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Tác dụng ngăn lây Virus viêm gan B sang bào thai của Tenofovir và Lamivudine cuối thai kỳ ở thai phụ tải lượng virus máu cao

nckh
Thông tin nghiên cứu
Loại tài liệu
Bài báo trên tạp chí khoa học (Journal Article)
Tiêu đề
Tác dụng ngăn lây Virus viêm gan B sang bào thai của Tenofovir và Lamivudine cuối thai kỳ ở thai phụ tải lượng virus máu cao
Tác giả
Lê Thị Lan Anh; Nguyễn Văn Bàng; Vũ Tường Vân; Marc Bourliere
Năm xuất bản
2015
Số tạp chí
32
Trang bắt đầu
13-18
ISSN
1859-431X
Abstract

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