Highly active antiretroviral therapy in a large urban clinic: Risk factors for virologic failure and adverse drug reactions
Highly active antiretroviral therapy in a large urban clinic: Risk factors for virologic failure and adverse drug reactions
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DOI：
10.7326/0003-4819-131-2-199907200-00002
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发表时间：
1999-07-20
影响因子：
39.2
通讯作者：
Moore, RD
中科院分区：
文献类型：
--
作者：
Lucas, GM;Chaisson, RE;Moore, RD
背景：在临床试验中，高效抗逆转录病毒疗法 (HAART) 可将 60% 至 90% 的 HIV-1 感染患者血浆 HIV-1 RNA 水平降低至 500 拷贝/mL 以下。这种疗法在临床试验之外的表现尚不清楚。目的：在大型城市诊所开始接受含有蛋白酶抑制剂的治疗的一组患者中，确定与抑制 HIV-1 RNA 水平失败和药物不良反应相关的因素。设计：回顾性队列研究。地点：马里兰州巴尔的摩的约翰·霍普金斯 HIV 诊所。患者：273 名未使用过蛋白酶抑制剂的患者开始服用至少含有一种其他抗逆转录病毒药物的蛋白酶抑制剂治疗方案测量：人口统计学变量、血浆 HIV-1 RNA 水平、CD4(+) 淋巴细胞计数和药物不良反应。结果：在 1 至 90 天时，队列中 42% 的人检测不到 HIV-1 RNA 水平，在 3 至 7 个月时，44% 的人，在 7 至 14 个月时，37% 的人检测不到 HIV-1 RNA 水平。与在两个或多个时间点抑制病毒载量失败相关的因素包括较高的漏诊率、非白人种族、年龄在 40 岁或以下、注射药物使用、较低的基线 CD4(+) 淋巴细胞计数和较高的基线病毒载量。在多变量模型中，只有较高的漏诊率与 1 年时的病毒抑制独立相关。利托那韦与药物不良反应相关的频率约为茚地那韦或奈非那韦的两倍，并且女性经历的不良反应明显多于男性。结论：在临床环境中开始HAART的未经选择的患者实现病毒抑制的频率远低于对照临床试验中患者的频率。错过就诊是未能抑制 HIV-1 RNA 水平的最重要的风险因素。需要进行研究来确定能够最大限度地提高市中心诊所的 HAART 效果的干预措施。
Background: In clinical trials, highly active antiretroviral therapy (HAART) reduces plasma HIV-1 RNA levels to less than 500 copies/mL in 60% to 90% of patients with HIV-1 infection. The performance of such therapy outside of the clinical trial setting is unclear.Objective: To determine factors associated with failure to suppress HIV-1 RNA levels and adverse drug reactions in a cohort of patients in whom protease inhibitor-containing therapy was begun in a large urban clinic.Design: Retrospective cohort study.Setting: Johns Hopkins HIV Clinic in Baltimore, Maryland.Patients: 273 protease inhibitor-naive patients began taking a protease inhibitor regimen containing at least one other antiretroviral drug to which the patients had not previously been exposed.Measurements: Demographic variables, plasma HIV-1 RNA levels, CD4(+) lymphocyte counts, and adverse drug reactions.Results: Levels of HIV-1 RNA were undetectable in 42% of the cohort at 1 to 90 days, in 44% at 3 to 7 months, and in 37% at 7 to 14 months. Factors associated with failure to suppress viral load at two or more time points included higher rates of missed clinic appointments, nonwhite ethnicity, age 40 years or younger, injection drug use, lower baseline CD4(+) lymphocyte count, and higher baseline viral load. In a multivariate model, only higher rates of missed clinic appointments were independently associated with viral suppression at 1 year. Ritonavir was associated with adverse drug reactions about twice as frequently as indinavir or nelfinavir, and women experienced significantly more adverse effects than men.Conclusions: Unselected patients in whom HAART is started in a clinic setting achieve viral suppression substantially less frequently than do patients in controlled clinical trials. Missed clinic visits were the most important risk factor for failure to suppress HIV-l RNA levels. Studies are needed to identify interventions that maximize the performance of HAART in inner-city clinics.