College of Health Sciences and Medicine, Dilla University, Dilla, Ethiopia.
College of Health Science, Debre Berhan University, Debre Berhan, Ethiopia.
PLoS One. 2023 Sep 8;18(9):e0288132. doi: 10.1371/journal.pone.0288132. eCollection 2023.
With expanding access to pediatric antiretroviral therapy, several patients in the developing world were switched to the second-line regimen, and some require third-line medications. A delay in a second-line switch is associated with an increased risk of mortality and other undesired therapeutic outcomes, drives up program costs, and challenges the pediatric antiretroviral therapy service. Nevertheless, there remain limited and often conflicting estimates on second-line antiretroviral therapy use during childhood, especially in resource-limited settings like Ethiopia. Thus, this study intended to determine the incidence and predictors of switching to second-line antiretroviral therapy among children.
A retrospective cohort study was conducted by reviewing records of 424 randomly selected children on first-line antiretroviral therapy from January 2014 to December 2018 at public hospitals in the Central and Southern Zones of Tigray, Northern Ethiopia. Data were collected using extraction tool; entered into Epi-data; cleaned, and analyzed by STATA version-14. Kaplan-Meier curve, log-rank test, and life table were used for data description and adjusted hazard ratios and p-value for analysis by Cox proportional hazard regression. Variables at a P-value of ≤0.20 in the bi-variable analysis were taken to multivariable analysis. Finally, statistical significance was declared at a P-value of ≤0.05.
Analysis was conducted on 424 charts with a total person-time observation of 11686.1 child-months and an incidence switch rate of 5.6 (95%CI: 4.36-7.09) per 1000 child-month-observations. Being orphan [AHR = 2.36; 95%CI: 1.10-5.07], suboptimal adherence [AHR = 2.10; 95% CI: 1.12-3.92], drug toxicity [AHR = 7.05; 95% CI: 3.61-13.75], advanced latest clinical stage [AHR = 2.75; 95%CI: 1.05-7.15], and tuberculosis co-infection at baseline [AHR = 3.08; 95%CI: 1.26-7.51] were significantly associated with switch to second-line antiretroviral therapy regimen. Moreover, a long duration of follow-up [AHR = 0.75; 95% CI: 0.71-0.81] was associated with decreased risk of switching. Hence, it is better to prioritize strengthening the focused evaluation of tuberculosis co-infection and treatment failure with continuous adherence monitoring. Further research is also needed to evaluate the effect of drug resistance.
随着儿科抗逆转录病毒治疗可及性的扩大,发展中国家的一些患者已转为二线治疗方案,而有些则需要三线药物治疗。二线治疗方案的延迟切换与死亡率和其他不良治疗结果的风险增加、项目成本增加以及对儿科抗逆转录病毒治疗服务的挑战有关。然而,对于儿童二线抗逆转录病毒治疗的使用,尤其是在资源有限的环境下,如埃塞俄比亚,仍然存在有限的且常常相互矛盾的估计。因此,本研究旨在确定切换至二线抗逆转录病毒治疗方案的发生率和预测因素。
这是一项回顾性队列研究,对 2014 年 1 月至 2018 年 12 月期间在埃塞俄比亚北部提格雷中南部地区公立医院接受一线抗逆转录病毒治疗的 424 名随机选择的儿童的记录进行了审查。使用提取工具收集数据;将数据输入 Epi-data;使用 STATA 版本 14 进行清理和分析。使用 Kaplan-Meier 曲线、对数秩检验和生命表进行数据描述,并使用 Cox 比例风险回归进行调整后的风险比和 P 值分析。在双变量分析中 P 值≤0.20 的变量被纳入多变量分析。最后,宣布 P 值≤0.05 为具有统计学意义。
对 424 份图表进行了分析,总随访时间为 11686.1 个儿童月,每 1000 个儿童月观察到的发生率为 5.6(95%CI:4.36-7.09)。孤儿[调整后的危险比(AHR)=2.36;95%CI:1.10-5.07]、依从性不佳(AHR=2.10;95%CI:1.12-3.92)、药物毒性(AHR=7.05;95%CI:3.61-13.75)、晚期最新临床分期(AHR=2.75;95%CI:1.05-7.15)和基线时结核分枝杆菌合并感染(AHR=3.08;95%CI:1.26-7.51)与切换至二线抗逆转录病毒治疗方案显著相关。此外,较长的随访时间(AHR=0.75;95%CI:0.71-0.81)与切换风险降低相关。因此,最好优先加强对结核分枝杆菌合并感染和治疗失败的有针对性评估,并持续进行依从性监测。还需要进一步研究来评估耐药性的影响。