ll keep a close eye on this to see if anybody makes any big steps forward or back.
