Data from: Incidence and risk factors of first-line antiretroviral treatment failure among human immunodeficiency virus-infected children in Amhara regional state, Ethiopia: a retrospective follow-up study

Objective: This study aimed to assess the incidence and risk factors of treatment failure among Human Immunodeficiency Virus (HIV)/Acquired Immunodeficiency Syndrome infected (AIDS) children who were on Antiretroviral Therapy (ART) in Amhara National Regional State, Ethiopia. Methods: A retrospective follow-up study was conducted from January 2010 to March 2016. A total of 824 children under the age of 15 years who had started ART were included in the study. Data were collected from children’s medical chart and ART registration logbook using a standard checklist. A Weibull regression model was used to identify the risk factors for treatment failure. Adjusted Hazard Ratios with 95% confidence intervals were used to declare statistical significance. Results: The mean (±SD) age of the children was 6.4 ± 3.6 years with a median (IQR) follow up of 30.5 (IQR: 14.6, 51.4) months. Sixty-three children (7.7%, 95%CI:5.8, 9.5) developed treatment failure. Seventeen (27.0%) of whom were immunological and 46 (73.0 %) clinical failures. The incidence rate of treatment failure was 22.1/10000 person-months. The cumulative probability of failure was 0.4 with 28562.5 person-month observations. Lack of disclosure [AHR=4. 4, 95%CI (1.8, 11.3)], opportunistic infections during initiation of ART [AHR= 2.3, 95% CI (1.3, 4.1)] and prolonged follow up [AHR = 0.06, 95% CI (0.02, 0.18)] were the main predictors of treatment failure. Conclusion: This study revealed that the incidence of treatment failure remains a significant public health concern in Ethiopia. Undisclosed HIV status to children, the presence of opportunistic infections during initiation of ART and prolonged follow up was found to be the main predictors of treatment failure. Hence, early detection of the treatment failures and further studies on viral monitor need to consider.

研究目的：本研究旨在评估埃塞俄比亚阿姆哈拉民族区域州接受抗反转录病毒治疗（Antiretroviral Therapy, ART）的人类免疫缺陷病毒（Human Immunodeficiency Virus, HIV）/获得性免疫缺陷综合征（Acquired Immunodeficiency Syndrome, AIDS）感染儿童的治疗失败发生率及其危险因素。
研究方法：本研究为2010年1月至2016年3月开展的回顾性随访研究。共纳入824名启动抗反转录病毒治疗的15岁以下儿童。研究采用标准核查清单，从儿童病历档案及抗反转录病毒治疗登记日志中采集数据。使用威布尔回归模型（Weibull regression model）识别治疗失败的危险因素，以携带95%置信区间（Confidence Interval, CI）的调整后风险比（Adjusted Hazard Ratios）判定统计学显著性。
研究结果：研究对象的平均年龄（±标准差）为6.4±3.6岁，随访时长的中位数（四分位间距（Interquartile Range, IQR））为30.5（IQR: 14.6, 51.4）个月。共有63名儿童（7.7%，95%CI：5.8, 9.5）发生治疗失败，其中17例（27.0%）为免疫学失败，46例（73.0%）为临床失败。治疗失败的发生率为22.1/10000人月（person-month）。基于28562.5人月的观察数据，治疗失败的累积概率为0.4。未告知儿童自身HIV感染状况[调整后风险比（Adjusted Hazard Ratios, AHR）=4.4，95%CI(1.8, 11.3)]、启动抗反转录病毒治疗时合并机会性感染（opportunistic infections）[AHR=2.3，95%CI(1.3, 4.1)]以及较长随访时长[AHR=0.06，95%CI(0.02, 0.18)]是治疗失败的主要预测因素。
研究结论：本研究显示，埃塞俄比亚的儿童HIV/AIDS抗反转录病毒治疗失败发生率仍是一项亟需重视的公共卫生问题。未向儿童披露HIV感染状态、启动抗反转录病毒治疗时合并机会性感染以及较长随访时长是治疗失败的主要预测因素。因此，临床需加强治疗失败的早期识别，并开展针对病毒学监测的进一步研究。