免疫检查点抑制剂（ICIs）是癌症治疗领域的重大进步。然而，我们仍然缺乏有关其在 HIV 感染者 (PWH) 中使用的前瞻性真实世界数据。ANRS CO24 OncoVIHAC 研究 (NCT03354936) 是法国正在进行的一项针对接受 ICI 治疗癌症的 PWH 的前瞻性观察队列研究。我们评估了 ≥3 级免疫相关不良事件 (irAE) 的发生率。所有≥3级的irAE均通过事件审查进行审查。2018年1月17日至2023年12月5日期间，从33个中心招募了150名参与者，其中140名参与者纳入本次分析。截至数据截止日期2023年12月5日，中位随访时间为9.2个月（IQR：3.9-18.3），总计126.2人年。中位年龄为59岁（IQR：54-64）其中 111 名（79.3%）为男性。自 HIV 诊断以来的中位时间为 25 年 (12-31)，抗逆转录病毒 (ARV) 治疗的中位持续时间为 19.5 年 (7.7-25.4)，CD4 最低值为 117/μL (51-240)。 ICI 方案包括 111 名 (79.3%) 参与者的抗程序性细胞死亡蛋白 1 (PD-1)、25 名 (17.9%) 参与者的抗程序性死亡配体 1、抗 PD-1 和抗细胞毒性药物的组合T 淋巴细胞相关蛋白 4 为 3（2.1%），抗 PD-1 和抗血管内皮生长因子受体为 1（0.7%）。最常见的癌症是肺癌 (n=65)、头颈癌 (n=15)、黑色素瘤 (n=12)、肝癌 (n=11) 和霍奇金淋巴瘤 (n=9)。在随访期间，总共20 名参与者中发生了 34 例 ≥3 级 irAE，导致发病率为每 100 人年 26.9 例。 Kaplan-Meier 估计至少发生一次 ≥3 级 irAE 的参与者比例在 6 个月时为 13.8%，在 12 个月时为 15.0%，在 18 个月时为 18.7%。据报道，有 1 例因心肌炎而导致治疗相关死亡 (0.7%)。累积发病率的多变量分析显示，自 HIV 诊断以来时间 > 17 年的参与者（发病率比 (IRR)=4.66，p=0.002），CD4<200 细胞/μL（IRR=4.39，p<0.0001），阳性巨细胞病毒 (CMV) 血清学检查 (IRR=2.76，p=0.034)，有癌症手术史 (IRR=3.44，p=0.001) 的 ≥3 级 irAE 发生风险较高。本研究表明，首次1 年时≥3 级 irAE 发作率为 15.0%（95% CI：9.6% 至 22.9%），所有严重 irAE 发作的累积发生率为每 100 人年 26.9 例。 CD4 计数低、CMV 血清学阳性、癌症手术史以及 HIV 诊断后时间较长与严重 irAE 的发生有关。© 作者（或其雇主）2024。CC BY 允许重复使用-NC。禁止商业再利用。请参阅权利和权限。英国医学杂志出版。

Immune checkpoint inhibitors (ICIs) have been a major advance in cancer management. However, we still lack prospective real-world data regarding their usage in people with HIV infection (PWH).The ANRS CO24 OncoVIHAC study (NCT03354936) is an ongoing prospective observational cohort study in France of PWH with cancer treated with ICI. We assessed the incidence of grade ≥3 immune-related adverse events (irAEs). All grade ≥3 irAEs were reviewed by an event review.Between January 17, 2018, and December 05, 2023, 150 participants were recruited from 33 sites and 140 were included in this analysis. At the data cut-off date of December 05, 2023, the median follow-up was 9.2 months (IQR: 3.9-18.3), with a total of 126.2 person-years.Median age was 59 years (IQR: 54-64) and 111 (79.3%) were men. Median time since HIV diagnosis was 25 years (12-31), the median duration on antiretroviral (ARV) was 19.5 years (7.7-25.4), and the CD4 nadir was 117/µL (51-240). ICI regimens comprised anti-programmed cell death protein-1 (PD-1) for 111 (79.3%) participants, anti-programmed death-ligand 1 for 25 (17.9%), a combination of anti-PD-1 and anti-cytotoxic T-lymphocyte associated protein 4 for 3 (2.1%), and anti-PD-1 along with anti-vascular endothelial growth factor receptor for 1 (0.7%). The most frequent cancers were lung (n=65), head/neck (n=15), melanoma (n=12), liver (n=11) and Hodgkin's lymphoma (n=9).During follow-up, a total of 34 grade ≥3 irAEs occurred in 20 participants, leading to an incidence rate of 26.9 per 100 person-years. The Kaplan-Meier estimates of the proportion of participants with at least one episode of grade ≥3 irAEs were 13.8% at 6 months, 15.0% at 12 months and 18.7% at 18 months. One treatment-related death due to myocarditis was reported (0.7%). Multivariable analysis of cumulative incidence showed that participants with time since HIV diagnosis >17 years (incidence rate ratio (IRR)=4.66, p=0.002), with CD4<200 cells/µL (IRR=4.39, p<0.0001), with positive cytomegalovirus (CMV) serology (IRR=2.76, p=0.034), with history of cancer surgery (IRR=3.44, p=0.001) had a higher risk of incidence of grade ≥3 irAEs.This study showed that the incidence of a first episode of grade ≥3 irAE was 15.0% (95% CI: 9.6% to 22.9%) at 1 year and the cumulative incidence of all severe irAE episodes was 26.9 per 100 person-years. Low CD4 count, positive CMV serology, history of cancer surgery and a longer time since HIV diagnosis were associated with the occurrence of severe irAEs.© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.