AASLD2014替比夫定的安全和功效预防母婴传播乙肝孕妇在免疫

StephenW

1864

Efficacy and Safety of Telbivudine in Preventing Mother-to-infant HBV Transmission in HBV-infected Pregnant Women in Immune Tolerant Phase
Qiuju Sheng, Yang Ding, Han Bai, Jingyan Wang, Chong Zhang, Lianrong Zhao, Xiaoguang Dou;
Shengjing Hospital of China Medical University, Shenyang, China

Purpose: To evaluate the efficacy and safety of telbivudine (LdT) for preventing mother-to-infant hepatitis B virus (HBV) transmission in chronically infected pregnant women in immune tolerant phase.
Methods: Between Jun. 2010 and Nov. 2011, a total of 4536 HBV-infected pregnant women were included. 38 HBsAg-positive pregnant women with high viral load (HBV DNA> 1.0×107 IU / ml) were assigned to receive oral LdT 600 mg/d in the 28-32 weeks of pregnancy. HBV DNA levels were detected before delivery using Roche COBAS TaqMan Reagents, when detectable HBV DNA (HBV DNA>20 IU/ml ) occurred, the LdT treatment was stopped after delivery; while undetectable HBV DNA appeared, the LdT treatment was continued. ALT, HBsAg, HBeAg and HBV DNA levels of mothers were detected at baseline, before delivery and 1 month after delivery. Infants received IM Hepatitis B Immunoglobulin (HBIG) 200 IU within 12 h after birth and IM hepatitis B vaccine 10 μg immediately after birth, as well as 1 month and 6 months after birth, respectively. Mother-to-infant HBV transmission was defined as infant HBsAg positivity or detectable HBV DNA at 7 months after birth. Results: Of 4536 pregnant women, the HBsAg carrier rate was 5.49 %( 249/4536 ), which in pregnant women aged>20 years was 4.5 times higher than those aged ≤20 years (5.64 %(247/4382) vs. 1.30%(2/154)); among 249 HBsAg-positive pregnant women, 167 (67.07%) cases had positive HBeAg, 204 (81.93%) had detectable HBV DNA, and 38 (15.26%) had high viral load. The mean HBV DNA, HBsAg and HBeAg levels at baseline in 38 LdT-treated women were 3.37×108 IU/ml, 31793.54 IU/ml and 1450.34 s/co, respectively. At delivery, the serum HBV DNA levels declined by 3.21 log IU/ml(P<0.05), 2 (5.26%) cases whose serum HBV DNA levels were undetectable continued LdT therapy, the mean HBsAg and HBeAg levels were 28263.72 IU/ml and 1036.20 s/co, respectively (P<0.05). 36 cases who had detectable HBV DNA discontinued therapy after delivery, the mean HBV DNA levels increased by 1.85 log IU/ml after discontinuing LdT for 1 month (P<0.05), the mean HBsAg and HBeAg levels were 30310.26 IU/ml and 1592.46s/co, respectively (P>0.05). 39 infants did not appear congenital malformations with normal Apgar score and developmental indicators at birth. At 7 months after birth, no infants developed HBV infection, a 100 %success rate of blocking mother-to-infant transmission of HBV was achieved.
Conclusion: Telbivudine treatment effectively and safely prevents mother-to-infant transmission of HBV from chronically infected mothers with a high degree of infectivity late in pregnancy.

Disclosures:

The following people have nothing to disclose: Qiuju Sheng, Yang Ding, Han Bai, Jingyan Wang, Chong Zhang, Lianrong Zhao, Xiaoguang Dou

StephenW

1864
功效和替比夫定的安全预防母亲向婴儿传播乙肝乙肝病毒感染的孕妇在免疫耐受期
秋菊晟，杨鼎韩伯，井研县王冲张，莲蓉赵晓光斗;
中国医科大学，沉阳，中国附属盛京医院

目的：评价的有效性和替比夫定（LDT）安全预防慢性感染的孕妇母亲对婴儿的乙肝病毒（HBV）的传播在免疫耐受期。
方法：间2010年06月和2011年11月，被列入共有4536乙肝病毒感染的孕妇。 38例HBsAg阳性孕妇高病毒载量（HBV DNA>1.0×107 IU/ ml）的分配接受口服LDT600毫克/天，在28-32周的妊娠。采用罗氏COBAS TaqMan试剂在出厂前进行检测HBV DNA水平，当检测到HBV DNA（HBV DNA>20 IU/ ml）的发生后，LDT治疗分娩后停止;而检测不到HBV DNA出现了，LDT继续治疗。 ALT键，在基线检测母亲乙肝表面抗原，e抗原和HBV DNA水平，交付1个月后交付之前。婴儿出生后收到的IM乙肝免疫球蛋白（HBIG）200IU的12小时之内出生和IM乙肝疫苗后10微克，以及1个月，出生后6个月，分别为。母亲对婴儿的乙肝病毒传播被定义为婴幼儿乙肝表面抗原阳性或检测到HBV DNA在出生后7个月。结果：4536孕妇HBsAg携带率为5.49％（4536分之249），在孕妇年龄> 20年显着高于年龄≤20年的4.5倍（5.64％（4382分之247）与1.30％ （154分之2））;其中249例HBsAg阳性的孕妇，167（67.07％）例HBeAg阳性，204（81.93％）有检测到HBV DNA和38（15.26％）有较高的病毒载量。平均HBV DNA，HBsAg和HBeAg水平基线38 LDT治疗的妇女是3.37×108 IU/ ml时，31793.54 IU/ ml和1450.34 S / CO，分别为。分娩时，由3.21下降的血清HBV DNA水平日志IU/毫升（P <0.05），2（5.26％）情况下，其血清HBV DNA水平检测不到继续LDT治疗，平均HBsAg和HBeAg水平分别为28263.72 IU/ ml和1036.20 S / CO，分别为（P <0.05）。 36案件谁曾检测到HBV DNA的停止治疗分娩后，平均HBV DNA水平上升了1.85 LDT停止1个月（P <0.05），之后登录国际单位/毫升，平均HBsAg和HBeAg水平分别为30310.26 IU/ ml和1592.46s / CO，分别为（P> 0.05）。 39婴儿没有出现先天畸形与正常新生儿Apgar评分，出生时发育指标。在出生后7个月内，没有发达的婴儿HBV感染，阻断母亲向婴儿传播乙肝病毒的100％的成功率达到了。
结论：替比夫定治疗安全有效地防止母亲向婴儿传播乙肝病毒的慢性感染与母亲在怀孕后期高度传染性。