Dasabuvir Sodium

BeschreibungDasabuvir sodium (Exviera®), an oral non-nucleoside NS5B polymerase inhibitor discovered and developed by Abbvie, is a component of an all-oral hepatitis C treatment regimen Viekira Pak approved by the US FDA in December 2014 for the treatment of adult patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection. The investigational regimen consists of the fixed-dose combination of paritaprevir (XXVII) (veruprevir, ABT- 450, vide infra) with ritonavir booster (150/100 mg) co-formulated with the NS5A inhibitor ombitasvir (XXV) (ABT-267, vide infra) 25 mg, dosed once daily, and nonnucleoside NS5B polymerase inhibitor dasabuvir (X) (ABT-333) 250 mg with or without ribavirin (weight-based), dosed twice daily. The drug was granted breakthrough therapy designation by the US FDA in May 2013. AbbVie’s application is supported by the data from six Phase III studies covering over 2300 patients in 25 countries representing one of the largest clinical programs in hepatitis C research and development. Across six studies, the 12-week therapeutic regimen achieved impressive cure rates, notching a 99% sustained virologic response mark in some populations.