Linking HIV Prevention and post-partum care: Safety, efficacy and feasibility of cabotegravir-LA PrEP in high-risk breastfeeding population in Botswana

将艾滋病毒预防与产后护理联系起来：卡博特韦-LA PrEP 在博茨瓦纳高危母乳喂养人群中的安全性、有效性和可行性

• 批准号: 10403232
• 负责人: Rebecca Marie Zash
• 金额: $ 66.81万
• 依托单位: BETH ISRAEL DEACONESS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-24 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10403232
• 关键词: AIDS prevention; Address; Adherence; Adult; Adverse effects; Africa; Africa South of the Sahara; Appointment; Award; Birth Rate; Botswana; Breast Feeding; Breastfed infant; Caring; Centers for Disease Control and Prevention (U.S.); Child; Childhood; Clinical; Communities; Country; Data; Development; Drug Kinetics; Drug resistance; Effectiveness; Enrollment; Epidemic; Epidemiology; Evaluation; Female Adolescents; Fertility; Formulation; Growth; Guidelines; HIV; HIV Infections; HIV resistance; Healthcare; Healthcare Systems; High Prevalence; High Risk Woman; Human Milk; Hybrids; Incidence; Income; Infant; Infant Care; Infrastructure; Injectable; Injections; Integrase Inhibitors; Lactation; Link; Location; Male Adolescents; Measures; Mothers; Motivation; Observational Study; Oral; Outcome; Outpatients; Persons; Pharmaceutical Preparations; Plasma; Population; Postpartum Depression; Postpartum Period; Postpartum Women; Pregnancy; Prevalence; Prevention Guidelines; Prevention strategy; Public Health; Race; Reporting; Reproductive Health; Resistance to infection; Risk; Safety; Sampling; Scientist; Services; Sexual Health; Site; Tenofovir; Testing; Time; Weight Gain; Woman; cardiometabolism; child bearing; emtricitabine; follow-up; health organization; high risk; implementation barriers; implementation study; innovation; maternal serum; maternal weight; novel; pediatric human immunodeficiency virus infection; postpartum care; pre-exposure prophylaxis; pregnant; prevent; primary caregiver; programs; reproductive; safety study; success; treatment guidelines; uptake; ward; young woman

Project Summary/Abstract: Preventing HIV among young women is key to ending the HIV epidemic. However, prevention strategies have been hampered by poor adherence to oral pre- exposure prophylaxis (PrEP) in women and difficult implementing PrEP for young healthy women who have limited interaction with the healthcare system. The recent announcement that injectable long-acting cabotegravir (CAB-LA) is associated with a 9-fold decrease in the incidence of HIV infection in women compared with oral PrEP has the potential to transform the course of the HIV epidemic if CAB-LA can be effectively implemented. In addition to identifying strategies to efficiently reach young women at risk for HIV, breastfeeding safety data for CAB- LA are needed to achieve widespread use in women. Countries with high HIV prevalence also have high fertility and women spend up to 1/3 of their reproductive years pregnant and breastfeeding. Additionally, HIV acquisition risk is 2-4 times higher during the post-partum period, and preventing HIV during breastfeeding also prevents pediatric HIV infection. We propose to address both implementation challenges and lack of breastfeeding safety data by evaluating a strategy of starting CAB-LA PrEP in high risk women who are admitted to the post- partum ward after delivery, and co-locating follow up PrEP services with post-partum and pediatric care, in a primarily breastfeeding population in Botswana. The immediate post-partum period is a unique time to reach young women with PrEP because they are engaged in regular healthcare and highly motivated to stay healthy. In addition to assessing feasibility, uptake, acceptability and retention of this approach, we will also measure HIV incidence with CAB-LA PrEP in a real-world, high HIV prevalence setting. This will be the first large study to evaluate the pharmacokinetics of CAB-LA in breastfeeding women without HIV (and their infants), and this study will perform additional important safety evaluations related to use of integrase inhibitors, including the impact of CAB on maternal weight and cardiometabolic outcomes, post- partum depression and infant growth. We expect this innovative strategy will be easily scalable, influence HIV prevention guidelines and result in the advancement of HIV prevention strategies for women around the world.

项目摘要/摘要：在年轻女性中预防艾滋病毒是结束艾滋病毒的关键 流行病。然而，预防策略因对口服药的坚持不够而受到阻碍。 妇女暴露预防(PrEP)和健康青年难以实施PrEP 与医疗保健系统互动有限的女性。最近宣布的 注射用长效卡波替格韦(CAB-LA)与减少9倍的 与口服PrEP相比，女性HIV感染的发病率有可能改变 如果CAB-LA能够有效实施，艾滋病毒流行的进程。除了识别 有效接触感染艾滋病毒的年轻女性的战略，为CAB提供母乳喂养安全数据- 要实现在女性中的广泛使用，就需要LA。艾滋病毒高流行率的国家也 生育率高，妇女在生育年限中有1/3怀孕， 母乳喂养。此外，在产后感染艾滋病毒的风险要高出2-4倍 在这一时期，在母乳喂养期间预防艾滋病毒也能预防儿童艾滋病毒感染。我们 建议通过以下方式解决实施挑战和缺乏母乳喂养安全数据 评估在入院后的高危女性中启动CAB-LA PrEP的策略 产后病房，并与产后和产后共同安排PrEP后续服务 儿童护理，在博茨瓦纳以母乳喂养为主的人口中。产后即刻 经期是接触年轻女性进行PrEP的独特时机，因为她们正在进行定期的 医疗保健和保持健康的高度动力。除了评估可行性、吸纳量、 这一方法的可接受性和保留性，我们还将使用CAB-LA来衡量艾滋病毒发病率 在现实世界中准备，艾滋病毒高流行率的环境。这将是第一个评估的大型研究 CAB-LA在未感染艾滋病毒的哺乳妇女(及其婴儿)中的药代动力学 这项研究将进行与使用整合酶相关的其他重要的安全性评估 抑制剂，包括CAB对母亲体重和心脏代谢结果的影响， 产后抑郁与婴儿生长发育。我们预计这一创新战略将很容易扩展， 影响艾滋病毒预防指导方针并导致艾滋病毒预防战略的推进 对世界各地的女性来说。