The JNJ-4178 hepatitis C virus (HCV) regimen, jointly developed by Achillion and Janssen, cured high rates of the virus after just six or eight weeks of treatment in a recent trial.
The Phase IIb, multicenter, randomized, open-label OMEGA-1 study included 365 people ages 18 to 70 with genotypes 1, 2, 4 and 5 of hep C who did not have cirrhosis and were either being treated for the first time or had previously been treated with interferon. The trial deliberately excluded anyone with genotype 3 of the virus and anyone previously treated with direct-acting antivirals (DAAs).
Results were presented at the Annual Meeting of the American Association for the Study of Liver Diseases in Washington, DC.
The participants were evenly randomized to receive six weeks (183 people) or eight weeks (182 people) of JNJ-4178, a triple DAA regimen that includes the investigational NS5B polymerase inhibitor AL-335, the investigational NS5A inhibitor odalasvir and the approved NS3/4A protease inhibitor Olysio (simeprevir).
A total of 98.9 percent (181 of 183) of those treated for six weeks and 97.8 percent (178 of 182) of those treated for eight weeks achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure). The researchers compared these cure rates with historical controls of results from previous trials of interferon-free DAA regimens and concluded that JNJ-4178 is noninferior to, or as effective as, those regimens.
The regimen proved safe and well tolerated. Most adverse health events were mild—the most common were headache and fatigue—and there were no serious adverse health events.
To read a press release about the study, click here.
To read the conference abstract, click here.