Mavyret demonstrated high rates of safety and efficacy among patients with hepatitis C genotypes 1 and 4 who had previously been treated with other direct-acting antivirals, according to a recently published study.
“Patients that have virologic failure with NS5A inhibitor-containing regimens commonly develop resistance-associated substitutions that decrease the efficacy of subsequent retreatment,” Fred Poordad, MD, from the University of Texas Health, and colleagues wrote. “Effective retreatment of patients who have had virologic failure on NS5A inhibitor-containing regimens has been challenging, and retreatment options for this population are currently limited.”
In part two of the MAGELLAN-1 study, researchers enrolled 91 patients with HCV, including patients with cirrhosis, who had prior treatment with a NS3/4A protease and/or NS5A inhibitor-based DAA regimen.
Patients had genotype 1 (n = 87) or 4 (n = 4) and were mostly men (70%) and white (76%). The researchers randomly assigned patients to receive either 12 weeks (n = 44) or 16 weeks (n =47) of Mavyret (glecaprevir/pibrentasvir, AbbVie).
Thirty-nine patients in the 12-week arm (89%; 95% CI, 76-95) and 43 patients in the 16-week arm (91%; 95% CI, 80-97) achieved SVR. The researchers observed one on-treatment virologic failure and four relapses in the 12-week arm and four on-treatment virologic failures in the 16-week arm.
All patients whose prior DAA treatment included only NS3/4A protease inhibitors achieved SVR. Patients whose prior treatment included only NS5A inhibitors had SVR rates of 88% in the 12-week arm (95% CI, 64-97) and 94% in the 16-week arm (95% CI, 74-99).
Patients who had prior treatment with both NS3/4A and NS5A inhibitors had the lowest SVR rates in both the 12-week (79%; 95% CI, 52-92) and 16-week arms (81%; 95% CI, 57-93). Three of six patients with prior experience with both inhibitor classes who did not achieve SVR and experienced on-treatment virologic failure.
Most adverse events were mild (65%), and no patient discontinued treatment due to adverse events. The most common adverse event was headache in both the 12-week (14%) and 16-week arms (23%). The researchers did not correlate any of the three serious adverse events to the treatment drug. – by Talitha Bennett
Disclosure: The authors report no relevant financial disclosures.