Passive immunoprophylaxis after liver transplantation in HBsAg-positive patients

Samuel, Didier; Bismuth, H; Bismuth, A; Arulnaden, Jean Louis; Mathieu, D; Reynès, M; Benhamou, Jean‐Pierre; Bréchot, Christian

doi:10.1016/0140-6736(91)92515-4

Cited by 390 publications

(190 citation statements)

References 12 publications

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“…In the reports that established the beneficial effect of long-term HBIG prophylaxis, failure to maintain anti-HBs levels above 100 IU/L was associated with an increased rate of HBV recurrence. 4,8,17,29 These studies, however, were focused on the first 6 or at most 12 months after liver transplantation and did not address the effect of different anti-HBs levels after that time. On the other hand, HBV graft infection seems to be infrequent, although still possible, beyond 18 months after liver transplantation, 4,8,10,17 suggesting a much decreased although persistent risk of HBV graft infection after that time.…”

Section: Discussionmentioning

confidence: 99%

“…Thus, in HBV DNA-negative, HBsAg-positive liver transplant recipients treated with HBIG for at least 6 months, the rate of HBV graft reinfection has been shown to be only 10% to 30%. 4,8,9,17 However, the need to administer HBIG on a long-term or probably indefinite basis adds considerably to an already very expensive procedure. 9 Moreover, although the use of antiviral agents and especially lamivudine 18 have shown promising results, there are not yet well-established alternatives to HBIG treatment.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Hepatitis B immunoglobulin discontinuation followed by hepatitis B virus vaccination: A new strategy in the prophylaxis of hepatitis B virus recurrence after liver transplantation

et al. 2000

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It is widely agreed that hepatitis B virus immunoglobulinSeveral reports have clearly shown that liver transplantation in patients with hepatitis B virus (HBV) infection-as defined by positivity for hepatitis B surface antigen (HBsAg)-is associated with a high rate of recurrence of HBV infection after transplantation, resulting in severe graft disease in most cases and in a significant decrease in both graft and patient survival. [1][2][3][4] It is widely accepted that the risk of HBV recurrence after liver transplantation is directly proportional to the level of viral replication before transplantation, with those recipients seropositive for HBeAg and HBV DNA by hybridization technique having the highest rate of recurrence after transplantation, irrespective of the type of liver disease. 2,4 Many prophylactic strategies have been proposed to prevent HBV infection of the graft, but only long-term passive immunoprophylaxis with HBV-specific immunoglobulin (HBIG) has obtained a significant reduction in the risk of HBV graft infection and in both graft and patient mortality after liver transplantation. [4][5][6][7] The presence of serum HBV DNA before transplantation is, however, a major predictor of lack of response to this prophylactic regimen.In light of these evidences, the European Concerted Action on Viral Hepatitis (EUROHEP) recommended in 1994 to refrain from transplanting chronic HBV carriers found to be positive for either hepatitis B e antigen (HBeAg) or HBV DNA by direct hybridization. Moreover, the rest of the recipients with HBV-related disease should receive HBIG immunoprophylaxis to maintain anti-HBs levels above 100 IU/L for at least 12 months after transplantation. 6 Currently, the beneficial effect of long-term HBIG administration has become widely accepted; still no consensus has been reached regarding the optimal duration of HBIG treatment. The rate of HBV graft infection recurrence 12 months after liver transplantation seems to be much decreased but it can still undoubtedly occur. 4,6,[8][9][10] Moreover the finding of HBV DNA in peripheral mononuclear blood beyond 12 months of effective HBIG prophylaxis argues in favor of a potentially indefinite risk of graft infection. 11-13 As a consequence, most liver transplant centers are currently administering HBIG on a life-long basis. Because HBIG use is highly expensive, an alternative strategy aiming at the discontinuation of HBIG prophylaxis during the second year of treatment would be an important cost-effective measure. We present here an assessment of the efficacy of a new prophylactic strategy consisting of the discontinuation of HBIG administration followed by active immunization with HBV vaccination in patients transplanted for HBVrelated liver diseases. PATIENTS AND METHODSPatients. Between July 1990 and April 1996, 36 HBsAg-positive recipients were submitted to liver transplantation at the Hospital Abbreviations: HBV, hepatitis B virus; HBsAg, hepatitis B virus surface antigen; HBIG, hepatitis B virus immunoglobulin; HBeAg, hepatitis B vi...

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Hepatitis B immunoglobulin discontinuation followed by hepatitis B virus vaccination: A new strategy in the prophylaxis of hepatitis B virus recurrence after liver transplantation

et al. 2000

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“…Subsequently, the use of high doses of intravenous (IV) hepatitis B immune globulin (HBIG) after OLT reduced HBV recurrence and improved survival. [5][6][7][8][9][10][11][12] Investigators of the European Concerted Action of Viral Hepatitis project 5 reported a 75% rate of HBV recurrence after OLT in patients receiving no prophylaxis or very short-term HBIG treatment and a 33% rate in patients receiving long-term HBIG prophylaxis. The benefit appeared to be greatest among patients with negative HBV DNA and hepatitis Be antigen (HBeAg) before OLT.…”

confidence: 99%

“…13,14 Furthermore, reinfection of the graft by HBV may still occur despite IV HBIG. [5][6][7][8][9][10][11][12] Graft reinfection may be caused by inadequate neutralization because of overwhelming amounts of HBV or break-through infection by escape HBV surface protein mutants. 15,16 Recently, long-term survival and HBV recurrence data using IV HBIG prophylaxis were reported by Samuel et al 17 Excluding patients with delta hepatitis and fulminant liver failure, 89 patients with HBV cirrhosis underwent OLT.…”

confidence: 99%

Intramuscular hepatitis B immune globulin combined with lamivudine for prophylaxis against hepatitis B recurrence after liver transplantation

et al. 1999

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Immunoprophylaxis using intravenous (IV) hepatitis B immune globulin (HBIG) decreases the recurrence of hepatitis B virus (HBV) infection after orthotopic liver transplantation (OLT). However, IV HBIG is expensive, has significant side effects, and is inconvenient to administer. An alternative approach for prophylaxis using intramuscular (IM) HBIG and oral lamivudine was prospectively evaluated in this study. Ten consecutive patients with cirrhosis with HBV infection who underwent OLT were included in this study. Nine of 10 patients received lamivudine, 150 mg/d, for an average duration of 8.6 months before OLT. Two of 10 patients with detectable HBV DNA at the time of OLT received 10,000 U (45 mL) of IV HBIG daily for 7 consecutive days, followed by 5 mL of IM HBIG weekly for the next 3 weeks, then every 3 weeks. The other 8 patients were HBV DNA negative at OLT and received one dose of IV HBIG (45 mL) during surgery, followed by 5 mL of IM HBIG weekly for 4 weeks, then every 3 weeks. All patients received lamivudine, 150 mg/d, after OLT. During a mean follow-up of 15.6 months, 9 of 10 patients achieved a protective hepatitis B surface antibody (HBsAb) titer greater than 200 IU/L and had no evidence of HBV recurrence. One patient failed to develop an adequate HBsAb titer and developed histological and virological evidence of recurrence. One patient died unrelated to HBV recurrence. Our preliminary data suggest that this combination prophylaxis with IM HBIG and lamivudine is effective and potentially cost saving.

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“…Almost uniformly, these protocols have used high intravenous (IV) doses of HBIG, with the typical protocol administering an induction dose of 10,000 IU intraoperatively during the anhepatic phase, followed by 10000 IU/d for 6 consecutive days. [3][4][5][6][7][8] Maintenance dosing of HBIG has typically consisted of 10,000 IU IV monthly 3,7,8 or a tapering schedule from weekly to monthly. 4,5 Even greater doses have been reported to be in use internation-ally: a protocol from Seoul 9 reported substituting 40000 IU of HBIG while keeping the same schedule of induction doses followed by monthly dosing.…”

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confidence: 99%

Liver transplantation for chronic hepatitis B infection with the use of combination lamivudine and low-dose hepatitis B immune globulin

Yoshida

Erb

Partovi³

et al. 1999

Liver Transpl

131

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Current protocols for prophylaxis against allograft reinfection after liver transplantation for chronic hepatitis B virus (HBV) infection include the administration of large doses of hepatitis B immune globulin (HBIG), with considerable associated economic costs. Monotherapeutic prophylaxis with lamivudine has been complicated by the development of resistant strains of HBV. We studied the effectiveness of a posttransplantation prophylaxis protocol using combination lamivudine and low-dose HBIG in 7 consecutive patients with chronic HBV infection, 4 of whom were serum HBV DNA positive before pretransplantation lamivudine therapy. All patients were serum HBV DNA negative at transplantation and received lamivudine, 100 mg/d, posttransplantation. HBIG, 2170 IU, was administered intramuscularly intraoperatively and daily for 14 days. Maintenance HBIG therapy consisted of 2170 IU intramuscularly twice weekly, tapered to every 2 to 4 weeks by 12 months posttransplantation.Target serum HBIG (HBV surface antibody) titers were less than 500 IU/L for 6 months, then greater than 300 IU/L until 12 months posttransplantation. Induction serum HBIG titers were determined daily in 5 patients, and both serum HBIG and hepatitis B surface antigen were determined every 4 weeks in all patients. One patient died 61 days posttransplantation; the surviving patients (n ‫؍‬ 6) were followed up for a mean of 532 days (range, 395 to 648 days). No patient has developed allograft reinfection. In the induction period, a target HBIG titer of greater than 500 IU/L was not achieved until a mean of 6.8 days (range, 5 to 10 days). In the maintenance period, all patients achieved the target HBIG titer. This suggests combination lamivudine and low-dose HBIG is effective in preventing allograft reinfection by HBV.

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Passive immunoprophylaxis after liver transplantation in HBsAg-positive patients

Cited by 390 publications

References 12 publications

Hepatitis B immunoglobulin discontinuation followed by hepatitis B virus vaccination: A new strategy in the prophylaxis of hepatitis B virus recurrence after liver transplantation

Hepatitis B immunoglobulin discontinuation followed by hepatitis B virus vaccination: A new strategy in the prophylaxis of hepatitis B virus recurrence after liver transplantation

Intramuscular hepatitis B immune globulin combined with lamivudine for prophylaxis against hepatitis B recurrence after liver transplantation

Liver transplantation for chronic hepatitis B infection with the use of combination lamivudine and low-dose hepatitis B immune globulin

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