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Hepatitis B Immune Globulin Therapy May Improve Graft and Patient Survival After Liver Transplantation: Presented at AASLD

By Cheryl Lathrop

BOSTON -- November 2, 2009 -- Hepatitis B immune globulin (HBIG) therapy is associated with improved graft/patient survival versus lamivudine independently of de novo hepatitis B reduction in liver transplant recipients, according to data released here at the Liver Meeting 2009, the 60th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD).

HBIG did not statistically significantly improve graft or patient survival relative to all other patients, but there was a trend towards a reduction in risk, noted Michael R. Marvin, MD, University of Louisville, Louisville, Kentucky, reporting the findings here on October 31.

At the 2009 American Transplant Congress last spring, Dr. Marvin and colleagues presented results of a multivariate study demonstrating that patients treated with HBIG for prophylaxis of de novo hepatitis had increased patient and graft survival when HBIG was used, compared with lamivudine.

To follow up this result, they screened the United Network for Organ Sharing (UNOS) Standard Transplant Analysis and Research (STAR) registry data for all liver transplant recipients who received either HBIG, lamivudine, both, or neither treatment. The group determined 2 cohorts of patients for this study: (1) a group of patients coinfected with hepatitis B surface antigen (HBSAg)(+)/hepatitis C (HepC) versus patients with hepatitis C alone; and (2) the entire UNOS database regardless of indication for HBIG therapy.

Differences in patient/graft survival between groups were adjusted for significant covariates using multivariable Cox models.

In the coinfected cohort, 797 transplant patients were examined. In all, 101 of these patients received HBIG alone, 15 patients received lamivudine alone, 19 received both treatments, 304 received neither treatment, and 358 had missing information. Among the 22,341 patients known to be HBSAg(-) but HepC(+), 236 received HBIG alone, 124 received lamivudine alone, 67 received both, 12,559 received neither, and the rest had missing information.

HBIG did not statistically significantly improve graft or patient survival relative to all other patients, but there was a trend towards a reduction in risk (graft, P = .26; patient, P = .065). Graft failure for the lamivudine-only patients relative to the "neither therapy" group was the worst (hazard ratio = 1.5; 95% confidence interval, 1.08-2.07; P = .015). HBIG conferred an approximately 40% reduction in the risk of graft failure (P = .01) and patient death (P = .018) relative to lamivudine-only treatment.

In the cohort comprising the entire UNOS database, 90,867 transplant recipients were examined. In all, 1,604 received HBIG alone, 265 received lamivudine alone, 280 received both treatments, 36,986 received neither treatment, and 51,732 had missing information. There were significant differences in adjusted patient and graft survival with the HBIG-only group, which exhibited improved graft and patient survival over the lamivudine-only group (P = .003 and P = .0003, respectively). Survival of the combination-therapy group was in the middle, between the lamivudine and the HBIG-only groups.

The UNOS registry data suggest that HBIG therapy is associated with improved graft/patient survival versus lamivudine, independently of de novo hepatitis B reduction in liver transplant recipients.

"The mechanism by which HBIG offers this survival advantage is not clear, and warrants further study," the authors noted.

[Presentation title: HBIG May Improve Graft and Patient Survival After Liver Transplantation. Abstract 521]

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