An interferon-free combination of the direct-acting antivirals faldaprevir and deleobuvir with ribavirin cured hepatitis C in a majority of patients treated for 12 to 40 weeks, but outcomes were significantly better for people with HCV genotype 1b, researchers reported in the August 15, 2013, New England Journal of Medicine.
The advent of direct-acting antiviral agents (DAAs) active against hepatitis C virus (HCV) has brought about a new treatment paradigm. DAAs will initially be approved for use in combination with interferon-based therapy, but many patients and providers are waiting for all-oral regimens that work without pegylated interferon and its difficult side effects.
Stefan Zeuzem from Johann Wolfgang Goethe University in Frankfurt and an international team of colleagues conducted the Phase 2b SOUND-C2 trial to test all-oral regimens containing Boehringer Ingelheim's HCV protease inhibitor faldaprevir (formerly BI 201335) plus the non-nucleosideNS5B HCV polymerase inhibitor deleobuvir(formerly BI 207127), with or without ribavirin.
This open-label study included 362 previously untreated genotype 1 chronic hepatitis C patients. A majority were men, almost all were white, and the mean age was about 50 years. About 10% had liver cirrhosis, about one-quarter had the favorable IL28B CC gene pattern, and approximately two-thirds had easier-to-treat HCV subtype 1b, though proportions varied across study arms.