AbbVie has presented new clinical data showing high rates of efficacy for its experimental hepatitis C therapy ABT-493 and ABT-530 in patients with genotype 1 forms of the illness.
The Phase II MAGELLAN-1 trial is investigating the efficacy, safety and pharmacokinetics of ABT-493 (an NS3/4A protease inhibitor) and ABT-530 (an NS5A inhibitor), with and without RBV, in adults with GT1 and genotypes 4-6 chronic HCV infection who failed prior therapy with direct-acting antivirals.
According to the results, 91 percent of patients with of genotype 1 HCV achieved a sustained virologic response after 12 weeks’ treatment with ABT-493/ABT-530 with ribavirin (RBV) in the primary intent-to-treat analysis. Also, 86 percent who received the combination without RBV achieved SVR12.
"Retreatment options for those patients who have previously failed therapy are limited, and present a particular challenge for treating physicians," said Fred Poordad, vice president of academic and clinical affairs at The Texas Liver Institute in San Antonio.
"The high SVR rates seen in the ongoing MAGELLAN-1 study are significant as they show promise in addressing this particular clinical challenge.”
On the safety side, no patients discontinued treatment due to adverse events, and two patients experienced virologic failure, one from each arm. The most common adverse events were headache (30 percent), fatigue (27 percent) and nausea (20 percent).