AbbVie presents positive Phase III results in patients with chronic hepatitis C

The first detailed results from US drugmaker AbbVie’s (NYSE: ABBV) pivotal Phase III study, PEARL-III, have been presented at the 21st Conference on Retroviruses and Opportunistic Infections (CROI).

PEARL-III evaluated the efficacy and safety of 12 weeks of treatment with AbbVie’s investigational therapy with or without ribavirin (RBV) in non-cirrhotic, adult patients with chronic genotype 1b (GT1b) hepatitis C virus (HCV) infection who were new to treatment. The 419-patient study met its primary and secondary endpoints with sustained virologic response rates 12 weeks post-treatment (SVR12) of 99.5 and 99.0% achieved with the AbbVie regimen with and without RBV, respectively. There were no study drug discontinuations due to adverse events.

Scott Brun, vice president, pharmaceutical development, AbbVie, said: “We are excited about the strong PEARL-III results which demonstrate the AbbVie regimen achieved high SVR rates with no discontinuations due to adverse events in patients new to treatment with genotype 1b infection. Additionally, with these data, we continue to be on track to begin major regulatory submissions in the second quarter of 2014. AbbVie will continue to disclose additional detailed phase III study results at future scientific congresses and in publications.”