Tenofovir and Lamivudine in late pregnancy to prevent intra-unterine transmission of hepatitis B virus in hyperviremic mothers. Objective. This randomized open-label clinical trial aimed at comparing the effect of Lamivudine and Tenofovir in repressing the viral replication of HBV in late pregnancy to prevent intra-uterine transmission of the virus to infants born to hyperviremic mothers. Population and methods. A cohort of 864 healthy pregnant chronic HBsAg( +) women were enrolled to screen hyperviremia ( 10 exponent 6 copies/mL) at 32 weeks of gestation and after signing formal consent for participation, they were randomized into 2 groups, under either Lamivudine 100mg (47 cases) or Tenofovir 300mg (49 cases) daily for 8 weeks of preparrtum and 4 weeks of pospartum. Their infants received Engerix-B vaccine at birth and at 1, 2 and 11 months and were followed up to 52 weeks of life. Intra-uterine transmission was defined by presence of HBV DNA or/and HBsAg in umbilical cordon blood sample at birth. Results. Among 112/864 (12.96 percent) hyperviremic pregnant women screened, 96 signed formal consent for participation, only 82 mother-child pairs completed the study protocol and entered into analysis population. Mean maternal viral load was 5.09.10 exponent 8 +/- 3.19.10 exponent 8copies/mL at 32 weeks of gestation and decreased to 1.13.10 exponent 6+/- 3.91.10 exponent 6 at the moment of labor (p0.0001). The viral reduction was stronger in Tenofovir group than in Lamivudine one (p0.028), particularly in 4 log10 (p0.0001). A viral reduction of 1-3 log10 was found aggregated in 75.8 percent of Lamivudine group mothers while a reduction in 4 to 8 log 10 found in 65.3 percent of Tenofovir group. A positivity in cordon blood of HBV DNA(+) in 7/82 newborms (8.5 percent) and of HBsAg(+) in 21/82 (25.6 percent) was found, without significant difference between 2 groups of infants regardless their mothers under Lamivudine or Tenofovir (p
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