Prevention of mother-to-child transmission of hepatitis B virus: protocol for a one-arm, open-label intervention study to estimate the optimal timing of tenofovir in pregnancy

Bierhoff, Marieke; Nelson, Kenrad E.; Guo, Nan; Jia, Yuanxi; Angkurawaranon, Chaisiri; Jittamala, Podjanee; Carrara, Verena I.; Watthanaworawit, Wanitda; Ling, Clare; Tongprasert, Fuanglada; Vugt, Michèle van; Rijken, Marcus J.; Nosten, François; McGready, Rose; Ehrhardt, Stephan; Thio, Chloe L.

doi:10.1136/bmjopen-2020-038123

Cited by 11 publications

(5 citation statements)

References 44 publications

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“…However, though antiviral therapy is now well accepted for the women at high risk of MTCT, safety, timely initial drug administration, and discontinuation need to be elucidated. For example, Bierhoff et al [80] are conducting a study to evaluate the procedures following early initiation of maternal TDF, before 20 weeks of pregnancy, to determine the effectiveness, safety, and feasibility of this approach in a low-resource setting.…”

Section: Mother-to-child Transmission (Mtct)mentioning

confidence: 99%

Hepatitis B Virus Infection in Pregnancy: Immunological Response, Natural Course and Pregnancy Outcomes

Sirilert

Tongsong

2021

JCM

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This review aimed to provide an update on the impact of pregnancy on the natural course of hepatitis B virus (HBV) infection and also on the impact of HBV infection on adverse pregnancy outcomes, including mother-to-child transmission (MTCT). For the literature review, original research articles, review articles, and guidelines were narratively reviewed and comprehensively validated. The databases of PubMed, EMBASE, and CINAHL were carefully searched for articles in English on topics related to HBV infection, pregnancy, and vertical transmission from 1960 to May 2021. Immunological changes during pregnancy such as suppression of Th1 response and induction of Th2 immunity lead to an impaired immune reaction to HBV and stimulate viral activity along with the reduction of CD8 T cells to escape immune detection. The impact of pregnancy on the natural course of chronic HBV infection seems to be minimal, while pregnancy can increase morbidity and mortality in the case of advanced HBV hepatitis or cirrhosis. Importantly, hepatitis flare or alanine aminotransferase (ALT) flare can occur during pregnancy and is more common during the postpartum period due to the interaction between HBV and the immune response. Interestingly, the impact of HBV infection on adverse pregnancy outcomes is more serious than ever thought. Updated evidence indicates that pregnancies with chronic HBV infection increase the risk of preterm birth and gestational diabetes, especially in cases of positive hepatitis e antigen (HBeAg).

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Section: Mother-to-child Transmission (Mtct)mentioning

confidence: 99%

Hepatitis B Virus Infection in Pregnancy: Immunological Response, Natural Course and Pregnancy Outcomes

Sirilert

Tongsong

2021

JCM

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“…Since its approval, additional studies have shown that anti-HBV NA administration during pregnancy can significantly reduce MTCT of HBV (Tavakolpour et al, 2018;Funk et al, 2021). Among them, tenofovir (TFV) is the only approved NA with high efficacy against the virus and no detected clinical resistance to date, and tenofovir disoproxil fumarate (TDF) treatment, a pro-drug of TFV, has been recommended by the WHO to treat chronic HBV infection (WHO, 2015) since 2015, particularly in pregnant women (Lin et al, 2018;Bierhoff et al, 2020). TDF received US FDA approval for HIV in 2001 first, and approval for HBV in 2008, administered at a dose of 300 mg once daily.…”

Section: Introductionmentioning

confidence: 99%

Distribution Evaluation of Tenofovir in the Breast Milk of Mothers With HBeAg-Positive Chronic HBV Infection After Treatment With Tenofovir Alafenamide and Tenofovir Disoproxil Fumarate by a Sensitive UPLC-MS/MS Method

Yang

Zhou

Cheng³

et al. 2021

Front. Pharmacol.

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Tenofovir alafenamide (TAF) is a novel prodrug of tenofovir (TFV) that has been approved for the treatment of chronic hepatitis B virus (HBV) infection. It has greater plasma stability and more favorable renal safety than tenofovir disoproxil fumarate (TDF), the first approved oral prodrug of TFV. However, the distribution of TFV in the breast milk of mothers treated with TAF is still unclear. In this study, sixteen participants with chronic HBV infection were enrolled and received antiretroviral therapy with 25 mg of TAF or 300 mg of TDF daily from 24 to 28 weeks of gestation until the 4th week postpartum. For the first time, the distribution of TFV in the breast milk of mothers with chronic HBV infection treated with TAF and its difference from TDF were evaluated by using a sensitive UPLC–MS/MS method. Chromatographic separation was achieved on a Waters ACQUITY UPLC BEH C18 column (1.7 µm 2.1 × 100 mm). Mass spectrometry analysis was performed in positive electrospray ionization mode and multiple reaction monitoring (MRM) conditions of transitions m/z 288.1→176.2 for TFV. This method was linear from 0.5 to 500 ng/ml. Surprisingly, on the third postpartum day, the median Cmax of TFV in the breast milk was much higher in the mothers treated with TAF (101.2 ng/ml) than TDF (21.6 ng/ml) at a similar Tmax of 4 h. Accordingly, the median AUC0-8 value was 755.6 ng h/mL in the mothers taking TAF, which was at a 5-fold higher level than TDF. The concentration of TFV in the breast milk of mothers in both groups decreased with increasing lactation time. These data indicated that there was a relatively higher exposure of TFV in the breast milk of mothers taking TAF, despite the lower dosage compared to TDF. This study provides support for further evaluating the safety of breastfeeding after the administration of TAF and TDF.

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“…HBV infection in adults results in chronic hepatitis in less than 5% of cases, whereas in infants and young children, it causes the development of a chronic form of the disease in 95% of subjects ( 5 ). Knowing the hepatitis B status of pregnant women is critical for effective disease management and prevention of mother-to-child transmission ( 6 ). Prevalence rates of hepatitis B among pregnant women varied considerably from one study site to another, ranging from 1.1 to 9.6% in Cameroon ( 7-9 ).…”

Section: Discussionmentioning

confidence: 99%

Protection level of anti-hepatitis B vaccine in a pediatric Cameroonian population

Nkenfou,

Kemenang,

Essomba

et al. 2023

J Public Health Afr

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Background: Despite the availability for nearly twenty years of an effective vaccine, hepatitis B remains one of the most frequent viral diseases throughout the world. Mother-to-child transmission is one of the primary routes of transmission in children. Objective: To assess the vaccine response in children born to HBV-infected mothers. Methods: HBsAg-positive consenting mothers registered in the antenatal care (ANC) service database of Centre Hospitalier Dominicain St-Martin de Porres, Yaounde were enrolled with their children. Socio-demographic characteristics were collected using a tested questionnaire. The 5 markers of hepatitis B were tested and the quantification of anti-HBsAg antibodies was done by indirect ELISA method. The data collected was analyzed using Microsoft excel and Epi-info software. Results: Out of 5,996 women registered, 143 were identified as HBsAg positive (2.38% prevalence), of which 50 were enrolled in the study. Of the 50 positive mothers, 78 children were included with a mean age ± standard deviation of 2.33 ± 2.86 years. No child was infected with HBV, but all have been exposed to the virus (HBeAb-positive). Overall 64 (82.05%) received at birth both anti-HBs immunoglobulin (HBIG) and a dose of vaccine, while 14 (17.95%) received only the birth dose of vaccine. 72 (92.31%) children received all three recommended doses of the vaccine. Vaccine responders were 62.82% (above 10 IU/mL), while 37.18% of children were non-responders; representing a higher risk group if not boosted. Conclusion: The coverage of anti-HBV vaccine in children in this study was 92.31%. The protection level of 62.82% is below the 95% recommended rate by WHO. The factors sustaining this suboptimal protection should be investigated.

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Prevention of mother-to-child transmission of hepatitis B virus: protocol for a one-arm, open-label intervention study to estimate the optimal timing of tenofovir in pregnancy

Cited by 11 publications

References 44 publications

Hepatitis B Virus Infection in Pregnancy: Immunological Response, Natural Course and Pregnancy Outcomes

Hepatitis B Virus Infection in Pregnancy: Immunological Response, Natural Course and Pregnancy Outcomes

Distribution Evaluation of Tenofovir in the Breast Milk of Mothers With HBeAg-Positive Chronic HBV Infection After Treatment With Tenofovir Alafenamide and Tenofovir Disoproxil Fumarate by a Sensitive UPLC-MS/MS Method

Protection level of anti-hepatitis B vaccine in a pediatric Cameroonian population

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