Tenofovir Alafenamide to Prevent Perinatal Hepatitis B Transmission: A Multicenter, Prospective, Observational Study

Author(s):  
Qing-Lei Zeng ◽  
Zu-Jiang Yu ◽  
Fanpu Ji ◽  
Guang-Ming Li ◽  
Guo-Fan Zhang ◽  
...  

Abstract Background Few safety and effectiveness results have been published regarding the administration of tenofovir alafenamide fumarate (TAF) during pregnancy for the prevention of mother-to-child transmission (MTCT) of hepatitis B virus (HBV). Methods In this multicenter prospective observational study, pregnant women with HBV DNA levels higher than 200,000 IU/ml who received TAF or tenofovir disoproxil fumarate (TDF) from gestational weeks 24-35 to delivery were 1:1 enrolled and followed until postpartum month 6. Infants received immunoprophylaxis. The primary endpoint was the safety of mothers and infants. The secondary endpoint was the hepatitis B surface antigen (HBsAg)-positive rate at 7 months for infants. Results In total, 116 and 116 mothers were enrolled, and 117 and 116 infants were born, in the TAF and TDF groups, respectively. TAF was well tolerated during a mean treatment duration of 11.0 weeks. The most common maternal adverse event was nausea (19.0%). One (0.9%), 3 (2.6%), and 9 (7.8%) mothers had abnormal alanine aminotransferase levels at delivery and at postpartum months 3 and 6, respectively. The TDF group had safety profiles that were comparable to those of the TAF group. No infants had birth defects in either group. The infants’ physical and neurological development at birth and at 7 months in the TAF group were comparable with those in the TDF group. The HBsAg positive rate was 0% at 7 months in all 233 infants. Conclusion Antiviral prophylaxis with TAF was determined to be generally safe for both mothers and infants and reduced the MTCT rate to 0%.

2019 ◽  
Vol 11 (1) ◽  
pp. e2019052
Author(s):  
Seung Beom Han ◽  
Hye Jo Shin ◽  
Eui Soo Lee ◽  
Jae Wook Lee ◽  
Nack-Gyun Chung ◽  
...  

Background: Vaccination for hepatitis B virus (HBV) after chemotherapy among pediatric patients with acute leukemia is still a debated issue. We investigated HBV immunity before and after chemotherapy and assessed immune response to re-vaccination after chemotherapy.  Methods:  We retrospectively analyzed data of children and adolescents aged <19 years requested for vaccination after chemotherapy for acute leukemia to evaluate hepatitis B surface antibody (HBsAb) status before and after chemotherapy and to identify factors related to HBsAb positivity after chemotherapy. Results:  Of 89 enrolled patients, 61 (68.5%) with acute leukemia were HBsAb positive before chemotherapy. Of these 61 patients, 48 (78.7%) seroconverted to HBsAb negative status after chemotherapy; there were 76 (85.4%) HBsAb negative patients after chemotherapy. HBsAb positive patients when compared to HBsAb negative patients after chemotherapy had a significantly higher HBsAb positive rate (100.0% vs. 63.2%, p=0.008) before chemotherapy. Following HBsAb testing after one dose of the HBV vaccination, 33 (43.4%) of the 76 HBsAb negative patients seroconverted to a HBsAb positive status. HBsAb positive patients after a single dose of HBV vaccination had a significantly higher HBsAb positive rate at the time of diagnosis compared to HBsAb negative patients (84.8% vs. 48.8%, p=0.001). Conclusions:  Based on these results, HBV re-vaccination after chemotherapy is recommended for all children and adolescents with acute leukemia. In addition, further investigation is required to improve the immunogenicity of HBV re-vaccination.   Keywords: Acute Leukemia; Chemotherapy; Hepatitis B vaccine; Hepatitis B virus; Child.


2015 ◽  
Vol 61 (5) ◽  
pp. 719-729 ◽  
Author(s):  
Shigeru Kusumoto ◽  
Yasuhito Tanaka ◽  
Ritsuro Suzuki ◽  
Takashi Watanabe ◽  
Masanobu Nakata ◽  
...  

2019 ◽  
Vol 144 (5) ◽  
pp. 612-619
Author(s):  
Dongju Won ◽  
Younhee Park ◽  
Dasom Choi ◽  
Hyon-Suk Kim

Context.— High-throughput automated immunoanalyzers for hepatitis B virus serologic markers have been introduced but have not been compared to existing systems. Objective.— To compare hepatitis B surface antigen, hepatitis B surface antibody, and total hepatitis B core antibody analyses between our Architect i2000 platform and newer high-throughput fully automated immunoanalyzers. Design.— From May to June 2018, a total of 932, 914, and 1055 samples tested for hepatitis B surface antigen, hepatitis B surface antibody, and total hepatitis B core antibody, respectively, with the Architect i2000 system for routine testing in our center were tested again with Alinity i, Atellica IM, and Cobas e801 systems. Results.— Total concordance rates among the systems were 98.0%, 89.5%, and 93.0% for hepatitis B surface antigen, hepatitis B surface antibody, and total hepatitis B core antibody, respectively. Cohen's κ values exceeded 0.8. The correlations between serum hepatitis B surface antibody levels quantified by all 4 systems were high (r &gt; 0.85). The hepatitis B surface antibody averages were greater for the Alinity i, Atellica IM, and Cobas e801 than for the Architect i2000 (P &lt; .001). Conclusions.— Alinity i, Atellica IM, and Cobas e801 automated immunoanalyzers performed well when compared with the existing Architect i2000 system with regard to detection of hepatitis B viral infection. However, the new systems have higher titer and positivity rates for hepatitis B surface antibody and are more sensitive. Notably, the Atellica IM has a lower positive rate for total hepatitis B core antibody than does the Architect i2000.


2021 ◽  
Vol 8 ◽  
pp. 204993612098595
Author(s):  
Luisa Roade ◽  
Mar Riveiro-Barciela ◽  
Rafael Esteban ◽  
Maria Buti

Nucleos(t)ide analogues with high barrier to resistance are regarded as the principal therapeutic option for chronic hepatitis B (CHB). Treatment with entecavir (ETV), tenofovir disoproxil (TDF) and the later released tenofovir alafenamide (TAF) is highly effective at controlling hepatitis B virus (HBV) infection and, in the vast majority of patients, is well tolerated. No significant differences in viral suppression have been described among the different regimens, although an earlier achievement in biochemical response has been suggested first under TDF and recently under TAF. High barrier to resistance NAs rarely achieve hepatitis B surface antigen sero-clearance, and therefore should be maintained life-long in most cases. This has increased concerns about treatment-related toxicity, especially in patients under TDF with additional risk factors for kidney and bone impairment. TAF has shown a better bone and kidney safety profile than TDF, although it is not yet available worldwide due to its higher cost. Emergence of adverse events should be monitored since treatment-switch to ETV/TAF seems to be effective and safe in HBV mono-infected subjects. Finally, although an effective antiviral treatment leads to a clear improvement in clinical outcome of CHB patients; the risk of developing hepatocellular carcinoma (HCC) is not completely avoided with viral suppression. Whether tenofovir-based regimens provide any additional benefit over ETV in HCC prevention remains unclear and requires further investigation.


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