Post-hoc analyses of phase III trials of Viekirax (ombitasvir/paritaprevir/ritonavir) + Exviera (dasabuvir) shows benefits in hepatitis C infection- AbbVie

New data from a post-hoc analysis of five completed Phase III clinical trials shows that patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection who received the recommended regimen of AbbVie’s Viekirax (ombitasvir/paritaprevir/ritonavir tablets) + Exviera (dasabuvir tablets), with or without ribavirin (RBV), achieved high sustained virologic response rates at 48 weeks post-treatment (SVR48), regardless of the presence of baseline resistance-associated variants (RAVs).

The study found that no matter whether certain NS5A RAVs were present, 100 percent (n=148/148) of patients with GT1b chronic HCV infection who received VIEKIRAX + EXVIERA without RBV for 12 weeks, achieved SVR48. Results also showed 97 percent of patients with GT1a chronic HCV infection with or without baseline NS5A RAVs (n=57/59 and n=351/361 respectively) achieved SVR48 when receiving the recommended regimen of VIEKIRAX + EXVIERA with RBV. These findings included patients new to therapy and patients previously treated with pegylated interferon/ribavirin (pegIFN/RBV) (treatment-experienced), as well as GT1 patients with compensated cirrhosis. These late-breaking data will be presented at The International Liver Congress (ILC) 2016.

Comment: The post-hoc analysis was performed on data from five completed Phase III studies: PEARL-IV (GT1a treatment-naïve, n=90), SAPPHIRE-II (GT1a pegIFN/RBV treatment-experienced, n=214), TURQUOISE-II (GT1a compensated cirrhosis – 24 week treatment arm, n=118), PEARL-II (GT1b pegIFN/RBV treatment-experienced, n=89) and TURQUOISE-III (GT1b compensated cirrhosis, n=59). Patients who did not achieve SVR for reasons other than virologic failure (such as early treatment discontinuations or SVR12 data unavailable) were excluded from the analysis.