Experimental Hepatitis C Drugs Show Promise in Patients Who Failed Prior Therapy

A phase 2 study for the investigational treatments ABT-493 and ABT-530 showed high rates of sustained viralogic response (SVR) for non-cirrhotic chronic hepatitis C virus (HCV) in patients who failed prior direct-acting antiviral (DAA) therapy.

The ongoing, open-label, multicenter, phase 2 trial called MAGELLAN-1 evaluated the safety and efficiency of AbbVie’s ABT-493 and ABT-530, with or without ribavirin (RBV), in adults suffering from HCV genotype 1 (GT1) and genotypes 4-6.

Researchers enrolled 50 GT1 non-cirrhotic patients who previously failed DAA therapy randomized to receive ABT-493 and ABT-530 once-daily at doses of 200/80-mg (Arm A), 300/120-mg with 800-mg RBV (Arm B), or 300/120-mg without RBV (Arm C), for 12 weeks. The primary endpoint for efficacy was SVR at 12 weeks (SVR₁₂).

The results of the study showed that 91% (n=20/22) of GT1 patients achieved SVR₁₂ with 12 weeks of ABT-493 and ABT-530 plus RBV.

Furthermore, 86% (n=19/22) of patients who received ABT-493 and ABT-530 without RBV achieved SVR₁₂. Meanwhile, 95% of patients with or without RBV (n=20/21, n=19/20; respectively) 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, MD, 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.”

Two patients had virologic failure — one from each arm – and no patients stopped treatment because of adverse events. The most common adverse events included headache, fatigue, and nausea.

“While high virologic cure rates have been demonstrated in clinical studies with current DAA regimens, we recognize that not all patients achieve a cure,” said Rob Scott, MD, vice president of development and chief medical officer at AbbVie. “Through our ongoing clinical development program, we are striving to give HCV patients a potential option for retreatment.”