Department of Global Health and Infection, Brighton and Sussex Medical School, Brighton, UK.
Africa Health Research Institute, Durban, South Africa.
J Int AIDS Soc. 2018 Jun;21(6):e25112. doi: 10.1002/jia2.25112.
HIV treatment guidelines now recommend antiretroviral therapy (ART) initiation regardless of CD4 count to maximize benefit both for the individual and society. It is unknown whether the initiation of ART at higher CD4 counts would affect adherence levels. We investigated whether initiating ART at higher CD4 counts was associated with sub-optimal adherence (<95%) during the first 12 months of ART.
A prospective cohort study nested within a two-arm cluster-randomized trial of universal test and treat was implemented from March 2012 to June 2016 to measure the impact of ART on HIV incidence in rural KwaZulu-Natal. ART was initiated regardless of CD4 count in the intervention arm and according to national guidelines in the control arm. ART adherence was measured monthly using a visual analogue scale (VAS) and pill counts (PC). HIV viral load was measured at ART initiation, three and six months, and six-monthly thereafter. We pooled data from participants in both arms and used random-effects logistic regression models to examine the association between CD4 count at ART initiation and sub-optimal adherence, and assessed if adherence levels were associated with virological suppression.
Among 900 individuals who initiated ART ≥12 months before study end, median (IQR) CD4 at ART initiation was 350 cells/mm (234, 503); median age was 34.6 years (IQR 27.4 to 46.4) and 71.7% were female. Adherence was sub-optimal in 14.7% of visits as measured by VAS and 20.7% by PC. In both the crude analyses and after adjusting for potential confounders, adherence was not significantly associated with CD4 count at ART initiation (adjusted OR for linear trend in sub-optimal adherence with every 100 cells/mm increase in CD4 count: 1.00, 95% CI 0.95 to 1.05, for VAS, and 1.03, 95% CI 0.99 to 1.07, for PC). Virological suppression at 12 months was 97%. Optimal adherence by both measures was significantly associated with virological suppression (p < 0.001 for VAS; p = 0.006 for PC).
We found no evidence that higher CD4 counts at ART initiation were associated with sub-optimal ART adherence in the first 12 months. Our findings should alleviate concerns about adherence in individuals initiating ART at higher CD4 counts, however long-term outcomes are needed. ClinicalTrials.gov NCT01509508.
艾滋病治疗指南现在建议无论 CD4 计数如何，都开始进行抗逆转录病毒治疗（ART），以最大限度地提高个体和社会的效益。目前尚不清楚在更高的 CD4 计数时开始 ART 是否会影响依从水平。我们调查了在更高的 CD4 计数时开始 ART 是否与治疗的前 12 个月内的依从率（<95%）低有关。
2012 年 3 月至 2016 年 6 月，我们进行了一项前瞻性队列研究，该研究嵌套在一项针对普遍检测和治疗的两臂群组随机试验中，旨在衡量 ART 对夸祖鲁-纳塔尔省农村地区 HIV 发病率的影响。干预组无论 CD4 计数如何均开始进行 ART，而对照组则按照国家指南进行。使用视觉模拟量表（VAS）和药片计数（PC）每月测量一次 ART 依从性。在开始 ART 时、三个月和六个月以及此后每六个月测量一次 HIV 病毒载量。我们汇总了来自两个组别的参与者的数据，并使用随机效应逻辑回归模型来检查开始 ART 时的 CD4 计数与依从率低之间的关系，并评估了依从水平与病毒学抑制之间的关系。
在研究结束前至少开始 ART 治疗 12 个月的 900 名个体中，中位（IQR）CD4 在开始 ART 时为 350 个细胞/mm（234, 503）；中位年龄为 34.6 岁（IQR 27.4 至 46.4），71.7%为女性。VAS 测量时，14.7%的就诊者依从性不佳，PC 测量时为 20.7%。在未调整和调整潜在混杂因素后，依从性与开始 ART 时的 CD4 计数均无显著相关性（VAS 每增加 100 个细胞/mm 时，线性趋势的调整后的不依从比值比为 1.00，95%CI 0.95 至 1.05，PC 为 1.03，95%CI 0.99 至 1.07）。12 个月时的病毒学抑制率为 97%。两种方法的最佳依从性均与病毒学抑制显著相关（VAS 的 p 值<0.001；PC 的 p 值=0.006）。
我们没有发现开始 ART 时较高的 CD4 计数与治疗的前 12 个月内的 ART 依从率低有关的证据。我们的发现应该缓解对开始 CD4 计数较高的个体的依从性的担忧，然而，需要长期结果。ClinicalTrials.gov NCT01509508。
