Division of Antiviral Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, United States.
Antiviral Res. 2010 Jan;85(1):232-40. doi: 10.1016/j.antiviral.2009.07.016. Epub 2009 Aug 7.
Since the approval of Retrovir, (zidovudine, AZT) in 1987 by the Food and Drug Administration, a number of regulatory initiatives were codified into regulation which contributed to the rapid development of new treatments for HIV-1 infection. These initiatives are a testament to the efforts of AIDS activists and regulators to improve access to drugs for serious and life-threatening diseases. Currently, 28 antiretroviral drugs and combinations of antiretrovirals are available to treat HIV-1 infection. The broadening armamentarium of approved antiretroviral drugs provides new options and more choices for physicians and HIV patients. Importantly, the introduction of these newly approved HIV drugs has shown that the majority of HIV-1-infected treatment-naïve and treatment-experienced patients can achieve maximal virologic suppression (less than 50 copies/mL HIV-1 RNA). This article describes the past and current regulatory challenges in the development of new HIV treatments and provides an overview of the drug regulations that were required for the approval of HIV drugs. This article forms part of a special issue of Antiviral Research marking the 25th anniversary of antiretroviral drug discovery and development, Vol 85, issue 1, 2010.
自 1987 年美国食品和药物管理局批准（叠氮胸苷，AZT）以来，许多监管措施被编纂成法规，这促进了新的 HIV-1 感染治疗方法的快速发展。这些举措证明了艾滋病活动家和监管机构为改善严重和危及生命的疾病药物的可及性所做的努力。目前，有 28 种抗逆转录病毒药物和抗逆转录病毒药物组合可用于治疗 HIV-1 感染。批准的抗逆转录病毒药物的武器库不断扩大，为医生和 HIV 患者提供了新的选择和更多的选择。重要的是，这些新批准的 HIV 药物的引入表明，大多数 HIV-1 感染的初治和经治患者都可以实现最大的病毒学抑制（HIV-1 RNA 低于 50 拷贝/mL）。本文描述了新的 HIV 治疗方法开发中的过去和当前监管挑战，并概述了批准 HIV 药物所需的药物法规。本文是抗病毒研究特刊的一部分，该特刊纪念抗逆转录病毒药物发现和开发 25 周年，第 85 卷，第 1 期，2010 年。
