An interferon-free regimen of faldaprevir, deleobuvir, and ribavirin proved to be effective in a phase II clinical trial involving 362 patients with previously untreated chronic hepatitis C virus genotype 1 infection, according to a report published in the New England Journal of Medicine.
The new combination therapy achieved sustained virologic response rates of 52%-69% 12 weeks after treatment was completed, reported Dr. Stefan Zeuzem of Johann Wolfgang Goethe University Medical Center, Frankfurt am Main (Germany), and his associates (N. Engl. J. Med. 2013;369:630-9).
Those sustained virologic response rates compare well with rates of 68%-75% reported in phase III trials of the regimen of pegylated interferon, ribavirin, and telaprevir or boceprevir that is the current standard of care, the investigators noted.
The new, interferon-free regimen may offer an advantage over the standard of care by avoiding interferon’s detrimental effects on white-cell and platelet counts, they said.
The open-label trial, sponsored by Boehringer Ingelheim, enrolled patients at 48 medical centers in Europe, Australia, and New Zealand. They were randomly assigned to one of five treatment groups with various dosages of the protease inhibitor faldaprevir and the nonnucleoside polymerase inhibitor deleobuvir, with or without the addition of daily ribavirin. Treatment intervals of 16, 28, and 40 weeks were tested.
The primary efficacy endpoint was a sustained virologic response (an undetectable plasma level of hepatitis C virus [HCV] RNA) 12 weeks after the completion of treatment. That endpoint was achieved in 52%-69% of patients with several combinations of faldaprevir, deleobuvir, and ribavirin, and with all treatment durations, Dr. Zeuzem and his colleagues said.