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FDA approves telaprevir for HCV genotype-1
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The FDA has approved telaprevir for the treatment of chronic hepatitis C virus genotype-1 infection combined with peginterferon alfa and ribavirin in adult patients with compensated liver disease previously untreated or who have failed previous therapy.
FDA approval of telaprevir (Incivek, Vertex Pharmaceuticals) was based upon data from three phase 3 trials that included about 2,250 previously treated or untreated adult patients. A sustained virologic response occurred among 79% of patients assigned telaprevir compared with standard treatment alone.
“With the approval of Incivek, there are now two important new treatment options for hepatitis C that offer a greater chance at a cure for some patients with this serious condition,” Edward Cox, MD, MPH, director of the FDA’s Office of Antimicrobial Products at the Center for Drug Evaluation and Research, said in a press release. “The availability of new therapies that significantly increase responses while potentially decreasing the overall duration of treatment is a major step forward in the battle against chronic hepatitis C infection.”
Common adverse events included rash, anemia, nausea, fatigue, headache, diarrhea, pruritus, and anal or rectal irritation and pain.
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