FDA修订Viread怀孕数据：'不会增加不良后果的风险'

StephenW

FDA News
FDA revises Viread pregnancy data: ‘no increased risk for adverse outcomes’
April 25, 2019

The FDA approved revisions to the Viread product labeling to include safety and pregnancy-related outcome data from three published trials in pregnant women with chronic hepatitis B.

The update reads as follows: “Published studies in HBV-infected subjects do not report an increased risk of adverse pregnancy-related outcomes with the use of Viread during the third trimester of pregnancy.”

The controlled trials comprised 327 women who received Viread (tenofovir disoproxil fumarate or TDF, Gilead) between 28 weeks to 32 weeks gestation through 1 month to 2 months postpartum and followed for up to 12 months after delivery.

Results showed no new safety findings and no increased risk for adverse pregnancy-related outcomes in pregnant women compared with the known safety profile of TDF.

Researchers reported two stillbirths, one case of talipes, and one occurrence of multiple congenital abnormalities in infants exposed to TDF. At 12 months follow-up of the full cohort of infants, the researchers found no clinically relevant drug-related safety findings.



Reference: www.fda.gov

StephenW

FDA新闻
FDA修订Viread怀孕数据：'不会增加不良后果的风险'
2019年4月25日

美国食品和药物管理局批准对Viread产品标签进行修订，以包括三项已发表的慢性乙型肝炎孕妇试验的安全性和妊娠相关结果数据。

更新内容如下：“HBV感染受试者的已发表研究未报告妊娠晚期使用Viread导致不良妊娠相关结局的风险增加。”

对照试验包括327名女性，她们在妊娠28周至32周之间，产后1个月至2个月内接受Viread（替诺福韦地索普西富马酸盐或TDF，Gilead），并在分娩后随访12个月。

结果显示，与已知的TDF安全性相比，孕妇没有新的安全性发现且妊娠期不良妊娠相关结局的风险增加。

研究人员报告了暴露于TDF的婴儿中有两例死产，一例是talipes，另一例是多发性先天性异常。在对整个婴儿队列进行随访12个月后，研究人员发现没有临床相关的药物相关安全性发现。



参考：www.fda.gov