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: 10676833
• 负责人: Rebecca Marie Zash
• 金额: $ 58.64万
• 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/10676833
• 关键词: AIDS prevention; Address; Adherence; Admission activity; Adult; Adverse effects; Africa; Africa South of the Sahara; Appointment; Award; Birth Rate; Botswana; Breast Feeding; Breastfed infant; Caring; 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; 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; Recommendation; Reporting; Reproductive Health; Resistance; 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：预防年轻女性感染艾滋病毒是终结艾滋病毒的关键 流行性。然而，预防策略因口服预防措施依从性差而受到阻碍。 女性暴露预防 (PrEP) 和年轻健康人群实施 PrEP 的困难 与医疗保健系统互动有限的女性。最近的公告称 注射用长效卡博特韦 (CAB-LA) 可导致 9 倍的 与口服 PrEP 相比，女性 HIV 感染率有可能改变 如果 CAB-LA 能够有效实施，艾滋病毒流行的进程将会得到改善。除了识别 有效接触面临艾滋病毒风险的年轻女性的策略、CAB-母乳喂养安全数据 需要 LA 才能在女性中广泛使用。艾滋病毒感染率高的国家也 生育率高，女性生育年龄的 1/3 都处于怀孕状态 哺乳。此外，产后感染艾滋病毒的风险要高出 2-4 倍。 母乳喂养期间预防艾滋病毒也可以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的问题： 评估在入院后的高危女性中开始 CAB-LA PrEP 的策略 产后病房，并将后续 PrEP 服务与产后和产后服务放在同一地点 博茨瓦纳主要母乳喂养人群的儿科护理。产后即刻 这段时期是接触 PrEP 的年轻女性的独特时期，因为她们定期参加活动 医疗保健和保持健康的积极性。除了评估可行性、采用率之外， 为了接受并保留这种方法，我们还将使用 CAB-LA 来衡量 HIV 发病率 在现实世界、艾滋病毒高流行环境中进行 PrEP。这将是第一个评估 CAB-LA 在未感染 HIV 的母乳喂养妇女（及其婴儿）中的药代动力学，以及 这项研究将进行与整合酶的使用相关的额外重要的安全性评估 抑制剂，包括 CAB 对产妇体重和心脏代谢结果的影响，术后 产妇抑郁和婴儿生长。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南并促进艾滋病毒预防策略的进步 为世界各地的女性。