US FDA grants "Breakthrough" status for AbbVie's HCV regimen

US drugmaker AbbVie (NYSE: ABBV) says that its investigational direct-acting antiviral (DAA) combination with and without ribavirin for the treatment of genotype 1 (GT1) hepatitis C virus (HCV) infection has been designated as a “Breakthrough Therapy” by the US Food and Drug Administration.

The designation is based, in part, on positive data from AbbVie's clinical development program, including the Phase IIb clinical trial M11-652, known as "Aviator." The Aviator study was conducted in 571 patients infected with HCV GT1. Results from the treatment arms evaluating ABT-450/r + ABT-267 + ABT-333 with and without ribavirin demonstrated that the regimen provided high sustained viral response rates (SVR) with 12 weeks of therapy in patients who had not been previously treated (treatment naive) and in those who had failed prior therapy with pegylated interferon and ribavirin (null responders), regardless of sex, HCV subtype, stage of fibrosis, viral load or IL28B genotype.