Prophylaxis Of Hepatitis Research Articles

Epidemiology of Sharp Injuries and Hepatitis B Vaccination among Sudanese Dental House Officers

Occupational sharps injuries have been investigated among dental healthcare personnel but none have reported findings from Sudan. Data on hepatitis B vaccination is scanty among dental practitioners. The aim of the survey is to describe the epidemiology of sharps injuries and hepatitis B vaccination among dental house officers. A cross-sectional survey using an anonymous questionnaire was used to collect data from 161 dental house officers at a tertiary dental care facility in Khartoum. The response rate was 95%. Sharps injuries were experienced by 37.3% of house officers. Most injuries were caused by hollow bore needles (73.3%). The one hand scoop technique was practiced by 87.6% and 60.2% used sharps disposal containers. The surgery department was the major source of incident reporting (65.5%). Most of the injured house officers did not report their injury (90%). Only 32.9% were aware of a post exposure prophylaxis protocol at the hospital. Full vaccination against hepatitis B was reported by 43.5% of respondents and 6.7% received prophylaxis for hepatitis B. Adequate education and training; provision of hepatitis B vaccination and up-scaling of dental facilities to meet safer dental practices will help to reduce sharps injuries and improve hepatitis B vaccination.

Minimization of Anti–hepatitis B Surface Antigen Immunoglobulins for Prophylaxis of Hepatitis B Viral Recurrence in the First Month After Liver Transplantation: The Meaning of HBsAg Quantitative Level at the Time of Transplant

BackgroundHepatitis B virus recurrence after liver transplantation (LT) has practically disappeared with a prophylaxis combining anti–hepatitis B surface antigen Immunoglobulins (HBIg) and antiviral drugs. Recently, cost-saving requirements pushed us to move from a fixed schedule of 50,000 IU intravenous HBIg in the first month after LT to an “on demand” administration guided by close monitoring of HBV surface antigen (HBsAg) and anti-HBV surface Antigen antibody (HBsAb) with a serological target of HBsAg negative and HBsAb >300 mIU/mL. In this context, we investigated the meaning of HBsAg quantitative determination at LT in predicting the need of HBIg in the first month after LT. MethodsFrom February 2012 to July 2013, we performed 35 LTs in HBsAg-positive patients, 18 of whom had hepatitis Delta virus coinfection (Delta-positive). Anti-HBV prophylaxis was based on nucleos(t)ide analogues from day 1 post-LT and intravenous HBIg (10,000 IU intraoperatively and, in the following days, 5,000 IU and 2,500 IU pulses to reach and maintain the serological target). ResultsThe HBsAg quantitative level at LT was significantly higher in Delta-positive recipients. Complete negativization of HBsAg and HBsAb serum level >300 mIU/mL was achieved on day 3 in Delta-positive and on day 2 in Delta-negative. A positive linear correlation between HBsAg quantitative level at LT and HBIg administered in the first month after LT was observed (RHO = .788), with a total of 32,500 IU HBIg used in HDV-positive and 22,000 IU in HDV-negative recipients (P = .0016). Compared to the old schedule, we saved a median of 14,750 IU in HDV-positive and 28,000 IU in Delta-negative. No HBV recurrence was observed in a median follow-up of 10.5 months. ConclusionsDelta-positive patients need higher doses of HBIg to reach the serological target after LT because they have greater HBsAg quantitative levels at LT. In future studies, pre-LT HBsAg quantitative determination will be helpful to predict the actual need of HBIg early after LT.

The risk of hepatitis B virus reactivation and the role of antiviral prophylaxis in hepatitis B surface antigen negative/hepatitis B core antibody positive patients with diffuse large B-cell lymphoma receiving rituximab-based chemotherapy

The risk factors and the role of prophylactic antiviral therapy of hepatitis B virus (HBV) reactivation in patients with hepatitis B surface antigen (HBsAg) negative/hepatitis B core antibody (HBcAb) positive disease remain controversial. We reviewed 629 patients with diffuse large B-cell lymphoma (DLBCL). Among 629 patients, 150 of 246 patients with resolved HBV (HBsAg negative and HBcAb positive) were treated with rituximab-combined therapy. Among these 150 patients, none of 104 patients (0.0%) who were hepatitis B surface antibody (HBsAb) positive experienced HBV reactivation versus four of 46 patients (8.7%) who were HBsAb negative (p = 0.008). One of 113 patients (0.9%) with International Prognostic Index (IPI) 0–2 suffered HBV reactivation versus three of the remaining 37 patients (8.1%) with IPI 3–5 (p = 0.047). HBsAb and IPI are potential risk factors for HBV reactivation. The use of prophylactic agents may not be recommended for these patients until the occurrence of HBV reactivation.

Epidemiology of Hepatitis B Virus Infection in China: Current Status and Challenges.

The prevalence of hepatitis B is high in China. Based on the National Disease Supervision Information Management System of China, the mean reported incidence of hepatitis B was 84.3 per 100,000 in China between 2005 and 2010. There are differences in population distribution based on region and ethnic group. Here, risk factors, virological characteristics, and prophylaxis of hepatitis B in China are reviewed. Although the prevalence of HBV infection is gradually declining, there are many challenges in HBV infection control, including higher prevalence in floating population, poor compliance of antiviral therapy, and high disease burden.

Clinical Outcomes and Risk Factors of Hepatitis B Virus Recurrence in Patients Who Received Prophylaxis With Entecavir and Hepatitis B Immunoglobulin Following Liver Transplantation

IntroductionAlthough entecavir (ETV) and hepatitis B immunoglobulin (HBIG) have widely been used for prophylaxis of hepatitis B virus (HBV) recurrence following liver transplantation (OLT), there have been few studies about clinical outcomes and risk factors of HBV recurrence. Materials and methodsThis study retrospectively assessed clinical outcomes and identified risk factors of post-transplant HBV recurrence in 154 patients who received prophylaxis with both ETV and HBIG after OLT. ResultsThe median follow-up duration was 28.0 months (range, 1.0–57.8). Post-transplant HBV recurrence occurred in 5 patients (3.2%) without any ETV-resistant mutants. The overall rates of HBV recurrence at 1, 2, and 4 years were 0.6%, 1.6%, and 6.2%, respectively. We found that recurrent hepatocellular carcinoma (HCC) was an independent risk factor of HBV recurrence (hazard ratio = 13.5, 95% confidence interval, 2.4–74.4; P = .006). ConclusionsProphylaxis with a combination of ETV and HBIG resulted in a low HBV recurrence rate following OLT without any emergence of ETV-resistant mutants. Recurrent HCC was an independent risk factor of HBV recurrence in patients who received prophylaxis with both ETV and HBIG for prophylaxis following OLT.

THU0430 Serological Prevalence of Hepatitis B Virus Infection Among Patients with Different Rheumatic Diseases

BackgroundReactivation of HBV is well-recognized and frequently reported in rheumatic patients, particularly those receiving disease modifying anti-rheumatic drugs [1, 2]. This might occur during [2] or after [3] cessation of...

Prophylaxis of hepatitis B infection in solid organ transplant recipients

Rates of transmission of hepatitis B virus (HBV) infection from organ donors with HBV markers to recipients along with reactivation of HBV during immunosuppression following transplantation have fallen significantly with the advent of hepatitis B immune globulin (HBIg) and effective antiviral therapy. Although the availability of potent antiviral agents and HBIg has highly impacted the survival rate of HBV-infected patients after transplantation, the high cost associated with this practice represents a major financial burden. The availability of potent antivirals with high genetic barrier to resistance and minimal side effects have made it possible to recommend an HBIg-free prophylactic regimen in selected patients with low viral burden prior to transplant. Significant developments over the last two decades in the understanding and treatment of HBV infection necessitate a re-appraisal of the guidelines for prophylaxis of HBV infection in solid organ transplant recipients.

Entecavir versus lamivudine for hepatitis B prophylaxis in patients with haematological disease

Hepatitis B reactivation in patients receiving immunosuppressive therapy or chemotherapy may be associated with acute hepatitis, liver failure and/or death. To audit the efficacy of entecavir as compared to lamivudine for the prophylaxis of HBV reactivation in patients with haematological disease receiving immunosuppression or chemotherapy. Patients treated for haematological disease with pretreatment serological evidence of chronic hepatitis B (CHB) (HBV surface antigen, HBsAg positive) or resolved HBV infection (HBsAg negative but HBV core antibody positive) are included in this study. Patients received lamivudine 100 mg or entecavir 0.5 mg daily. Hepatitis B serology, HBV DNA and ALT were audited at baseline, 6 months, year 1, 2 and 3. HBV reactivation was defined as a 1 log increase in HBV DNA from baseline or reversion to sAg positivity. The occurrence of jaundice, symptomatic hepatitis, liver failure or death were audited. Of the 40 patients included in the study, 65% (4 CHB and 22 resolved HBV) received entecavir and 35% (11 CHB and 3 resolved HBV) received lamivudine. One patient with resolved HBV experienced HBV seroreversion related to premature cessation of entecavir. Eight patients with CHB (two from entecavir group and six from lamivudine group) had detectable HBVDNA levels at baseline; one case of HBV reactivation related to probable lamivudine resistance was identified. No HBV related deaths occurred. Lamivudine and entecavir are both efficacious in the prophylaxis of hepatitis B reactivation. Entecavir should be used in preference to lamivudine in patients CHB with detectable baseline HBV DNA levels.

OC-20 Prophylaxis of hepatitis B after liver transplantation: report of an Italian survey in a cohort of 2260 patients

s of the 46th A.I.S.F. Annual Meeting 2013 / Digestive and Liver Disease 45S (2013), S1–S48 S7 the increase of HRR. The analysis of survival benefit comparing the risk of waiting list drop-out with the mortality of the 170 transplanted patients with same HRR, showed an important benefit for LT in patients with HRR>16.3. Conclusions: In patients with MELD<18, the combination of ascites, sodium, albumin, bilirubin and renal function in a new score (HRR) is superior than MELD in identifying both patients at a high risk of waitlist drop-out and patients in whom LT may be safely deferred.

The Survival Benefit of Liver Transplantation for Hepatocellular Carcinoma Patients with Hepatitis B Virus Infection and Cirrhosis

BackgroundA precise predictive survival model of liver transplantation (LT) with antiviral prophylaxis for hepatitis B virus (HBV)-associated hepatocellular carcinoma (HCC) and cirrhosis has not been established. The aim of our study was to identify predictors of outcome after LT in these patients based on tumor staging systems, antitumor therapy pre-LT, and antiviral prophylaxis in patients considered to be unfit by Milan or UCSF criteria.MethodsFrom 2002 to 2008, 917 LTs with antiviral prophylaxis were performed on patients with HBV-cirrhosis, and 313 had concurrent HCC.ResultsStratified univariate and multivariate analyses demonstrated that independent predictors for poor survival were tumor size >7.5 cm (P = 0.001), tumor number >1 (P = 0.005), vascular invasion (P = 0.001), pre-LT serum alpha-fetoprotein (AFP) level ≥1000 ng/ml (P = 0.009), and pre-LT aspartate aminotransferase (AST) level ≥120 IU/L (P = 0.044). Pre-LT therapy for HCC was an independent predictor of better survival (P = 0.028). Based on CLIP and TNM tumor staging systems, HCC patients with HBV-cirrhosis who met the following criteria: solitary tumor ≤7.5 cm, or ≤4 multifocal nodules, the largest lesion ≤5 cm and total tumor diameter ≤10 cm, or more nodules with the largest lesion ≤3 cm, and pre-LT serum AFP level <1000 µg/L and AST level <120 IU/L without vascular invasion and lymph node metastasis who were unfit for UCSF, had survival rates of 89% at 5 years. There was a 47% 5-year survival rate for patients with HCC exceeding the revised criteria.ConclusionsThe current criteria for LT based on tumor size, number and levels of AFP and AST may be modestly expanded while still preserving excellent survival after LT. The expanded criteria combined with antiviral prophylaxis and pre-LT adjuvant therapy for HCC may be a rational strategy to prolong survival after LT for HCC patients with HBV-associated cirrhosis.

A Large Single Center Cohort of Liver Transplants from HBcAb-Positive Donors: Null Risk of Denovo Hepatitis B Infection and Excellent Post-Transplant Survival

Introduction: The utilization of hepatitis-B core antibody (HBcAb) positive and hepatitis-B surface antigen (HBSAg) negative have been proposed to maximize the donor pool. However, these grafts might carry occult HBV infection, therefore risking potential recipients of developing “de novo” hepatitis B (DNHB) post-transplant. It has also been suspected than these grafts might have inferior post-transplant survival. We designed this study to better understand the safety of this practice and to assess the transplant outcomes of recipients of HbcAb positive/HbsAg negative donors. Methods: From June, 2005 through June, 2010 458 liver transplants in 413 patients were performed at Albert Einstein Hospital in São Paulo, Brazil. We excluded from this analysis: recipients with acute liver failure (n=45) and those who were in need of an urgent retransplant (n=46). All recipients of HbcAb+HbsAg- grafts were kept with life-long prophylaxis for hepatitis B post-transplant: hepatitis B immuneglobulin plus lamivudine when the cause of cirrhosis was hepatitis B (n=13) and lamivudine monotherapy for the other recipients (n=53). Serology for hepatitis B infection and histological evaluation of the graft for at least 6 months post-transplant were used to detect DNHB. Mean follow-up was 27.5 months. Outcomes of transplants from HbcAb+HbsAg-donors were compared to those from other donors. Main endpoints were the incidence of DNHB and post-transplant survival. The Kaplan-Meier and log-rank test method were used to calculate patient and graft survivals; T test and Mann-Whitney were used to compare donors and recipients demographics variables. [PS1] Results: Among 367 patients that were included in the study, the mean MELD score was 25 (ranging from 7 to 40). The mortality for those in the waiting list was 11.1%. We used HbcAb+HbsAg-grafts in 66 transplants (18% of the cohort). Eighty percent of those who receive a HbcAb+HbsAg- allograft did not present cirrhosis due to hepatitis B (n=53). When we compared age, gender, BMI, ICU length of stay and laboratory tests of the donors in both groups, we found that HbcAb+HbsAg-donors were older than the controls (49 vs 42.2 years, p=0.006). In the HbcAb+HbsAg- group, there was no case of DNHB: post-transplant HbsAg test was negative in 88.7% of[PS2] these patients; in 77.3% of these patients, graft biopsy had no signs of VHB injury[PS3]. 1-year patient and graft survival were respectively 86.8% and 79.2% for the HbcAb+ group and 87% and 80.4% for the HbcAb negative graft group, (NS). Conclusion: The use of grafts form HbcAb+HbsAg- donors is safe even in patients who undergone liver transplantation for diseases different than hepatitis B. With proper prophylaxis and follow-up the incidence of DNHB is null. The utilization of HbcAb+HbsAg- donors has no impact on post-transplant survival.

Lamivudine prophylaxis for hepatitis B virus carrier patients with breast cancer during adjuvant chemotherapy

This study aimed to assess the efficacy of lamivudine prophylaxis on hepatic complications in HBsAg-positive patients with breast cancer undergoing adjuvant chemotherapy and to describe the temporal trend in HBV surveillance and prophylaxis during the last decade. Patients with stage I-III curatively resected invasive breast cancer who received adjuvant and/or neoadjuvant chemotherapy between 2000 and 2009 were eligible for this study. Patients with positive HBsAg and normal liver function were enrolled. Hepatotoxicity, defined as alanine aminotransferase (ALT) ≥100 IU/ml, and HBV reactivation were compared according to lamivudine prophylaxis. Annual trends in HBV surveillance and use of lamivudine prophylaxis were also reviewed. One hundred sixty-five HBsAg-positive patients with breast cancer were enrolled. After the year 2004, surveillance of HBV infection status and use of lamivudine prophylaxis increased significantly (2.5 vs. 57.6 %, P < 0.001). Seventy-three (44.2 %) patients received lamivudine prophylaxis and 92 (55.8 %) patients did not. The incidence of hepatotoxicity was significantly lower in the group receiving prophylaxis (2.7 vs. 14.1 %, P = 0.011) with fewer premature terminations of planned adjuvant chemotherapy (0 vs. 10.9 %, P = 0.004) in the prophylaxis group. Among the patients for whom the baseline HBV DNA titer was available, the HBV reactivation rate was lower, albeit not significantly, in the prophylaxis group (0 %) compared with the no prophylaxis group (20 %) (P = 0.104). Lamivudine-withdrawal hepatitis was not detected; however, one case of breakthrough HBV reactivation during lamivudine treatment was observed in this study. Over the past decade, there has been an increase in the awareness of HBV reactivation and in the use of lamivudine during cytotoxic chemotherapy. Lamivudine prophylaxis reduced hepatic complications during adjuvant chemotherapy in patients with breast cancer. Lamivudine prophylaxis should be considered in HBsAg-positive patients with breast cancer who are candidates for adjuvant chemotherapy.

Safety and efficacy of abatacept in eight rheumatoid arthritis patients with chronic hepatitis B

There are no previous studies on the use of abatacept in patients with chronic hepatitis B. This medical record review assessed the safety and efficacy of abatacept in 8 patients with rheumatoid arthritis (RA) and chronic hepatitis B. A retrospective analysis of patients with RA and chronic hepatitis B treated with abatacept was conducted. The primary outcome was the 4-variable Disease Activity Score in 28 joints using the erythrocyte sedimentation rate (DAS28-ESR) at each followup visit along with markers of hepatitis B reactivation, including aspartate aminotransferase, alanine aminotransferase, and hepatitis B viral load. A total of 47 visit data points were recorded. The mean ± SD duration of followup of patients receiving abatacept was 19.1 ± 12.7 months (range 3-33 months). Analysis was limited to 18 months of followup (included 77% of all visits [36 of 47]). Four patients were started on antiviral prophylaxis for hepatitis B with the initiation of abatacept, while 4 patients were not. Among the 4 patients who received antiviral prophylaxis, RA improved as evidenced by a statistically significant decrease in DAS28-ESR scores, and none had reactivation of hepatitis B. In the 4 patients without antiviral prophylaxis, there was no significant decrease in the DAS28-ESR scores and all 4 experienced reactivation of hepatitis B. There were no adverse events other than the hepatitis B reactivation. Use of abatacept in patients with RA and chronic hepatitis B appears feasible if antiviral prophylaxis for hepatitis B is given concurrently. In these patients there were no non-hepatitis-related adverse effects. These data are encouraging and should lead to initiation of controlled trials of abatacept in hepatitis B.

Hepatitis A immunisation in persons not previously exposed to hepatitis A.

In many parts of the world, hepatitis A infection represents a significant cause of morbidity and socio-economic loss. Whilst hepatitis A vaccines have the potential to prevent disease, the degree of protection afforded against clinical outcomes and within different populations remains uncertain. There are two types of hepatitis A virus (HAV) vaccine, inactivated and live attenuated. It is important to determine the efficacy and safety for both vaccine types. To determine the clinical protective efficacy, sero-protective efficacy, and safety and harms of hepatitis A vaccination in persons not previously exposed to hepatitis A. We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, Science Citation Index Expanded, and China National Knowledge Infrastructure (CNKI) up to November 2011. Randomised clinical trials comparing HAV vaccine with placebo, no intervention, or appropriate control vaccines in participants of all ages. Data extraction and risk of bias assessment were undertaken by two authors and verified by a third author. Where required, authors contacted investigators to obtain missing data. The primary outcome was the occurrence of clinically apparent hepatitis A (infectious hepatitis). The secondary outcomes were lack of sero-protective anti-HAV immunoglobulin G (IgG), and number and types of adverse events. Results were presented as relative risks (RR) with 95% confidence intervals (CI). Dichotomous outcomes were reported as risk ratio (RR) with 95% confidence interval (CI), using intention-to-treat analysis. We conducted assessment of risk of bias to evaluate the risk of systematic errors (bias) and trial sequential analyses to estimate the risk of random errors (the play of chance). We included a total of 11 clinical studies, of which only three were considered to have low risk of bias; two were quasi-randomised studies in which we only addressed harms. Nine randomised trials with 732,380 participants addressed the primary outcome of clinically confirmed hepatitis A. Of these, four trials assessed the inactivated hepatitis A vaccine (41,690 participants) and five trials assessed the live attenuated hepatitis A vaccine (690,690 participants). In the three randomised trials with low risk of bias (all assessing inactivated vaccine), clinically apparent hepatitis A occurred in 9/20,684 (0.04%) versus 92/20,746 (0.44%) participants in the HAV vaccine and control groups respectively (RR 0.09, 95% CI 0.03 to 0.30). In all nine randomised trials, clinically apparent hepatitis A occurred in 31/375,726 (0.01%) versus 505/356,654 (0.18%) participants in the HAV vaccine and control groups respectively (RR 0.09, 95% CI 0.05 to 0.17). These results were supported by trial sequential analyses. Subgroup analyses confirmed the clinical effectiveness of both inactivated hepatitis A vaccines (RR 0.09, 95% CI 0.03 to 0.30) and live attenuated hepatitis A vaccines (RR 0.07, 95% CI 0.03 to 0.17) on clinically confirmed hepatitis A. Inactivated hepatitis A vaccines had a significant effect on reducing the lack of sero-protection (less than 20 mIU/L) (RR 0.01, 95% CI 0.00 to 0.03). No trial reported on a sero-protective threshold less than 10 mIU/L. The risk of both non-serious local and systemic adverse events was comparable to placebo for the inactivated HAV vaccines. There were insufficient data to draw conclusions on adverse events for the live attenuated HAV vaccine. Hepatitis A vaccines are effective for pre-exposure prophylaxis of hepatitis A in susceptible individuals. This review demonstrated significant protection for at least two years with the inactivated HAV vaccine and at least five years with the live attenuated HAV vaccine. There was evidence to support the safety of the inactivated hepatitis A vaccine. More high quality evidence is required to determine the safety of live attenuated vaccines.

P116 Assessing the sexual violence services currently provided in genitourinary medicine clinics

BackgroundMany patients present to Genitourinary medicine (GUM) clinics following sexual violence (SV) occurring in circumstances including sexual assault (SA), domestic violence (DV), sex work (SW) and trafficking. BASHH has guidelines...

Viral Hepatitis in Liver Transplantation

Liver transplantation is the only alternative for patients with end-stage liver disease. Viral hepatitis B and C are among the most common causes of cirrhosis and hepatocellular carcinoma and a frequent indication for liver transplantation. Hepatitis B virus immunoglobulin and nucleot(s)ide analogues have facilitated the management of patients with hepatitis B who have received liver transplants and resulted in excellent long-term outcomes. On the contrary, recurrence of hepatitis C is the main cause of graft loss in most transplant programs. Current therapeutic approaches are far from optimal, because sustained virologic responses are only achieved in one-third of treated patients, and adverse effects are common and severe. However, the rapid development of direct-acting antivirals against hepatitis C virus will change the management of this disease and in a few years prevent graft infection with this virus.

Prevention and Risk Factors of the HBV Recurrence After Orthotopic Liver Transplantation: 160 Cases Follow-Up Study

The aim of this study was to analyze the combination with long-term, low-dose hepatitis B immunoglobulin (HBIG) and nucleos(t)ide analogs as prophylaxis for hepatitis B virus (HBV) recurrence and to assess the risk factors of HBV recurrence after orthotopic liver transplantation (OLT). One hundred sixty patients undergoing OLT with HBV-related liver disease make up the cohort studied. Long-term, low dosage of HBIG in combination with nucleos(t)ide analogs were used as prophylaxis for HBV recurrence after OLT. Patient preoperative data were collected by a retrospective method, and the rate and risk factors of HBV recurrence post-OLT after a long-term follow-up were analyzed. Nineteen patients developed hepatitis B recurrence for a rate of recurrence of 11.88% (19/160). There was no significant correlation between HBV recurrence after OLT and the level of HBV DNA, HBeAg state pre-OLT, or the use of nucleoside analog drug therapy pre-OLT (P>0.05). Of 19 patients with HBV recurrence, 17 patients used Lamivudine, and HBV YMDD mutants were detected in nine cases. The HBV-YMDD mutation was the major reason for recurrence of HBV in our study (P<0.001). Long-term use of combination prophylaxis with nucleoside analogs and low-dose HBIG can effectively prevent hepatitis B recurrence after OLT, and that a positive preoperative serum HBV DNA status did not affect the recurrence rate of HBV post-OLT. Preoperative nucleoside analogs therapy is unlikely to be obligatory if the patients received effective combination prophylaxis postoperatively. HBV YMDD mutation is the primary reason for HBV recurrence in patients treated with Lamivudine after OLT.

Prevention of HBV recurrence after liver transplant: The role of combination therapy

The prognosis after liver transplantation is related to the efficacy of prophylaxis of hepatitis B virus (HBV) graft re-infection. The risk of HBV re-infection is directly related to HBV viral load at the time of transplantation. HBV prophylaxis after transplantation with long-term administration of hepatitis B immunoglobulins (HBIG) or monoprophylaxis with lamivudine can significantly reduce the risk of HBV recurrence. Antivirals can control HBV replication in patients with decompensated HBV cirrhosis awaiting transplantation. However, there is a risk of HBV viral breakthrough during nucleo(t)side antiviral treatment. Efficacy of antivirals and the risk of viral resistance should be taken into account. The post-transplant combination of antiviral therapy and HBIG prophylaxis is very effective in reducing the rate of HBV re-infection to less than 10%, increasing the survival rate. The current 5-year survival after transplantation for HBV related liver disease is 85%. In patients without active viral replication at transplantation, the possibility of discontinuing HBIG prophylaxis over the long-term after transplantation with maintenance of antiviral treatment or HBV vaccination is under evaluation. In conclusion, the prophylaxis of HBV re-infection combining antiviral therapy prior to transplantation, and combination of HBIG and antiviral therapy post-transplantation is effective in reducing the rate of HBV re-infection.

Efficacy, safety, and pharmacokinetics of intramuscular hepatitis B immune globulin, Igantibe ®, for the prophylaxis of viral B hepatitis after liver transplantation

Background Long-term prophylaxis of hepatitis B virus (HBV) positive liver transplanted subjects with intravenous hepatitis B immunoglobulin (HBIG) is effective, however use of intramuscular HBIG could be as effective with fewer adverse events and lower cost. Aim We conducted a prospective, non-randomized, clinical study to assess the efficacy and safety of HBIG from Grifols, Igantibe ®, for the prophylaxis of HBV reactivation. Methods Eighteen adult patients submitted to liver transplantation for HBV-related disease more than 18 months earlier were treated with doses of 2000 I.U. intramuscular Igantibe ® every 14 days for 6 months. Results Mean trough serum HBsAb IgG titers from months 4 to 6 (primary efficacy variable) were protective (≥150 I.U./L) at each time point. Individual measurements were also protective throughout the study. HBV replication remained negative for all available subjects until study completion. Pharmacokinetic analysis showed a half-life of 27 days and extensive exposure to the study drug. Safety and tolerability of intramuscular Igantibe ® were good, with only one adverse event. Conclusion Standard-dose intramuscular Igantibe ® administration proved efficacious in post-liver transplantation prophylaxis by attaining protective levels for up to 6 months, was safe and well tolerated. Pharmacokinetic analysis revealed a long half-life and extensive exposure.

Immunoglobulins for preventing hepatitis A

Hepatitis A (infectious hepatitis) is a common epidemic disease. Immunoglobulins for passive immunisation are used as prevention. To assess the beneficial and harmful effects of the pre- and post-exposure prophylaxis with immunoglobulins for preventing hepatitis A. We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, The Chinese Biomedical Database, and Science Citation Index Expanded for trials until October 2008. In addition, we read through reference lists of the identified publications and handsearched three journals. Randomised clinical trials on immunoglobulin prophylaxis for preventing hepatitis A, irrespective of blinding, publication status, or language. Data were extracted by two authors and verified by a third author. Results were presented as relative risks (RR) with 95% confidence intervals (CI). The primary outcome was occurrence of hepatitis A (infectious hepatitis). We included 13 trials with 567,476 participants randomised to pre- or post-exposure prophylaxis. The trials had high risk of bias. The trials were heterogeneous in terms of study setting, participants, interventions, and outcome measures. Our meta-analysis with six randomised trials showed that immunoglobulins, when used for pre-exposure prophylaxis, significantly reduced the number of adult patients with hepatitis A at 6 to 12 months (1020/286503 versus 761/134529; RR 0.53; 95% CI 0.40 to 0.70; random-effects model) in comparison with no intervention or inactive control. Four trials showed a similar effect in children aged 3 to 17 at 6 to 12 months follow-up (917/210822 versus 677/78960; RR 0.45; 95% CI 0.34 to 0.59). Comparing different doses of immunoglobulins, higher dosage was generally more effective than lower dosage (1.5 ml better than 0.75 ml and 0.75 ml better than 0.1 ml) in preventing hepatitis A. No significant systemic adverse events were reported. One trial showed that immunoglobulin was more effective than placebo for post-exposure prophylaxis. It appeared that there was no significant difference between immunoglobulins and inactivated hepatitis A vaccine in seroconversion to hepatitis A vaccine antibodies at four weeks (RR 1.16; 95% CI 0.98 to 1.38), but immunoglobulins were significantly less effective than vaccine regarding antibody levels at 8, 12, or 24 weeks. Immunoglobulins seem to be effective for pre-exposure and post-exposure prophylaxis of hepatitis A. However, caution is warranted for the positive findings due to the limited number of trials, year of conductance, and risk of bias. Conductance of rigorous trials will be justifiable.