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艾滋病2016年研究着眼于HIV PrEP的使用之前和期间怀孕和哺乳 [复制链接]

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发表于 2016-8-26 18:18 |只看该作者 |倒序浏览 |打印
                                                                                AIDS 2016: Study Looks at Use of HIV PrEP Before and During Pregnancy and Breastfeeding                                                               
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                 Details                                                                                Category: Pre-exposure Prophylaxis (PrEP)                                                                Published on Thursday, 25 August 2016 00:00                                                        Written by Liz Highleyman               
                                                                                               

Image courtesy HIVE/UCSF


                                       
               
               
                Truvada for pre-exposure prophylaxis (PrEP) when it was offered as an additional tool for preventing HIV infection during the pre-conception period, pregnancy, and breastfeeding, according to study findings presented at the 21st International AIDS Conference (AIDS 2016) last month in Durban and published in the July 19 online edition of the American Journal of Obstetrics and Gynecology.

        Transmission of HIV to the negative partner is a concern when serodiscordant heterosexual couples wish to conceive. Some couples opt for assisted reproductive technology such as "sperm washing" (separating individual sperm from semen) and artificial insemination, but these are expensive and not widely available.
        Given the development of highly effective antiretroviral therapy (ART) that maintains viral suppression -- and the growing recognition that people on treatment with undetectable viral load probably cannot transmit HIV through sex -- "treatment as prevention" may be enough to protect the HIV-negative partner when trying to conceive naturally. But adding PrEP offers an extra measure of protection, for example if the positive partner misses medication doses or experiences viral "blips" for other reasons. If the woman is HIV-negative, protecting her from infection also protects the baby, as recent infection is associated with high viral load that makes mother-to-child HIV transmission more likely.
        Once-daily Truvada (tenofovir/emtricitabine) was approved for HIV prevention based on findings from clinical trials, including the iPrEx study of mostly gay and bisexual men and the Partners PrEPstudy of serodiscordant heterosexual couples, showing that PrEP reduces the risk of HIV infection by 90% or more if used consistently.
        To date there have been no randomized controlled studies of Truvada or tenofovir PrEP for pregnant women or those trying to conceive; these are unlikely in the future for ethical and logistical reasons. In PrEP clinical trials women generally stopped the drugs if they became pregnant, and there are no published reports of PrEP use after 7 weeks gestation or during lactation. 

        However, tenofovir disoproxil fumarate and emtricitabine have been used by thousands of HIV-positive pregnant women over many years as part of antiretroviral treatment. Observational studies and data from the Antiretroviral Pregnancy Registry do not show increased likelihood of birth defects or adverse pregnancy outcomes. These drugs are regarded as generally safe and well-tolerated for both mothers and fetuses, though there is some evidence that infants born to women who take tenofovir during pregnancy may be smaller and have reduced bone density. The Microbicide Trials Network's ongoing EMBRACE study (MTN-016) hopes to shed more light on the safety of PrEP during pregnancy.
        Dominika Seidman from the University of California at San Francisco, Shannon Weber of HIVE (who presented the findings at AIDS 2016), and colleagues aimed to characterize use of Truvada for PrEP and to identify gaps in HIV prevention services for women at risk of HIV before conception and during pregnancy and breastfeeding.
        Pregnancy is an important opportunity to assess women for HIV risk. Many women who do not otherwise receive regular medical care do seek care when they become pregnant, and many may remain at ongoing risk for HIV infection after giving birth.
        The researchers performed a retrospective chart review of 27 women considered to be at "substantial risk" for HIV infection who received care at 2 centers -- the University of California at San Francisco and Montefiore Medical Center in the Bronx, New York City -- between 2010 and 2015. If eligible they were referred to specialty clinics for women living with or at risk of HIV that started offering PrEP in 2010
        Women were identified by clinicians, health educators, and health departments. The median time from identification as being at "substantial risk" to consultation was 30 days, and 2 women were lost to follow-up before consultation.
        About two-thirds (18 women) were identified when they were already pregnant, at a median of 5 months gestation; none had received counseling about safer conception to reduce HIV risk. About a third (8 women) were identified pre-conception and 1 was identified during the post-partum period.
        The median age was 27 years; 12 were Latina, 5 were black, 4 were white, 2 were Asian, and 4 were of other races/ethnicities. Just over half had unstable housing, 22% had ongoing intimate partner violence, 22% were active substance users, and 44% had a history of mental health issues.
        All but 1 had HIV-positive partners, and the remaining woman had a male partner who had sex with men. Among the HIV-positive partners 19 (73%) were on ART and 11 (42%) had documented viral suppression; of the remainder, 10 (39%) had known detectable virus and 5 (19%) had unknown viral loads.
        A majority of women were assessed for post-exposure prophylaxis (PEP), but nearly a third were not asked about their recent HIV exposures. Of those assessed, 7 were deemed eligible and 4 of them were offered PEP, but only 2 started taking it.
        Among the 24 women who were offered daily Truvada PrEP, 16 (67%) chose to use it. Among the rest, two-thirds chose to use condoms, over half relied on their partner's treatment-as-prevention, and a fifth relied on abstinence. The likelihood of accepting PrEP was similar before conception and during pregnancy.
        The median length of time on PrEP was 30 weeks. Half the women reported some challenges maintaining good adherence, with a third each citing side effects, social stressors, and difficulty taking daily pills. The researchers did not identify any PrEP-related pregnancy complications. There was only 1 HIV seroconversion, in a woman not taking PrEP.
        Half the women on PrEP chose to breastfeed, as did half of those not taking PrEP. Among the women who were in care at the time of delivery, half did not attend a post-partum follow-up visit, so their long-term outcomes are unknown.
        In their conference poster the researchers described 3 "missed opportunities":
  •                 A woman came to the emergency department after an assault when she was 27 weeks pregnant. She said her partner was living with HIV and not on ART. However, she was not offered PEP or PrEP and was lost to follow-up.
  •                 A second woman was diagnosed with syphilis at 32 weeks into pregnancy. She had multiple partners, some of whom were HIV-positive, was homeless, engaged in exchange sex, and used methamphetamine. She was treated for syphilis and had multiple prenatal care visits, but was never offered PEP or PrEP and was also lost to follow-up.
  •                 A third woman was identified as being at high risk for HIV infection, with an HIV-positive partner, but was not referred for PrEP due to pregnancy complications including fetal anomalies. She remained in care and was HIV-negative at the time of delivery, but her infant later died. She was lost to follow-up but returned to care at 10 months post-partum and was diagnosed with HIV.
        "Women at 2 United States centers frequently chose to use pre-exposure prophylaxis for HIV prevention when it was offered preconception and during pregnancy and lactation," the study authors concluded.
        "Further research and education are needed to close critical gaps in screening for women who are at risk of HIV for pre- and post-exposure prophylaxis eligibility and gaps in care linkage before and during pregnancy and lactation," they added. "Post-partum women are particularly vulnerable to loss-to-follow-up and miss opportunities for safe and effective HIV prevention."
        8/25/16
        References
        D Seidman, S Weber, K Oza, et al. Use of HIV pre-exposure prophylaxis during pregnancy and lactation at 2 U.S. centers. 21st International AIDS Conference. Durban, July 18-22, 2016. Abstract WEPEC195.
        D Seidman, S Weber, MT Timoney, et al. Use of HIV pre-exposure prophylaxis during the preconception, antepartum and postpartum periods at two United States medical centers. American Journal of Obstetrics and Gynecology. July 19, 2016 (online ahead of print).
       

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发表于 2016-8-26 18:19 |只看该作者
艾滋病2016年研究着眼于HIV PrEP的使用之前和期间怀孕和哺乳

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细节
    类别:暴露前预防(PrEP的)
    发布时间周四,2016年8月25日00:00
    撰写由Liz Highleyman

ALT

图片提供HIVE / UCSF

特鲁瓦达的,当它被提出作为孕前期,妊娠期和哺乳期间预防艾滋病毒感染的额外工具暴露前预防(PrEP的),根据研究在第21届国际艾滋病大会(艾滋病2016)提出的调查结果于上月在德班,并发表在美国妇产科杂志的7月19日网络版上。

艾滋病毒传染给伴侣负时血清不一致异性夫妇希望受孕的关注。一些夫妇选择辅助生殖技术例如“精洗”(从精液中分离个体精子)和人工授精,但这些是昂贵的并且不能广泛使用。

鉴于保持抑制病毒的高效抗逆转录病毒疗法(ART)的发展 - 以及人们日益认识到,人们在处理与检测不到病毒载量可能无法通过性行为传播艾滋病病毒 - “治疗预防”可能不足以保护艾滋病毒尝试自然受孕时负的合作伙伴。但是,增加的PrEP提供额外的保护措施,例如,如果积极的合作伙伴错过用药剂量或遇到病毒“光点”其他原因。如果女人是HIV阴性,保护她不受感染还可以保护宝宝,因为近期感染与病毒载量高,使母亲对孩子的艾滋病毒传播的可能性有关。

每日一次特鲁瓦达(替诺福韦/恩曲他滨)被批准为基于临床试验,其中大多是同性恋和双性恋男子的iPrEx研究和血清不一致异性伴侣的合作伙伴准备学习,这表明PrEP的降低HIV感染风险的发现艾滋病预防由90%或更多,如果一致地使用。

迄今为止,已为孕妇或那些试图受孕特鲁瓦达或替诺福韦的PrEP的随机对照研究;这些都不太可能在未来的伦理和后勤方面的原因。在PrEP的临床试验中女性普遍停止了药物,如果他们怀孕了,有学前班没有公布的报告后7周的妊娠或哺乳期间使用。

然而,富马酸替诺福韦酯和恩曲他滨已被用于数千名HIV呈阳性的孕妇多年来作为抗逆转录病毒治疗的一部分。从抗逆转录病毒妊娠登记处观察性研究和数据不显示出生缺陷或不良妊娠结局的可能性增加。这些药物被视为一般安全和耐受性良好的母亲和胎儿,虽然有一些证据表明,出生谁采取替诺福韦在怀孕期间可能会更小,减少骨质密度的妇女的婴儿。该杀菌剂试验网络的不断EMBRACE研究(MTN-016)希望在怀孕期间阐明的PrEP安全更多的光。

从加州大学旧金山分校,HIVE的香农·韦伯(谁在艾滋病2016年提出的调查结果),和他的同事多米妮卡塞德曼旨在表征使用特鲁瓦达为准备和在之前感染HIV的风险识别,为妇女艾滋病预防服务的差距受孕和怀孕和哺乳期间。

怀孕是评估妇女艾滋病毒风险的重要契机。谁不否则定期接受医疗照顾很多女性就医时,他们怀孕,许多可能保持在分娩后感染艾滋病持续的风险。

研究人员进行了回顾性分析认为是在谁的2个中心接受治疗“重大风险”艾滋病毒感染的27名妇女的 - 加州大学旧金山和Montefiore医疗中心大学在布朗克斯,纽约 - 之间2010年和2015年。如果他们有资格被称为专科诊所为患有或感染艾滋病毒风险的妇女是在2010年开始提供的PrEP

妇女被临床医生,健康教育,卫生等部门鉴定。从识别为处于“重大风险”来诊的中位时间为30天,2名妇女失去了后续协商之前。

约三分之二(18女),当他们已经​​怀孕,在5个月妊娠的中位数进行鉴定;没有收到咨询有关安全的概念,以减少感染艾滋病的风险。约三分之一(8名妇女)被确定受孕前和1在产后期被确定。

平均年龄为27岁; 12人拉丁,5是黑人,4是白人,2人是亚裔,4例其他种族/族裔的。超过一半有不稳定的住房,22%有持续的亲密伴侣暴力,22%的活性物质用户,44%有心理健康问题的历史。

所有,但1例HIV阳性合作伙伴,其余的女人有一个男性伴侣谁曾与男性发生性关系。其中HIV阳性合作伙伴19(73%)是对艺术和11(42%)以前的病毒抑制;余量,10(39%)已公知的可检测的病毒和5(19%)的具有未知的病毒载量。

大多数妇女被评定为暴露后预防(PEP),但近三分之一没有问他们最近HIV风险。这些评价中,有7被认为合格,其中4人提供了PEP,但只有2开始服用。

在被提供日常特鲁瓦达PrEP的谁的24名妇女,16(67%)选择使用它。在其他地区,三分之二选择使用避孕套,一半以上对他们的伴侣的治疗作为预防依赖,以及第五依靠禁欲。接受学前班的可能性是受孕前和怀孕期间相似。

时间对PrEP的平均长度为30周。有一半的妇女报告的一些挑战,保持良好的粘附,用各占三分之一援引副作用,社会压力和困难,每日服用药片。研究人员没有发现任何的PrEP相关的妊娠并发症。现在只有1 HIV血清学转换,在一个女人不采取PrEP的。

一半的PrEP的妇女选择母乳喂养​​,就像那些未服用PrEP的一半。其中谁在照顾在分娩时妇女,半天没参加产后随访,所以他们的长期结果是未知的。

在他们的会议的海报,研究人员描述3“失去的机会”:

    一个女人来到急诊科的攻击后,当她是27周的孕妇。她说她的合伙人感染艾滋病毒,而不是艺术。但是,她没有提供PEP或准备和丢失跟进。
    第二个女人32周时查出患有梅毒成孕。她有多个合作伙伴,其中一些人是HIV阳性,无家可归,从事交流性行为,使用甲基苯丙胺。她被治疗梅毒和曾多次产前检查的访问,但从未提供PEP或准备和也失去了跟进。
    第三个女子被确定为感染艾滋病的高风险,与HIV阳性的合作伙伴,但没有因怀孕并发症,包括胎儿异常转诊PrEP的。她留在护理和在交货时HIV阴性,但她的婴儿后死亡。她失去了随访,但回到10个月产后照顾,被诊断为HIV。

“妇女在2美国中心通常选择使用接触前预防的,当它被提供孕前和孕期和哺乳期艾滋病预防,”该研究的作者总结说。

“进一步的研究和教育需要关闭主要差距在筛查的妇女谁在为前和暴露后感染HIV的风险预防护理连锁资格和缺口前,怀孕和哺乳期间,”他们补充道。 “产后的妇女特别容易流失到跟进和安全有效的艾滋病预防错过的机会。”

16年8月25日

参考

ð塞德曼,S·韦伯,K皇座,等。艾滋病暴露前使用妊娠和哺乳在2美国中心期间预防。第21届国际艾滋病大会。德班,7月18日至22日,2016年摘要WEPEC195。

ð塞德曼,S·韦伯,MT蒂莫尼等。艾滋病暴露前的使用过程中的两个美国医疗中心孕前,产前及产后期预防。美国妇产科杂志的。 2016年7月19日(提前在网上打印)。
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