Effect of telbivudine on maternal-infant blocking of hepatitis B virus surface antigen and e antigen in pregnant women with high load of hepatitis B virus in late pregnancy

doi:10.3877/cma.j.issn.1674-1358.2019.03.008

Abstract

Abstract:

Objective

To evaluate the efficacy of tebivudine in the treatment for maternal-infant blockade of pregnant women with both serum hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg) positive and high load of hepatitis B virus (HBV) infection in late pregnancy.

Methods

From July 1st, 2007 to June 30th, 2017, pregnant women with chronic HBV infection in late pregnancy (28 weeks of pregnancy) and babies delivered in the outpatient Department of Gynaecology and Obstetrics, Beijing Ditan Hospital, Capital Medical University were selected. Total of 250 pregnant women with both HBsAg and hepatitis B e antigen (HBeAg) positive, normal liver function, HBV DNA ≥ 1 × 10⁶ copies/ml and with complete follow-up data were collected. The pregnant women were fully informed of the advantages and disadvantages of the maternal-infant blocking of the anti-viral medication during pregnancy. According to the voluntary principle, the pregnant women were divided into tebivudine group (150 cases) and control group (100 cases) according to whether treated with tebivudine. The pregnant women in tebivudine group received oral tebivudine 600 mg/d, from 28 weeks of pregnancy to 42 days after delivery. The control group did not use antiviral drugs. The serum HBV DNA load were detected in both groups at 28 weeks and at the time of delivery. The adverse reactions of pregnant women in tebivudine group after taking medicine were observed. The infants of both groups were immunized with active and passive immunization after birth; hepatitis B vaccine was injected intramuscularly within 6 hours, 1 month and 6 months, respectively, while intramuscular injection of hepatitis B immunoglobulin for 200 IU. The positive rate of HBsAg and the load of HBV DNA in 6 hours after the bith and at 7-month of the baby were detected (venous blood was drawn before passive immunization).

Results

Compared with the control group, the average HBV DNA load was significantly lower in tebivudine group after treatment and before delivery, with significant difference (t = 31.07, P < 0.001). The positive rate of serum HBV DNA in tebivudine group was significantly higher than that of control group within 6 hours of the babies birth, with significant difference (0.00% vs. 17.00%; χ² = 27.36, P < 0.001). At the age of 7 months, the HBV DNA load of the infants in tebivudine group were all lower than the limit of detection, and the positive rate of HBV DNA in the control group was 10.00%. Fisher accurate test showed that the intrauterine infection rate of control group was significantly higher than that of tebivudine group (12.00% vs. 0.00%), with significant difference (P < 0.001). No serious adverse reactions were found during the follow-up period of tebivudine use, and no birth defects were found.

Conclusions

With the increase of serum HBV DNA load in pregnant women before delivery, the risk of HBV intrauterine infection increases. Normal liver function, both HBsAg and HBeAg positive, high HBV DNA load with tebivudine antiviral therapy in late of pregnancy could significantly reduce the serum HBV DNA load of pregnant women and block HBV intrauterine infection of effectively. It is safe for both mothers and infants to use tebivudine in late pregnancy.

Key words: Telbivudine, Hepatitis B immunoglobulin, Hepatitis virus B, Hepatitis B surface antigen, Hepatitis B e antigen, Maternal-infant blockade, Intrauterine infection

Zhenhua Li, Baojiang Xie, Liju Zhang, Wei Yi, Nuo Yi. Effect of telbivudine on maternal-infant blocking of hepatitis B virus surface antigen and e antigen in pregnant women with high load of hepatitis B virus in late pregnancy[J]. Chinese Journal of Experimental and Clinical Infectious Diseases(Electronic Edition), 2019, 13(03): 214-220.

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References 25

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组别	例数	初产[例（%）]	年龄（ ± s，岁）	顺产[例（%）]	配偶HBV感染[例（%）]^a
替比夫定组	150	135（90.00）	27.07 ± 4.33	48（32.00）	2（1.33）
对照组	100	91（91.00）	26.21 ± 4.15	38（38.00）	4（4.00）
统计量	?	χ² = 0.07	t= 1.56	χ² = 0.96	—
P值	?	0.79	0.12	0.33	0.22

组别	例数	初产[例（%）]	年龄（ ± s，岁）	顺产[例（%）]	配偶HBV感染[例（%）]^a
替比夫定组	150	135（90.00）	27.07 ± 4.33	48（32.00）	2（1.33）
对照组	100	91（91.00）	26.21 ± 4.15	38（38.00）	4（4.00）
统计量	?	χ² = 0.07	t= 1.56	χ² = 0.96	—
P值	?	0.79	0.12	0.33	0.22

组别	例数	胎龄占比（38周/39周，%）	男性[例（%）]	平均出生体重（g）^a
替比夫定组	150	24.00/43.33	80（53.33）	3 386.7（2 500～4 100）
对照组	100	43.00/48.00	57（57.00）	3 448（2 800～4 450）
χ²值	?	—	0.33	—
P值	?	0.0065^a	0.57	0.1800^a

组别	例数	胎龄占比（38周/39周，%）	男性[例（%）]	平均出生体重（g）^a
替比夫定组	150	24.00/43.33	80（53.33）	3 386.7（2 500～4 100）
对照组	100	43.00/48.00	57（57.00）	3 448（2 800～4 450）
χ²值	?	—	0.33	—
P值	?	0.0065^a	0.57	0.1800^a

组别	例数	平均血清HBV DNA水平[±s，log₁₀拷贝/ml]		HBV DNA低于检测下限[例（%）]
组别	例数	未服药前（孕28周）	服药后（分娩时）	HBV DNA低于检测下限[例（%）]
替比夫定组	150	7.41 ± 0.46	4.17 ± 0.78	37（24.67）
对照组	100	7.24 ± 0.49	7.07 ± 0.57	0（0.00）
统计量	?	t = 2.710	t = 31.070	χ²= 28.950
P值	?	0.007	<0.001	<0.001

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