Randomized trial of emtricitabine/tenofovir disoproxil fumarate after hepatitis B immunoglobulin withdrawal after liver transplantation
This study was conducted in compliance with all regulatory obligations as well as the institutional review board and informed consent regulations at each investigational site.
Lewis W. Teperman and Thomas Schiano have received research grants from Gilead Sciences, Inc.; Lewis W. Teperman has served as a speaker. Fred Poordad has served on advisory boards and as a speaker and has received research grants and unrestricted grants from Gilead Sciences. Natalie Bzowej has served in an advisory capacity for Gilead Sciences. Paul Martin has received unrestricted grants from Gilead Sciences. John Flaherty, Phillip Dinh, Stephen Rossi, and G. Mani Subramanian are employees of Gilead Sciences. Surakit Pungpapong and James Spivey have nothing to disclose.
This study was sponsored by Gilead Sciences, Inc. In collaboration with the investigators, Gilead Sciences designed the study, conducted statistical analyses, and interpreted the data, which Gilead Sciences holds. The authors had unrestricted access to the primary data and were not limited by Gilead Sciences in the writing of this article. The corresponding author (Lewis W. Teperman) takes full responsibility for the veracity of the data and the statistical analysis.
Address reprint requests to Lewis W. Teperman, M.D., Mary Lea Johnson Richards Organ Transplant Center, New York University Langone Medical Center, 403 East 34th Street, New York, NY 10016. Telephone: 212-263-8134; FAX: 212-263-8157; E-mail: firstname.lastname@example.org
Long-term prophylaxis with hepatitis B immunoglobulin (HBIG) for the prevention of hepatitis B virus (HBV) recurrence after orthotopic liver transplantation (OLT) in patients with chronic HBV infection is inconvenient and costly. This randomized, prospective phase 2 study compared emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) after HBIG withdrawal to FTC/TDF plus HBIG for the prevention of HBV recurrence after OLT. Forty patients with a median time since liver transplantation of 3.4 years (interquartile range = 1.9-5.6 years) received 24 weeks of open-label FTC/TDF plus HBIG before randomization. Patients who maintained confirmed viral suppression were randomized to continue FTC/TDF plus HBIG (n = 19) or receive FTC/TDF alone (n = 18) for an additional 72 weeks. No patient experienced HBV recurrence through 72 weeks of the study while he or she was receiving the 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 posttransplant population. The withdrawal of HBIG after 6 months' treatment with FTC/TDF should be considered in liver transplant recipients to prevent chronic HBV recurrence. Liver Transpl 19:594–601, 2013. © 2013 AASLD.