May 10, 2013
The second-generation protease inhibitor faldaprevir combined with pegylated interferon and ribavirin cured approximately 80 percent of previously untreated individuals with genotype 1 hepatitis C virus (HCV) infection, according to Professor Peter Ferenci of the Medical University of Vienna. Ferenci presented these results of the phase III STARTVerso trial at the recent International Liver Congress in Amsterdam.
The researchers randomized 656 persons with chronic HCV infection to receive one of two doses of faldaprevir, 120 milligrams (mg) once daily or 240 mg once daily, or placebo for 12 weeks in combination with pegylated interferon and ribavirin. At 12 weeks, researchers randomized the participants receiving 120 mg faldaprevir to continue treatment to week 24 or to receive placebo, but all participants continued the interferon and ribavirin to week 24. At week 24, those who had a good early response to therapy were eligible to stop treatment, while those who did not have a good early response received an additional 24 weeks of interferon and ribavirin to week 48.
Results showed that 80 percent of patients who received 240 mg faldaprevir and 79 percent of patients who received 120 mg faldaprevir achieved sustained virological response in 12 weeks compared with 52 percent in the placebo group. A total of 88 percent of participants achieved early treatment success and could stop all treatment at week 24. Of these, 89 percent were in the 240 mg faldaprevir group and 86 percent in the 120 mg group. HCV genotype 1a and 1b showed a modest difference in response rates in the faldaprevir 240 mg group (76 versus 83 percent), which favored genotype 1b. The difference was greater in the faldaprevir 120 mg group (69 versus 84 percent).
Researchers discontinued treatment due to adverse events in 4 percent of the placebo group, 4 percent of the 120 mg faldaprevir group, and 5 percent of the 240 mg group. Serious adverse events occurred in 7 percent of the faldaprevir group. There was no incidence of anemia in the study groups to week 24. Ferenci concluded that the 240 mg dose of faldaprevir had no clear advantages over the lower dose.
The full report, "Faldaprevir Plus Pegylated Interferon Alfa-2A and Ribavirin in Chronic HCV Genotype-1 Treatment-Naïve Patients: Final Results From STARTVerso1, a Randomised Double Blind Placebo-Controlled Phase III Trial," was published online in the journal Hepatology (2013; doi: 10.1002/hep.26276).
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