ARTICLE | Clinical News

ABT-450 plus ritonavir/ombitasvir: Phase II data

November 17, 2014 8:00 AM UTC

The open-label, international Phase II CORAL-I trial in 34 non-cirrhotic, liver transplant patients with recurrent chronic HCV genotype 1 infection showed that AbbVie's all-oral 3D regimen -- comprising co-administration with once-daily 150 mg ABT-450 plus 100 mg ritonavir, once-daily 25 mg ombitasvir and twice-daily 250 mg dasabuvir -- with ribavirin for 24 weeks led to an SVR 12 and 24 weeks after end of treatment in 97.1% of patients. No patient experienced on-treatment virologic breakthrough, but 1 patient experienced post-treatment relapse. Data were presented at the American Association for the Study of Liver Diseases meeting in Boston and published in The New England Journal of Medicine.

Earlier this year, AbbVie and Enanta said EMA accepted for review a pair of MAAs for ABT-450 plus ritonavir, ombitasvir and dasabuvir with and without ribavirin to treat HCV genotype 1 infection. The applications were submitted on May 8 and are under accelerated assessment, which shortens the review period to 150 days from 210 (see BioCentury, May 12). One MAA covers a tablet comprising ombitasvir, ABT-450 and ritonavir; the other covers dasabuvir. An NDA for the all-oral HCV regimen, which has breakthrough therapy designation in the U.S., is under Priority Review by FDA to treat HCV genotype 1 infection. AbbVie declined to disclose the PDUFA date; the company submitted the NDA in April (see BioCentury, June 16). ...