(HealthDay News) – For patients with hepatitis C virus (HCV), treatment with faldaprevir and deleobuvir plus ribavirin is effective, according to a study published in the Aug. 15 issue of the New England Journal of Medicine.
Stefan Zeuzem, MD, from the Johann Wolfgang Goethe University Medical Center in Frankfurt, Germany, and colleagues conducted a phase 2b trial of faldaprevir and deleobuvir involving 362 previously untreated patients with HCV genotype 1. Participants were randomized to one of five groups: 120mg faldaprevir once daily plus 600mg deleobuvir three times daily plus ribavirin, for 16, 28, or 40 weeks (TID16W, TID28W, TID28W); 120mg faldaprevir once daily plus 600mg deleobuvir twice daily plus ribavirin for 28 weeks (BID28W); or 120mg faldaprevir once daily plus 600mg deleobuvir three times daily without ribavirin for 28 weeks (TID28W-NR).
The researchers found that the primary end point of sustained virologic response 12 weeks after the completion of therapy was achieved by 59%, 59%, and 52% in the TID16W, TID28W, and TID40W groups, respectively; 69% in the BID28W group; and 39% in the TID28W-NR group. For the ribavirin-containing regimens, there was no significant difference according to treatment duration or dosage. The response was significantly higher in the TID28W group vs. the TID28W-NR group. The response rates were 56–85%for patients with genotype 1b infection vs. 11–47% for genotype 1a infection, and 58–84% with IL28B CC vs. 33–64% for non-CC genotypes.
“In conclusion, the interferon-free combination of faldaprevir and deleobuvir with ribavirin for the treatment of HCV genotype 1 infection was effective,” the authors write.
The study was funded by Boehringer Ingelheim, the manufacturer of faldaprevir and deleobuvir.