Vertex Hepatitis C Drug Passes Pivotal Test, Cures Three Out of Every Four Patients
Luke Timmerman5/25/10Follow @ldtimmerman
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assigned to get a 12-week course of telaprevir in addition to the standard drugs, an 8-week course, or a typical 48-week course of the standard treatment.
The patients who took 12 weeks of telaprevir did the best, achieving the 75 percent cure rate, which is known clinically as a sustained viral response, or SVR. Next best was the 8-week course of telaprevir, which induced a 69 percent cure rate. The control group on standard therapy had a 44 percent cure rate. The difference between the Vertex patients, and the control patients, was highly statistically significant for both the 12-week and 8-week groups.
Side effects were consistent with prior studies, Vertex said. The most common side effects for patients on the Vertex therapy included fatigue, rash, pruritis (itching), nausea, headache and anemia. About 7 percent of patients on the 12-week course of telaprevir dropped out of the study because of adverse events, about double the dropout rate for those in the control group.
Vertex’s chief medical officer Bob Kauffman, whom I interviewed a couple weeks ago for this telaprevir clinical trial preview story, called today’s results “groundbreaking.” In particular, he pointed to the new drug’s ability to cut the duration of treatment in half.
“These results for telaprevir show that 75 percent of patients in the 12-week telaprevir arm achieved a viral cure, with the majority receiving only 24 weeks of therapy, marking what we believe may be a potentially dramatic improvement in the future treatment of hepatitis C,” Kauffman said in the statement.
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