Trial of ABT 493 (glecaprevir) + ABT 530 (pibrentasvir) shows efficacy in chronic hepatitis C- AbbVie

AbbVie has announced high SVR12 rates with 8 weeks of treatment with its investigational, pan-genotypic regimen of ABT 493 (glecaprevir) + ABT 530 (pibrentasvir) (G/P) across all major chronic hepatitis C virus (HCV) genotypes. In more than 700 genotype 1-6 (GT1-6) chronic HCV infected patients without cirrhosis and who are new to treatment, 97.5 percent (n=693/711) achieved sustained virologic response at 12 weeks post treatment (SVR12), regardless of baseline viral load. The rate of virologic failure was 1 percent (n=9/711). These data are the first to be released from registrational studies in AbbVie's G/P clinical development program, designed to investigate a faster path to virologic cure for all major HCV genotypes (GT1-6) and with the goal of addressing areas of continued unmet need.

These new top-line data comprise results from the 8-week arms of three registrational clinical trials evaluating the efficacy and safety of G/P � the ENDURANCE-1, ENDURANCE-3 and SURVEYOR-2 (Part 4) studies. Across the 8-week arms of all three studies, there were no discontinuations due to adverse events (AEs). The most common AEs, occurring at a rate greater than 10 percent across these arms were headache and fatigue; and there were no AEs in any study arm at a rate greater than 20 percent. No clinically relevant laboratory abnormalities, including ALT changes, were observed. Additional data from the ENDURANCE-1 and SURVEYOR-2 (Part 4) studies will be presented at The Liver Meeting.