AbbVie announced positive results from the ongoing MAGELLAN-1 study, evaluating the efficacy, safety, and pharmacokinetics of ABT-493 and ABT-530, with and without ribavirin (RBV), for the treatment of genotype 1 (GT1) and genotypes 4-6 chronic hepatitis C virus (HCV) infection in non-cirrhotic adults who failed previous therapy with direct-acting antivirals (DAA). Study data are currently being presented at The International Liver Congress (ILC) 2016 in Barcelona, Spain.
MAGELLAN-1 is a randomized, open-label, multicenter Phase 2 clinical program investigating ABT-493 and ABT-530, with and without RBV, across all HCV genotypes in two parts. Part 1 of the study included 50 patients with GT1 HCV infection without cirrhosis who failed a regimen containing a protease inhibitor and/or NS5A inhibitor, with or without a NS5B polymerase inhibitor. Patients were randomized to receive either once daily ABT-493 and ABT-530 200/80mg (Arm A), 300/120mg with 800mg RBV (Arm B), or 300/120mg without RBV (Arm C) for 12 weeks. The primary efficacy endpoint was SVR12.
Preliminary study results showed that 91% of GT1 chronic HCV infected patients achieved SVR12 with 12 weeks treatment of ABT-493 and ABT-530 with RBV. In addition, 86% of GT1 patients treated with ABT-493 and ABT-530 without RBV achieved SVR12.
The second part of the study is underway to evaluate the effect of once-daily ABT-493 (300mg) and ABT-530 (120mg) without RBV in a larger group of DAA treatment-experienced patients, including those with compensated cirrhosis and in genotypes 4–6.
The investigational, once-daily, pan-genotypic regimen includes ABT-493, an NS3/4A protease inhibitor, and ABT-530, an NS5A inhibitor.
For more information call (800) 633-9110 or visit Abbvie.com.