AbbVie reports completion of Triple Therapy combination programme for Hepatitis C

AbbVie announced completion of its Phase III Hepatitis C virus (HCV) studies for its triple combination of ABT 450/r, ABT 267 and ABT 333 . Results from the TURQUOISE-II study which examined treatment of HCV in 380 patients with cirrhosis, a difficult-to-treat population, showed that patients treated for 12 weeks with the AbbVie combination achieved 92 percent sustained virologic response at 12 weeks post treatment (SVR12). 96 percent of patients treated with the AbbVie regimen for 24 weeks achieved SVR12.

The PEARL-II and PEARL-III studies evaluated the potential for ribavirin-free therapy in genotype 1b (GT1b) experienced and naive patients, respectively. PEARL-IV evaluated the potential for ribavirin-free therapy in genotype 1a (GT1a) naive patients. Results from the PEARL-II study (n=179) showed that 100 percent of the GT1b experienced patients treated with the AbbVie combination without ribavirin achieved SVR12. Patients treated with the ribavirin-containing regimen, achieved 97 percent SVR12.

Results from the PEARL-III study (n=419) showed that GT1b naive patients treated with the combination, with and without ribavirin, achieved 99 percent SVR12. The PEARL-IV study (n=305) showed that even in the more difficult to treat GT1a patients, the regimen with ribavirin achieved an SVR12 rate of 97 percent and the ribavirin-free regimen produced an SVR12 rate of 90 percent.

Over six Phase III trials of more than 2300 patients with genotype 1 Hepatitis C were completed by the three drug combination and showed impressive 12 week cure rates and a 99% sustained virologic response. AbbVie plans to file for FDA approval in mid 2014.