Trial results of ABT 450/r, ABT 267, ABT 333 in HCV published in NEJM - AbbVie

AbbVie has announced detailed results from two Phase III pivotal studies, SAPPHIRE-I and SAPPHIRE-II, which are testing its triple combination of ABT 450/r, ABT 267 and ABT 333 in patients with Hepatitis C. Data is being presented at the International Liver Congress 2014 and have been published online in The New England Journal of Medicine. In the SAPPHIRE-I (N=631) and SAPPHIRE-II (N=394) placebo-controlled studies, adult, non-cirrhotic patients with chronic genotype 1 (GT1) Hepatitis C virus (HCV) infection receiving the investigational AbbVie regimen with ribavirin (RBV) for 12 weeks achieved sustained virologic response rates 12 weeks post-treatment (SVR12) of 96.2% and 96.3%, respectively. In SAPPHIRE-II, treatment-experienced sub-populations randomized to the AbbVie regimen with RBV were prior null responders (49.2%), prior relapsers (29.0%) and prior partial responders (21.9%) to pegylated interferon and RBV.

Discontinuations due to adverse events were reported in 0.6% of patients in both arms in SAPPHIRE-I and in 1.0% of patients receiving the AbbVie regimen in SAPPHIRE-II and no patients receiving placebo. The most commonly reported treatment-emergent adverse events (>10% in either arm) for both SAPPHIRE-I and SAPPHIRE-II were fatigue, headache, nausea, asthenia, insomnia, pruritus and diarrhea. See: "Treatment of HCV with ABT-450/r�Ombitasvir and Dasabuvir with Ribavirin" Jordan J. Feld et al. New England Journal of Medicine, April 11, 2014 DOI: 10.1056/NEJMoa1315722