Smooth sailing so far for AbbVie's GT1 HCV comboAbbVie released the first Phase III results from its SAPPHIRE-1 study, which is investigating its multi-drug hepatitis C combo with ribavirin in genotype 1 patients. Patients who had not yet received therapy saw an SVR12 rate of 96%. GT-1 is the most prolific type of HCV worldwide. The company confirmed that it is on track for “major regulatory submissions” in the second quarter of 2014.
Gilead's candidate sofosbuvir—which is slated to receive an approval decision Dec. 8—recently received an FDA advisory panel's full support for use in GT-1 infection, along with interferon and ribavirin.
Merck, too, has a dog in the fight. Its protease inhibitors MK-5172 and MK-8472 are currently undergoing testing in Phase II trials for GT-1. ISI Group analyst Mark Schoenebaum noted earlier this month that the drug may be only 18 months behind Gilead in the race for the first all-oral treatment for GT1.