Roberts – Board Membership: Jannsen, Roche, Gilead, BMS The following people have nothing to disclose: Lingling Han Purpose:HCV infection
is the most common indication for liver transplantation(LT). HCV recurrence after LT is universal, leading to premature graft failure in 30-50% of patients(pts). Inter-feron-based HCV therapies are limited by toxicity and poor efficacy. ABT-450 is an HCV NS3/4A protease inhibitor(dosed with ritonavir, ABT-450/r) identified by AbbVie HSP inhibitor and Enanta. Ombitasvir is an NS5A inhibitor; dasabuvir is an NS5B RNA polymerase inhibitor. We examined safety and efficacy of ABT-450/r/ombitasvir and dasabuvir plus
ribavirin(3D+RBV) in non-cirrhotic LT recipients with recurrent HCV genotype(GT) 1 infection. Methods:In this ongoing open-label phase 2 trial, pts received 24 weeks of co-formulated ABT-450/r/ombitas-vir(150mg/100mg/25mg QD) and dasabuvir(250mg BID) plus RBV(dosed at investigator discretion). Eligibility criteria included LT≥12 months before screening, HCV treatment-naive since LT, and screening biopsy Metavir score≤F2. Due to interactions between calcineurin inhibitors(CNIs) and study regimen, modified CNI dosing was advised(tacroli-mus: 0.5mg once weekly or 0.2mg every 3 days; cyclospo-rine: 1/5 the daily pre-study dose once daily). RVR, EOTR, SVR4, SVR12, and SVR24 Apoptosis Compound Library mw rates MycoClean Mycoplasma Removal Kit are reported. Updated SVR
rates will be presented. Results:All 34 enrolled pts achieved RVR and EOTR(Table). SVR4, SVR12, and SVR24 rates are 97.1%(33/34), 97.0%(32/33), and 93.3%(14/15). No pt had breakthrough on treatment; 1 relapsed. Advised lower CNI dosing resulted in stable CNI levels. The most common treatment-emergent adverse events(AEs) were fatigue(50.0%) and headache(44.1%). One pt discontinued treatment after week 18 due to AEs(moderate rash, memory impairment, anxiety); this pt achieved SVR12. Five pts with grade 2(N=4) or grade 3(N=1) hemoglobin decreases received erythropoietin at investigator discretion. No pt was transfused or had an episode of acute rejection. Conclusions:LT recipients with recurrent HCV GT1 infection achieved high SVR rates with the interfer-on-free 3D+RBV regimen. The regimen was generally well-tolerated and drug-drug interactions were manageable. Disclosures: Parvez S. Mantry – Consulting: Salix, Gilead, Janssen, Abbvie; Grant/Research Support: Salix, Merck, Gilead, Boehringer-Ingelheim, Mass Biologics, Vital Therapies, Santaris, Vertex, Bristol-Myers Squibb, Abbive, Bayer-Onyx; Speaking and Teaching: Gilead, Janssen, Salix, Bayer-Onyx Paul Y.