Entecavir Monotherapy Is Effective in Suppressing Hepatitis B Virus After Liver Transplantation

Fung, James; Cheung, Clement S.K.; Chan, See‐Ching; Yuen, Man‐Fung; Chok, Kenneth S. H.; Sharr, WW; Dai, Wing Chiu; Chan, Albert C. Y.; Cheung, Tan–To; Tsang, Skm; Lam, Banny K.; Lai, Ching–Lung; Lo, Chung‐Mau

doi:10.1053/j.gastro.2011.06.083

Cited by 194 publications

(166 citation statements)

References 36 publications

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“…9,22,23 World over, there is a recent trend to shift from HBIG related immunoprophylaxis towards monotherapy with anti virals. 24 However long term results are awaited from these studies. At present, we believe that until guidelines are available on immune-prophylaxis for post liver transplant HBV recurrence, high anti HBs titer plasma (HIP) is a good and cheap alternative to expensive commercial HBIG when given in combination with nucleoside analogs.…”

Section: Discussionmentioning

confidence: 99%

Hepatitis B Immunoglobulin Prophylaxis after Liver Transplantation: Experience in a Tertiary Transplant Centre

Varghese

Sachan

Reddy

et al. 2014

Journal of Clinical and Experimental Hepatology

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Background: Prophylaxis with hepatitis B immunoglobulin (HBIG) and nucleoside analogs can prevent hepatitis B virus (HBV) recurrence after liver transplant (LT). Aim: To determine the efficacy and cost of maintaining immunoprophylaxis with HBIG and hyperimmune plasma (HIP) for 6 months after LT. Material & methods: The study included 22 HBV related LT recipients who were on entecavir and either HBIG or HIP for 6 months. Post transplant HBIG or HIP dose and cost incurred towards prophylaxis were noted. The cost of 200 IU of HBIG at the time of study was Rs 8250/-(US Dollars 135) and that of 2000 IU of HIP was Rs 8000/-(USD 130.7). The loading and maintenance costs at end of 6 months were compared between the two groups. Response to HBIG and HIP was assessed by checking for HBsAg reactivity, anti HBs titer response and HBV DNA viral load. Statistical analysis: Median and range, Kruskal Wallis (KW) sign rank Sum Test and Correlation Coefficient (r2) was used for analysis. Results: Thirteen recipients received HBIG and 9 recipients HIP. The anti HBs response to HIP was significantly high compared to HBIG (KW Sign rank Sum test P < 0.05); titers remained high until the study period. Between 8 and 30 days, the titer achieved by both HBIG and HIP was similar (KW Sign rank Sum test not significant). Despite low anti HBs titer of <100 IU/L, none of the recipients on HBIG had HBsAg reactivity while 3 on HIP had transient HBsAg positivity. The total cost with HBIG was 13.9 times the cost of HIP. Conclusion: HIP immunoprophylaxis in combination with entecavir achieves a high anti HBs titer at a significant low cost during anhepatic and loading phase. HBV reactivation rates with HBIG and HIP is low despite low anti HBs titer. ( J CLIN EXP HEPATOL 2014;4:209-213)

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Section: Discussionmentioning

confidence: 99%

Hepatitis B Immunoglobulin Prophylaxis after Liver Transplantation: Experience in a Tertiary Transplant Centre

Varghese

Sachan

Reddy

et al. 2014

Journal of Clinical and Experimental Hepatology

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“…Similarly, entecavir, Telbivudine monotherapy [78,[88][89][90][91] pre-and post LT resulted in 0% to 8% HBV recurrence rate (Table 2). Only one study found a relatively high rate of recurrent HBV infection (22.5%) using ENT [91] (Table 3). Based on experience in non-transplant patients, telbivudine can be substituted for lamivudine.…”

Section: Anti-hbs Target Levelsmentioning

confidence: 95%

“…ComposVarela/2011 [38] Cai/2012 [147] Di Costanzo/2013 [22] Gao [103] Hwang/2011 [97] Hwang/2008 [98] Hu/2012 [148] Ishigami/2011 [149] Kim/2013 [104] Jiménez-Pérez/2010 [93] McGonigal/2013 [101] Perrella/2012 [56] Perrakis/2013 [100] Perrillo/2013 [150] Roche/2010 [28] Tanaka/2012 [102] Teperman/2010 [57] Ueda/2013 [151] Varghese/2014 [105] Xie/2010 [95] Xi/2009 [100] Yasunaka/2011 [46] antiviral NAs and further studies needed to test their effectiveness as part of combination therapy with HBIG and/or montherapy strategies [78][79][80] .…”

Section: Authormentioning

confidence: 99%

Controversies Regarding the Hepatitis B Immune Globulin Prophylaxis (HBIG) for Liver Transplantation Recipients

Jazayeri

Rizzetto²,

Alavian

2014

Journal of Gastroenterology and Hepatology Research

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“…(2) Fung et al (8) investigated the efficacy of ETV as monoprophylaxis in 80 LT recipients. Eighteen (22.5%) patients had persistent HBsAg positivity either without seroclearance (n 5 8) or reappearance of HBsAg after initial seroclearance (n 5 10).…”

Section: See Article On Page 1205mentioning

confidence: 99%

“…Development of alternative strategies aimed to reduce or discontinue the requirement of IV HBIG, including the use of intramuscular or subcutaneous HBIG, switch to antiviral monotherapy, or HBV vaccination or monoprophylaxis with antiviral from the start, have been employed. (2,(4)(5)(6) Combination prophylaxis with lowdose intramuscular HBIG decreases costs by more than 90% as compared with an IV regimen, with a recurrence rate as low as 4% at 4 years.(5) Monoprophylaxis with lamivudine (LAM) has been evaluated, being started before LT and continued after transplantation without HBIG.(7) Rates of recurrence reached 20%-41% at 3 years after LT due to the emergence of escape mutations in the polymerase gene.(2) Fung et al (8) investigated the efficacy of ETV as monoprophylaxis in 80 LT recipients. Eighteen (22.5%) patients had persistent HBsAg positivity either without seroclearance (n 5 8) or reappearance of HBsAg after initial seroclearance (n 5 10).…”

mentioning

confidence: 99%

Withdrawal of posttransplant hepatitis B virus prophylaxis: A blind test

Roche

Samuel

2016

Liver Transpl

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Hepatitis B virus (HBV)-induced liver disease remains an indication for liver transplantation (LT) in Western countries and is the leading indication in Asia. The outcome has dramatically improved over the past 2 decades reflecting pretransplant antiviral B therapy and posttransplant combination prophylaxis with antiviral therapy and hepatitis B immune globulin (HBIG). A seminal study demonstrated a dramatic reduction in the rate of HBV recurrence in patients receiving longterm intravenous (IV) HBIG and was associated with improved graft and patient survival over 20 years ago.(1)The mechanisms by which HBIG protects the transplanted liver against HBV reinfection are not fully understood.(2) HBIG is thought to bind to circulating viral particles and to prevent their attachment at the hepatocyte membrane. Also, by binding to infected hepatocytes expressing hepatitis B surface antigen (HBsAg), it might enhance antibody-dependent cellmediated cytotoxicity. The advent of antiviral therapy enhanced post-LT prophylaxis with the ability to combine HBIG with a nucleos(t)ide analogue with a high genetic barrier to resistance such as entecavir (ETV) or tenofovir (TDV). Combination prophylaxis has synergistic effects, with HBIG neutralizing circulating virions and nucleos(t)ide analogue inhibiting viral replication, allowing a reduction of dose and/or duration of HBIG. A recent systematic review reported HBV recurrence in only 1% of patients treated with a combination of HBIG and ETV or TDV.(3) Thus, the ability to improve the efficacy of HBV prophylaxis is limited with possible improvement including reduction of costs and more convenient regimens.Several studies have identified predictors of HBV recurrence.(2) Patients at low recurrence risk are those who have low or undetectable HBV DNA levels at LT. Patients at high risk are those who are hepatitis B e antigen (HBeAg) positive, with pretransplant HBV DNA levels over 10 5 copies/mL or 20,000 IU/mL, those with limited antiviral options if HBV recurrence occurred (ie, human immunodeficiency virus or hepatitis D virus coinfection, preexisting drug resistance or intolerance), those with a high risk of hepatocellular carcinoma (HCC) recurrence, and those at risk due to noncompliance.(4) Using current potent antiviral therapies before LT, the majority of patients achieve undetectable HBV DNA levels at the time of LT, and thus are at low risk for HBV recurrence.The use of IV HBIG has limitations, including cost, parenteral administration, limited supply, need for frequent clinic visits, and antibody to hepatitis B surface antigen (anti-HBs) monitoring. Development of alternative strategies aimed to reduce or discontinue the requirement of IV HBIG, including the use of intramuscular or subcutaneous HBIG, switch to antiviral monotherapy, or HBV vaccination or monoprophylaxis with antiviral from the start, have been employed. (2,(4)(5)(6) Combination prophylaxis with lowdose intramuscular HBIG decreases costs by more than 90% as compared with an IV regimen, with a recurrence rate a...

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Entecavir Monotherapy Is Effective in Suppressing Hepatitis B Virus After Liver Transplantation

Cited by 194 publications

References 36 publications

Hepatitis B Immunoglobulin Prophylaxis after Liver Transplantation: Experience in a Tertiary Transplant Centre

Hepatitis B Immunoglobulin Prophylaxis after Liver Transplantation: Experience in a Tertiary Transplant Centre

Controversies Regarding the Hepatitis B Immune Globulin Prophylaxis (HBIG) for Liver Transplantation Recipients

Withdrawal of posttransplant hepatitis B virus prophylaxis: A blind test

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