Safety and Efficacy of Subcutaneous Hepatitis B Immunoglobulin After Liver Transplantation: An Open Single-Arm Prospective Study

Currently, nucleos(t)ide analogs (NAs) in monotherapy are favored as prophylaxis against hepatitis B recurrence after liver transplantation. However, in patients at risk of renal failure, renal safety of NAs is of concern. We investigated the safety and efficacy of subcutaneous (SC) hepatitis B immunoglobulins (HBIG) in monotherapy. This is a single-arm prospective trial in patients transplanted >1 year. We included 43 Caucasian patients. The majority was treated with calcineurin inhibitors, and several patients had other risk factors for renal impairment as well: diabetes mellitus (n = 10/43), arterial hypertension (n = 11/43), and hyperlipidemia (=10/43). At inclusion, 42% (n = 18) had chronic kidney disease ≥ grade 3a. All patients were switched from IV HBIG with or without NAs to SC HBIG without NAs. After one year, the targeted titer was lowered to ≥150 IU/l in patients with low risk of recurrence. Mean follow-up time was 36 ± 5 months. None of the patients had a relapse of HBsAg or HBV DNA. The treatment was well tolerated, safe and the renal function remained unchanged both in patients with (n = 18) or without (n = 25) renal impairment at baseline. The mean HBsAb titer could be decreased from 343 ± 163 to 199 ± 81 IU/l in the low-risk group (n = 17) and 218 ± 71 IU/l in the high-risk group (n = 26). In 86% (n = 37) doses, reductions were possible, which significantly lowered the cost of treatment. SC HBIG without NAs had a 100% success rate in the long-term prevention of HBsAg and HBV DNA reappearance, without deterioration of renal function.

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“…The convenience of self‐administration was already demonstrated in earlier trials and confirmed in this trial .…”

Section: Discussionsupporting

confidence: 81%

“…As the regular intravenous (IV) administration of HBIG is inconvenient, some investigators have used intramuscular (IM) injections . Recently, subcutaneous (SC) injections were used with high success rates to increase the independency and autonomy of patients .…”

Section: Introductionmentioning

confidence: 99%

Personalized subcutaneous administration of hepatitis B surface antibodies without nucleos(t)ide analogs for patients at risk of renal failure after liver transplantation: a prospective single center cohort study

et al. 2018

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“…Different agent strengths, routes of administration, and types of AV have shown little or no effect on patient survival (25,26). The study by Angus et al (27) showed significant reduction in the rate of HBV recurrence in the first year post-LT in patients using lamivudine and HBIG.…”

Section: Discussionmentioning

confidence: 99%

Role of nucleoside/nucleotide analogues and low-dose hepatitis B immune globulin in prophylaxis of hepatitis B recurrence among cadaveric liver transplant recipients

Ajayi

Luu

Saberi

et al. 2018

Turk J Gastroenterol

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“…Combination prophylaxis with low-dose IM HBIG (400-800 IU IM) decreases costs by more than 90% as compared with an IV regimen with a recurrence rate as low as 4% at 4 years [22]. More recently, subcutaneous regimens of HBIG administered 6 months after LT have proven effective as well, with some advantage in tolerability and possibility of self-administration by patients at home [23]. Degertekin et al .…”

Section: Prevention Of Hbv Recurrencementioning

confidence: 99%

“…Alternative approaches have been studied, which include the use of low-dose intramuscular (IM) HBIG [22], subcutaneous HBIG [23], withdrawal of HBIG after a finite period or prophylaxis regimens without HBIG. The ability to achieve undetectable HBV DNA before LT in the majority of patients using potent antivirals allows the use of prophylaxis regimens minimizing the dose or duration of HBIG.…”

Section: Prevention Of Hbv Recurrencementioning

confidence: 99%

Prevention of Hepatitis B Virus Reinfection in Liver Transplant Recipients

Roche¹,

Samuel²

2014

Intervirology

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Antiviral therapy using newer nucleos(t)ide analogues with lower resistance rates such as entecavir or tenofovir could suppress hepatitis B virus (HBV) replication, improve liver function, delay or obviate the need for liver transplantation in some patients, and reduce the risk of HBV recurrence. The combination of long-term antiviral and low-dose hepatitis B immune globulin (HBIG) can effectively prevent HBV recurrence in more than 90% of transplant recipients. Some form of HBV prophylaxis needs be continued indefinitely after transplantation. However, in patients with a low risk of HBV recurrence (i.e. HBV DNA levels undetectable before transplantation), it is possible to discontinue HBIG and maintain long-term antiviral therapy. A more cautious approach to prophylaxis regimen is necessary for those patients with high pretransplant HBV DNA levels, those with limited antiviral options if HBV recurrence occurs (i.e. HIV or HDV coinfection, preexisting drug resistance), those with a high risk of hepatocellular carcinoma recurrence, and those with a risk of noncompliance to antiviral therapy.

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Safety and Efficacy of Subcutaneous Hepatitis B Immunoglobulin After Liver Transplantation: An Open Single-Arm Prospective Study

Abstract: Life-long hepatitis B immunoglobulin (HBIG) administration is a main component of prophylactic strategy to prevent hepatitis B virus (HBV) reinfection after liver transplantation (LT

Cited by 35 publications

References 21 publications

Personalized subcutaneous administration of hepatitis B surface antibodies without nucleos(t)ide analogs for patients at risk of renal failure after liver transplantation: a prospective single center cohort study

Personalized subcutaneous administration of hepatitis B surface antibodies without nucleos(t)ide analogs for patients at risk of renal failure after liver transplantation: a prospective single center cohort study

Role of nucleoside/nucleotide analogues and low-dose hepatitis B immune globulin in prophylaxis of hepatitis B recurrence among cadaveric liver transplant recipients

Prevention of Hepatitis B Virus Reinfection in Liver Transplant Recipients

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