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Prophylaxis against de novo hepatitis B for liver transplantation utilizing hep B core (+) donors: does hepatitis B immunoglobulin provide a survival advantage?

ABSTRACT: Donor liver allografts with positive serology for hepatitis B core antibody [HBc (+)] have been increasingly used for liver transplantation. However, the optimal prophylactic regimen to prevent development of de novo hepatitis B has not been determined. To evaluate this, we screened United Network for Organ Sharing (UNOS) Standard Transplant Analysis and Research (STAR) registry data for adult recipients of HBc (+) organs who were HBsAg (-), and evaluated the effects of using prophylactic anti-viral therapies (HBIG and lamivudine) on patient and graft survival. Out of a total cohort of 958 patients transplanted since 2004, 61 received HBIG alone, 116 received lamivudine alone, 66 both, 509 neither and 206 were missing this information. Based on several multivariable Cox regression models, patients receiving HBIG therapy-only were observed to have a statistically significant (approximately 70%) reduction in risk of mortality compared with patients receiving lamivudine-only therapy [HR=0.29, 95% CI (0.10, 0.86), P=0.026], and a nonstatistically significant reduction in risk of graft failure. However, no graft failures were attributed to de novo hepatitis B, suggesting that any improved graft/patient survival possibly associated with HBIG therapy occurs independently of de novo hepatitis B virus (HBV) reduction. While this study cannot prove that HBIG therapy is protective for graft and patient survival after liver transplantation, these findings do highlight the need to further examine and study prophylactic use in recipients of HBc (+) donors.

SUBMITTER: Brock GN

PROVIDER: S-EPMC3086971 | biostudies-literature | 2011 Jun

REPOSITORIES: biostudies-literature

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Prophylaxis against de novo hepatitis B for liver transplantation utilizing hep B core (+) donors: does hepatitis B immunoglobulin provide a survival advantage?

Brock Guy N GN Mostajabi Farida F Ferguson Nicole N Carrubba Christopher J CJ Eng Mary M Buell Joseph F JF Marvin Michael R MR

Transplant international : official journal of the European Society for Organ Transplantation 20110315 6

Donor liver allografts with positive serology for hepatitis B core antibody [HBc (+)] have been increasingly used for liver transplantation. However, the optimal prophylactic regimen to prevent development of de novo hepatitis B has not been determined. To evaluate this, we screened United Network for Organ Sharing (UNOS) Standard Transplant Analysis and Research (STAR) registry data for adult recipients of HBc (+) organs who were HBsAg (-), and evaluated the effects of using prophylactic anti-v ...[more]

PMID: 21401727

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Project description:BackgroundDonors positive for hepatitis B core antibody (HBcAb) are an important source of organs in hepatitis B virus (HBV) endemic areas despite the risk of occult infection. We analyzed the long-term outcomes of hepatitis B immunoglobulin in de novo HBV prevention following liver transplantation (LT) using HBcAb-positive grafts.MethodsThe prospectively collected data from 2,201 recipients at Seoul National University Hospital (SNUH) and Seoul National University Boramae Medical Center between 1988 and 2018 were retrospectively reviewed. A total of 1,458 patients were enrolled. Of the 1,458, 478 (32.8%) grafts were core-positive, 152 (10.4%) of which belonged to HBV surface antigen-negative recipients. During the anhepatic phase, hepatitis B immunoglobulin 4,000 IU was administered intravenously and daily until postoperative day 3.ResultsThe 152 patients with hepatitis B surface antigen-negative received HBcAb-positive graft. De novo HBV developed in 21 (13.8%) of these recipients. De novo HBV occurred in 1, 11, 0, and 9 of the 4 HBcAb- and hepatitis b surface antibody (anti-HB)-negative, 49 HBcAb-negative and anti-HB-positive, 1 HBcAb-positive and anti-HB-negative, and 98 HBcAb- and anti-HB-positive recipients, respectively. Patients with higher Model for End-stage Liver Disease (MELD) score (23.8±8.7 vs. 19.5±9.2) or HBcAb-negative recipients (22.6% vs. 9.1%) had a higher risk of de novo infection. The median follow-up and serum HBV surface antigen-positivity detection time was 69 and 18 months, respectively. The median HBV surface antibody titer was 65.0 IU/L at de novo infection. Nineteen patients of 21 were treated with nucleoside analogs (NAs), and seven of 19 achieved seroconversion. No patient died of de novo HBV infection.ConclusionsWith close monitoring of viral serum markers and appropriate initiation of NAs, de novo HBV infection can be prevented and treated appropriately with the hepatitis B immunoglobulin monoprophylaxis protocol.

Project description:INTRODUCTION:The first World Health Organization (WHO) global health sector strategy on hepatitis B and C viruses (HBV and HCV) has called for the elimination of viral hepatitis as a major public health threat by 2030. This study assesses policies and programmes in support of elimination efforts as reported by patient groups in Europe. METHODS:In 2016 and 2017, hepatitis patient groups in 25 European countries participated in a cross-sectional survey about their countries' policy responses to HBV and HCV. The English-language survey addressed overall national response; public awareness/engagement; disease monitoring; prevention; testing/diagnosis; clinical assessment; and treatment. We performed a descriptive analysis of data and compared 2016 and 2017 findings. RESULTS:In 2017, 72% and 52% of the 25 European study countries were reported to not have national HBV and HCV strategies respectively. The number of respondents indicating that their governments collaborated with civil society on viral hepatitis control increased from 13 in 2016 to 18 in 2017. In both 2016 and 2017, patient groups reported that 9 countries (36%) have disease registers for HBV and 11 (44%) have disease registers for HCV. The number of countries reported to have needle and syringe exchange programmes available in all parts of the country dropped from 10 (40%) in 2016 to 8 in 2017 (32%). In both 2016 and 2017, patient groups in 5 countries (20%) reported that HCV treatment is available in non-hospital settings. From 2016 to 2017, the reported number of countries with no restrictions on access to direct-acting antivirals for HCV increased from 3 (12%) to 7 (28%), and 5 fewer countries were reported to refuse treatment to people who are currently injecting drugs. CONCLUSIONS:The patient-led Hep-CORE study offers a unique perspective on the readiness of study countries to undertake comprehensive viral hepatitis elimination efforts. Viral hepatitis monitoring should be expanded to address policy issues more comprehensively and to incorporate civil society perspectives, as is the case with global HIV monitoring. Policy components should also be explicitly added to the WHO framework for monitoring country-level progress against viral hepatitis.

Project description:Background:Given the high mortality rate for patients with end-stage kidney disease receiving dialysis and the efficacy and safety of hepatitis C virus (HCV) treatments, discarded kidneys from HCV-infected donors may be a neglected public health resource. Objective:To determine the tolerability and feasibility of using direct-acting antivirals (DAAs) as prophylaxis before and after kidney transplantation from HCV-infected donors to non-HCV-infected recipients (that is, HCV D+/R- transplantation). Design:Open-label nonrandomized trial. (ClinicalTrials.gov: NCT02781649). Setting:Single center. Participants:10 HCV D+/R- kidney transplant candidates older than 50 years with no available living donors. Intervention:Transplantation of kidneys from deceased donors aged 13 to 50 years with positive HCV RNA and HCV antibody test results. All recipients received a dose of grazoprevir (GZR), 100 mg, and elbasvir (EBR), 50 mg, immediately before transplantation. Recipients of kidneys from donors with genotype 1 infection continued receiving GZR-EBR for 12 weeks after transplantation; those receiving organs from donors with genotype 2 or 3 infection had sofosbuvir, 400 mg, added to GZR-EBR for 12 weeks of triple therapy. Measurements:The primary safety outcome was the incidence of adverse events related to GZR-EBR treatment. The primary efficacy outcome was the proportion of recipients with an HCV RNA level below the lower limit of quantification 12 weeks after prophylaxis. Results:Among 10 HCV D+/R- transplant recipients, no treatment-related adverse events occurred, and HCV RNA was not detected in any recipient 12 weeks after treatment. Limitation:Nonrandomized study design and a small number of patients. Conclusion:Pre- and posttransplantation HCV treatment was safe and prevented chronic HCV infection in HCV D+/R- kidney transplant recipients. If confirmed in larger studies, this strategy should markedly expand organ options and reduce mortality for kidney transplant candidates without HCV infection. Primary Funding Source:Merck Sharp & Dohme.

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Prophylaxis against de novo hepatitis B for liver transplantation utilizing hep B core (+) donors: does hepatitis B immunoglobulin provide a survival advantage?

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Prophylaxis against de novo hepatitis B for liver transplantation utilizing hep B core (+) donors: does hepatitis B immunoglobulin provide a survival advantage?

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