International Liver Congress

International Liver Congress

April 29, 2013
1 min read

Faldaprevir/peginterferon/ribavirin improved SVR, shortened therapy for chronic HCV

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

We were unable to process your request. Please try again later. If you continue to have this issue please contact

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.