Sampson Mario R, Troy Stephanie B, Belew Yodit, Arya Vikram, Struble Kimberly A
Division of Clinical Pharmacology 4, Office of Clinical Pharmacology, Office of Translational Sciences Division of Antiviral Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
Curr Opin HIV AIDS. 2020 Jan;15(1):61-65. doi: 10.1097/COH.0000000000000587.
Outline some regulatory considerations and scientific challenges related to the development of long-acting antiretrovirals (ARVs) for the treatment and prevention of HIV-1 infection.
Poor adherence to oral ARV regimens continues to pose challenges for effective treatment and prevention of HIV-1 infection. The development of long-acting ARV modalities for treatment and prevention of HIV-1 infection is emerging as a promising alternative to the current treatment and prevention paradigm and has gained considerable interest.
The development of long-acting ARVs can present some unique drug development challenges. Advance planning and prioritization of studies early in development can facilitate the development of long-acting ARVs for the prevention and treatment of HIV-1 infection for all populations, including pediatric patients and pregnant women.
概述与开发用于治疗和预防HIV-1感染的长效抗逆转录病毒药物（ARV）相关的一些监管考量和科学挑战。
口服抗逆转录病毒治疗方案的依从性差仍然是有效治疗和预防HIV-1感染面临的挑战。开发用于治疗和预防HIV-1感染的长效抗逆转录病毒药物剂型正在成为当前治疗和预防模式的一种有前景的替代方案，并已引起广泛关注。
长效抗逆转录病毒药物的开发可能带来一些独特的药物开发挑战。在开发早期进行预先规划和研究优先级排序，可以促进长效抗逆转录病毒药物的开发，用于所有人群（包括儿科患者和孕妇）的HIV-1感染预防和治疗。
