Meloni Seema T, Chang Charlotte A, Eisen Geoffrey, Jolayemi Toyin, Banigbe Bolanle, Okonkwo Prosper I, Kanki Phyllis J
Department of Immunology and Infectious Diseases, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, United States of America.
Center for Global Health, Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States of America.
PLoS One. 2016 Oct 20;11(10):e0164030. doi: 10.1371/journal.pone.0164030. eCollection 2016.
While there has been a rapid global scale-up of antiretroviral therapy programs over the past decade, there are limited data on long-term outcomes from large cohorts in resource-constrained settings. Our objective in this evaluation was to measure multiple outcomes during first-line antiretroviral therapy in a large treatment program in Nigeria.
We conducted a retrospective multi-site program evaluation of adult patients (age ≥15 years) initiating antiretroviral therapy between June 2004 and February 2012 in Nigeria. The baseline characteristics of patients were described and longitudinal analyses using primary endpoints of immunologic recovery, virologic rebound, treatment failure and long-term adherence patterns were conducted.
Of 70,002 patients, 65.2% were female and median age was 35 (IQR: 29-41) years; 54.7% were started on a zidovudine-containing and 40% on a tenofovir-containing first-line regimen. Median CD4+ cell counts for the cohort started at 149 cells/mm3 (IQR: 78-220) and increased over duration of ART. Of the 70,002 patients, 1.8% were reported as having died, 30.1% were lost to follow-up, and 0.1% withdrew from treatment. Overall, of those patients retained and with viral load data, 85.4% achieved viral suppression, with 69.3% achieving suppression by month 6. Of 30,792 patients evaluated for virologic failure, 24.4% met criteria for failure and of 45,130 evaluated for immunologic failure, 34.0% met criteria for immunologic failure, with immunologic criteria poorly predicting virologic failure. In adjusted analyses, older age, ART regimen, lower CD4+ cell count, higher viral load, and inadequate adherence were all predictors of virologic failure. Predictors of immunologic failure differed slightly, with age no longer predictive, but female sex as protective; additionally, higher baseline CD4+ cell count was also predictive of failure. Evaluation of long-term adherence patterns revealed that the majority of patients retained through 84 months maintained ≥95% adherence.
While improved access to HIV care and treatment remains a challenge in Nigeria, our study shows that a high quality of care was achieved as evidenced by strong long-term clinical, immunologic and virologic outcomes.
在过去十年中，全球抗逆转录病毒治疗项目迅速扩大，但在资源有限的环境中，来自大型队列的长期结果数据有限。我们此次评估的目的是在尼日利亚的一个大型治疗项目中，测量一线抗逆转录病毒治疗期间的多种结果。
我们对2004年6月至2012年2月在尼日利亚开始接受抗逆转录病毒治疗的成年患者（年龄≥15岁）进行了一项回顾性多中心项目评估。描述了患者的基线特征，并使用免疫恢复、病毒学反弹、治疗失败和长期依从模式等主要终点进行了纵向分析。
在70002名患者中，65.2%为女性，中位年龄为35岁（四分位间距：29 - 41岁）；54.7%开始使用含齐多夫定的一线治疗方案，40%开始使用含替诺福韦的一线治疗方案。该队列的CD4 +细胞计数中位数起始为149个细胞/mm³（四分位间距：78 - 220），并在抗逆转录病毒治疗期间有所增加。在70002名患者中，报告有1.8%死亡，30.1%失访，0.1%退出治疗。总体而言，在保留且有病毒载量数据的患者中，85.4%实现了病毒抑制，其中69.3%在第6个月时实现了抑制。在30792名接受病毒学失败评估的患者中，24.4%符合失败标准；在45130名接受免疫失败评估的患者中，34.0%符合免疫失败标准，免疫标准对病毒学失败的预测能力较差。在多因素分析中，年龄较大、抗逆转录病毒治疗方案、较低的CD4 +细胞计数、较高的病毒载量和依从性不足均为病毒学失败的预测因素。免疫失败的预测因素略有不同，年龄不再具有预测性，但女性具有保护作用；此外，较高的基线CD4 +细胞计数也可预测失败。对长期依从模式的评估显示，在随访84个月仍保留的患者中，大多数患者的依从性≥95%。
尽管在尼日利亚，改善获得艾滋病毒护理和治疗的机会仍然是一项挑战，但我们的研究表明，通过强大的长期临床、免疫和病毒学结果证明，实现了高质量的护理。
