Tenofovir and lamivudine in late pregnancy to prevent perinatal transmission of hepatitis B virus in highly viremic mothers in Vietnam

Tóm tắt

Objective. We evaluated effect and safety of lamivudine and tenofovir in late pregnancy
for preventing perinatal transmission of hepatitis B virus (HBV) to infants born to highly
viremic mothers in view of searching a rational regimen to control this transmission pathway
that perpetuates the infection in highly endemic region. Population and methods. Analysis
population consisted of 82 mother-child pairs who completed the study protocol. Pregnant
chronic HBsAg(+) women with high viremia (>107

copies/mL) at 32 weeks of gestation were
randomly located in 2 groups (lamivudine 100mg or tenofovir 300mg daily for 8 weeks of
prepartum to week 4 pospartum). At birth infants received recombinant HBV vaccine without
HBIg and were followed until week 52. Mother-to-child perinatal transmission was defined by
the presence of HBsAg in serum at week 52. Results. A sharp decrease of mean maternal viral
load 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) with undetectable HBV DNA in 2 cases (2.3%) was noted. 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). At birth, HBsAg was positive in 21/82 (25.6%) and
HBV DNA detectable in 7/82 newborns (8.5%), without significant difference between two
groups of infants regardless of their mothers under lamivudine or tenofovir (p=0.075 and 0.591,
respectively). At week 52, HBsAg and HBV DNA was present in serum of 2/82 infants (2.4%).
Conclusion. Both tenofovir and lamivudine in late pregnancy showed the same safety and
effect of repressing HBV replication, and strikingly reduced perinatal transmission of HBV to
infants born to highly viremic mothers. From the point of view of cost-effectiveness, a priority of
lamivudine use in this situation seems more rational in low-income nations.