Phase 2 clinical trials of treatment regimens based on telaprevir in combination with peginterferon alfa-2a and ribavirin show significantly improved virologic responses in chronic hepatitis C virus patients, according to two studies published in the April 30 issue of the New England Journal of Medicine.
John G. McHutchison, M.D., of Duke University in Durham, N.C., and colleagues conducted a trial of 250 patients infected with hepatitis C virus genotype 1 who were randomized to one of three telaprevir treatment groups, and found that all three treatment groups had a higher rate of significantly improved virologic response, but higher rates of discontinuation due to adverse effects.
Christophe Hezode, M.D., of the University of Paris in France, and colleagues conducted a study of 334 chronic, previously untreated hepatitis C virus genotype 1 patients who were randomized to treatment with one of four combinations of telaprevir, peginterferon alfa-2a and ribavirin, and discovered that the 81 patients who received telaprevir, peginterferon alfa-2a and ribavirin for 12 weeks, followed by peginterferon alfa-2a and ribavirin for 12 more weeks, had the best sustained virologic response. The lowest response was seen in the group lacking ribavirin.
"A drug-induced rash necessitated that telaprevir be discontinued in some patients," Hezode and colleagues write. "Larger and longer studies are required to assess the efficacy and safety of telaprevir for hepatitis C virus infection."
Both studies were supported by Vertex Pharmaceuticals Inc., of Cambridge, Mass. Authors of both studies also disclosed financial relationships with a variety of pharmaceutical companies.
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