RESULTS OF THE PHASE 2 STUDY M12-999: INTERFERON-FREE REGIMEN OF ABT-450/R/ABT-267+ABT-333+RIBAVIRIN IN LIVER TRANSPLANT RECIPIENTS WITH RECURRENT HCV GENOTYPE 1 INFECTION
P. Kwo1, P. Mantry2, E. Coakley3, H. Te4, H. Vargas5, R. Brown Jr.6, F. Gordon7, J. Levitsky8, N. Terrault9, J. Burton Jr10, W. Xie3, C. Setze3, P. Badri3, R.A. Vilchez3, X. Forns11
1Indiana University, Indianapolis, IN, 2The Liver Institute at Methodist Dallas Medical Center, Dallas, TX, 3AbbVie Inc., North Chicago, 4University of Chicago Medicine, Chicago, IL, 5Mayo Clinic, Phoenix, AZ,6Columbia University Medical Center Center for Liver Disease and Transplantation, New York, NY, 7Lahey Hospital & Medical Center, Burlington, MA, 8Northwestern University Comprehensive Transplant Center, Chicago, IL, 9University of California, San Francisco, San Francisco, CA, 10University of Colorado, Denver, Aurora, CO, United States, 11Liver Unit, Hospital Clinic, IDIBAPS and CIBEREHD, Barcelona, Spain
Background and Aims: Recurrence of HCV infection after liver transplantation is universal and is a primary cause of graft loss. Interferon-based HCV therapies have treatment-limiting toxicities and low efficacy. ABT-450 is an HCV NS3/4A protease inhibitor(dosed with ritonavir 100mg, ABT-450/r) identified by AbbVie and Enanta. ABT-267 is an NS5A inhibitor, and ABT-333 is an NS5B RNA polymerase inhibitor. We examined the safety and efficacy of ABT-450/r+ABT-267+ABT-333+RBV in adult liver transplant recipients with recurrent HCV genotype 1 infection.
Conclusions: The interferon-free regimen of ABT-450/r+ABT-267+ABT-333+RBV was generally well-tolerated and achieved high RVR, EOTR, and SVR4 rates in liver transplant recipients with recurrent HCV GT1 infection.