Efficacy and Safety of Lamivudine or Telbivudine in Preventing Mother‐to‐Child Transmission of Hepatitis B Virus: A Real‐World Study

Abstract

Background. There are few large sample studies evaluating the safety and efficacy of lamivudine (LAM) or telbivudine (LdT) in preventing hepatitis B mother-to-child transmission (MTCT) in highly viremic mothers in the third trimester of pregnancy in real-world settings. The purpose of this study was to analyze a large sample size of HBV-infected mothers to better understand the safety and efficacy of LAM and LdT under the aforementioned criteria. Methods. During the period of November 2008 to November 2017, we retrospectively enrolled mothers with HBV DNA>1×106 IU/mL who received LAM or LdT during the third trimester of pregnancy and compared them to untreated mothers. All mothers were divided into the three following groups: the LAM group, the LdT group, and the control group. Results. A total of 2624 HBV-infected mothers were enrolled in the study, with 363 in the LAM group, 1283 in the LdT group, and 978 in the control group. The MTCT rates were significantly lower in the LAM or LdT group than that in the control group (0.4% or 0.3% versus 9.0%, P<0.001). Infants born to untreated mothers had a significantly higher risk of HBV infection (OR=28.6, 95% CI: 10.4–78.7, P<0.001). There were no significant differences in perinatal complications between the three groups (P>0.05). There were also no differences for gestational age or infants’ height, weight, Apgar scores, or birth defect rates. Postpartum discontinuation of antiviral therapy did not seem to increase the risk of postpartum alanine aminotransferase (ALT) flare. Conclusion. LAM or LdT treatment initiated in the third trimester for mothers with HBV DNA>1×106 IU/mL was equally safe and effective in preventing MTCT.

Characterization of T cell immunity in chronic hepatitis B virus-infected mothers with postpartum alanine transaminase flare

“…Studies have shown that along with the administration of the HBV vaccine and immunoglobulin, antepartum antiviral therapy (AVT) can further reduce the incidence of MTCT in pregnant women with high viral loads [ 7 – 9 ]. Previous studies mainly focused on the effectiveness and safety of AVT, as well as the probability and severity of maternal alanine transaminase (ALT) flare after delivery [ 10 ]. The characteristics of postpartum ALT flare are mainly mild to moderate abnormalities, which can resolve spontaneously in the majority of mothers [ 11 ].…”

Efficacy and Safety of Telbivudine in Preventing Mother-to-Child Transmission of Hepatitis B Virus

“…This is consistent with the published studies that LdT did not cause infant birth defects. [4,15,17,18,20] In our study, we believe the reduced MTCT rate of HBV in infants could be attributed to the lowing reasons: (a) signi cantly reduced maternal viral load by LdT before delivery; and (b) timely administration of hepatitis B vaccine and hepatitis B immune globulin (within 2 hours of delivery).…”

“…Nucleos(t)ide analogs (NAs) have been shown to to reduce the viral loads during pregnancy and can effectively block the MTCT of HBV. [9][10][11][12][15][16][17] Oral antiviral drugs are usually given in the second and third trimesters of gestation. However, the exact timing of therapy is still controversial.…”

Efficacy and safety of tenofovir disoproxil fumarate or telbivudine used throughout pregnancy for the prevention of mother-to-child transmission of hepatitis B virus: A cohort study

“…ALT flares are more common in untreated mothers and patients who discontinue antiviral therapy. According to various studies, 10 %-73 % of patients experience postpartum ALT flares [4,22,28,30]. ALT flares were less likely to be experienced in those on continued antiviral therapy.…”

“…Although the combination of hepatitis B vaccination and hepatitis B immunoglobulin (HBIG) prevents approximately 75 %-90 % of HBV MTCT rates, HBV transmission cannot be eliminated in infants born to mothers with a high HBV load [2,3]. An increasing number of studies have suggested that the treatment of pregnant mothers with neocleos(t)ide analogs (NAs) in the second or third trimester of pregnancy can reduce the risk of MTCT from mothers with a high HBV load [4][5][6][7].…”