Alema Niguse Meles, Asgedom Solomon Weldegebreal, Maru Mahlet, Berihun Beletu, Gebrehiwet Teklu, Atey Tesfay Mehari, Demsie Desalegn Getnet, Bantie Abere Tilahun, Yehualaw Adane, Taferre Chernet, Seid Sofia Assen, Girma Timsel, Allene Mengesha Dessie, Tamru Sintayehu Mulugeta
Department of Pharmacy, College of Medicine and Health Sciences, Adigrat University, Ethiopia.
Department of Clinical Pharmacy, School of Pharmacy, College of Health Sciences, Mekelle University, Ethiopia.
Ann Med Surg (Lond). 2022 Aug 17;81:104303. doi: 10.1016/j.amsu.2022.104303. eCollection 2022 Sep.
Regimen change remains a significant challenge towards the achievement of human immunodeficiency virus (HIV) treatment success. In developing countries where limited treatment options are available, strategies are required to ensure the sustainability and durability of the starting regimens. Nevertheless, information regarding the rate and predictors of regimen change is limited in these settings.
This study was undertaken to determine the prevalence and predictors of changes in ART regimens among patients initiating highly active antiretroviral therapy (HAART) at XX.
An institutional based retrospective cross-sectional study was conducted among adult naïve HIV patients who had initiated HAART at XX between 2010. Data were extracted by reviewing their medical charts using a pretested structured check-list. The Kaplan-Meier survival analyses were used to describe the probability of ARV regimen changes while Cox proportional hazard regression models were employed to identify the predictors of ARV regimen modifications. Data were analyzed using SPSS version 21 software, and statistical significant was deemed at p < 0.05.
A total of 770 patients were enrolled in this study of these 165 (21.43%) had their ART regimen modified at least once. Drug toxicity was the main reason for regimen change followed by TB comorbidity, and treatment failure. Positive baseline TB symptoms (aHR = 1.63, p = 0.037), and Zidovudine based regimen (aHR = 1.76, p = 0.011) as compared to Stavudine based regimen were at higher risk of ART modification. Conversely, urban residence, baseline World Health organization (WHO) stage 2 as compared to WHO stage 1, baseline CD4 count ≥301 as compared to CD4 count ≤200 were at lower risk of ART modification.
The rate of initial HAART regimen change was found to be high. Thus, less toxic and better tolerated HIV treatment options should be available and used more frequently. Moreover, early detection and initiation of ART by the government is highly demanded to maximize the benefit and reduce risk of ART modifications.
方案变更仍然是实现人类免疫缺陷病毒（HIV）治疗成功的一项重大挑战。在治疗选择有限的发展中国家，需要采取策略来确保起始治疗方案的可持续性和持久性。然而，在这些环境中，关于方案变更的发生率和预测因素的信息有限。
本研究旨在确定在XX开始接受高效抗逆转录病毒治疗（HAART）的患者中，抗逆转录病毒治疗（ART）方案变更的患病率和预测因素。
在XX于2010年之间开始接受HAART的成年初治HIV患者中进行了一项基于机构的回顾性横断面研究。通过使用预先测试的结构化检查表查阅他们的病历提取数据。采用Kaplan-Meier生存分析来描述抗逆转录病毒治疗方案变更的概率，同时采用Cox比例风险回归模型来确定抗逆转录病毒治疗方案变更的预测因素。使用SPSS 21版软件进行数据分析，统计学显著性以p < 0.05为标准。
本研究共纳入770例患者，其中165例（21.43%）至少有一次ART方案变更。药物毒性是方案变更的主要原因，其次是合并结核病和治疗失败。与基于司他夫定的方案相比，基线时结核症状阳性（校正风险比[aHR]=1.63，p = 0.037）以及基于齐多夫定的方案（aHR = 1.76，p = 0.011）发生ART方案变更的风险更高。相反，与WHO第1期相比，城市居住、基线时WHO第2期，与CD4细胞计数≤200相比，基线CD4细胞计数≥301发生ART方案变更的风险较低。
发现初始HAART方案变更率较高。因此，应提供毒性更小、耐受性更好的HIV治疗选择并更频繁地使用。此外，政府强烈需要尽早检测并启动ART，以最大化获益并降低ART方案变更的风险。
