June 7, 2010
A Phase III trial of Vertex Pharmaceuticals' experimental hepatitis C virus drug telepravir boosted cure rates of infected patients taking standard treatment, the firm recently announced. With standard therapy and telepravir, 75 percent had a sustained virological response, compared with 44 percent of patients taking standard therapy only. Telepravir works by blocking protease enzymes made by HCV.
The trial enrolled 1,095 treatment-naive patients with hepatitis C genotype-1. Patients received 12- or 8-week telepravir or placebo in combination with standard therapy, interferon and ribavirin, for 24 or 48 weeks depending on their progress.
Of those who took the longer 12-week course of telepravir, 75 percent had no detectable virus in their blood 24 weeks after completing treatment, which is seen as a cure. The eight-week telepravir group had a 69 percent cure rate.
Telepravir recipients dropped out the trial at about double the rate of control patients, with 7 percent leaving. The drug can cause an extreme rash and an increased risk of anemia. However, about 70 percent of all telepravir patients who were effectively cured achieved this by 24 weeks. That shorter timeline and higher success rate, compared with up to 48 weeks for standard therapy, could encourage more HCV patients to seek treatment, experts say.
Data from two additional Phase III trials are expected in the third quarter, after which Vertex says it may apply to the Food and Drug Administration for approval.
A similar HCV drug, Merck's boceprevir, is in late-stage testing, and results are expected later this year.
New York Times
05.26.2010; Andrew Pollack
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