Department of Infectious Diseases and Clinical Microbiology, Marmara University, Istanbul, Turkey.
Department of Infectious Diseases and Clinical Microbiology, Ege University, Izmir, Turkey.
AIDS Res Ther. 2021 Jan 9;18(1):4. doi: 10.1186/s12981-020-00328-6.
There is limited evidence on the modification or stopping of antiretroviral therapy (ART) regimens, including novel antiretroviral drugs. The aim of this study was to evaluate the discontinuation of first ART before and after the availability of better tolerated and less complex regimens by comparing the frequency, reasons and associations with patient characteristics.
A total of 3019 ART-naive patients registered in the HIV-TR cohort who started ART between Jan 2011 and Feb 2017 were studied. Only the first modification within the first year of treatment for each patient was included in the analyses. Reasons were classified as listed in the coded form in the web-based database. Cumulative incidences were analysed using competing risk function and factors associated with discontinuation of the ART regimen were examined using Cox proportional hazards models and Fine-Gray competing risk regression models.
The initial ART regimen was discontinued in 351 out of 3019 eligible patients (11.6%) within the first year. The main reason for discontinuation was intolerance/toxicity (45.0%), followed by treatment simplification (9.7%), patient willingness (7.4%), poor compliance (7.1%), prevention of future toxicities (6.0%), virologic failure (5.4%), and provider preference (5.4%). Non-nucleoside reverse transcriptase inhibitor (NNRTI)-based (aHR = 4.4, [95% CI 3.0-6.4]; p < 0.0001) or protease inhibitor (PI)-based regimens (aHR = 4.3, [95% CI 3.1-6.0]; p < 0.0001) relative to integrase strand transfer inhibitor (InSTI)-based regimens were significantly associated with ART discontinuation. ART initiated at a later period (2015-Feb 2017) (aHR = 0.6, [95% CI 0.4-0.9]; p < 0.0001) was less likely to be discontinued. A lower rate of treatment discontinuation for intolerance/toxicity was observed with InSTI-based regimens (2.0%) than with NNRTI- (6.6%) and PI-based regimens (7.5%) (p < 0.001). The percentage of patients who achieved HIV RNA < 200 copies/mL within 12 months of ART initiation was 91% in the ART discontinued group vs. 94% in the continued group (p > 0.05).
ART discontinuation due to intolerance/toxicity and virologic failure decreased over time. InSTI-based regimens were less likely to be discontinued than PI- and NNRTI-based ART.
目前有关抗逆转录病毒疗法（ART）方案的调整或停药的证据有限，包括新型抗逆转录病毒药物。本研究旨在通过比较首次治疗 1 年内方案的停药频率、原因及其与患者特征的相关性，评估在有更好耐受性和更简单方案的情况下，ART 方案的停药情况。
研究纳入了 2011 年 1 月至 2017 年 2 月在 HIV-TR 队列中登记且首次接受 ART 的 3019 例 ART 初治患者。仅纳入每位患者首次治疗 1 年内的首次方案调整进行分析。原因按在线数据库中的编码形式进行分类。采用竞争风险函数分析累积发生率，采用 Cox 比例风险模型和 Fine-Gray 竞争风险回归模型分析与 ART 方案停药相关的因素。
在 3019 例符合条件的患者中，有 351 例（11.6%）在首次治疗 1 年内停用了初始 ART 方案。停药的主要原因为不耐受/毒性（45.0%），其次为治疗简化（9.7%）、患者意愿（7.4%）、依从性差（7.1%）、预防未来毒性（6.0%）、病毒学失败（5.4%）和医生建议（5.4%）。与整合酶抑制剂（INSTI）为基础的方案相比，非核苷类逆转录酶抑制剂（NNRTI）为基础的（aHR=4.4，95%CI 3.0-6.4；p<0.0001）或蛋白酶抑制剂（PI）为基础的（aHR=4.3，95%CI 3.1-6.0；p<0.0001）方案更易导致 ART 停药。较晚时期（2015 年 2 月至 2017 年 2 月）开始 ART（aHR=0.6，95%CI 0.4-0.9；p<0.0001）与 ART 停药的可能性降低相关。INSTI 为基础的方案与 NNRTI （6.6%）和 PI （7.5%）为基础的方案相比，不耐受/毒性导致的停药率较低（2.0%）（p<0.001）。在 ART 停药组，开始 ART 后 12 个月内 HIV RNA<200 拷贝/ml 的患者比例为 91%，而继续治疗组为 94%（p>0.05）。
因不耐受/毒性和病毒学失败导致的 ART 停药率随时间推移而降低。与 PI 和 NNRTI 为基础的 ART 相比，INSTI 为基础的方案不太可能被停用。
