The addition of faldaprevir to pegylated interferon/ribavirin therapy significantly improved rates of sustained virologic response and allowed for shorter treatment duration among patients with chronic hepatitis C in a study presented at the International Liver Congress in Amsterdam.
In the STARTVerso1 study, patients with chronic HCV genotype 1 received 48 weeks of therapy with peginterferon alfa-2a and ribavirin (PEG/RBV) and were randomly assigned either placebo (n=132) for 24 weeks, 120 mg faldaprevir (FDV, Boehringer Ingelheim Pharmaceuticals) (n=259) for 12 or 24 weeks, or 240 mg FDV (n=261) for 12 weeks. HCV RNA below 25 IU/mL after 4 weeks and undetectable RNA at 8 weeks were considered early success among treated patients, and therapy, including PEG/RBV, was stopped at 24 weeks.
Sustained virologic response (SVR) at 12 weeks occurred in more 120-mg (79%) and 240-mg (80%) treated patients than placebo participants (52%, P<.0001). Treatment was stopped at 24 weeks due to early response in 87% and 89% of the 120-mg and 240-mg groups, respectively, compared with 22% of placebo recipients. Among those who stopped treatment early, SVR12 was achieved by 86% of the 120-mg group, 89% of the 240-mg group and 90% of placebo patients.
Serious adverse events occurred at similar rates (6% of placebo recipients; 7% of treated groups), as did treatment discontinuation due to adverse events (4% of the placebo and 120-mg groups; 5% of the 240-mg group). Discontinuation of FDV, but not PEG/RBV, due to adverse events occurred in 1% of the 120-mg group and 3% of the 240-mg group. Anemia, rash and GI issues were reported most commonly.
“Faldaprevir has shown efficacy in a range of genotype-1a and 1b HCV patients with and without cirrhosis,” researcher Peter Ferenci, MD, Medical University of Vienna, said in a press release. “The viral cure rates and potential for shorter treatment duration seen in STARTVerso1 are very encouraging for the many patients currently facing a year of interferon-based treatment.”
For more information:
Ferenci P. #1416: Faldaprevir Plus Pegylated Interferon Alfa-2A and Ribavirin in Chronic HCV Genotype-1 Treatment-Naive Patients: Final Results From STARTVerso1, A Randomized, Double Blind, Placebo-Controlled Phase III Trial. Presented at: The International Liver Congress 2013; April 24-28, Amsterdam.