Aim: To describe our centers http://www.selleckchem.com/products/ly2606368.html experience with NTZ in post LT HCV recurrence.
Methods: When used at our center, NTZ was prescribed off-label in prior non-responders or in patients with aggressive disease, such as early cholestatic HCV recurrence. NTZ was mainly used as lead in therapy for PEG-IFN/RBV. Demographics, clinical, immunosuppression and virologic data in LT recipients treated with NTZ/PEG-IFN/RBV were collected for descriptive analysis. The primary endpoint was sustained virologic response (SVR). Results: Nineteen patients were treated with NTZ, 2 were excluded for introduction of telaprivir to the course of treatment. The study group included 17 patients, mean age 50±4 years, including 13 (76%) males (13 (76% ) Caucasian, 2 (12%) Black, and 2 (12%) Hispanic), all had HCV genotype 1. NTZ was used in 13 (76%) prior non-responders and in 4 (23%) patients as part of their first course of HCV treatment post LT. Of the 13 non-responders, 9 (69%) were converted from tacrolimus to cyclosporine due to severity of HCV recurrence and 6 (46%) had advanced fibrosis prior to NTZ therapy. NTZ was introduced at 4.9±3.4 years post LT, as 4 week lead-in 10 (77%) and extended a further 4-16 weeks in 3 (23%) cases. Five (38%) patients previously had a <1 log and 4 (31%) had a >2log drop in viral
Kinase Inhibitor Library load, none had cleared virus on prior PEG-IFN/RBV, and 5 (38%). With NTZ/PEG-IFN/RBV 1 (8%) patient had <1 log and 5 (38%) had >2 log drop in viral load, with the latter 5 clearing HCV on treatment and 4 achieving SVR (31%), 2 with advanced fibrosis. Of the 4 treatment naive patients post-LT
receiving 4 week lead-in NTZ and PEG-IFN/RBV, 2 (cyclosporine) were treated for cholestatic HCV infection with <2 log response. Two patients (on tacrolimus) were treated 4-5 years post LT, without advanced fibrosis. Both cleared HCV on therapy, but 1 died before completing therapy (due to de novo malignancy) and 1 died after completing therapy but before SVR was established (due to pulmonary hemorrhage). Conclusion: LT recipients with HCV genotype 1 recurrence but without access to or success of direct acting agents, who are being considered for PEG-IN/ RBV may benefit from NTZ lead-in therapy. Disclosures: Paul Y. Kwo - Advisory Committees or Review Panels: Abbott, Novartis, Merck, Gilead, BMS, Janssen; Consulting: Diflunisal Vertex; Grant/Research Support: Roche, Vertex, GlaxoSmithKline, Merck, BMS, Abbott, Idenix, Vital Therapeutics, Gilead, Vertex, Merck, Idenix; Speaking and Teaching: Merck, Merck Marwan Ghabril – Grant/Research Support: Salix The following people have nothing to disclose: Marshall E. McCabe, Saurabh Agrawal, Marco A. Lacerda, A. Joseph Tector Introduction: Treatment (Tx) of Hepatitis C Virus (HCV) infection in kidney transplant (KT) recipients with interferon (IFN)-based regimens has been contra-indicated. IFN-free therapies with good safety profiles offer the opportunity of HCV Tx after KT for the first time.