are called sustained viral responses (SVR), measured 24 weeks after patients complete their course of therapy to make sure the virus didn’t bounce back. Telaprevir has even better results, with cure rates exceeding 60 percent for patients newly-diagnosed with hepatitis C, from other clinical trials.
“The SVR rates achieved in this difficult-to-treat population, with safety results consistent with prior telaprevir studies, add to the growing body of data supporting further development of telaprevir across the broad hepatitis C patient population,” said Freda Lewis-Hall, Vertex’s chief medical officer, in a statement.
Still, the safety profile of the drug isn’t completely benign. Adverse events in the Prove 3 trial showed patients had nausea, fatigue, headache, rash, diarrhea, and insomnia, among other effects. Rashes caused 5 percent of patients to drop out of the study. Back in November at the U.S. liver meeting, Vertex said 16 percent of patients in the Prove 3 trial dropped out of the study because of adverse events, compared with 4 percent in the control group.
Vertex is trying to build a competitive advantage in hepatitis C, which has become increasingly crowded with competitors looking to pile in with anti-viral combinations that aspire to make this disease more manageable, like HIV. Schering-Plough, with boceprevir, is the closest competitor to Vertex in the class of protease inhibitors. But Vertex is betting that it will have an edge in this tough-to-treat population that it observed in the Prove 3 study, and it is looking to buttress this case with an ongoing study of 650 patients called Realize. I described how these drugs stack up from a competitive standpoint in more detail back in September.
