Grinspoon Steven K, Zanni Markella V, Triant Virginia A, Kantor Amy, Umbleja Triin, Diggs Marissa R, Chu Sarah M, Fitch Kathleen V, Currier Judith S, Bloomfield Gerald S, Casado José L, de la Peña Mireia, Fantry Lori E, Gardner Edward, Aberg Judith A, Malvestutto Carlos D, Fichtenbaum Carl J, Lu Michael T, Ribaudo Heather J, Douglas Pamela S
Metabolism Unit, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Division of General Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA; Division of Infectious Diseases, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Lancet HIV. 2025 Feb;12(2):e118-e129. doi: 10.1016/S2352-3018(24)00276-5. Epub 2025 Jan 17.
Risk estimation is an essential component of cardiovascular disease prevention among people with HIV. We aimed to characterise how well atherosclerotic cardiovascular disease (ASCVD) risk scores used in clinical guidelines perform among people with HIV globally.
In this prospective cohort study leveraging REPRIEVE data, we included participants aged 40-75 years, with low-to-moderate traditional cardiovascular risk, not taking statin therapy. REPRIEVE participants were enrolled from sites in 12 countries across Global Burden of Disease Study (GBD) regions. We assessed the performance of the pooled cohort equations (PCE) risk score for ASCVD and the data-collection on adverse effects of anti-HIV drugs (D:A:D) risk score. We calculated C statistics, observed-to-expected (OE) event ratios, and Greenwood-Nam-D'Agostino goodness-of-fit (GND) statistics, overall and in subgroups by race, sex, and GBD regions (clustering low-income and middle-income countries and high-income countries). We did a recalibration for PCE risk score among people with HIV in high-income countries. REPRIEVE was registered with ClinicalTrials.gov, NCT02344290.
We included 3893 participants, recruited between March 26, 2015, and July 31, 2019. The median age was 50 years (IQR 45-55), with 2684 (69%) male and 1209 (31%) female participants. 1643 (42%) were Black or African American, 1346 (35%) participants were White, 566 (15%) were Asian, and 338 (9%) were recorded as other race. Overall, discrimination of the PCE risk score was moderate (C statistic 0·72 [95% CI 0·68-0·76]) and calibration was good (OE event ratio 1·11; GND p=0·87). However, calibration suggested overprediction of risk in low-income and middle-income countries and corresponding underprediction in high-income countries. When restricted to high-income countries, we found underprediction (OE event ratio >1·0) among women (2·39) and Black or African American participants (1·64). Findings were similar for the D:A:D risk score (C statistic 0·71 [0·65-0·77]; OE event ratio 0·89; p=0·68). Improved calibration of the PCE risk score in high-income countries was achieved by multiplying the original score by 2·8 in Black or African American women, 2·6 in women who were not Black or African American, and 1·25 in Black or African American men.
Among the global cohort of people with HIV in REPRIEVE, the PCE risk score underpredicted cardiovascular events in women and Black or African American men in high-income countries and overpredicted cardiovascular events in low-income and middle-income countries. Underprediction in subgroups should be considered when using the PCE risk score to guide statin prescribing for cardiovascular prevention among people with HIV in high-income countries. Additional research is needed to develop risk scores accurate in predicting ASCVD among people with HIV in low-income and middle-income countries.
US National Institutes of Health, Kowa Pharmaceuticals America, Gilead Sciences, and ViiV Healthcare.
风险评估是艾滋病毒感染者心血管疾病预防的重要组成部分。我们旨在描述临床指南中使用的动脉粥样硬化性心血管疾病（ASCVD）风险评分在全球艾滋病毒感染者中的表现。
在这项利用REPRIEVE数据的前瞻性队列研究中，我们纳入了年龄在40 - 75岁、传统心血管风险低至中度且未接受他汀类药物治疗的参与者。REPRIEVE参与者来自全球疾病负担研究（GBD）区域12个国家的研究地点。我们评估了ASCVD的合并队列方程（PCE）风险评分和抗逆转录病毒药物不良反应数据收集（D:A:D）风险评分的表现。我们计算了C统计量、观察到的与预期的（OE）事件比率以及格林伍德 - 南 - 达戈斯蒂诺拟合优度（GND）统计量，总体以及按种族、性别和GBD区域（将低收入和中等收入国家与高收入国家聚类）进行亚组分析。我们对高收入国家艾滋病毒感染者的PCE风险评分进行了重新校准。REPRIEVE已在ClinicalTrials.gov注册，注册号为NCT02344290。
我们纳入了3893名参与者，招募时间为2015年3月26日至2019年7月31日。中位年龄为50岁（四分位间距45 - 55岁），其中男性2684名（69%），女性1209名（31%）。1643名（42%）为黑人或非裔美国人，1346名（35%）参与者为白人，566名（15%）为亚洲人，338名（9%）记录为其他种族。总体而言，PCE风险评分的辨别力中等（C统计量0.72 [95%置信区间0.68 - 0.76]）且校准良好（OE事件比率1.11；GND p = 0.87）。然而，校准表明低收入和中等收入国家存在风险预测过高，而高收入国家则相应地存在预测过低。当仅限于高收入国家时，我们发现女性（2.39）和黑人或非裔美国参与者（1.64）中存在预测过低（OE事件比率>1.0）。D:A:D风险评分的结果相似（C统计量0.71 [0.65 - 0.77]；OE事件比率0.89；p = 0.68）。通过将原始评分乘以2.8用于黑人或非裔美国女性、乘以2.6用于非黑人或非裔美国女性以及乘以1.25用于黑人或非裔美国男性，实现了高收入国家PCE风险评分的校准改善。
在REPRIEVE的全球艾滋病毒感染者队列中，PCE风险评分在高收入国家的女性和黑人或非裔美国男性中对心血管事件预测过低，但在低收入和中等收入国家中对心血管事件预测过高。在高收入国家，当使用PCE风险评分指导艾滋病毒感染者的他汀类药物处方以预防心血管疾病时，应考虑亚组中的预测过低情况。需要进一步研究来开发在低收入和中等收入国家准确预测艾滋病毒感染者ASCVD的风险评分。
美国国立卫生研究院、美国科瓦制药公司、吉利德科学公司和维泰凯医疗保健公司。
