Miller Christopher J, Baker Jason V, Bormann Alison M, Erlandson Kristine M, Huppler Hullsiek Katherine, Justice Amy C, Neuhaus Jacqueline, Paredes Roger, Petoumenos Kathy, Wentworth Deborah, Winston Alan, Wolfson Julian, Neaton James D
Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota, United States of America.
Division of Infectious Diseases, University of Minnesota, Minneapolis, Minnesota, United States of America; Hennepin County Medical Center, Minneapolis, Minnesota, United States of America.
PLoS One. 2014 Apr 11;9(4):e95061. doi: 10.1371/journal.pone.0095061. eCollection 2014.
Non-AIDS conditions such as cardiovascular disease and non-AIDS defining cancers dominate causes of morbidity and mortality among persons with HIV on suppressive combination antiretroviral therapy. Accurate estimates of disease incidence and of risk factors for these conditions are important in planning preventative efforts.
With use of medical records, serious non-AIDS events, AIDS events, and causes of death were adjudicated using pre-specified criteria by an Endpoint Review Committee in two large international trials. Rates of serious non-AIDS which include cardiovascular disease, end-stage renal disease, decompensated liver disease, and non-AIDS cancer, and other serious (grade 4) adverse events were determined, overall and by age, over a median follow-up of 4.3 years for 3,570 participants with CD4+ cell count ≥300 cells/mm³ who were taking antiretroviral therapy and had an HIV RNA level ≤500 copies/mL. Cox models were used to examine the effect of age and other baseline factors on risk of a composite outcome of all-cause mortality, AIDS, or serious non-AIDS.
Five-year Kaplan-Meier estimates of the composite outcome, overall and by age were 8.3% (overall), 3.6% (<40), 8.7% (40-49) and 16.1% (≥50), respectively (p<0.001). In addition to age, smoking and higher levels of interleukin-6 and D-dimer were significant predictors of the composite outcome. The composite outcome was dominated by serious non-AIDS events (overall 65% of 277 participants with a composite event). Most serious non-AIDS events were due to cardiovascular disease and non-AIDS cancers.
To date, few large studies have carefully collected data on serious non-AIDS outcomes. Thus, reliable estimates of event rates are scarce. Data cited here, from a geographically diverse cohort, will be useful for planning studies of interventions aimed at reducing rates of serious non-AIDS events among people with HIV.
在接受抑制性联合抗逆转录病毒治疗的艾滋病毒感染者中，心血管疾病和非艾滋病定义的癌症等非艾滋病相关疾病是发病和死亡的主要原因。准确估计这些疾病的发病率及其危险因素对于规划预防措施至关重要。
在两项大型国际试验中，终点审查委员会使用预先指定的标准，通过医疗记录对严重非艾滋病事件、艾滋病事件和死亡原因进行判定。确定了包括心血管疾病、终末期肾病、失代偿性肝病和非艾滋病癌症在内的严重非艾滋病事件以及其他严重（4级）不良事件的发生率，总体发生率以及按年龄划分的发生率。对3570名CD4 + 细胞计数≥300个细胞/mm³、正在接受抗逆转录病毒治疗且HIV RNA水平≤500拷贝/mL的参与者进行了为期4.3年的中位随访。使用Cox模型研究年龄和其他基线因素对全因死亡率、艾滋病或严重非艾滋病综合结局风险的影响。
综合结局的五年Kaplan-Meier估计值，总体及按年龄划分分别为8.3%（总体）、3.6%（<40岁）、8.7%（40 - 49岁）和16.1%（≥50岁）（p<0.001）。除年龄外，吸烟以及较高水平的白细胞介素-6和D-二聚体是综合结局的显著预测因素。综合结局主要由严重非艾滋病事件主导（在277名发生综合事件的参与者中总体占65%）。大多数严重非艾滋病事件是由心血管疾病和非艾滋病癌症引起的。
迄今为止，很少有大型研究仔细收集关于严重非艾滋病结局的数据。因此，事件发生率的可靠估计很少。这里引用的来自地理分布多样队列的数据，将有助于规划旨在降低艾滋病毒感染者严重非艾滋病事件发生率的干预研究。
