Institute of Infectious Diseases, University of Bari, Policlinico Consorziale, Bari, Italy.
Institute of Infectious Diseases, University of Bari, Policlinico Consorziale, Bari, Italy.
Atherosclerosis. 2017 Aug;263:398-404. doi: 10.1016/j.atherosclerosis.2017.05.004. Epub 2017 May 5.
PREVALEAT (PREmature VAscular LEsions and Antiretroviral Therapy) II is a multicenter, longitudinal cohort study aimed at the evaluation of cardiovascular risk among advanced HIV-positive, treatment-naïve patients starting their first therapy. We hypothesized that these patients, present a higher cardiovascular (CV) risk.
The study included all consecutive naïve patients with less than 200 CD4 cells/ml starting antiretroviral therapy. Our primary objective was to evaluate changes in carotid intima- media thickness (IMT). Secondary endpoints included changes in flow mediated vasodilation (FMD), inflammatory markers, triglycerides and cholesterol. Patients were evaluated at time 0, and after 3, 6 and 12 months.
We enrolled 119 patients, stratified into three different groups: patients receiving atazanavir/ritonavir boosted (ATV/r) based regimens, efavirenz (EFV) based regimens and darunavir/ritonavir boosted (DRV/r) based regimens. At baseline, advanced naïve patients showed a relevant deterioration of CV conditions in terms of traditional CV risk factors, endothelial dysfunction and serum biomarkers. During the 12-month follow up period, mean blood lipids significantly increased: total cholesterol from 159 to 190 mg/dL, HDL-C from 31 to 41 mg/dL, and LDL-C from 99 to 117 mg/dL. D-dimers steadily decreased (median level 624 at baseline and 214 at T3), whereas ICAM and VCAM consistently raised. DRV/r and ATV/r determined a more marked decrease of D-dimers as compared to EFV. Regarding the epi-aortic changes (IMT >1 mm or presence of atherosclerotic plaques), patients in the DRV/r group were at risk of developing pathological IMT during the study (OR 6.0, 95% CI 0.9-36.9), as compared to EFV ones.
CV risk was elevated in advanced naïve patients and tended to remain high in the first year of therapy.
PREVALEAT（PREmature VAscular LEsions and Antiretroviral Therapy）II 是一项多中心、纵向队列研究，旨在评估开始首次治疗的晚期 HIV 阳性、未经治疗的患者的心血管风险。我们假设这些患者存在更高的心血管（CV）风险。
该研究纳入了所有 CD4 细胞计数<200 个/ml 的初治患者。我们的主要目的是评估颈动脉内膜中层厚度（IMT）的变化。次要终点包括血流介导的血管扩张（FMD）、炎症标志物、甘油三酯和胆固醇的变化。患者在 0 时、3、6 和 12 个月时进行评估。
我们共纳入 119 例患者，分为三组：接受阿扎那韦/利托那韦（ATV/r）为基础方案、依非韦伦（EFV）为基础方案和达芦那韦/利托那韦（DRV/r）为基础方案的患者。基线时，晚期初治患者在传统心血管危险因素、内皮功能障碍和血清生物标志物方面表现出明显的心血管状况恶化。在 12 个月的随访期间，平均血脂显著升高：总胆固醇从 159 增至 190mg/dL，HDL-C 从 31 增至 41mg/dL，LDL-C 从 99 增至 117mg/dL。D-二聚体水平持续下降（中位水平为基线时 624pg/ml，T3 时 214pg/ml），而 ICAM 和 VCAM 持续升高。与 EFV 相比，DRV/r 和 ATV/r 导致 D-二聚体更明显下降。关于主动脉外膜变化（IMT>1mm 或存在动脉粥样硬化斑块），DRV/r 组患者在研究期间发生病理性 IMT 的风险增加（OR 6.0，95%CI 0.9-36.9），与 EFV 组相比。
晚期初治患者的心血管风险升高，在治疗的第一年仍倾向于保持较高水平。
