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怀孕的艾滋病毒感染者接受抗逆转录病毒疗法的安全数据时间表
William R Short1, Matty M Zimmerman2, Ola Mohamed1
1Division of Infectious Diseases, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
概括
许多抗逆转录病毒药物在FDA批准后缺乏怀孕安全数据. 这些重要药物需要平均6年才能被纳入怀孕安全性分析.
科学领域:
- 药物监督 药物监督 药物监督
- 生殖健康 生殖健康
- 药品安全 药品安全
背景情况:
- 抗逆转录病毒药物对于控制HIV/AIDS至关重要.
- 美国食品和药物管理局 (FDA) 通常在没有全面的怀孕安全数据的情况下批准这些药物.
- 关于在怀孕期间使用抗逆转录病毒药物的有限数据对母亲和婴儿都有风险.
研究的目的:
- 量化FDA对抗逆转录病毒药物的批准和从怀孕登记处获得可靠的安全数据之间的时间滞后.
- 为了突出怀孕期间评估基本药物的安全性的延迟.
主要方法:
- 该研究计算了自FDA批准抗逆转录病毒药物的日期以来的时间间隔.
- 这个间隔被测量,直到这些药物被纳入抗逆转录病毒妊娠登记的前性分析.
- 注册表分析的纳入标准要求至少有200个第一季度的暴露.
主要成果:
- 发现FDA批准和纳入抗逆转录病毒妊娠登记册分析之间的中位延迟是6年.
- 这表明,对于使用这些药物的孕妇来说,产生关键的安全信息存在显著的滞后.
结论:
- 在获得怀孕期间使用抗逆转录病毒药物的足够安全数据后,FDA批准后,有相当大的延迟.
- 这种延迟强调了对孕妇群体必需药物的安全性评估需要加快.
- 需要改进策略,以确保为关键治疗药物及时提供怀孕安全数据.
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