UC Berkeley-UCSF Graduate Program in Bioengineering, San Francisco and Berkeley, CA, USA.
Department of Bioengineering and Therapeutic Sciences, University of California San Francisco, San Francisco, CA, USA.
Drug Deliv Transl Res. 2017 Dec;7(6):805-816. doi: 10.1007/s13346-017-0391-6.
Oral pre-exposure prophylaxis for the prevention of HIV-1 transmission (HIV PrEP) has been widely successful as demonstrated by a number of clinical trials. However, studies have also demonstrated the need for patients to tightly adhere to oral dosing regimens in order to maintain protective plasma and tissue concentrations. This is especially true for women, who experience less forgiveness from dose skipping than men in clinical trials of HIV PrEP. There is increasing interest in long-acting (LA), user-independent forms of HIV PrEP that could overcome this adherence challenge. These technologies have taken multiple forms including LA injectables and implantables. Phase III efficacy trials are ongoing for a LA injectable candidate for HIV PrEP. This review will focus on the design considerations for both LA injectable and implantable platforms for HIV PrEP. Additionally, we have summarized the existing LA technologies currently in clinical and pre-clinical studies for HIV PrEP as well as other technologies that have been applied to HIV PrEP and contraceptives. Our discussion will focus on the potential application of these technologies in low resource areas, and their use in global women's health.
口服暴露前预防（PrEP）在预防 HIV-1 传播方面取得了广泛的成功，这一点已被多项临床试验所证明。然而，研究也表明，为了保持保护性的血浆和组织浓度，患者需要严格遵循口服剂量方案。对于女性来说，这一点尤其如此，在 HIV PrEP 的临床试验中，与男性相比，女性因剂量漏服而导致的保护效果下降更为明显。人们越来越关注长效（LA）、使用者独立性的 HIV PrEP 形式，这些形式可能会克服这一依从性挑战。这些技术有多种形式，包括 LA 注射剂和植入剂。目前正在进行一项用于 HIV PrEP 的 LA 注射候选药物的 III 期疗效试验。本综述将重点介绍用于 HIV PrEP 的 LA 注射和植入平台的设计考虑因素。此外，我们还总结了目前正在进行 HIV PrEP 临床前和临床研究的 LA 技术，以及已应用于 HIV PrEP 和避孕药具的其他技术。我们的讨论将集中在这些技术在资源匮乏地区的潜在应用，以及它们在全球妇女健康方面的应用。
