The Texas Liver Institute, University of Texas Health, San Antonio, TX, USA.
Groupe Hospitalier Cochin-Saint Vincent De Paul, Paris, France.
AbbVie Inc., North Chicago, IL, USA.
Vall d'Hebron University Hospital and CiBERHED del Instituto Carlos III, Barcelona, Spain.
Royal Adelaide Hospital, Adelaide, Australia.
Hôpital Henri Mondor, Université Paris-Est, Créteil, France.
Private Practice, Bakersfield, California, USA.
Piedmont Healthcare/Carolinas Center for Liver Disease, Statesville, North Carolina, USA.
Henry Ford Health System, Detroit, Michigan, USA.
Monash Health and Monash University, Caulfield South, Victoria, Australia.
University of North Carolina, Chapel Hill, North Carolina, United States.
North Shore University Hospital, Manhasset, New York, United States.
Southwest CARE Center, Santa Fe, New Mexico, United States.
MAGELLAN-1 Part 2 was a randomized, open-label, phase 3 study to evaluate the efficacy and safety of ribavirin (RBV)-free glecaprevir and pibrentasvir (G/P; 300 mg/120 mg) in patients with chronic HCV and prior virologic failure on at least one NS3/4A protease and/or NS5A inhibitor-containing therapy. Patients with compensated liver disease, with or without cirrhosis, and HCV genotype (GT) 1, 4, 5, or 6 were randomized 1:1 to receive 12 or 16 weeks of G/P. The primary endpoint was sustained virologic response at 12 weeks post-treatment (SVR12).
Among 91 patients treated, 87 had GT1 and four had GT4 infection. SVR12 was achieved by 89% (39/44) and 91% (43/47) of patients who received 12 and 16 weeks of G/P, respectively. Virologic relapse occurred in 9% (4/44) of patients treated with 12 weeks of G/P; there were no relapses with 16 weeks of treatment. Prior treatment history with one class of inhibitor (protease or NS5A) had no impact on SVR12, while prior treatment with both classes of inhibitors was associated with lower SVR12 rate. The most common adverse event was headache (≥10% of patients) and there were no serious adverse events (AEs) assessed as related to study drugs or AEs leading to discontinuation.
Sixteen weeks of G/P treatment achieved a high SVR12 rate in patients with HCV GT1 infection and prior failure to regimens containing either NS5A inhibitors or NS3 protease inhibitors.
Patients with hepatitis C virus (HCV) who have virologic failure after treatment containing an NS5A inhibitor have limited retreatment options.