FDA gives breakthrough therapy designation to experimental hepatitis C regimen

NORTH CHICAGO, Ill. — An experimental drug regimen under development by AbbVie could change the way hepatitis C is treated, according to a special designation it received from the Food and Drug Administration.

AbbVie said the FDA granted breakthrough therapy designation to its direct-acting antiviral, or DAA combination drug therapy consisting of three drugs, which go under the code names ABT-450/r, ABT-267 and ABT-333, with or without the common antiviral drug ribavirin. The agency uses breakthrough therapy designation to promote expedited development and review of drugs for serious or life-threatening conditions that have the potential to significantly improve treatment. The drug is part of a therapy regimen that would allow for elimination of interferons, biotech drugs for hepatitis C that, while effective, also carry harmful side effects.

The drug currently is in phase-3, or late-stage clinical development, and the FDA designation was granted on the basis of results from a phase-2b trial titled "Aviator," in 571 patients.

The drug maker said that after 12 weeks of treatment, a high rate of patients who had not received treatment for hepatitis C before or who had failed treatment with combination interferon and ribavirin therapies had shown high sustained viral response, or SVR rates, essentially meaning they were cured. This included 99% of those who had not received treatment and 93% of those who had failed interferon-ribavirin treatment, with only one relapse and four of the 247 patients treated for 12 and 24 weeks with triple DAA and ribavirin dropping out due to harmful side effects.