title: Randomized trial of emtricitabine/tenofovir disoproxil fumarate after hepatitis B immunoglobulin withdrawal after liver transplantation.
abstract: 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.
authors: Mary Lea Johnson Richards Organ Transplant Center, New York University Langone Medical Center, New York, NY 10016, USA. lewis.teperman@nyumc.org
authors: Lewis W
authors: LW
authors: Teperman
authors: Fred
authors: F
authors: Poordad
authors: Natalie
authors: N
authors: Bzowej
authors: Paul
authors: P
authors: Martin
authors: Surakit
authors: S
authors: Pungpapong
authors: Thomas
authors: T
authors: Schiano
authors: John
authors: J
authors: Flaherty
authors: Phillip
authors: P
authors: Dinh
authors: Stephen
authors: S
authors: Rossi
authors: G Mani
authors: GM
authors: Subramanian
authors: James
authors: J
authors: Spivey
mesh_terms: D000225:Adenine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage*; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004359:Drug Therapy, Combination / Q000379:methods; D000068679:Emtricitabine; D005260:Female; D019694:Hepatitis B, Chronic / Q000517:prevention & control / Q000628:therapy*; D006801:Humans; D007136:Immunoglobulins / Q000627:therapeutic use*; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D063065:Organophosphonates / Q000627:therapeutic use*; D011446:Prospective Studies; D012008:Recurrence; D000068698:Tenofovir; D016896:Treatment Outcome; D014481:United States
chemical_list: D000998:Antiviral Agents; D007136:Immunoglobulins; D063065:Organophosphonates; D003841:Deoxycytidine; D000068698:Tenofovir; D000068679:Emtricitabine; D000225:Adenine; C045213:hepatitis B hyperimmune globulin