scholarly journals Efficacy and safety of stratified versus routine prophylaxis in living kidney transplantation from HBsAg+ donors to HBsAg− recipients: protocol for a multicentre, prospective, observational study

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e046293
Author(s):  
Xianding Wang ◽  
Saifu Yin ◽  
Turun Song ◽  
Zhongli Huang ◽  
Yu Fan ◽  
...  

IntroductionIt remains unclear whether kidney transplantation (KT) from hepatitis B surface antigen (HBsAg) +donors to HBsAg− recipients (D(HBsAg+)/R(HBsAg−)) provides comparable transplant outcomes without hepatitis B virus (HBV) transmission compared with D(HBsAg−)/R(HBsAg−) KT. Moreover, no consensus has been reached for standardised prophylaxis regimens to prevent HBV transmission after D(HBsAg+)/R(HBsAg−) KT. We developed stratified prophylaxis regimens, including pretransplant antiviral treatment of donors, and pretransplant hepatitis B vaccination and post-transplant antiviral treatment of recipients, based on donors’ and recipients’ HBV serological characteristics. However, the safety and efficacy of stratified prophylaxis regimens remains unknown.Methods and analysisWe are conducting a prospective, multicentre, observational study. Between September 2020 and December 2023, 100 cases of (D(HBsAg+)/R (HBsAg−)) KT will be recruited from four university-affiliated hospitals with a follow-up at least 2 years. They will naturally receive stratified prophylaxis regimens or routine prophylaxis based on clinical experience to compare the efficacy and safety of these two regimens in (D(HBsAg+)/R(HBsAg−)) KT. The primary outcome will be post-transplant HBV infection to evaluate safety, defined as post-transplant HBsAg−→+or HBV DNA−→+. The composite endpoint of prevention failure will be also an endpoint of safety (any one of HBsAg−→+, HBV DNA−→+, HB e antigen−→+, HB e antibody−→+ and HB c antibody−→+). The efficacy will be evaluated by transplant outcomes, including death-censored graft survival, patient survival, acute rejection, delayed graft function and kidney graft function.Ethics and disseminationThis study will be registered as a clinical audit at each participating hospital and has obtained approval from the Ethics Committee of West China Hospital (reference: 2020-683, 8 September 2020).Trial registration numberNCT04562051.

Author(s):  
Xian-ding Wang ◽  
Jin-peng Liu ◽  
Tu-run Song ◽  
Zhong-li Huang ◽  
Yu Fan ◽  
...  

Abstract Background Data on kidney transplantation (KTx) from hepatitis B surface antigen (HBsAg)–positive (HBsAg+) donors to HBsAg-negative (HBsAg−) recipients [D(HBsAg+)/R(HBsAg-)] are limited. We aimed to report the outcomes of D(HBsAg+)/R(HBsAg−) KTx in recipients with or without hepatitis B surface antibody (HBsAb). Methods Eighty-three D(HBsAg+)/R(HBsAg−) living KTx cases were retrospectively identified. The 384 cases of KTx from hepatitis B core antibody–positive (HBcAb+) living donors to HBcAb-negative (HBcAb−) recipients [D(HBcAb+)/R(HBcAb−)] were used as the control group. The primary endpoint was posttransplant HBsAg status change from negative to postive (-− →+). Results Before KTx, 24 donors (28.9%) in the D(HBsAg+)/R(HBsAg−) group were hepatitis B virus (HBV) DNA positive, and 20 recipients were HBsAb−. All 83 D(HBsAg+)/R(HBsAg−) recipients received HBV prophylaxis, while no D(HBcAb+)/R(HBcAb−) recipients received prophylaxis. After a median follow-up of 36 months (range, 6–106) and 36 months (range, 4–107) for the D(HBsAg+)/R(HBsAg−) and D(HBcAb+)/R(HBcAb−) groups, respectively, 2 of 83 (2.41%) D(HBsAg+)/R(HBsAg−) recipients and 1 of 384 (0.26%) D(HBcAb+)/R(HBcAb−) became HBsAg+, accompanied by HBV DNA-positive (P = .083). The 3 recipients with HBsAg−→+ were exclusively HBsAb−/HBcAb− before KTx. Recipient deaths were more frequent in the D(HBsAg+)/R(HBsAg−) group (6.02% vs 1.04%, P = .011), while liver and graft function, rejection, infection, and graft loss were not significantly different. In univariate analyses, pretransplant HBsAb−/HBcAb− combination in the D(HBsAg+)/R(HBsAg−) recipients carried a significantly higher risk of HBsAg−→+, HBV DNA−→+, and death. Conclusions Living D(HBsAg+)/R(HBsAg−) KTx in HBsAb+ recipients provides excellent graft and patient survivals without HBV transmission. HBV transmission risks should be more balanced with respect to benefits of D(HBsAg+)/R(HBsAg−) KTx in HBsAb-/HBcAb− candidates.


2014 ◽  
Vol 28 (10) ◽  
pp. 525-528 ◽  
Author(s):  
Julie van Schalkwyk ◽  
Melica Nourmoussavi ◽  
Andrea Massey ◽  
Reka Gustafson ◽  
Elizabeth Brodkin ◽  
...  

BACKGROUND: Perinatal transmission of hepatitis B virus (HBV) can occur despite postexposure prophylaxis (PEP). Recent literature suggests that antiviral treatment during pregnancy when maternal HBV DNA levels are elevated can further decrease vertical transmission. However, HBV DNA screening is not routinely performed antenatally.OBJECTIVE: To determine the rates of HBV prevalence and perinatal transmission in an antenatal cohort.METHODS: A retrospective review of public health records (December 2008 to December 2010) was performed for both mothers and newborns.RESULTS: A total of 725 mother-infant pairs were included. Of these, 574 of 715 (80%) women had antenatal hepatitis B e antigen (HBeAg) testing performed, and 127 of 574 (22%) were HBeAg positive (HBeAg+). Of babies born to hepatitis B surface antigen-positive (HBsAg+) mothers, only 573 of 725 (79%) received complete PEP. In addition, 172 of 725 (24%) infants did not receive post-PEP blood testing or were lost to follow-up. Of the 552 infants with results available, seven cases (1.3%) of mother-to-child HBV transmission were observed, six of which involved infants born to HBeAg+ women.CONCLUSIONS: Our findings suggest that routine HBeAg screening could identify a subset of mother-infant pairs among HBsAg+ pregnant women who are at higher risk for vertical HBV transmission. Determination of viral load in expectant HBeAg+ mothers may provide more precise insight into HBV transmission to their infants.


2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Xianding Wang ◽  
Jinpeng Liu ◽  
Tao Lin

Abstract Background and Aims Data on kidney transplantation (KTx) from hepatitis B surface antigen (HBsAg)+ donors to HBsAg- recipients [D(HBsAg+)/R(HBsAg-)] are limited. We aimed to report the outcomes of D(HBsAg+)/R(HBsAg-) KTx in recipients with or without hepatitis B surface antibody (HBsAb). Method Eighty-three D(HBsAg+)/R(HBsAg-) living KTx cases were retrospectively identified. The 384 cases of KTx from hepatitis B core antibody (HBcAb)+ living donors to HBcAb- recipients [D(HBcAb+)/R(HBcAb-)] were used as the control group. Primary endpoint was post-transplant HBsAg -→+. Results Before KTx, 24 donors (28.9%) in the D(HBsAg+)/R(HBsAg-) group were hepatitis B virus (HBV) DNA+, and 20 recipients were HBsAb-. All eighty-three D(HBsAg+)/R(HBsAg-) recipients received HBV prophylaxis, while no D(HBcAb+)/R(HBcAb-) recipients received prophylaxis. After a median follow-up of 36 months (range 6-106) and 36 months (range 4-107) for the D(HBsAg+)/R(HBsAg-) and D(HBcAb+)/R(HBcAb-) groups, respectively, 2/83 (2.41%) D(HBsAg+)/R(HBsAg-) recipients and 1/384 (0.26%) D(HBcAb+)/R(HBcAb-) became HBsAg+, accompanied with HBV DNA+ (P=0.083). The three recipients with HBsAg-→+ were exclusively HBsAb-/HBcAb- before KTx. Recipient deaths were more frequent in the D(HBsAg+)/R(HBsAg-) group (6.02% vs. 1.04%, P=0.011), while liver and graft function, rejection, infection, and graft loss were not significantly different. In univariate analyses, pre-transplant HBsAb-/HBcAb- combination in the D(HBsAg+)/R(HBsAg-) recipients carried a significantly higher risk of HBsAg-→+, HBV DNA-→+, and death. Conclusion Living D(HBsAg+)/R(HBsAg-) KTx in HBsAb+ recipients provides excellent graft and patient survivals without HBV transmission. HBV transmission risks should be more balanced with respect to benefits of D(HBsAg+)/R(HBsAg-) KTx in HBsAb-/HBcAb- candidates.


2021 ◽  
Vol 15 (1) ◽  
pp. 11
Author(s):  
Lianda Siregar ◽  
Imelda Maria Loho ◽  
Agus Sudiro Waspodo ◽  
Siti Nadliroh ◽  
Rahmanandhika Swadari ◽  
...  

Background: There is currently no data regarding the efficacy of prophylactic telbivudine in hepatitis B patients undergoing chemotherapy. This study aims to describe the results of preemptive telbivudine and lamivudine to prevent chemotherapy-related HBV reactivation.Methods: The medical records of all patients with HBsAg positive or HBs-Ag negative, anti-HBc positive, who were referred to the hepatology clinic between May 2014 and December 2016, were retrospectively reviewed. As this is a descriptive study, no statistical analysis was done.Results: A total of 52 patients with prophylactic telbivudine or lamivudine therapy were included, with 26 patients in each group. Rituximab-based treatment was given in nine and five patients in the telbivudine and lamivudine group, respectively. The number of patients who completed antiviral treatment up to six months after chemotherapy was 17 patients in each group. There was less incidence of HBV reactivation in the telbivudine group (2 of 17 patients, 11.8%) than in the lamivudine group (7 of 17 patients, 41.2%). Delayed reactivation was noticed in 1 of 2 patients in the telbivudine group and 3 of 7 patients in the lamivudine group. The median log10[HBV DNA] at reactivation was 4.52 (1.70 – 8.35) IU/mL. Severe hepatitis was observed in two patients in the lamivudine group and one patient in the telbivudine group. Of 34 patients who completed antiviral treatment, two patients died due to primary cancer. No interruption of chemotherapy or mortality due to hepatitis was noticed in both groups.Conclusions: Preemptive telbivudine or lamivudine in HBsAg positive or HBsAg negative, anti-HBc positive patients seems to be a good treatment option.


Gut ◽  
2020 ◽  
pp. gutjnl-2020-321309 ◽  
Author(s):  
Hye-Lin Kim ◽  
Gi-Ae Kim ◽  
Jae-A Park ◽  
Hye-Rim Kang ◽  
Eui-Kyung Lee ◽  
...  

ObjectiveThe cost-effectiveness of antiviral treatment in adult immune-tolerant (IT) phase chronic hepatitis B (CHB) patients is uncertain.DesignWe designed a Markov model to compare expected costs and quality-adjusted life-years (QALYs) of starting antiviral treatment at IT-phase (‘treat-IT’) vs delaying the therapy until active hepatitis phase (‘untreat-IT’) in CHB patients over a 20-year horizon. A cohort of 10 000 non-cirrhotic 35-year-old patients in IT-phase CHB (hepatitis B e antigen-positive, mean serum hepatitis B virus (HBV) DNA levels 7.6 log10 IU/mL, and normal alanine aminotransferase levels) was simulated. Input parameters were obtained from previous studies at Asan Medical Center, Korea. The incremental cost-effectiveness ratio (ICER) between the treat-IT and untreat-IT strategies was calculated.ResultsFrom a healthcare system perspective, the treat-IT strategy with entecavir or tenofovir had an ICER of US$16 516/QALY, with an annual hepatocellular carcinoma (HCC) incidence of 0.73% in the untreat-IT group. With the annual HCC risk ≥0.54%, the treat-IT strategy was cost-effective at a willingness-to-pay threshold of US$20 000/QALY. From a societal perspective considering productivity loss by premature death, the treat-IT strategy was extremely cost-effective, and was dominant (ICER <0) if the HCC risk was ≥0.43%, suggesting that the treat-IT strategy incurs less costs than the untreat-IT strategy. The most influential parameters on cost-effectiveness of the treat-IT strategy were those related with HCC risk (HBV DNA levels, platelet counts and age) and drug cost.ConclusionStarting antiviral therapy in IT phase is cost-effective compared with delaying the treatment until the active hepatitis phase in CHB patients, especially with increasing HCC risk, decreasing drug costs and consideration of productivity loss.


BMC Medicine ◽  
2020 ◽  
Vol 18 (1) ◽  
Author(s):  
Lin Jia ◽  
Ran Xue ◽  
Yueke Zhu ◽  
Juan Zhao ◽  
Juan Li ◽  
...  

Abstract Background Hepatitis B virus-related acute-on-chronic liver failure (HBV-ACLF) is a severe condition with high mortality due to lack of efficient therapy. Until now, the use of methylprednisolone (MP) in HBV-ACLF is still controversial. We aimed to evaluate the efficacy and safety of MP in HBV-ACLF. Methods Totally 171 HBV-ACLF patients from three medical centers were randomly allocated into MP group (83 patients treated with MP intravenously guttae for 7 days plus standard treatment: 1.5 mg/kg/day [day 1–3], 1 mg/kg/day [day 4–5], and 0.5 mg/kg/day [day 6–7]) and control group (88 patients treated with standard treatment). The primary endpoints were 6-month mortality and prognostic factors for 6-month survival. The survival time, cause of death, adverse events, liver function, and HBV DNA replication were analyzed. Results The 6-month mortality was significantly lower in MP group than control group [32.4% vs. 42.5%, P = 0.0037]. MP treatment was an independent prognostic factor for 6-month survival [HR (95% CI) 0.547(0.308–0.973); P = 0.040]. Factors associated with reduced 6-month mortality in MP group included HBV DNA and lymphocyte/monocyte ratio (LMR) (P < 0.05). Based on ROC curve, LMR+MELD had a better predictive value for prognosis of HBV-ACLF under MP treatment. No significant difference in HBV DNA replication was observed between groups (P > 0.05). Conclusions MP therapy is an effective and safe clinical strategy in HBV-ACLF, increasing the 6-month survival rate. Clinical trials registered at http://www.chictr.org.cn as ChiCTR-TRC-13003113 registered on 16 March 2013.


Blood ◽  
2003 ◽  
Vol 101 (6) ◽  
pp. 2419-2425 ◽  
Author(s):  
Jean-Pierre Allain ◽  
Daniel Candotti ◽  
Kate Soldan ◽  
Francis Sarkodie ◽  
Bruce Phelps ◽  
...  

The risk of hepatitis B virus (HBV) transmission by transfusion in sub-Saharan Africa is considered to be relatively low, and testing of blood donors is often not done or is done relatively poorly. To re-examine this attitude, we identified HBV chronically infected blood donors from a major hospital in Ghana with a range of hepatitis B surface antigen (HBsAg) assays. Test efficacy was estimated using HBV DNA as a gold standard, and the risk of HBV infection in blood recipients was estimated for different testing strategies. Particle agglutination, dipstick, and enzyme immunoassay (EIA) HBsAg screening detected 54%, 71%, and 97% of HBV infectious donors, respectively. The risk of HBV transmission to recipients less than 10 years old ranged between 1:11 and 1:326 with blood unscreened and screened by EIA, respectively. For older recipients, the risk decreased a further 4-fold because of the high frequency of natural exposure to HBV. A total of 98% of HBsAg-confirmed positive samples contained HBV DNA. HBV DNA load was less than 1 × 104 IU/mL in 75% of HBsAg-reactive samples, most of them anti-HBe reactive. Approximately 0.5% of HBsAg-negative but anti-HBc-positive samples contained HBV DNA. The use of sensitive HBsAg tests is critical to prevent transfusion transmission of HBV infection to young children in a population with a 15% prevalence of chronic HBV infection in blood donors. However, this will not have much effect on the prevalence of this infection unless other strategies to protect children from infection are also advanced in parallel.


2012 ◽  
Vol 2012 ◽  
pp. 1-5 ◽  
Author(s):  
P. Gerner ◽  
Andre Hörning ◽  
S. Kathemann ◽  
K. Willuweit ◽  
S. Wirth

Background. It has been suggested that chronic hepatitis B infection leads to growth impairment, but data are inconsistent and underlying factors are not defined.Methods. Children and adolescents with chronic hepatitis B (HBV) or C (HCV) were retrospectively evaluated for growth, weight, antiviral treatment, biochemical signs of liver inflammation, route of infection, and HBV DNA, respectively.Results. In all, 135 children (mean age 6.1 years, 81 male, 54 female) with HBV (n=78) or HCV (n=57) were studied. Route of infection was vertical in 50%, parenteral in 11%, and unknown in 39%. ALT levels were above 1.5 times above normal in 30% while 70% had normal/near normal transaminases. 80% were Caucasian, 14% Asian, 1% black, and 4% unknown. Mean baseline height measured in SDS was significantly lower in the study population than in noninfected children (boys −1.2, girls −0.4,P<0.01). 28 children were below 2 standard deviations of the norm while 5 were above 2 standard deviations. SDS measures in relation to individual factors were as follows: elevated ALT: boys −1.4, females −0.5 (P<0.01), ALT normal/near normal: boys +0.4, females +0.6; parenteral transmission: boys −3.3, girls −0.9 (P<0.01), vertical transmission: boys −0.2, females −0.2. Antiviral treatment itself or HBV-DNA load did not reach statistically significant differences.Conclusions. Chronic HBV or HCV may lead to compromised growth which is mostly influenced by liver inflammation. Our data may argue for early antiviral treatment in children with significant ALT elevation.


Sign in / Sign up

Export Citation Format

Share Document