An interferon-free oral combination of 3 direct-acting antiviral agents developed by Bristol-Myers Squibb led to sustained virological response in more than 90% of treatment-naive chronic hepatitis C patients with HCV genotype 1a or 1b, according to a report in the February 2014 issue of Gastroenterology.
The advent of direct-acting drugs that interfere with different steps of the HCV lifecycle has revolutionized treatment for chronic hepatitis C, but many patients and providers are waiting for all-oral regimens that avoid the side effects of interferon and, ideally, ribavirin.
Gregory Everson from the University of Colorado at Denver and colleagues conducted a Phase 2a trial to evaluate the safety and efficacy of an all-oral triple combination of the HCV NS5A inhibitor daclatasvir (formerly BMS-790062), the HCV protease inhibitor asunaprevir (formerly BMS-650032), and the non-nucleoside polymerase inhibitor BMS-791325.
This open-label study (AI443-014) included 66 previously untreated chronic hepatitis C patients. About 60% were men, most were white, and the median age was 50 years. Three-quarters had harder-to-treat HCV subtype 1a, the rest 1b. About one-third had the favorable IL28B CC gene pattern associated with good interferon responsiveness. Patients with liver cirrhosis — a harder-to-treat group — were excluded.
Participants were randomly assigned to receive 60 mg once-daily daclatasvir, 200 mg twice-daily asunaprevir, and 75 mg or 150 mg twice-daily BMS-791325 for either 12 or 24 weeks. The primary endpoint was sustained virological response, or HCV RNA >25 IU/mL, at 12 weeks after completing treatment (SVR12).