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