Prevalence of adverse events associated with potent antiretroviral treatment: Swiss HIV Cohort Study
Prevalence of adverse events associated with potent antiretroviral treatment: Swiss HIV Cohort Study
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DOI：
10.1016/s0140-6736(01)06413-3
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发表时间：
2001-10-20
期刊：
影响因子：
168.9
通讯作者：
Telenti, A
中科院分区：
文献类型：
--
作者：
Fellay, J;Boubaker, K;Telenti, A
关于抗逆转录病毒治疗不良事件的数据记录在临床试验、上市后分析和轶事报告中。这些数据可能不是对所有可能被定义为有效抗逆转录病毒治疗的治疗组合的最新或全面评估。方法采用标准的临床和实验室方法，对1160例接受抗逆转录病毒治疗的患者的不良事件发生率进行评估。我们使用多变量分析测量了与药物方案（蛋白酶抑制剂[PI]，非核苷和核苷类似物逆转录酶抑制剂）和特定化合物相关的毒性作用。发现47%（1160例中545例）的患者出现临床不良事件，27%（712例中194例）的患者出现实验室不良事件，可能或肯定归因于抗逆转录病毒治疗。其中，9%（545人中的47人）和16%（194人中的30人）分别被评为严重或严重。单pi和保留pi -抗逆转录病毒治疗与相当的不良事件发生率相关。与单一pi治疗相比，使用双pi -抗逆转录病毒治疗和三级抗逆转录病毒治疗与更高的不良事件发生率相关（比值比[OR] 2.0 [95% CI 1.0-4.0]和3.9[1.2-12.9]）。确定了齐多夫定、拉米夫定、司他夫定、二腺苷、阿巴卡韦、利托那韦、沙奎那韦、因地那韦、奈非那韦、依非韦伦和奈韦拉平的化合物特异性关联。我们记录了HIV-1的抗逆转录病毒治疗引起的高发生率毒性效应。这些数据为方案特异性和化合物特异性不良事件提供了参考，并可用于上市后毒性效应分析。
Background Data on adverse events to antiretroviral treatment have been recorded in clinical trials, postmarketing analyses, and anecdotal reports. Such data might not be an up-to-date or comprehensive assessment of all possible treatment combinations defined as potent antiretroviral treatment.Methods Using a standard clinical and laboratory method, we assessed prevalence of adverse events in 1160 patients who were receiving antiretroviral treatment. We measured the toxic effects associated with the drug regimen (protease inhibitor [PI], non-nucleoside and nucleoside analogue reverse transcriptase inhibitor) and specific compounds using multivariate analyses.Findings 47% (545 of 1160) of patients presented with clinical and 27% (194 of 712) with laboratory adverse events probably or definitely attributed to antiretroviral treatment. Among these, 9% (47 of 545) and 16% (30 of 194), respectively, were graded as serious or severe. Single-PI and PI-sparing-antiretroviral treatment were associated with a comparable prevalence of adverse events. Compared with single-PI treatment, use of dual-PI-antiretroviral treatment and three-class-antiretroviral treatment was associated with higher prevalence of adverse events (odds ratio [OR] 2.0 [95% CI 1.0-4.0], and 3.9 [1.2-12.9], respectively). Compound specific associations were identified for zidovudine, lamivudine, stavudine, didanosine, abacavir, ritonavir, saquinavir, indinavir, nelfinavir, efavirenz, and nevirapine.Interpretation We recorded a high prevalence of toxic effects attributed to antiretroviral treatment for HIV-1. Such data provides a reference for regimen-specific and compound-specific adverse events and could be useful in postmarketing analyses of toxic effects.