[Efficacy and safety of telbivudine in pregnant women to prevent perinatal trans

StephenW

Zhonghua Gan Zang Bing Za Zhi. 2012 Mar;20(3):201-5. doi: 10.3760/cma.j.issn.1007-3418.2012.03.013.
[Efficacy and safety of telbivudine in pregnant women to prevent perinatal transmission of hepatitis B virus]. [Article in Chinese]
Han GR, Jiang HX, Wang GJ, Yue X, Wang CM, Kan NY, Wu MM.
Source
Department of Gynecology and Obstetrics, the Second Affiliated Hospital of the Southeast University, Nanjing 210003, China.

Abstract
Objective  To evaluate the efficacy and safety of telbivudine use during the second and third trimester of pregnancy for reducing hepatitis B virus (HBV) transmission from highly viremic hepatitis B e antigen-positive (HBeAg+) mothers to their fetuses. Methods  Pregnant women, between weeks 20 to 32 of gestation, who were HBeAg+ and had HBV DNA more than 1.0*10(7) copies/mL were enrolled in our study. The women were offered inclusion into one of two treatment arms, based upon their personal preference: telbivudine or no telbivudine. The patients in the telbivudine treatment arm were adminstered 600 mg/d tebivudine at least until postpartum week 4. All delivered infants in both treatment arms were administered hepatitis B immune globulin (HBIG; 200 IU) within 12 hours of delivery and recombinant HBV vaccine (20 mug) at 0, 1 and 6 months. The HBV perinatal transmission rate was determined by measuring HBsAg and HBV DNA in infants at postpartum week 28. Results  A total of 220 pregnant women were enrolled in our study, 120 chose the telbivudine arm and 100 chose the control arm. All telbivudine treated subjects were registered in the Antiretroviral Pregancy Registry. Telbivudine treatment was associated with a marked reduction in the mothers' serum HBV DNA, HBeAg and ALT levels before delivery. A striking decline of HBV DNA levels in treated mothers was observed at week 2 of treatment, which was followed by a gradual and steady decrease that continued until delivery. Thirty-seven (31%) of the telbivudine-treated mothers and none (0%) of the untreated controls had polymerase chain reaction-undetectable viremia at delivery. At week 28, 0% of the infants delivered from telbivudine-treated mothers were HBsAg+ or HBV DNA+, as compared to 8% HBsAg+ or HBV DNA+ in the untreated control arm (P = 0.002). No telbivudine discontinuations occurred from adverse events, and no congenital deformities were observed in the infants delivered to telbivudine-treated mothers. Eighty mothers discontinued telbivudine at week 4 postpartum, and there were no cases of severe hepatitis. There were no significant differences between the two treatment arms for postpartum hemorrhage, adverse events during pregnancy, cesarean section, gestational age, or infants' height/weight or Apgar scores.
Conclusions  Telbivudine use during the second and third trimester of pregnancy in HBeAg+ highly viremic mothers can safely reduce perinatal HBV transmission rates. Telbivudine was well-tolerated by our patient group. Furthermore, no safety concerns were observed in either the telbivudine-treated mothers or their delivered infants in short term follow-up.

StephenW

中华肝脏病杂志。 2012 03 20（3）:201-5。 DOI：10.3760/cma.j.issn.1007-3418.2012.03.013。
孕妇替比夫定的疗效和安全，以防止B型肝炎病毒母婴传播。
[文章在中国]
韩遗传资源，HX的江，王国俊，岳，王厘米，阚纽约，吴MM的。
源处，东南大学，南京210003，中国第二附属医院妇产科。

摘要

在怀孕的第二和第三孕期目的评价替比夫定使用的有效性和安全性，降低高度毒血症的B型肝炎B型肝炎病毒（HBV）传输的e抗原阳性（HBeAg阳性）母亲胎儿。方法孕妇，妊娠，为HBeAg +和HBV DNA的超过1.0×10（7）拷贝/毫升，在我们的研究中招收20至32周之间。妇女们提供了一两个治疗武器，根据个人喜好，列入：替比夫定或没有替比夫定。替比夫定治疗组的患者至少直到adminstered，产后4周600毫克/ðtebivudine的。在两个治疗武器的所有管理接生的婴儿乙肝免疫球蛋白（HBIG 200 IU），0，1个月和6个月在12小时内交货，重组乙肝疫苗（20杯）。通过测量婴儿在产后28周HBsAg和HBV DNA，乙肝病毒母婴传播率确定。结果在我们的研究对象，共有220名孕妇，120选择了替比夫定臂控制臂和100选择。所有替比夫定治疗的受试者在抗逆转录病毒妊娠登记处登记。替比夫定治疗，在分娩前母亲的血清HBV  -  DNA，HBeAg和ALT水平显着下降。在对待母亲的HBV DNA水平的一个显着的下降，2周的治疗，这是一个渐进的和稳步下降，直至交付继续观察。三十七岁的替比夫定治疗的母亲并没有未处理对照组（0％）（31％）在交付聚合酶链反应检测不到的病毒血症。在28周，从替比夫定治疗的母亲提供婴儿的0％为HBsAg +或HBV DNA +相比，8％的HBsAg +或HBV DNA在未经处理的控制臂+（p = 0.002）。没有替比夫定停药的不良事件发生，并没有先天畸形在替比夫定治疗的母亲提供婴儿观察。停产4周产后八十母亲替比夫定，并有严重的肝炎病例。有两个治疗组之间没有显着性差异，产后出血，妊娠期间的不良事件，剖宫产，胎龄，或婴幼儿的身高/体重或Apgar评分。结论使用替比夫定在HBeAg阳性+高病毒血症的母亲在怀孕的第二和第三孕期可以安全地降低母婴传播率。替比夫定是我们的病人组耐受性良好。此外，没有安全顾虑的替比夫定治疗的母亲接生的婴儿，或在短期内跟进观察。