Abstract
Objectives
To describe the impact of immune checkpoint inhibitors (ICPi) in infection control in people living with HIV (PLWHIV) and to explore their safety compared with a matched cohort of people living without HIV (PLWOHIV). Secondary, to report inclusion and exclusion criteria for PLWHIV in clinical trials (CT) with ICPi.
Methods
Observational, retrospective, single-center study. PLWHIV initiating ICPi from January 2018 until June 2023 were included. Biomarkers of HIV infection control were collected at baseline and after ICPi initiation. Safety data were compared with a 1:2 matched cohort of PLWOHIV. CT with ICPi starting recruitment between January 2018 and December 2022 were analyzed.
Results
Twenty-eight PLWHIV were included, most male (22; 78.6%), median age 57 years (IQI 55.0–60.0). Follow-up data on infection control were available in 19 (67.9%) patients. In 17 (89.5%) the viral load was <200 copies/ml throughout the complete follow-up, in 13 (68.4%) CD4 + remained above 200 cells/µl and in 13 (68.4%) the CD4/CD8 ratio persisted ≥0.4. In 11 (57.9%) all three conditions were met. Forty-eight PLWOHIV were identified for the matched cohort. Adverse events rates were similar between groups.
A total of 126 CT with ICPi were identified: 91 (72.2%) explicitly excluded PLWHIV, 24 (19.0%) did not mention HIV infection, and 11 (8.7%) allowed their inclusion under certain conditions.
Conclusions
ICPi in PLWHIV appeared to have a safety profile similar to that observed in PLWOHIV without evident negative effects on viral control. However, PLWHIV remain frequently excluded from ICPi CT.
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