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Aim: Reactivation of hepatitis B virus (HBV) after liver transplantation (LT) remains a problem; thus, development of more effective HBV reactivation prophylaxis is desirable. We evaluated the efficacy of a combination of a long‐term nucleotide analog (NA), such as entecavir (ETV) or tenofovir alafenamide (TAF), and short‐term hepatitis B immunoglobulin (HBIG) in preventing HBV reactivation and compared it with conventional HBV prophylaxis. Methods: Between February 1999 and August 2023, 135 patients underwent living‐donor liver transplantation for liver cirrhosis or acute liver failure caused by HBV infection or received an LT from a hepatitis B core antibody‐positive donor. Recipients who had undergone LT were classified as being in the first or second era (namely until September 2017 and from October 2017), respectively, and outcomes of prophylaxis against HBV reactivation were compared between the two eras. Results: In the second era, recipients with HBV‐related disease or who had received hepatitis B core antibody‐positive liver received combination therapy with short‐term HBIG and an NA such as TAF and ETV long‐term. The duration of HBIG treatment was markedly shorter than in the first era in both categories of patients and HBIG could be discontinued in all cases. Surprisingly, we observed HBV reactivation in the first era, but not in the second era, in both groups. Conclusions: We have established a protocol for prophylaxis against HBV reactivation using a combination of short‐term HBIG and long‐term NA. This protocol was found to be sufficient to prevent HBV reactivation after LT. [ABSTRACT FROM AUTHOR]

Objective To investigate the long-term safety and effectiveness of withdrawal of hepatitis B immuneglobulin (HBIG) and/or nucleos(t)ide analogues (NAs) to prevent hepatitis B virus (HBV) reinfection in liver transplant recipients with hepatitis B-related diseases after successful vaccination. Methods Baseline data of 76 liver transplant recipients undergoing hepatitis B immune reconstitution after receiving hepatitis B vaccines were retrospectively analyzed. The vaccination and response, the follow-up results of respondents with HBIG and/or NAs withdrawal, and the reinfection of HBV after withdrawal of HBIG and/or NAs were analyzed. Results The time interval from liver transplantation to hepatitis B vaccination was 26 (20, 40) months. The time interval from vaccination to response was 15 (8,27) months. Initially, 76 recipients withdrew HBIG, and 36 recipients withdrew HBIG and NAs. During the follow-up, 12 of 76 recipients who withdrew HBIG resumed use of HBIG, and 16 of 36 recipients who withdrew HBIG and NAs resumed use of NAs. The withdrawal time of HBIG and NAs was 135 (98,150) and 133 (34,149) months, respectively. Sixteen respondents did not receive booster, and 36 respondents received boosters on a regular basis. The time interval between the first booster and HBIG withdrawal was 44 (11,87) months. No significant differences were observed in baseline data between the respondents with and without boosters (all P>0.05). During the follow-up, 9 recipients were lost to follow-up, 5 were re-infected with HBV, 3 died, and 1 recipient developed graft loss and underwent secondary liver transplantation. Among 5 recipients re-infected with HBV, 4 cases had virus mutation. Significant differences were found between re-infected and uninfected patients regarding withdrawal of NAs and hepatitis B e antigen (HBeAg) positive before transplantation (both P<0.05). Conclusions Long-term withdrawal of HBIG is feasible and safe for recipients with successful hepatitis B immune reconstitution after liver transplantation for hepatitis B-related diseases. Nevertheless, whether antiviral drugs can be simultaneously withdrawn remains to be validated. [ABSTRACT FROM AUTHOR]

Background : The utility of hepatitis B immunoglobulin (HBIg) in hepatitis D virus (HDV)-reactivation prophylaxis remains contentious. This study compared liver transplant (LT) patients based on whether they received perioperative HBIg to assess its protective effect against HDV reactivation. Methods : Fifty-seven recipients with hepatitis B virus (HBV) and HBV/HDV, who were at least 1 year posttransplantation as of January 1, 2021, were enrolled in this single-center study. Tests for hepatitis B surface antigen (HBsAg), anti-HDV antibody, and quantitative reverse transcription polymerase chain reaction for HBV DNA and HDV RNA were performed. Interviews were conducted to assess compliance with the nucleos(t) ide analogue (NA) regimen and to document preoperative HBV/HDV status. Liver function tests were also carried out. The nonparametric Mann-Whitney U-test was utilized to determine statistical significance, with P

Recommended post-liver transplant (LT) prophylaxis in patients with hepatitis delta includes a nucleos(t)ide analogue (NA) and anti-hepatitis B immunoglobulin (HBIG) indefinitely. We analysed the use of HBIG in real-life clinical practice and its impact on HBV/HDV recurrence in 174 HDV-related LT patients from 10 Spanish liver transplant centres (1988--2018). Median post-LT follow-up was 7.8 (2.3--15.1) years and patient survival at 5 years was 90%. Most patients (97%) received HBIG in the immediate post-LT, but only 42% were on HBIG at the last control. Among those discontinuing HBIG, the median time on treatment was 18 (7--52) months. Post-LT HBsAg+ was detected in 16 (9%) patients and HBV-DNA in 12 (7%). Despite HBsAg positivity, HDV recurrence was reported only in three patients (1.7%), all of whom were not receiving NA and had discontinued HBIG. Our data suggest that a finite HBIG prophylaxis in HDV-LT is feasible, especially if high-barrier NAs are used. [ABSTRACT FROM AUTHOR]

Introduction: Taye and colleagues reported that the rate of mother-to-child transmission (MTCT) of hepatitis B virus (HBV) was as high as 20.7% in Ethiopia based on their meta-analysis of three studies [1]. However, numerous studies demonstrate that the overall rate of MTCT is below 5% after timely neonatal administration of hepatitis B immunoglobulin (HBIG) and hepatitis B vaccine after birth. Concerns: The reports on which the meta-analysis was conducted appear to be problematic. The infants of HBV-infected mothers were not vaccinated against HBV at all, in one report. In another report, MTCT was defined based on positive hepatitis B surface antigen (HBsAg) in the umbilical cord blood, which is not correct because vast majority (> 95%) of positive HBsAg in umbilical cord blood is not infected with, but exposed to, HBV. Thus, MTCT of HBV calculated to be as high as 20.7% in this meta-analysis was overestimated, and much higher than the reported rate of 1-3% immunoprophylaxis failure in other parts of the world, including in Africa. Conclusions: The rate of MTCT of HBV in Ethiopia in this meta-analysis was overestimated. High-quality investigations are required to understand the real picture of immunoprophylaxis against MTCT of HBV in Ethiopia. [ABSTRACT FROM AUTHOR]

Background: The extent to which maternal antibodies against the hepatitis B surface antigen (HBsAb) acquired transplacentally affect the immune responses to the hepatitis B vaccine (HBVac) in infants is still uncertain.Objective: To explore the impact of the HBsAb on the immune response to the HBVac in a mouse model.Methods: According to the doses of the HBVac (2, 5 μg) injected, 267 BALB/c mice were divided into two groups. Each group was subdivided into 3 subgroups based on the doses of the hepatitis B immunoglobulin (HBIG) (0, 25, 50 IU) administered. The HBsAb titers were detected 4 weeks after completing the HepB vaccination. Results: Among all the mice, 40 had an HBsAb titer

Hepatitis B virus (HBV) infection is a major public health burden. In HBV endemic regions, high prevalence is also correlated with the infections acquired in infancy through perinatal transmission or early childhood exposure to HBV, the so-called mother-to-child transmission (MTCT). Children who are infected with HBV at a young age are at higher risk of developing chronic HBV infection than those infected as adults, which may lead to worse clinical outcome. To reduce the incidence of HBV MTCT, several interventions for the infants or the mothers, or both, are already carried out. This review explores the newest information and approaches available in literature regarding HBV MTCT prevalence and its challenges, especially in high HBV endemic countries. This covers HBV screening in pregnant women, prenatal intervention, infant immunoprophylaxis, and post-vaccination serological testing for children., Competing Interests: Conflict-of-interest statement: Authors declare no conflict-of-interest., (©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.)

Introduction: Taye and colleagues reported that the rate of mother-to-child transmission (MTCT) of hepatitis B virus (HBV) was as high as 20.7% in Ethiopia based on their meta-analysis of three studies [1]. However, numerous studies demonstrate that the overall rate of MTCT is below 5% after timely neonatal administration of hepatitis B immunoglobulin (HBIG) and hepatitis B vaccine after birth., Concerns: The reports on which the meta-analysis was conducted appear to be problematic. The infants of HBV-infected mothers were not vaccinated against HBV at all, in one report. In another report, MTCT was defined based on positive hepatitis B surface antigen (HBsAg) in the umbilical cord blood, which is not correct because vast majority (> 95%) of positive HBsAg in umbilical cord blood is not infected with, but exposed to, HBV. Thus, MTCT of HBV calculated to be as high as 20.7% in this meta-analysis was overestimated, and much higher than the reported rate of 1-3% immunoprophylaxis failure in other parts of the world, including in Africa., Conclusions: The rate of MTCT of HBV in Ethiopia in this meta-analysis was overestimated. High-quality investigations are required to understand the real picture of immunoprophylaxis against MTCT of HBV in Ethiopia., Competing Interests: No Conflict of Interest is declared, (Copyright (c) 2024 Jie Tang, Hong Zhao.)

Background/Aims Hepatitis B core antibody (anti-HBc)-positive donors are used as an extended donor pool, and current guidelines recommend the usage of nucleos(t)ide analogues (NAs) as prophylaxis for preventing de novo hepatitis B virus infection (DNH). We analyzed the long-term outcomes of a large cohort of liver transplantation (LT) patients receiving anti-HBc-positive grafts and evaluated the risk of DNH when hepatitis B immunoglobulin (HBIG) monotherapy was used as prophylaxis. We also compared the cost-effectiveness of HBIG and NAs. Methods We retrospectively reviewed 457 patients with anti-HBc-positive grafts and 898 patients with anti-HBc-negative grafts who underwent LT between January 2001 and December 2018. We compared recipient characteristics according to the anti-HBc status of the donor, and compared the costs of using NAs for the rest of the patient’s life and using HBIG to maintain hepatitis B surface antibody titers above 200 IU/L. Results The 1-, 5-, and 10-year patient survival rates were 87.7%, 73.5%, and 67.7%, respectively, in patients with anti-HBc-positive grafts, and 88.5%, 77.4%, and 70.3%, respectively, in patients with anti-HBc-negative grafts (P=0.113). Among 457 recipients with anti-HBc-positive grafts, 117 (25.6%) were non-HBV recipients. The overall incidence of DNH was 0.9%. When using HBIG under insurance coverage, the cumulative cost was lower compared with using NA continuously without insurance coverage in Korea. Conclusions Anti-HBc-positive grafts alone do not affect patient survival or graft survival. HBIG monoprophylaxis has good outcomes for preventing DNH, and the patient’s long-term cost burden is low in Korea because of the national insurance system in this cohort.

Background: Vertical mother-to-child transmission (MTCT) of the hepatitis B virus (HBV) remains an important issue. Timely administration of hepatitis B immunoglobulin (HBIG) and of the HBV vaccine is effective in preventing MTCT in infants born to HBV-infected mothers. However, HBIG is often not easily available in low-income countries or regions. Methods: We compared in a retrospective cohort study the HBV vaccine efficacy alone and in combination with HBIG in preventing vertical MTCT in infants born to HBeAg-negative carrier mothers in Jiangsu province, China. Based on the administration of the HBV vaccine and HBIG shortly after birth, children were divided into two groups: Group 1, administration of the HBV vaccine alone, and Group 2, concurrent use of HBIG and of the HBV vaccine. Results: A total of 620 infants born to HBeAg-negative carrier mothers were enrolled into this study. Group 1 included 195 children who had received the HBV vaccine alone after birth, and Group 2, 425 children who had received both HBIG and the HBV vaccine. Children were followed up to the age of 68 and 42 months, respectively. MTCT of HBV occurred in 0% (0/195) in Group 1 (HBV vaccine alone) and 0% (0/425) in Group 2 (HBV vaccine and HBIG) (p = 1.00). Conclusion: In this retrospective cohort study, we found that HBV vaccination alone shortly after birth was effective in preventing MTCT of HBV in infants born to HBeAg-negative carrier mothers.

The mother-to-child transmission of hepatitis B virus (HVB), frequent in endemic countries, accounts for about 40-50% of chronic HBV infections worldwide. Therefore, blocking the transmission is a significant step toward eliminating hepatitis B. The study presented a case of a successfully prophylactic baby girl born to a mother with chronic HBV infection diagnosed during pregnancy. She was prescribed antiviral therapy in the last trimester. The child was followed-up by the authors, proving her protection against HBV. In addition, we collected epidemiological data from family household contacts. The results revealed the source of the infection - the grandmother of the baby with chronic HBV infection. [ABSTRACT FROM AUTHOR]

Background: Hepatitis B immunoglobulin (HBIG) in combination with a potent nucleos(t)ide analog is considered the standard of care for prophylaxis against hepatitis B virus (HBV) reinfection after liver transplantation for HBV-associated disease., Aim: To evaluate patients' satisfaction, preferences, and requirements for subcutaneous (SC), intramuscular (IM), and intravenous (IV) HBIG treatments., Methods: A self-completion, cross-sectional, online, 22-question survey was conducted to examine perceptions and satisfaction with current HBIG treatment in adults receiving HBIG treatment following liver transplantation for HBV-associated disease in France, Italy, and Turkey. Hypothetical HBIG products with different administration modes were evaluated using target product profile assessment and a conjoint (trade-off) exercise., Results: Ninety patients were enrolled; 32%, 17%, and 51% were SC, IM, and IV HBIG users, respectively. Mean duration of treatment was 36.2 months. SC HBIG had the least negative impact on emotional well-being and social life and was perceived as the most convenient, easiest to administer, least painful, and had the highest self-rating of treatment compliance. More IM HBIG users than SC or IV HBIG users reported that administration frequency was excessive (67%, 28%, and 28%, respectively). In the target product profile assessment, 76% of patients were likely to use hypothetical SC HBIG. In the conjoint exercise, administration route, frequency, and duration were key drivers of treatment preferences., Conclusion: Ease, frequency, duration, and side effects of HBIG treatment administration were key drivers of treatment preferences, and SC HBIG appeared advantageous over IM and IV HBIG for administration ease, convenience, and pain. A hypothetical SC HBIG product elicited a favorable response. Patient demographics, personal preferences, and satisfaction with HBIG treatment modalities may influence long-term treatment compliance., Competing Interests: Conflict-of-interest statement: Glynou K is an employee of Biotest AG. Eletskaya M is an employee of Lumanity (previously Cello Health Insight); the study was conducted under a contract with Biotest AG. Rizza G received consulting fees under a contract with Biotest AG. The authors have no non-financial competing interests to declare., (©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.)

Aim: Reactivation of hepatitis B virus (HBV) after liver transplantation (LT) remains a problem; thus, development of more effective HBV reactivation prophylaxis is desirable. We evaluated the efficacy of a combination of a long-term nucleotide analog (NA), such as entecavir (ETV) or tenofovir alafenamide (TAF), and short-term hepatitis B immunoglobulin (HBIG) in preventing HBV reactivation and compared it with conventional HBV prophylaxis., Methods: Between February 1999 and August 2023, 135 patients underwent living-donor liver transplantation for liver cirrhosis or acute liver failure caused by HBV infection or received an LT from a hepatitis B core antibody-positive donor. Recipients who had undergone LT were classified as being in the first or second era (namely until September 2017 and from October 2017), respectively, and outcomes of prophylaxis against HBV reactivation were compared between the two eras., Results: In the second era, recipients with HBV-related disease or who had received hepatitis B core antibody-positive liver received combination therapy with short-term HBIG and an NA such as TAF and ETV long-term. The duration of HBIG treatment was markedly shorter than in the first era in both categories of patients and HBIG could be discontinued in all cases. Surprisingly, we observed HBV reactivation in the first era, but not in the second era, in both groups., Conclusions: We have established a protocol for prophylaxis against HBV reactivation using a combination of short-term HBIG and long-term NA. This protocol was found to be sufficient to prevent HBV reactivation after LT., (© 2024 Japan Society of Hepatology.)

The advance in treatment against hepatitis B virus (HBV) infection with the development of nucleos(t)ide analogues (NAs) with high genetic barrier to resistance, including entecavir and tenofovir, has improved clinical outcomes of patients transplanted for HBV infection, by preventing HBV recurrence after liver transplantation (LT) effectively. Currently, after LT, the combination of hepatitis B immunoglobulin (HBIG) and a high‐barrier NA is considered as the standard of care for prophylaxis against HBV recurrence. However, because of the high cost of intravenous high‐dose HBIG, other routes of HBIG administration, such as intramuscular or subcutaneous, have come to the foreground. In addition, several transplant centres tend to use a NA as monoprophylaxis, following a short post‐LT period of HBIG and NA combination. Lately, studies using HBIG‐free prophylactic regimens with entecavir or tenofovir have shown promising outcomes in preventing HBV recurrence, mostly regarding patients with undetectable HBV DNA at the time of LT. Although vaccination against HBV has been an attractive prophylactic approach, its efficacy has been controversial. Moreover, further studies are needed regarding long‐term outcomes of complete withdrawal anti‐HBV prophylaxis. For patients transplanted for HBV/HDV co‐infection, combined regimen should be administered for a longer period post‐LT. Finally, the use of grafts from hepatitis B core antibody‐positive donors is safe for HBV‐negative recipients, with the administration of lifelong antiviral prophylaxis. [ABSTRACT FROM AUTHOR]

Objectives: China has implemented universal hepatitis B vaccination since 2002 and provided charge-free hepatitis B immunoglobulin (HBIG) to infants of HBV-infected mothers since July 2011. We aimed to compare mother-to-child transmission (MTCT) in children born before and since July 2011. Methods: In total, 5,149 children of HBV-infected mothers were tested for HBV markers. Group one contained 1,160 children born during August 2002–June 2011 and group two contained 3,989 children born during July 2011–June 2016. Results: In total, 92 (1.8%, 95% confidence interval [95%CI] 1.4–2.2) children were infected with HBV. None (0%, 95%CI 0.0–0.1) of 3,716 children of mothers with negative hepatitis B e antigen (HBeAg) was infected, whereas 92 (6.4%, 95%CI 5.2–7.8) of 1,433 children of HBeAg-positive mothers were infected (p < 0.0001). Among children of HBeAg-positive mothers, MTCT occurred in 10.3% (19/185) (95%CI 6.3–15.6) in group one and 5.8% (73/1,248) (95%CI 4.6–7.3) in group two (p = 0.02). Conclusions: Implementing charge-free active-passive immunoprophylaxis greatly reduces MTCT of HBV in children of HBeAg-positive mothers, highlighting the importance of timely administration of both hepatitis B vaccine and HBIG to prevent MTCT. The still remaining MTCT suggests that reducing maternal virus load before delivery is an additional important measure. [ABSTRACT FROM AUTHOR]

Background: In endemic areas, vertical transmission of hepatitis B virus (HBV) remains a major source of the global reservoir of infected people. Eliminating mother-to-child transmission (MTCT) of HBV is at the heart of World Health Organization's goal of reducing the incidence of HBV in children to less than 0.1% by 2030. Universal screening for hepatitis B during pregnancy and neonatal vaccination are the main preventive measures., Aim: To evaluate the efficacy of HBV vaccination combined with one dose of immunoglobulin in children born to hepatitis B surface antigen (HBsAg)-positive mothers in Djibouti city., Methods: We conducted a study in a prospective cohort of HBsAg-positive pregnant women and their infants. The study ran from January 2021 to May 2022, and infants were followed up to 7 mo of age. HBV serological markers and viral load in pregnant women were measured using aVidas microparticle enzyme-linked immunosorbent assay (Biomérieux, Paris, France) and the automated Amplix platform (Biosynex, Strasbourg, France). All infants received hepatitis B immunoglobulin and were vaccinated against HBV at birth. These infants were closely monitored to assess their seroprotective response and for failure of immunoprophylaxis. Simple logistic regression was also used to identify risk factors associated with immunoprophylaxis failure and poor vaccine response. All statistical analyses were performed with version 4.0.1 of the R software., Results: Of the 50 pregnant women recruited, the median age was 31 years, ranging from 18 years to 41 years. The MTCT rate in this cohort was 4% (2/50) in HBsAg-positive women and 67% (2/3) in hepatitis B e antigen-positive women with a viral load > 200000 IU/mL. Of the 48 infants who did not fail immunoprophylaxis, 8 (16%) became poor responders (anti-HB < 100 mIU/mL) after HBV vaccination and hepatitis B immunoglobulin, while 40 (84%) infants achieved a good level of seroprotection (anti-HB > 100 mIU/mL). Factors associated with this failure of immunoprophylaxis were maternal HBV DNA levels (> 200000 IU/mL) and hepatitis B e antigen-positive status (odds ratio = 158, 95% confidence interval: 5.05-4958, P < 0.01). Birth weight < 2500 g was associated with a poor immune response to vaccination (odds ratio = 34, 95% confidence interval: 3.01-383.86, P < 0.01)., Conclusion: Despite a failure rate of immunoprophylaxis higher than the World Health Organization target, this study showed that the combination of immunoglobulin and HBV vaccine was effective in preventing MTCT of HBV. Therefore, further studies are needed to better understand the challenges associated with immunoprophylaxis failure in infants in Djibouti city., Competing Interests: Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article., (©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.)

Background: The utility of hepatitis B immunoglobulin (HBIg) in hepatitis D virus (HDV)-reactivation prophylaxis remains contentious. This study compared liver transplant (LT) patients based on whether they received perioperative HBIg to assess its protective effect against HDV reactivation., Methods: Fifty-seven recipients with hepatitis B virus (HBV) and HBV/HDV, who were at least 1 year posttransplantation as of January 1, 2021, were enrolled in this single-center study. Tests for hepatitis B surface antigen (HBsAg), anti-HDV antibody, and quantitative reverse transcription polymerase chain reaction for HBV DNA and HDV RNA were performed. Interviews were conducted to assess compliance with the nucleos(t) ide analogue (NA) regimen and to document preoperative HBV/HDV status. Liver function tests were also carried out. The nonparametric Mann-Whitney U-test was utilized to determine statistical significance, with P<0.05 considered significant. Data analysis was conducted using GraphPad Prism software., Results: The prevalence of HDV RNA, HBV DNA, HBsAg, and anti-HDV positivity in the HBIg group (n=23) was 4.3% (n=1), 17.4% (n=4), 8.7% (n=2), and 95.7% (n=22), respectively. In the non-HBIg group (n=34), these rates were 5.9% (n=2), 8.8% (n=3), 11.8% (n=4), and 97.1% (n=33), respectively. Interviews revealed that all reactivations occurred in patients who were noncompliant with their NA regimen. Eleven of the 13 patients initially reported to be monoinfected with HBV pretransplantation were anti-HDV-positive., Conclusions: No HDV replication occurred in either group due to spontaneous reactivation. High-efficacy NAs appear to be effective in sustaining HDV suppression post-LT. Most recrudescent cases of chronic hepatitis D are mild and self-limiting, typically resolving after 1-2 years of replication, as evidenced by liver function tests.

Background: The safety and necessity of hepatitis B immunoglobulin (HBIG) in preventing the mother‐to‐child transmission of hepatitis B virus (HBV) are still controversial because of its unclear mechanism of action and the inconsistent injection programs used during gestation. Objectives: This study aimed to show the dynamic transportation and distribution of HBIG in the maternal body and to provide evidence for its clinical efficacy in preventing mother‐to‐child HBV transmission. Study design: Pregnant mice were injected with Cy7‐labeled mouse anti‐human monoclonal hepatitis B surface antibodies through the tail vein. In vivo imaging technology was used to observe the dynamic transportation and distribution of HBIG in the pregnant mice. Results: HBIG fluorescence signals were higher in the uterus than in the liver, spleen, and kidneys. Fluorescence signals in the uterine region were obviously higher at the third trimester than at early and mid pregnancy. Conclusions: HBIG is gradually deposited in the mouse placenta during pregnancy, with the phenomenon being more significant in the third trimester. Highlight: Study of the distribution of hepatitis B immunoglobulin. [ABSTRACT FROM AUTHOR]

The aim of this study was to investigate the efficacy of antepartum administration of three doses of hepatitis B immunoglobulin (HBIG) in interrupting mother‐to‐child transmission (MTCT) of hepatitis B virus (HBV). In this trial, a total of 728 HBeAg‐positive pregnant women with chronic HBV infection who had an HBV DNA level higher than 6log10 copies/mL were enrolled. They were divided into three groups based on individual preference. Subjects in group A and group B received 200 IU (unit) HBIG and 400 IU (unit) HBIG intramuscularly once a month at the third, second and first month before delivery, respectively. Subjects in the control group (C) received no special treatment. All the infants received passive‐active immunoprophylaxis. The HBsAg‐positive rate of all infants at 7‐12 months of age was 5.1% (37/728). Specifically, the HBsAg‐positive rate of infants was comparable in all three groups (5.3% vs 5.1% vs 5%, P = 0.988). No significant difference was found in anti‐HBs levels between the infants aged 7‐12 months in the three groups (P = 0.469). HBV DNA levels of the umbilical cord blood in the HBV‐infected group were higher than those in the uninfected group (5.2 vs 3.4log10 copies/mL, P < 0.001), and these with family history of HBV infection were also higher (45.9% vs 28.5%, P = 0.034). To conclude, administration of passive‐active immunoprophylaxis to infants contributed to effective prevention of the MTCT of HBV; extra antepartum administration of HBIG during pregnancy could not decrease the rate of MTCT or increase the anti‐HBs levels of infants born to HBsAg‐positive mothers with HBV DNA higher than 6log10 copies/mL. [ABSTRACT FROM AUTHOR]

Background/aim: In this study, the efficiency of using low-dose hepatitis B immunoglobulin (HBIG) plus antiviral treatment according to individual needs has been evaluated in posttransplant hepatitis B virus (HBV) patients. Materials and methods: We retrospectively evaluated 179 patients who were admitted between 2009 and 2014. Five thousand IU intravenous HBIG was given in the anhepatic phase, and 400 IU/day intramuscular (IM) HBIG was given in the posttransplant period. After HBsAg seroconversion, 400 IU IM HBIG was continued as prophylaxis every two weeks. Results: The average follow-up period was 26 (2-65) months. Seventy patients had hepatocellular carcinoma (HCC). The HBV recurrence was 4.5% in the first year, and 5.8% in the third year. The HBsAg became negative in 11 (2-63) days, and anti-HBs became positive in 9 (1-31) days. HBsAg positivity occurred in 6 patients during the follow-up period. Five of these patients were those who underwent transplantation due to HCC. In 5 of the HCC patients, in whom HBsAg became positive, tumor recurrence was observed after 0.3-9.9 months. HBsAg positivity was more frequently detected in patients with HCC (P = 0.009). Conclusion: The HBV recurrence should be evaluated as a predictor of the HCC recurrence in patients who were transplanted due to HCC. [ABSTRACT FROM AUTHOR]

Bachground: The combinative regimens using oral nucleos(t)ide analogs (NA) plus either regular or on-demand low dose hepatitis B immunoglobulin (HBIG) have shown significant decrease in recurrence of post-liver transplantation (LT) hepatitis B, leading to considerable cost saving. Most of the protocols aimed to maintain hepatitis B surface antibody (HBsAb) levels above 100 IU/mL. Objective: To demonstrate that the maintenance threshold for HBsAb level could be lowered to 50 IU/mL for hepatitis B virus (HBV) prophylaxis during post-LT. Materials and Methods: The authors conducted a retrospective study of 45 patients that undergone LT for HBV-related diseases between 2003 and 2015. All patients had been followed-up and placed on a post-LT anti-HBV regimen of on-demand low-dose HBIG plus NAs. A fixed dose of 800 U HBIG was given as required to maintain HBsAb levels above 50 IU/mL. HBV recurrence was defined as persistent reappearance of HBsAg. Results: The mean follow-up was 57.8±38.3 months (range 6 months to 12 years), and no patient experienced HBV recurrence during that period. However, two patients experienced a few episodes of non-sustained HBsAg seropositivity without active disease, which indicated an actuarial risk of recurrence of 4.4%. The mean level of HBsAb in each stratified period was well maintained above 50 IU/mL. The estimated cost of HBIG was approximately 50% of the cost for the regular low-dose regimen. Conclusion: The present regimen yielded good result and significant cost reduction. The authors propose the maintenance HBsAb level could be reduced to 50 IU/mL without compromising the clinical outcome. [ABSTRACT FROM AUTHOR]

Background: The most common indication for liver transplantation (LT) in South East Asia is hepatitis B virus (HBV)-related liver disease. Without proper prophylaxis, HBV will recur rapidly after LT. Currently, there is no universally accepted regimen, and most transplant centers use high-dose hepatitis B immunoglobulin (HBIG) for prophylaxis, which is costly. Objective: To review the authors' experience with low-dose short-course HBIG plus antiviral for HBV prophylaxis. Materials and Methods: Between July 2002 and December 2013, 90 patients who were positive for HBV surface antigen (HBsAg) underwent LT at the authors' institute. The protocol included continuing previously prescribed antiviral drug or giving lamivudine 150 mg orally before the operation in patients who had never received antiviral drug. All patients received 1,200 to 2,000 international units (IU) of HBIG intravenously during anhepatic phase, and 1,200 to 1,600 IU of intravenous HBIG daily for six days postoperatively. Oral antiviral drug was continued postoperatively. HBV recurrence was defined as the reappearance of HBsAg in serum. Cumulative incidence function was used to calculated cumulative recurrence rate. Results: At the end of follow-up, the post-transplant HBsAg status was positive in six patients (6.7%); two patients at three months, one patient at one year, two patients at seven years, and one patient at ten years after LT. Cumulative HBV recurrence rate was 2.3% at one year, 3.5% at five years, and 11.3% at ten years after LT. The median time-to-recurrence was 49.5 months. All treatments were well tolerated with no serious adverse event. Conclusion: Combination of low-dose short-course HBIG and long-term oral antiviral drug is effective in preventing HBV recurrence after LT. Since HBIG is very expensive, this low-dose short-course HBIG prophylaxis regimen can reduce the cost of LT without increasing the HBV recurrence rate. [ABSTRACT FROM AUTHOR]

Objective: To observe the recurrence condition of hepatitis B in different risk groups after liver transplantation in an attempt to provide useful information on whether to discontinue hepatitis B immunoglobulin (HBIG) in the future at an early stage. Methods: The patient population was divided into high, low-risk, and special groups [especially primary hepatocellular carcinoma (HCC)] according to the guidelines for the prevention and treatment of hepatitis B recurrence after liver transplantation. The recurrence condition and risk factors in this population were observed for hepatitis B. Measurement data were analyzed using a t -test and a rank-sum test. Count data were compared using a χ (2) test between groups. Results: This study finally included 532 hepatitis B-related liver transplant cases. A total of 35 cases had HBV recurrence after liver transplantation, including 34 cases that were HBsAg positive, one case that was HBsAg negative, and 10 cases that were hepatitis B virus (HBV) DNA positive. The overall HBV recurrence rate was 6.6%. The recurrence rate of HBV was 9.2% and 4.8% in the high- and low-risk HBV DNA positive and negative groups before surgery ( P = 0.057). Among the 293 cases diagnosed with HCC before liver transplantation, 30 had hepatitis B recurrence after surgery, with a recurrence rate of 10.2%. The independent related factors for the recurrence of hepatitis B in patients with HCC after liver transplantation were HCC recurrence ( HR =181.92, 95% CI 15.99~2 069.96, P < 0.001), a high postoperative dose of mycophenolate mofetil dispersible tablets (MMF) ( HR =5.190, 95% CI 1.289~20.889, P = 0.020), and a high dosage of HBIG ( HR = 1.012, 95% CI 1.001~1.023, P = 0.035). Among the 239 cases who were non-HCC before liver transplantation, five cases (recurrence rate of 2.1%) arouse postoperative hepatitis B recurrence. Lamivudine was used in all cases, combined with on-demand HBIG prophylaxis after surgery. There was no hepatitis B recurrence in non-HCC patients who treated with entecavir combined with HBIG after surgery. Conclusion: High-barrier-to-resistance nucleotide analogues combined with long-term HBIG have a good effect on preventing the recurrence of hepatitis B after liver transplantation. The discontinuation of HBIG may be considered at an early stage after administration of a high-barrier-to-resistance nucleotide analogue in low-risk patients. Domestically, the HBV infection rate is high, so further research is still required to explore the timing of HBIG discontinuation for high-risk patients, especially those with HCC.

The article discusses current approaches for prevention of hepatitis B vertical transmission. Guidelines for management of pregnancy in women with chronic hepatitis B, are presented, as well as modern approaches to the choice of delivery methods and the using of antiviral drugs during pregnancy to reduce the risk of vertical transmission. The results of clinical trials and meta-analyses of neonates active-passive immunization applying are discussed.

Prophylactic measures are used to reduce DNHB after HBsAg‐negative patients receive anti‐HBc–positive liver grafts. This study investigated the incidence of DNHB and clinical outcomes in pediatric LT recipients under HBIG prophylaxis, with or without hepatitis B vaccination. Between 1995 and 2013, 51 HBsAg‐negative pediatric recipients underwent living‐donor LT from anti‐HBc–positive donors. The median (range) age was 4 (0.1‐17) years, 23 (45%) were male, and 71% were negative for both anti‐HBc and anti‐HBc. During a median follow‐up of 12.1 (0.06‐19.9) years, 13 (25.4%) developed DNHB; 7 of the 13 achieved HBsAg seroconversion after administration of LAM or ETV. Among studied patients, 20 (39%) received hepatitis B vaccination, and 2 of them (10%) developed DNHB. At last follow‐up, 41% (21/51) discontinued HBIG either after successful HBV vaccination (n = 17) or retransplantation with anti‐HBc–negative grafts (n = 4). In conclusion, pediatric LT recipients of anti‐HBc–positive grafts, most of them were naïve to HBV infection, were at high risk of DNHB, and consistent monitoring for the early detection of DNHB was necessary. A combination use of post‐LT vaccination is promising prophylactic strategy against DNHB. [ABSTRACT FROM AUTHOR]

Background/aims A birth dose of hepatitis B immunoglobulin (HBIG), in combination with hepatitis B vaccine (HepB), is recommended for infants born to hepatitis B surface antigen (HBsAg)-positive mothers. However, the optimal dosage of HBIG remains to be resolved. This prospective cohort study aimed to compare the efficacy of two dosages of HBIG combined with HepB to prevent mother-to-child transmission (MTCT) of HBV. Methods From 2009 to 2011, we prospectively enrolled mother-infant pairs with positive maternal HBsAg in China. Infants were assigned to receive one dose of 100 IU or 200 IU HBIG within 12 h of birth according to maternal numbering, followed by completion of the 3-dose 10 μg HepB series. At 7 months, post-vaccination serologic testing (PVST) was performed in 545 and 632 infants in 100 IU and 200 IU HBIG groups, respectively, among whom, 451 and 529 were followed up to 12 months. Results Maternal and birth characteristics were comparable between infants in 100 IU and 200 IU HBIG groups. At 7 months, the rates of perinatal infection were 1.5% (8/545) and 1.9% (12/632) in 100 IU and 200 IU HBIG groups, respectively ( p  = .568). One non-responder infant in 200 IU HBIG group became newly infected at 12 months. The antibody to hepatitis B surface antigen (anti-HBs) positive rates were 98.5% (529/537) and 98.2% (609/620) in 100 IU and 200 IU HBIG groups at 7 months, respectively ( p  = .704), and the corresponding figures were 98.2% (431/439) and 97.1% (496/511) at 12 months ( p  = .266). The anti-HBs geometric mean concentrations were comparable between two groups at 7 months (707.95 mIU/mL vs. 602.56 mIU/mL, p  = .062) and 12 months (245.47 mIU/mL vs. 229.09 mIU/mL, p  = .407). Conclusions One birth dose of 100 IU HBIG, combined with the HepB series, might be enough for preventing MTCT of HBV in infants born to HBsAg-positive mothers. [ABSTRACT FROM AUTHOR]

Background The prevalence of occult hepatitis B virus ( HBV) infection ( OBI) in children due to mother-to-child transmission ( MTCT) despite immunoprophylaxis remains controversial and is still unknown in Japan. The aim of this study was to determine the OBI prevalence in such children in Japan and identify the genomic mutations that might be associated with the pathogenesis of OBI in children. Methods The data on 158 children born to HBV carrier mothers and who received complete passive-active immunoprophylaxis after birth in 2002-2014 were reviewed. HBV markers were detected using commercial enzyme-linked immunosorbent assay kits. HBV- DNA was detected using real-time and nested polymerase chain reaction. Complete genomic sequences were determined. Results Among the 158 children studied, three had HBV MTCT: two had OBI, and one had resolved HBV infection ( RBI). The prevalence of OBI and RBI was estimated to be 1.3% and 0.6%, respectively. The HBV genomes of the two OBI children were wild type and 100% identical to those of their mothers. Of these two children, one received repeated hepatitis B immunoglobulin ( HBIG) and developed overt HBV infection. Her HBV genome had a G145R mutation in the S gene that might have been induced by HBIG treatment. The RBI child was persistently positive for antibody to HBV core antigen (10-12 signal/cut-off ratio; S/CO). Conclusions A low prevalence of OBI was observed in children who received immunoprophylaxis for preventing MTCT in Japan. The development of overt HBV infection in infants with OBI indicates the necessity of close and long-term monitoring. [ABSTRACT FROM AUTHOR]

This study aimed to establish a second national standard for hepatitis B immunoglobulin (HBIG) that can be used for potency assays of hepatitis B and normal immunoglobulin. The candidate material was manufactured using a process approved as Good Manufacturing Practice. The freeze-dried candidate preparation was tested for physicochemical and biological properties, including pH, residual moisture, molecular size distribution, and potency. A collaborative study was performed involving four laboratories, including the National Institute of Food and Drug Safety Evaluation, as an official national control laboratory in Korea and manufacturers. The potency was calibrated against the second international standard for HBIG using two enzyme immunoassays: enzyme-linked immunosorbent assay and electrochemiluminescence immunoassay. Results from 240 assays were obtained from four laboratories, and combined potency estimates were obtained by calculating the geometric means. Intra- and inter-laboratory variability showed acceptable geometric coefficients of variation of 1.3–6.0 and 3.2–3.6%, respectively. The candidate preparation showed satisfactory stability in accelerated thermal degradation and real-time stability tests. Based on these results, the potency value of 105 IU/vial was assigned (95% confidence intervals: 100.0–109.2 IU/vial), and it was deemed suitable to serve as the Korean national standard for HBIG. • The potency was calibrated against the second international standard for HBIG. • The candidate preparation showed satisfactory stability. • The potency value of 105 IU/vial was assigned. [ABSTRACT FROM AUTHOR]

Recently, the Society of Infectious Diseases of Chinese Medical Association and Chinese GRADE Center jointly released the"2019 Chinese practice guideline for the prevention and treatment of hepatitis B virus mother-to-child transmission". We concerned several issues in the Guideline, including the improper citation of some references, no recommendations for some key strategies for the prevention of hepatitis B virus mother-to-child transmission, insufficient or even lack of evidence for some recommendations and others. Based on the principle of academic contention, we present in this article our comments on the Guideline to discuss these issues with the Guideline’s authors and readers. [ABSTRACT FROM AUTHOR]

Abstract Objective: To develop a guideline for the management of potential exposures to hepatitis B virus (HBV) at The Alfred Hospital, based on results of clinical audit, database analysis and literature review. Methods: i) Retrospective record review of all histories of patients who received HBV immunoglobulin (HBIG) at The Alfred between 1/1/2007 and 30/9/2011. ii) Analysis of HBV serological results of men who have sex with men (MSM) on Victorian NPEP Service (VNPEPS) database between 10/8/2005 and 31/12/2011. iii) Literature review to determine risks of HBV transmission and best practice for prevention of HBV transmission. Results: A total of 48 patients were potentially exposed to HBV and given HBIG, with sexual exposure the most common indication (n=20). The source was reported to be HBsAg positive in one case only. Of the MSM on the VNPEPS database, 63% were immune to HBV, and only 0.5% of patients tested had evidence of chronic HBV infection. The recommendations for use of HBIG in The Australian Immunisation Guidelines are ambiguous and differ from other international guidelines. Conclusion: This audit at a tertiary referral hospital identified problems with the management of those potentially exposed to HBV. In those non‐immune patients exposed to HBV, the combination of HBIG plus vaccination provides the best protection against infection. The risk of transmission of HBV is highly variable; rates of chronic HBV in PWID and MSM in Australia are low and do not warrant use of HBIG unless the source is known to be HBsAg positive.

This Phase-IV study evaluated the human rotavirus (RV) vaccine Rotarix (RIX4414) to provide additional local clinical data to the Taiwan Food and Drug Association (NCT01198769). Healthy infants aged 6–12 weeks who were given a hepatitis B immunoglobulin (HBIg) dose after birth, received two doses of RIX4414 (0, 2-month schedule). Anti-RV IgA antibody concentrations were measured using ELISA. A total of 15 infants were enrolled, and included in the according-to-protocol cohort. The anti-RV IgA antibody seroconversion rate 2 months post-Dose 2 was 100% (95% confidence interval = 78.2–100) and the geometric mean concentration was 254.7 U/ml (95% confidence interval = 145.0–447.7). Two episodes of gastroenteritis were reported, and one stool sample was tested for RV, which was negative. No fatal serious adverse events were reported during the study period between November 2010 and April 2011. The two-dose regimen of RIX4414 was highly immunogenic and safe when administered to healthy Taiwanese infants who received a HBIg dose after birth. Trial registration number: NCT01198769.

Introduction: Health Care Workers (HCWs) are at risk of occupational transmission of HIV, Hepatitis B and Hepatitis C, which can be minimized by following guidelines for standard precautions as well as taking Post Exposure Prophylaxis (PEP) measures. There are limited studies from India documenting details of PEP for HIV and Hepatitis B. Aim: We aimed to study the efficacy, tolerance, details of PEP regimens used among HCWs exposed to HIV and Hepatitis B as well as vaccination status and (Anti-Hepatitis B Surface Antigen) anti-HBS Antibody Titre Level Among HCWs exposed Hepatitis B. Study Design: This retrospective observational study was done at a rural based tertiary care teaching centre of Western India. Materials and Methods: Hospital Infection Control Committee of our institute was maintaining a record of all reported incidences of HIV and Hepatitis B positive exposures since 2003. We analysed reported incidences of exposures to HIV and Hepatitis B positive source occurred during the period of January 2003 to December 2015. Results: Of the total 96 exposures, 48 were to HIV and 48 were to Hepatitis B. Of the 48 exposures to HIV, PEP was warranted in 39. Of 39 exposures, only 14 (35.9%) received PEP within two hours. Basic regimen was used in 22 and expanded in 17 exposures. Only 12 (31.6%) reported side effects to PEP. Zidovudine based regimen was less well tolerated. All side effects were reported by female HCWs only. Of the 48 exposed to Hepatitis B, 33 (68.6%) were completely vaccinated. Out of 33, titre result was not available for eight. Three (12.0%) of remaining 25 were having low titre ( 100mIU/ml. Of the 48, in 17 (35.4%) incidences no action was required; 23 (47.9%) were managed with booster dose of Hepatitis B vaccine and eight (16.7%) with Hepatitis B immunoglobulin. No cases of sero-conversion was reported either for HIV or Hepatitis B from available data. Conclusion: Inspite of high incidences of exposures to HIV or Hepatitis B positive source, good efficacy of PEP was observed with no sero-conversion. PEP for HIV was well tolerated; female HCWs were less tolerant. Study emphasized the need for creating awareness about timely reporting of incidence, achieving maximum vaccination against Hepatitis B for all HCWs and need for anti-HBS antibody titre.

Objectives: HBV infection is a contagious disease that may transmit vertically from mothers to their neonates or horizontally by blood products and body secretions. Over 50�0of Iranian carriers have contracted the infection perinatally, making this the most likely route of transmission of HBV in Iran. This study assesses the serologic markers of HBV in children born to HBsAg positive mothers who received HBIG and 3 doses of HBV vaccine. Methods: To evaluate the effectiveness of vaccination against HBV, a study was conducted on 95 Children, born to hepatitis B surface antigen (HBsAg)-positive mothers, who had received Hepatitis B Immune Globulin and HBV vaccines during 2004-2008. All children were tested for the presence of HBsAg, anti-HBs and anti-HB core antigen (anti-HBc). Results: Among an estimated 30000 pregnant women during the five year study, about 130 (0.42�20were HBV carriers. Ninety-five children from these mothers were enrolled in this study. Only one child (1.1�20was HBsAg positive, while 88.4�0of children were Anti-HBs Positive. Eleven children (11.6�20were exposed to HBV as shown by the presence of anti-HBc. A significant difference was observed between the children’s age and Anti-HBs (p=0.0001). Conclusion: Passive-active immunoprophylaxis of high risk babies was highly efficacious in preventing perinatal transmission of the HBV carrier state. Also, evaluation of serologic markers in HBV infected people is important for designing the strategies for disease control.

Background and aim To prospectively evaluate the efficacy of vaccine alone compared with vaccine plus HBIG for preventing HBV transmission in neonates of HBsAg (+)/HBeAg (−) mothers. Methods Combined immunization is currently recommended for neonates of HBsAg (+) mothers in China. As a result, a randomized design is infeasible due to ethical reasons. In practice, Guangxi Zhuang Autonomous Region and Jiangsu Province implement vaccine alone and vaccine plus HBIG strategies for neonates born to HBsAg (+)/HBeAg (−) mothers, respectively. We alternatively enrolled neonates of HBsAg (+)/HBeAg (−) mothers from these two regions. Three doses of a recombinant yeast-derived hepatitis B vaccine were given at 0, 1 and 6 months with or without HBIG at birth. Results At 7 months, sera were collected from 132 neonates in Guangxi Zhuang Autonomous Region and 752 neonates in Jiangsu Province. Baseline characteristics of both mothers and neonates were comparable in the two regions. No differences were revealed regarding the occurrence of perinatal HBV transmission with or without HBIG at birth [0.1% (1/752) vs. 0.0% (0/132), p = 1.000]. The anti-HBs response rates were 97.7% (129/132) and 98.5% (740/751) for the neonates with vaccine alone and with HBIG ( p = 0.758), respectively. Vaccine alone induced a significantly higher anti-HBs GMC as compared to vaccine plus HBIG at 7 months of age (1555.3 mIU/mL vs. 654.9 mIU/mL, p < 0.0001). At 12 months of age, protective levels of anti-HBs remained in 97.4% (596/612) and 98.3% (118/120) of the neonates receiving and not receiving HBIG, respectively ( p = 0.771). The neonates receiving combined prophylaxis had a markedly lower anti-HBs GMC (210.7 mIU/mL vs. 297.0 mIU/mL, p = 0.011). Horizontal HBV transmission occurred in none of the successfully immunized neonates for both compared groups at 12 months of age. Conclusions Vaccine alone may be enough for preventing HBV transmission in neonates of HBsAg (+)/HBeAg (−) mothers. [ABSTRACT FROM AUTHOR]

Background The aim of this study was to determine the long-term efficacy of nucleos(t)ide analog (NA) and low-dose hepatitis B immunoglobulin ( HBIG) combination treatment for preventing post-transplant hepatitis B virus ( HBV) recurrence. Methods A total of 296 patients with HBV-associated liver disease who underwent liver transplantation ( LT) were enrolled. A combination of a daily NA and low-dose HBIG was used after LT. Results The median follow-up period was 46 months. HBV recurrence occurred in eight patients. The cumulative probability of HBV recurrence at 1, 3, 5, and 7 years was 1%, 3%, 3%, and 4%, respectively. Seven were on lamivudine ( LMV) or adefovir dipivoxil ( ADV), or LMV and ADV and HBIG combination treatment and one entecavir ( ETV) and HBIG. With Cox regression analysis, HBV recurrence was determined to be associated with the presence of hepatocellular cancer ( HCC) prior to LT ( HR: 12.3, P=.02). Overall, 44 patients died. Survival was significantly better in the ETV or tenofovir disoproxil fumarate ( TDF) and HBIG group than the other group ( P<.001). Conclusion The combination of ETV or TDF and low-dose HBIG achieved a more favorable prophylaxis against HBV recurrence after LT. The presence of HCC prior to LT was associated with post-transplant HBV recurrence. [ABSTRACT FROM AUTHOR]

Introduction: Health Care Workers (HCWs) are at risk of occupational transmission of HIV, Hepatitis B and Hepatitis C, which can be minimized by following guidelines for standard precautions as well as taking Post Exposure Prophylaxis (PEP) measures. There are limited studies from India documenting details of PEP for HIV and Hepatitis B. Aim: We aimed to study the efficacy, tolerance, details of PEP regimens used among HCWs exposed to HIV and Hepatitis B as well as vaccination status and (Anti-Hepatitis B Surface Antigen) anti-HBS Antibody Titre Level Among HCWs exposed Hepatitis B. Study Design: This retrospective observational study was done at a rural based tertiary care teaching centre of Western India. Materials and Methods: Hospital Infection Control Committee of our institute was maintaining a record of all reported incidences of HIV and Hepatitis B positive exposures since 2003. We analysed reported incidences of exposures to HIV and Hepatitis B positive source occurred during the period of January 2003 to December 2015. Results: Of the total 96 exposures, 48 were to HIV and 48 were to Hepatitis B. Of the 48 exposures to HIV, PEP was warranted in 39. Of 39 exposures, only 14 (35.9%) received PEP within two hours. Basic regimen was used in 22 and expanded in 17 exposures. Only 12 (31.6%) reported side effects to PEP. Zidovudine based regimen was less well tolerated. All side effects were reported by female HCWs only. Of the 48 exposed to Hepatitis B, 33 (68.6%) were completely vaccinated. Out of 33, titre result was not available for eight. Three (12.0%) of remaining 25 were having low titre (<10mIU/ml) of anti- HBS antibody. Five of six with incomplete vaccination status demonstrated anti HBS antibody titre > 100mIU/ml. Of the 48, in 17 (35.4%) incidences no action was required; 23 (47.9%) were managed with booster dose of Hepatitis B vaccine and eight (16.7%) with Hepatitis B immunoglobulin. No cases of sero-conversion was reported either for HIV or Hepatitis B from available data. Conclusion: Inspite of high incidences of exposures to HIV or Hepatitis B positive source, good efficacy of PEP was observed with no sero-conversion. PEP for HIV was well tolerated; female HCWs were less tolerant. Study emphasized the need for creating awareness about timely reporting of incidence, achieving maximum vaccination against Hepatitis B for all HCWs and need for anti-HBS antibody titre. [ABSTRACT FROM AUTHOR]

Advent of hepatitis B immunoglobulin (HBIG) as the mainstay of prophylaxis against hepatitis B recurrence after liver transplantation with antiviral drugs has resulted in excellent outcomes for liver transplantation in hepatitis B virus (HBV)-related cirrhosis in the last two decades. However, there is no consensus on a gold standard prophylaxis protocol and several controversies over the duration, dose, and route of administration of HBIG with or without different antivirals exist among liver transplantation centers. We present this review of different prophylaxis regimens including HBIG and antiviral monotherapy, combination of HBIG with antivirals, and withdrawal of HBIG and whole prophylaxis. HBIG monotherapy in either the intramuscular or the subcutaneous form is an accepted choice for prevention of HBV re-infection after liver transplantation in low risk patients. Withdrawal of HBIG monotherapy may be considered but should only occur after transitioning to an oral antiviral therapy such as adefovir, tenofovir, or entecavir. Lamivudine monotherapy may be associated with a higher recurrence rate compared to more potent antivirals. In high risk patients, intramuscular or subcutaneous HBIG in combination with an antiviral, most commonly lamivudine, is currently considered the standard of care. Complete discontinuation of all preventative therapy cannot be recommended at this time and should only be performed in the setting of a clinical trial. [ABSTRACT FROM PUBLISHER]

Historically, hepatitis B virus (HBV) liver transplantation (LT) recipients have less acute cellular rejection (ACR) than those without HBV. We questioned whether this has persisted in an era of decreased Hepatitis B immunoglobulin use (HBIG) given its in vitro immunoregulatory effects. We compared the incidence, risk factors and outcomes of ACR among 40,593 primary LT recipients with HBV, hepatitis C, steatohepatitis, and immune liver disease (OPTN 2000-2011). We also assessed the in vitro effect of HBIG on alloimmune lymphoproliferation and regulatory T cell generation using mixed lymphocyte reactions. In multivariate analysis, HBV status remained a strong independent predictor of freedom from ACR (OR 0.58, 95% CI: 1.5–2.1). Patient (67.7% vs 72.3%) and graft (60.8% vs 69.1%) survival were significantly lower in patients with ACR versus no ACR for all causes except HBV. HBIG use had no statistical association with ACR. In vitro , HBIG at concentrations equivalent to clinical dosing did not inhibit lymphoproliferation or promote regulatory T cell development. In summary, the incidence and impact of ACR is lower now for HBV LT and does not appear to be secondary to HBIG by our in vitro and in vivo analyses. Rather, it may be due to the innate immunosuppressive properties of chronic HBV infection. [ABSTRACT FROM AUTHOR]

Hepatitis B virus (HBV) infection causes long-term, life-threatening liver diseases worldwide. HBV is transmitted through either the horizontal or mother-to-infant route, which is the major route of transmission in endemic areas. Administration of hepatitis B immunoglobulin and hepatitis B vaccine to newborns of infected mothers prevents mother-to-infant transmission. Implementation of a universal hepatitis B vaccination program has proven successful in eliminating the infection and related complications. Nevertheless, efforts are still needed to improve global coverage of the hepatitis B vaccine. Infants born to highly viremic mothers are still at risk of infection despite current immunoprophylaxis. An increasing number of reports have shown promising efficacy and safety profiles with the use of nucleoside/nucleotide analogues in highly viremic pregnant women to prevent mother-to-infant transmission. [ABSTRACT FROM PUBLISHER]