Portsmouth S D, Osorio J, McCormick K, Gazzard B G, Moyle G J
Department of HIV Medicine, Chelsea and Westminster Hospital, London, UK.
HIV Med. 2005 May;6(3):185-90. doi: 10.1111/j.1468-1293.2005.00287.x.
Adherence to antiretroviral therapy is critical to treatment outcomes. Adherence studies in other therapeutic areas of medicine suggest that once-daily regimens support improved adherence when compared to twice-daily therapy. An expansion in the range of once-daily antiretrovirals is making once-daily therapy possible for persons with HIV infection.
A 24-week randomized open-label simplification study of twice-daily regimens based on stavudine immediate release or zidovudine to an all once-daily regimen based on the stavudine prolonged-release capsule (PRC), in persons with complete virological suppression on regimens also including efavirenz and lamivudine, was carried out. Subjects were assessed for adherence [using the Medication Event Monitoring System (MEMS) cap; Aardex Corporation, Union City, CA, USA], quality of life, tolerability and efficacy.
Forty-three patients were randomly assigned: 21 remained on their original regimen and 22 switched to once-daily therapy with stavudine PRC. Although high levels of adherence and good quality of life were present at study enrollment, adherence declined to a significantly lesser extent at week 24 in the group that switched to once-daily therapy. Efficacy was maintained in both groups and there were no differences in tolerability or toxicity.
Subjects switching from twice-daily therapy to once-daily therapy demonstrate less of a decline in adherence over 24 weeks. A once-daily regimen including stavudine PRC is as effective and tolerable as a regimen containing the twice-daily formulation.
坚持抗逆转录病毒治疗对治疗效果至关重要。医学其他治疗领域的依从性研究表明，与每日两次治疗相比，每日一次的治疗方案有助于提高依从性。每日一次抗逆转录病毒药物种类的增加使HIV感染者采用每日一次治疗成为可能。
对在包含依非韦伦和拉米夫定的治疗方案下实现完全病毒学抑制的患者，开展了一项为期24周的随机开放标签简化研究，将基于司他夫定速释片或齐多夫定的每日两次治疗方案简化为基于司他夫定缓释胶囊（PRC）的全每日一次治疗方案。使用药物事件监测系统（MEMS）帽（美国加利福尼亚州联合市Aardex公司）评估受试者的依从性、生活质量、耐受性和疗效。
43例患者被随机分组：21例维持原治疗方案，22例换用司他夫定PRC每日一次治疗。尽管研究入组时两组的依从性水平都很高且生活质量良好，但换用每日一次治疗的组在第24周时依从性下降程度明显较小。两组的疗效均得以维持，耐受性和毒性方面无差异。
从每日两次治疗转换为每日一次治疗的受试者在24周内依从性下降幅度较小。包含司他夫定PRC的每日一次治疗方案与包含每日两次剂型的方案一样有效且耐受性良好。
