ARTICLE | Clinical News

ABT-450 plus ritonavir/ombitasvir: Phase IIb data

November 17, 2014 8:00 AM UTC

Data from 91 evaluable non-cirrhotic patients with HCV genotype 4 infection in the open-label Phase IIb PEARL-I trial showed that an all-oral once-daily regimen comprising co-administration with 150 mg ABT-450 plus 100 mg ritonavir and 25 mg ombitasvir with ribavirin for 12 weeks led to an SVR 12 weeks after end of treatment in 100% of treatment-naive patients (n=42) and 100% of treatment-experienced patients (n=49). In 44 treatment-naive patients with HCV genotype 4 infection, the combination without ribavirin for 12 weeks led to an SVR12 rate of 90.9%. In the treatment-naive group that did not receive ribavirin, there was 1 on-treatment virologic breakthrough and 2 post-treatment relapses. There were no virologic failures in the other treatment arms. Data were presented at the American Association for the Study of Liver Diseases meeting in Boston.

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). ...