Early introduction of subcutaneous hepatitis B immunoglobulin following liver transplantation for hepatitis B virus infection: a prospective, multicenter study

Paolo De Simone; Renato Romagnoli; Francesco Tandoi; Paola Carrai; Giorgio Ercolani; Eugenia Peri; Fausto Zamboni; Laura Mameli; Fabrizio Di Benedetto; Umberto Cillo; Luciano De Carlis; Andrea Lauterio; Luigi Lupo; Giuseppe Tisone; Martin Prieto; Carmelo Loinaz; Antoni Mas; Abid Suddle; David Mutimer; Bruno Roche; Andrea Wartenberg-Demand; Gabriele Niemann; Heike Böhm; Didier Samuel

doi:10.1097/TP.0000000000001171

Early introduction of subcutaneous hepatitis B immunoglobulin following liver transplantation for hepatitis B virus infection: a prospective, multicenter study

Paolo De Simone, Renato Romagnoli, Francesco Tandoi, Paola Carrai, Giorgio Ercolani, Eugenia Peri, Fausto Zamboni, Laura Mameli, Fabrizio Di Benedetto, Umberto Cillo, Luciano De Carlis, Andrea Lauterio, Luigi Lupo, Giuseppe Tisone, Martin Prieto, Carmelo Loinaz, Antoni Mas, Abid Suddle, David Mutimer, Bruno RocheAndrea Wartenberg-Demand, Gabriele Niemann, Heike Böhm, Didier Samuel

Immunology and Immunotherapy

Research output: Contribution to journal › Article › peer-review

14 Citations (Scopus)

Abstract

BACKGROUND: Subcutaneous administration of hepatitis B immunoglobulin (HBIg) is effective in preventing hepatitis B virus (HBV) recurrence after liver transplantation, but early conversion to subcutaneous administration is undocumented.

METHODS: In a prospective study, patients transplanted for terminal liver disease due to HBV infection who were HBV DNA-negative at transplant were switched by week 3 posttransplantation from intravenous to subcutaneous HBIg (500 or 1000 IU weekly or fortnightly, adjusted according to serum anti-HBs trough level) if they were HBsAg- and HBV-DNA negative at time of switch. All patients concomitantly received nucleos(t)ide analogue antiviral therapy. Primary endpoint was failure rate by month 6, defined as serum anti-HBs of 100 IU/L or less or HBV reinfection despite serum anti-HBs greater than 100 IU/L.

RESULTS: Of 49 patients treated, 47 (95.9%) continued treatment until month 6. All patients achieved administration by a caregiver or self-injection by week 14. No treatment failures occurred. Mean anti-HBs declined progressively to month 6, plateauing at a protective titer of approximately 290 IU/L. All patients tested for HBV DNA remained negative (45/45). Only 1 adverse event (mild injection site hematoma) was assessed as treatment-related.

CONCLUSIONS: Introduction of subcutaneous HBIg administration by week 3 posttransplantation, combined with HBV virostatic prophylaxis, is effective and convenient for preventing HBV recurrence.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially.

Original language	English
Journal	Transplantation
DOIs	https://doi.org/10.1097/TP.0000000000001171
Publication status	Published - 25 Mar 2016

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10.1097/TP.0000000000001171Licence: Creative Commons: Attribution-NonCommercial-NoDerivs (CC BY-NC-ND)

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De Simone, P., Romagnoli, R., Tandoi, F., Carrai, P., Ercolani, G., Peri, E., Zamboni, F., Mameli, L., Di Benedetto, F., Cillo, U., De Carlis, L., Lauterio, A., Lupo, L., Tisone, G., Prieto, M., Loinaz, C., Mas, A., Suddle, A., Mutimer, D., ... Samuel, D. (2016). Early introduction of subcutaneous hepatitis B immunoglobulin following liver transplantation for hepatitis B virus infection: a prospective, multicenter study. Transplantation. https://doi.org/10.1097/TP.0000000000001171

@article{91aa175735314497833747dab6f319e3,

title = "Early introduction of subcutaneous hepatitis B immunoglobulin following liver transplantation for hepatitis B virus infection: a prospective, multicenter study",

abstract = "BACKGROUND: Subcutaneous administration of hepatitis B immunoglobulin (HBIg) is effective in preventing hepatitis B virus (HBV) recurrence after liver transplantation, but early conversion to subcutaneous administration is undocumented.METHODS: In a prospective study, patients transplanted for terminal liver disease due to HBV infection who were HBV DNA-negative at transplant were switched by week 3 posttransplantation from intravenous to subcutaneous HBIg (500 or 1000 IU weekly or fortnightly, adjusted according to serum anti-HBs trough level) if they were HBsAg- and HBV-DNA negative at time of switch. All patients concomitantly received nucleos(t)ide analogue antiviral therapy. Primary endpoint was failure rate by month 6, defined as serum anti-HBs of 100 IU/L or less or HBV reinfection despite serum anti-HBs greater than 100 IU/L.RESULTS: Of 49 patients treated, 47 (95.9%) continued treatment until month 6. All patients achieved administration by a caregiver or self-injection by week 14. No treatment failures occurred. Mean anti-HBs declined progressively to month 6, plateauing at a protective titer of approximately 290 IU/L. All patients tested for HBV DNA remained negative (45/45). Only 1 adverse event (mild injection site hematoma) was assessed as treatment-related.CONCLUSIONS: Introduction of subcutaneous HBIg administration by week 3 posttransplantation, combined with HBV virostatic prophylaxis, is effective and convenient for preventing HBV recurrence.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially.",

author = "{De Simone}, Paolo and Renato Romagnoli and Francesco Tandoi and Paola Carrai and Giorgio Ercolani and Eugenia Peri and Fausto Zamboni and Laura Mameli and {Di Benedetto}, Fabrizio and Umberto Cillo and {De Carlis}, Luciano and Andrea Lauterio and Luigi Lupo and Giuseppe Tisone and Martin Prieto and Carmelo Loinaz and Antoni Mas and Abid Suddle and David Mutimer and Bruno Roche and Andrea Wartenberg-Demand and Gabriele Niemann and Heike B{\"o}hm and Didier Samuel",

year = "2016",

month = mar,

day = "25",

doi = "10.1097/TP.0000000000001171",

language = "English",

journal = "Transplantation",

issn = "0041-1337",

publisher = "Lippincott Williams and Wilkins",

}

De Simone, P, Romagnoli, R, Tandoi, F, Carrai, P, Ercolani, G, Peri, E, Zamboni, F, Mameli, L, Di Benedetto, F, Cillo, U, De Carlis, L, Lauterio, A, Lupo, L, Tisone, G, Prieto, M, Loinaz, C, Mas, A, Suddle, A, Mutimer, D, Roche, B, Wartenberg-Demand, A, Niemann, G, Böhm, H & Samuel, D 2016, 'Early introduction of subcutaneous hepatitis B immunoglobulin following liver transplantation for hepatitis B virus infection: a prospective, multicenter study', Transplantation. https://doi.org/10.1097/TP.0000000000001171

TY - JOUR

T1 - Early introduction of subcutaneous hepatitis B immunoglobulin following liver transplantation for hepatitis B virus infection

T2 - a prospective, multicenter study

AU - De Simone, Paolo

AU - Romagnoli, Renato

AU - Tandoi, Francesco

AU - Carrai, Paola

AU - Ercolani, Giorgio

AU - Peri, Eugenia

AU - Zamboni, Fausto

AU - Mameli, Laura

AU - Di Benedetto, Fabrizio

AU - Cillo, Umberto

AU - De Carlis, Luciano

AU - Lauterio, Andrea

AU - Lupo, Luigi

AU - Tisone, Giuseppe

AU - Prieto, Martin

AU - Loinaz, Carmelo

AU - Mas, Antoni

AU - Suddle, Abid

AU - Mutimer, David

AU - Roche, Bruno

AU - Wartenberg-Demand, Andrea

AU - Niemann, Gabriele

AU - Böhm, Heike

AU - Samuel, Didier

PY - 2016/3/25

Y1 - 2016/3/25

N2 - BACKGROUND: Subcutaneous administration of hepatitis B immunoglobulin (HBIg) is effective in preventing hepatitis B virus (HBV) recurrence after liver transplantation, but early conversion to subcutaneous administration is undocumented.METHODS: In a prospective study, patients transplanted for terminal liver disease due to HBV infection who were HBV DNA-negative at transplant were switched by week 3 posttransplantation from intravenous to subcutaneous HBIg (500 or 1000 IU weekly or fortnightly, adjusted according to serum anti-HBs trough level) if they were HBsAg- and HBV-DNA negative at time of switch. All patients concomitantly received nucleos(t)ide analogue antiviral therapy. Primary endpoint was failure rate by month 6, defined as serum anti-HBs of 100 IU/L or less or HBV reinfection despite serum anti-HBs greater than 100 IU/L.RESULTS: Of 49 patients treated, 47 (95.9%) continued treatment until month 6. All patients achieved administration by a caregiver or self-injection by week 14. No treatment failures occurred. Mean anti-HBs declined progressively to month 6, plateauing at a protective titer of approximately 290 IU/L. All patients tested for HBV DNA remained negative (45/45). Only 1 adverse event (mild injection site hematoma) was assessed as treatment-related.CONCLUSIONS: Introduction of subcutaneous HBIg administration by week 3 posttransplantation, combined with HBV virostatic prophylaxis, is effective and convenient for preventing HBV recurrence.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially.

AB - BACKGROUND: Subcutaneous administration of hepatitis B immunoglobulin (HBIg) is effective in preventing hepatitis B virus (HBV) recurrence after liver transplantation, but early conversion to subcutaneous administration is undocumented.METHODS: In a prospective study, patients transplanted for terminal liver disease due to HBV infection who were HBV DNA-negative at transplant were switched by week 3 posttransplantation from intravenous to subcutaneous HBIg (500 or 1000 IU weekly or fortnightly, adjusted according to serum anti-HBs trough level) if they were HBsAg- and HBV-DNA negative at time of switch. All patients concomitantly received nucleos(t)ide analogue antiviral therapy. Primary endpoint was failure rate by month 6, defined as serum anti-HBs of 100 IU/L or less or HBV reinfection despite serum anti-HBs greater than 100 IU/L.RESULTS: Of 49 patients treated, 47 (95.9%) continued treatment until month 6. All patients achieved administration by a caregiver or self-injection by week 14. No treatment failures occurred. Mean anti-HBs declined progressively to month 6, plateauing at a protective titer of approximately 290 IU/L. All patients tested for HBV DNA remained negative (45/45). Only 1 adverse event (mild injection site hematoma) was assessed as treatment-related.CONCLUSIONS: Introduction of subcutaneous HBIg administration by week 3 posttransplantation, combined with HBV virostatic prophylaxis, is effective and convenient for preventing HBV recurrence.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially.

U2 - 10.1097/TP.0000000000001171

DO - 10.1097/TP.0000000000001171

M3 - Article

C2 - 27023394

SN - 0041-1337

JO - Transplantation

JF - Transplantation

ER -

Early introduction of subcutaneous hepatitis B immunoglobulin following liver transplantation for hepatitis B virus infection: a prospective, multicenter study

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