Results from eight other arms of the ELECTRON study, evaluating sofosbuvir alone and with RBV and/or pegylated IFN, were published earlier this month in the New England Journal of Medicine (N Engl J Med 368;34-44).
Advancing a Fixed-Dose Combination Tablet for HCV
Gilead is currently evaluating a once-daily fixed-dose combination tablet containing sofosbuvir and GS-5885 in several Phase 2 and 3 trials. The studies evaluate sofosbuvir/GS-5885 with and without RBV among a range of genotype 1 HCV patient populations.
- ION-1: This Phase 3 trial was initiated in October 2012 and is evaluating sofosbuvir/GS-5885 with and without RBV for 12 or 24 weeks among treatment-naïve genotype 1 patients. Pending a review of results from the two 12-week arms (n=50/arm) of an initial enrollment of 200 patients, ION-1 will continue to recruit patients and assess sofosbuvir/GS-5885 in a total of 800 individuals.
- ION-2: Gilead today announced that a second Phase 3 study for sofosbuvir/GS-5885, ION-2, is expected to begin screening patients in January 2013. This study will evaluate the fixed-dose combination, with RBV for 12 weeks and with and without RBV for 24 weeks of therapy among 400 treatment-experienced genotype 1 HCV patients. Participants in this study will have failed past therapy with regimens containing IFN or IFN plus a protease inhibitor.
- LONESTAR: Gilead also announced that enrollment is now underway for a new Phase 2 study of sofosbuvir/GS-5885 for 12 weeks and of sofosbuvir/GS-5885 with and without RBV for 8 weeks among genotype 1 treatment-naïve patients. Two additional arms in this trial will evaluate sofosbuvir/GS-5885 with and without RBV for 12 weeks among treatment-experienced genotype 1 patients who had previously received a protease inhibitor-containing regimen. This study, which will enroll 100 patients, is the first trial to evaluate the combination of sofosbuvir andGS-5885 for only eight weeks of treatment.
Sofosbuvir, GS-5885 and the fixed-dose combination tablet are investigational products and their safety and efficacy have not yet been established.