Résumé
Background: 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). Materials and methods: 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. Results: between 17 January 2018 and 5 December 2023, 150 participants were recruited from 33 sites and 140 were included in this analysis. At the data cut-off date of 5 December 2023, 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), median duration on 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 (PD1) for 111 (79.3%) participants, anti-programmed death-ligand 1 (PDL1) for 25 (17.9%), a combination of anti-PD1 and anti-human cytotoxic T-lymphocyte-associated protein 4 (CTLA4) for three (2.1%), and anti-PD1 along with anti-vascular endothelial growth factor (VEGFR) for one (0.7%). The most frequent cancers were lung (n = 65), head/neck (n = 15), melanoma (n = 12), liver (n = 11) and Hodgkin 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. Conclusions: this study showed that the incidence of a first episode of grade ≥3 irAE was 15.0% (95% CI 9.6–22.9) 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.