AbbVie is aiming to steal sales from hep C drugs from Gilead and BMS with a new combination offering a shorter, eight-week treatment for the most difficult-to-treat form of the disease.
Results presented at the International Liver Congress (ILC) in Amsterdam showed 95% of genotype 3 patients on its pan-genotypic regimen of glecaprevir+pibrentasvir were free of disease, 12 weeks after completing an eight-week treatment course.
The results were based on a previously untreated, cirrhosis-free, 157-patient arm of the ENDURANCE-3 study.
The FDA is taking into consideration a once-daily formulation of AbbVie’s ombitasvir, paritaprevir, and ritonavir tablets co-packaged with dasabuvir tablets (Viekira Pak).
The FDA’s acceptance of the new drug application for the genotype 1 chronic hepatitis C virus infection was based on data from 2 studies.
The original formulation was approved in 2014 with a recommended dosage of 2 ombitasvir, paritaprevir, ritonavir 12.5 milligrams (mg)/75 mg/50 mg tablets once daily and 1 dasabuvir 250 mg tablet twice daily.