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Abstract Details
A randomized trial of emtricitabine/tenofovir disoproxil fumarate after hepatitis B immunoglobulin withdrawal post-liver transplant
Teperman LW, Poordad F, Bzowej N, Martin P, Pungpapong S, Schiano T, Flaherty J, Dinh P, Rossi S, Subramanian GM, Spivey J. Liver Transpl. 2013 Feb 27. doi: 10.1002/lt.23628. [Epub ahead of print]
Source
New York University Langone Medical Center, Mary Lea Johnson Richards Organ Transplant Center, 403 East 34th Street, New York, NY 10016. Lewis.Teperman@nyumc.org.
Abstract
Long-term prophylaxis with hepatitis B immunoglobulin to prevent hepatitis B virus recurrence after orthotopic liver transplantation in patients with chronic hepatitis B virus infection is inconvenient and costly. This randomized, prospective phase 2 study evaluated emtricitabine/tenofovir disoproxil fumarate after hepatitis B immunoglobulin withdrawal compared with emtricitabine/tenofovir disoproxil fumarate plus hepatitis B immunoglobulin for preventing hepatitis B virus recurrence following orthotopic liver transplant. Forty patients having a median (interquartile range) time since liver transplant of 3.4 (1.9, 5.6) years received 24 weeks of open-label pre-randomization emtricitabine/tenofovir disoproxil fumarate plus hepatitis B immunoglobulin. Patients who maintained confirmed viral suppression were randomized to continue emtricitabine/tenofovir disoproxil fumarate plus hepatitis B immunoglobulin (n = 19) or to receive emtricitabine/tenofovir disoproxil fumarate alone (n = 18) for an additional 72 weeks. No patient experienced hepatitis B virus recurrence through 72 weeks of the study while receiving randomized treatment. Both treatment arms were safe and well tolerated; no serious or severe drug-related adverse events were observed. Renal function was consistent with that observed in a post-transplant population. Withdrawal of hepatitis B immunoglobulin after 6 months' treatment with emtricitabine/tenofovir disoproxil fumarate should be considered in liver transplant recipients to prevent chronic hepatitis B virus recurrence.