Background and Aims:Triple therapy(TT) with pegylated interferon(P), ribavirin(R) and a protease inhibitor(PI) improves sustained virologic response(SVR) rates in non-liver transplant(LT) genotype 1 HCV-infected patients. We aimed to determine extended rapid virologic response(eRVR) and adverse event(AE) rates in post-LT recipients treated with TT. Methods:6 high volume US transplant centers treated genotype 1 HCV-infected LT recipients with TT. Telaprevir was used in 89% with PR lead-in(LI) in 97%. 16 with ≥90 days of LI were excluded from efficacy but not safety analyses. Results:120 patients with a median age of 58 years, 77% male, 11% AA, and 55% with genotype 1a were analyzed. 54% had prior post-LT treatment(48% null, 24% partial, 28% relapsers), 83% stage 2-4 fibrosis & 11% fibrosing cholestatic hepatitis. Immunosuppression included cyclosporine in 61%, tacrolimus in 29%, steroids in 26% and mycophenolate in 77%. Median daily cyclosporine & tacrolimus doses prior/after PI were 200/50mg and 1.0/0.19mg, respectively. Median treatment duration was 148(IQR:66-219) days with median LI of 30(IQR:28-41) days. Despite erythopoetin use in 79%, GCSF in 43%, R & P dose reduction in 80% & 38% respectively, AEs were common: 45% of patients required blood transfusions, 20% required hospitalization, 26% experienced drug interruption or discontinuation, 33% had a creatinine increase ≥0.5 mg/dL, 4% experienced rejection & 1.7% died. 6 simultaneous liver-kidney transplant patients are receiving TT, and one renal Banff 2b rejection occurred. Viral negativity occurred at week 4 of TT in 63%(62/98) which increased to 78%(67/85) by week 12 leading to a 62% eRVR. HCV RNA remained negative at week 24 in 72%(46/64) & breakthrough occurred in 9% of patients. Conclusions:TT in highly selected post-LT recipients requires intense monitoring with common AE and a 1.7% risk of death. However, with appropriate management of drug-drug interactions, dose modifications, & AEs we achieved eRVR in 62% of LT recipients. SVR data will be presented on those who have completed therapy.
O'Leary, J.: Speaker’s Bureau, Vertex. Levitsky, J.: Speaker’s Bureau, Vertex. Everson, G.: Grant/Research Support, Vertex, Merck. Brown, R.: Other, Merck, Consultant, Vertex, Consultant.
To cite this abstract in AMA style:O'Leary J, Verna E, Burton J, Lai J, Saxena V, Levitsky J, Dodge J, Everson G, Trotter J, Stravitz R, Brown R, Terrault N. High Rate of eRVR with Protease Inhibitor-Triple HCV Therapy in Liver Transplant Recipients: A Multicenter Study from CRUSH-C, A [abstract]. Am J Transplant. 2013; 13 (suppl 5). http://atcmeetingabstracts.com/abstract/high-rate-of-ervr-with-protease-inhibitor-triple-hcv-therapy-in-liver-transplant-recipients-a-multicenter-study-from-crush-c-a/. Accessed November 19, 2017.
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