AASLD2014:临床结果（TDF）治疗与不治疗孕妇有慢性活动性乙型

StephenW

1862Clinical outcomes of tenofovir disoproxil fumarate (TDF) treatment versus no treatment for pregnant women with active chronic hepatitis B (CHB) and elevated alanine aminotransaminase (ALT)Wei Yi1, Calvin Q. Pan2, Min Liu1, Haodong Cai1;1Department of Obstetrics and gynaecology, Beijing Ditan Hospital, Capital Medical University, Beijing, China; 2Division of Gastroenterology and Hepatology, NYU Langone Medical Center, NYU School of Medicine, Flushing, NYAntiviral therapy for CHB during pregnancy remains a challenge as the safety data is limited. We evaluated the safety use of TDF for the entire pregnancy in managing mothers with elevated ALT. Methods: Mothers with active CHB who started or switched to TDF at the first trimester and mothers who preferred no treatment during pregnancy were enrolled. Patients were prospectively followed until postpartum week 28. Primary endpoints were safety of mothers and infants. Secondary end points were HBV DNA suppression with ALT normalization throughout the pregnancy and vertical transmission rates. Results: Among 139 mothers screened, 85 were enrolled with 39 mothers who received TDF and 46 mothers who were untreated. Their baseline values are shown in table 1. The mean (range) duration of TDF exposure for the treated group was 38 (28-41) weeks. TDF was well tolerated without significant adverse events (>grade II). Prior to the delivery, mean (SD) serum creatine levels were 52.92 (±8.36) mmol/L in the TDF group vs. 50.55 (±9.89) mmol/L in the untreated group (p=0.242); The serum phosphorus levels were similar between the treated and untreated groups (1.07 vs. 1.06 mmol/L, p=0.763); a complete virologic response (HBV DNA<500 copies/mL) was achieved in 38/39 (97.4%) patients on TDF treated vs. 2.2 %in the untreated group (p<0.001); ALT normalization was observed in 97.4 %in the TDF group vs. 56.5 %in the untreated group (p<0.001). The birth defect/congenital malformation rates were similar when comparing infants in the treated vs. untreated group (2.6 %vs. 2.2%, p=1.000). The infant baselines are also shown in table 1. Both infant groups received appropriate immunoprophylaxis and completed the follow ups. At the age 28 weeks, lower percentage of infants with HBsAg+ was observed in the TDF group vs. those in the untreated group (0 %vs. 6.5%, p=0.246). Conclusion: TDF treatment for entire pregnancy was safe for both mothers and infants. TDF therapy suppressed maternal viremia with normalization of ALT and may reduce immunoprophylaxis failure in infants.
Table 1. Baseline values

Disclosures:
Calvin Q. Pan - Advisory Committees or Review Panels: BMS, Gilead; Consulting: BMS, Gilead, Merck, Abbvie, Janssen ; Grant/Research Support: BMS, Gilead, Genentech, Merck; Speaking and Teaching: BMS, Gilead, Onyx
The following people have nothing to disclose: Wei Yi, Min Liu, Haodong Cai

StephenW

1862
的富马酸替诺福韦酯的临床结果（TDF）治疗与不治疗对孕妇有慢性活动性乙型肝炎（CHB）和升高的丙氨酸aminotransaminase（ALT）
魏毅，卡尔文问：Pan2，闵柳1，郝董才1;
教研室妇产科，北京地坛医院，首都医科大学，北京，中国;胃肠病学和肝病，纽约大学Langone医学中心，纽约大学医学院，纽约法拉盛的2区

抗病毒治疗慢性乙型肝炎在怀孕期间仍然是一个挑战，因为安全性数据是有限的。我们评估了安全使用TDF的整个孕期中ALT升高管理的母亲。方法：用积极的慢性乙肝母亲谁启动或切换到TDF在孕早期和母亲谁愿意在怀孕期间不接受任何治疗的患者。患者进行前瞻性随访至产后28周主要终点为母亲和婴儿的安全。次要终点为HBV DNA抑制在整个孕期ALT复常和母婴垂直传播率。结果：筛选出139的母亲，85人报读谁收到TDF39的母亲和46的母亲谁是未经处理的。其基准值示于表1。TDF曝光为治疗组的平均值（范围）的持续时间为38（28-41）个星期。 TDF耐受性良好，没有显著不良事件（>Ⅱ级）。在此之前交付，平均（SD）血清肌酸水平分别为52.92（±8.36）mmol / L的的TDF组与50.55（±9.89）mmol / L的模型组（P =0.242）;血清磷水平处理和未处理组（1.07与1.06毫摩尔/ L，P=0.763）之间的相似;一个完整的病毒学应答（HBV DNA<500拷贝/毫升）在38/39（97.4％）患者TDF模型组（P <0.001），治疗与2.2％实现; ALT复常观察到97.4％的华盈集团与56.5％，在模型组（P<0.001）。比较在处理与未处理组的婴儿在出生缺陷/先天性畸形的发生率相似（2.6％对2.2％，P =1.000）。婴儿基线也示于表1。两个婴儿组接受相应的免疫预防和完成后续起坐。在年龄28周，婴儿的HBsAg+的比例较低观察TDF集团在与这些模型组（0％对6.5％，P =0.246）。结论：TDF治疗整个孕期是安全的母亲和婴儿。 TDF治疗抑制母体的病毒血症与ALT正常化，并可能降低免疫预防失败的婴儿。

表1基线值
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披露：

卡尔文问：泛 - 咨询委员会或审查小组：BMS，基列;咨询：BMS，Gilead公司，默克公司，Abbvie，扬森;格兰特/研究支持：BMS，Gilead公司，基因泰克，默沙东;口语和教学：BMS，基列，玛瑙

下面的人都没有透露：卫衣，闵刘，蔡浩东

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