FDA grants breakthrough therapy status to AbbVie’s investigational HCV regimen

The pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) is for patients with chronic hepatitis C virus (HCV) genotype 1 who failed treatment with DAAs, including therapy with an NS5A inhibitor and/or protease inhibitor.

The breakthrough therapy designation, which allows for expedited development and review of therapies for severe or life-threatening conditions, was based on data from the phase 2 MAGELLAN-1 clinical study. 

In the study, 95% of patients achieved sustained viral response (SVR)12 with 12 weeks of ABT-493 and ABT-530 with and without ribavirin (RBV) in GT1 chronic HCV infected patients without cirrhosis who failed previous therapy with DAAs in a modified intent-to-treat analysis.

The company said 91% achieved SVR12 with RBV in the primary intent-to-treat analysis, while 86% achieved SVR12 without RBV

AbbVie executive vice president, research and development and chief scientific officer Michael Severino said: "The FDA's Breakthrough Therapy Designation is an important step in our effort to bring our pan-genotypic regimen to market, which we are also investigating as an eight week path to virologic cure for the majority of patients."

The company said will present new phase 3 data assessing the safety and efficacy of G/P across all major HCV genotypes (genotypes 1-6) at an upcoming scientific congress.

The regimen includes glecaprevir, an NS3/4A protease inhibitor, and pibrentasvir, an NS5A inhibitor. It is dosed once daily as three oral tablets. 

Glecaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals.

Image: AbbVie US Headquarters.  Photo: courtesy of AbbVie Inc.