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| |  Adding Telaprevir to Standard Therapy Improves Response, Halves Duration of HCV Treatment DURHAM, NC -- April 29, 2009 -- The addition of the anti-viral drug telaprevir to a standard treatment for hepatitis C can shorten the duration of therapy and increase the number of patients who can be cured of their disease, according to a study published in the April 30 issue of the New England Journal of Medicine. "Our study found that by combining the standard therapy with the direct anti-viral drug telaprevir, we could reduce the duration of treatment by 50%, to 24 weeks, and, at the same time, improve the cure rate by 50%," said principal investigator John McHutchison, MD, Duke Clinical Research Institute (DCRI), Durham, North Carolina. The randomised, phase 2b, double-blinded, 37-centre study of telaprevir in combination with peginterferon alfa-2a and ribavirin, examined the responses of 250 patients on 4 trial arms. The researchers measured rates of sustained viral response (SVR), defined as 24 weeks during which the hepatitis C virus remains undetectable in the body after the completion of therapy. "We observed that 67% of patients who received standard therapy for 48 weeks in conjunction with 12 weeks of telaprevir were cured of their hepatitis C," said Dr. McHutchison. "The rate was 61% in the group that took the standard therapy for only 24 weeks in combination with 12 weeks of telaprevir, suggesting that many patients may respond to treatment in only 6 months as compared with about 11 months, which is significant for this patient population, because the side effects of treatment can be so intense." The group that received standard therapy for up to 48 weeks had a SVR rate of 41%. The most frequently reported adverse side effect associated with telaprevir was a rash that was manageable in some patients, but caused others to discontinue the treatment, Dr. McHutchison said. "Treating genotype 1 hepatitis C, the most common form of the infection in the United States, can be challenging because the side effects are difficult for many people to endure, the duration of treatment is long, and traditionally less than half of patients are able to be cured of their disease," said senior investigator Andrew Muir, MD, Duke University. "Even though telaprevir does produce side effects of its own, its addition to standard therapy was able to improve response rates and shorten the duration of treatment necessary -- either one alone would have been an advance, and to be able to achieve both is a significant step in the right direction when it comes to treating hepatitis C."
SOURCE: Duke University Medical Center
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