Treatment with faldaprevir, a once-daily hepatitis C virus (HCV) NS3/4A protease inhibitor, in combination with pegylated interferon (PEG-IFN) and ribavirin (RBV) led to a sustained virologic response (SVR) at week 12 in 80% of patients with HCV genotype 1, findings from a large, randomized placebo-controlled trial of the drug revealed.
Co-investigator Christophe Moreno, MD, PhD, head of the Liver Unit, Erasme University Hospital, Brussels, Belgium, presented findings from the multicenter international STARTVerso 1 trial of 652 treatment-naive patients with HCV genotype 1 at the American College of Gastroenterology 2013 Annual Scientific Meeting (abstract 37). Dr. Moreno and his colleagues randomized patients to receive PEG-IFN and RBV in combination with once-daily faldaprevir 240 mg for 12 weeks (n=261), once-daily faldaprevir 120 mg for 12 or 24 weeks (n=259), or placebo for 24 weeks (n=132). Faldaprevir recipients who achieved a treatment response at weeks 4 and 8 could discontinue all treatment at week 24; those who did not exhibit an early response to treatment received 48 weeks of treatment with PEG-IFN and RBV. About half of the patients in the study were men; 78% were white; 20% were Asian; 17% had fibrosis scores of 3 or greater; 39% had the interleukin-28 (IL28)-B CC genotype; and 66% had HCV genotype 1b.
Among patients who were treated with faldaprevir, 79% and 80% of patients in the 120- and 240-mg groups, respectively, achieved SVR at week 12 compared with 52% of placebo recipients (P<0.0001 for both treatment groups vs. placebo). SVR rates at week 12 among IL28B CC patients in the 120- and 240-mg faldaprevir groups were 90% and 95%, respectively, compared with 71% of IL28B non-CC patients in either treatment group. Between 87% and 89% of faldaprevir recipients had early treatment success and stopped all treatments at 24 weeks. Of these early responders, 86% and 89% achieved SVR at week 12.