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AbbVie reports positive trial data for hepatitis C drug
AbbVie has announced positive data from Pearl-III, a new study evaluating the efficacy and safety of the company's new investigational therapy for hepatitis C.
The trial assessed the benefits of the AbbVie treatment over 12 weeks both with and without ribavirin in non-cirrhotic, adult patients with chronic genotype 1b hepatitis C virus infections who were new to treatment.
Pearl-III was able to meet its primary and secondary endpoints. Of the 419 patients involved, sustained virologic response rates of 99.5 and 99.0 percent 12 weeks post-treatment were achieved with the AbbVie regimen with and without ribavirin, respectively.
The AbbVie investigational regimen consists of the fixed-dose combination of ABT-450/ritonavir co-formulated with ABT-267, dosed once daily, and ABT-333 with or without ribavirin dosed twice daily.
Dr Scott Brun, vice-president of pharmaceutical development at AbbVie, said: "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."
This comes after the firm reported positive data from Sapphire-II, another phase III trial of its investigational three direct-acting-antiviral (3D) regimen for the treatment for hepatitis C, at the end of last year.
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