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Tenofovir/entecavir monotherapy after hepatitis B immunoglobulin withdrawal is safe and effective in the prevention of hepatitis B in liver transplant recipients
Author(s) -
Fernández I.,
Loinaz C.,
Hernández O.,
Abradelo M.,
Manrique A.,
Calvo J.,
Manzano M.,
García A.,
Cambra F.,
Castellano G.,
Jiménez C.
Publication year - 2015
Publication title -
transplant infectious disease
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.69
H-Index - 67
eISSN - 1399-3062
pISSN - 1398-2273
DOI - 10.1111/tid.12434
Subject(s) - medicine , entecavir , discontinuation , hepatitis b virus , hepatitis b , gastroenterology , hepatitis b immune globulin , seroconversion , fulminant hepatitis , liver transplantation , regimen , hepatitis , immunology , transplantation , antibody , lamivudine , virus
Background and aims Combination of hepatitis B immunoglobulin ( HBIG ) and a nucleos(t)ide analog ( NA ) is considered the standard of care for prophylaxis of hepatitis B virus ( HBV ) recurrence after liver transplantation ( LT ). However, use of lifelong HBIG has significant limitations. We evaluated the efficacy and safety of entecavir ( ETV ) or tenofovir disoproxil fumarate ( TDF ) after withdrawal of HBIG in patients who had been under HBIG ‐regimen prophylaxis post LT . Methods Patients at low risk of recurrence were eligible for HBIG discontinuation (fulminant HBV hepatitis, co‐infection with hepatitis D virus, and hepatitis B e antigen‐negative cirrhotic patients with HBV DNA levels <300 copies/ mL ). All patients had received HBIG , with or without NA , for at least 12 months after LT . After HBIG discontinuation, they continued with ETV or TDF monotherapy. Patients were followed up with HBV serum markers and evaluation of renal function. Results Between September 2011 and June 2014, 58 liver transplant recipients were converted to TDF (31, 53%) or ETV (27, 47%). Mean follow‐up after conversion was 28 ± 5 months (range 13–36 months). Five patients (8.6%) developed detectable hepatitis B surface antigen at 7, 9, 13, 15, and 22 months after HBIG discontinuation. However, in every case seroconversion was transitory, serum HBV DNA was undetectable, with no clinical manifestations of HBV recurrence. No adverse effects were observed or dose reductions required associated with ETV or TDF . Conclusions Maintenance therapy with newer NA s, after discontinuation of HBIG prophylaxis, was safe and effective, with a low rate of serological recurrence and no evident clinical, biochemical, or virological consequences.