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Efficicacy and safety of tenoforvir and lamivudine to prevent perinatal tranmission of hepatitis B virus in highly verimic mothers

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Bang Nguyen Van, Lan Anh Le Thi, Marc Bourlière, Philippe Halfon, Tuong Van Vu Thi, Sofiane Mohamed, Van Anh Nguyen Thi, Quynh Mai Nguyen Thi, Minh Hang Hoang Thi, Thu Hien Nguyen Thi

 ABSTRACT

 

Chronic hepatitis B virus (HBV) infection early in the life confers a high risk of chronicity, particularly in children born to highly viremic mothers, due to “viral vaccine breakthrough” phenomenon that could be treated by antivirals such as lamivudine and recently tenofovir.

Objectives

We evaluated efficacy and safety of lamivudine and tenofovir in late pregnancy in preventing perinatal transmission of hepatitis B virus (HBV) to infants born to highly viremic mothers.

Methods

A total of 82 pregnant chronic HBsAg(+) women with high viremia (>107 copies/mL) at 32 weeks of gestation were randomly assigned to 2 groups (lamivudine 100mg or tenofovir 300mg daily from 8 weeks of prepartum to week 4 postpartum). Infants received recombinant HBV vaccine without HBIg and were followed until week 52.

Results

HBV perinatal transmission rate, defined by HBsAg presence in children’s blood at week 52, was 1.2% (1/82). The mean maternal viral load sharply decreased from 5.09 x 108 ± 3.19 x 108 copies/mL at week 32 of gestation to 1.13 x 106 ± 3.91 x 106 at labor (p<0.001). The viral load reduction was stronger in tenofovir-treated mothers than in lamivudine-treated ones (p<0.028), particularly in 4 log10 reduction (p<0.001). No viral resistance to the drugs was noted. Drug adverse events were rare and transient, allowing complete full course in all cases, and flare was seen in no case.

Conclusions

Both lamivudine and tenofovir exhibited a high efficacy in preventing mother-to-child perinatal transmission of HBV and a good safety without viral resistance.

Keywords

Hepatitis B virus, perinatal transmission, highly viremic women, lamivudine, tenofovir, late pregnancy

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