Lamivudine in late pregnancy to prevent perinatal transmission of hepatitis B virus infection: a multicentre, randomized, double-blind, placebo-controlled study.
This randomized, double-blind, placebo-controlled study evaluated whether lamivudine given during late pregnancy can reduce hepatitis B virus (HBV) perinatal transmission in highly viraemic mothers. Mothers were randomized to either lamivudine 100 mg or placebo from week 32 of gestation to week 4 postpartum. At birth, infants received recombinant HBV vaccine with or without HBIg and were followed until week 52. One hundred and fifty mothers, with a gestational age of 26-30 weeks and serum HBV DNA >1000 MEq/mL (bDNA assay), were treated. A total of 141 infants received immunoprophylaxis at birth. In lamivudine-treated mothers, 56 infants received vaccine + HBIg (lamivudine + vaccine + HBIg) and 26 infants received vaccine (lamivudine + vaccine). In placebo-treated mothers, 59 infants received vaccine + HBIg (placebo + vaccine + HBIg). At week 52, in the primary analyses where missing data was counted as failures, infants in the lamivudine + vaccine + HBIg group had a significant decrease in incidence of HBsAg seropositivity (10/56, 18%vs 23/59, 39%; P = 0.014) and in detectable HBV DNA (11/56, 20%vs 27/59, 46%; P = 0.003) compared to infants in the placebo + vaccine + HBIg group. Sensitivity analyses to evaluate the impact of missing data at week 52 resulting from a high dropout rate (13% in the lamivudine + vaccine + HBIg group and 31% in the placebo + vaccine + HBIg group) remained consistent with the primary analysis in that lower transmission rates were still observed in the infants of lamivudine-treated mothers, but the differences were not statistically significant. No safety concerns were noted in the lamivudine-treated mothers or their infants. Results of this study suggest that lamivudine reduced HBV transmission from highly viraemic mothers to their infants who received passive/active immunization.
Xu
W-M
WM
Shanghai Infectious Disease Hospital, Shanghai, China. wmxu@sohu.com
Cui
Y-T
YT
Wang
L
L
Yang
H
H
Liang
Z-Q
ZQ
Li
X-M
XM
Zhang
S-L
SL
Qiao
F-Y
FY
Campbell
F
F
Chang
C-N
CN
Gardner
S
S
Atkins
M
M
D000328:Adult; D000914:Antibodies, Viral / Q000627:therapeutic use; D000998:Antiviral Agents / Q000627:therapeutic use*; D018890:Chemoprevention / Q000379:methods; D004311:Double-Blind Method; D005260:Female; D006509:Hepatitis B / Q000188:drug therapy* / Q000635:transmission*; D006514:Hepatitis B Surface Antigens / Q000097:blood; D017325:Hepatitis B Vaccines / Q000008:administration & dosage; D006801:Humans; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D019259:Lamivudine / Q000627:therapeutic use*; D010919:Placebos / Q000008:administration & dosage; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*; D016896:Treatment Outcome
D000914:Antibodies, Viral; D000998:Antiviral Agents; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D010919:Placebos; D019259:Lamivudine