Safety and tolerability of immune checkpoint inhibitors in people with HIV infection and cancer - insights from the national prospective real-world OncoVIHAC ANRS CO24 cohort study

Q: Which factors were associated with a higher risk of severe irAEs?

Lower CD4 counts (<200 cells/µL), positive CMV serology, history of cancer surgery, and a longer time since HIV diagnosis were associated with higher cumulative incidence of grade ≥3 irAEs.

Sep 21, 2026

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Immune checkpoint inhibitors (ICIs) have transformed cancer care, yet prospective real-world evidence in people with HIV infection (PWH) remains limited. The ANRS CO24 OncoVIHAC study is an ongoing prospective observational cohort in France assessing grade ≥3 immune-related adverse events (irAEs) among PWH with cancer treated with ICI. In 140 participants, 34 grade ≥3 irAEs occurred in 20 patients, incidence 26.9 per 100 person-years. Risk was higher with longer time since HIV diagnosis, low CD4, positive CMV serology, and prior cancer surgery.

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CategoryHealthcare

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Abstract

Background

Methods

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Introduction

Open access Original research Safety and tolerability of immune checkpoint inhibitors in people with HIV infection and cancer: insights from the national prospective real-world OncoVIHAC ANRS CO24 cohort study Lambert Assoumou ,1 Raghiatou Baldé,1 Christine Katlama,2 Baptiste Abbar,3 Pierre Delobel,4 Thierry Allegre,5 Armelle Lavole,6 Alain Makinson,7 Olivia Zaegel-Faucher,8 Laurent Greillier,9 Cathia Soulie,10 Marianne Veyri,11 Mathilde Bertheau,12 Michèle Algarte Genin,1 Séverine Gibowski,13 Anne-Geneviève Marcelin,10 Kevin Bihan,14 Marine Baron,3 Dominique Costagliola,1 Olivier Lambotte,15 Jean-Philippe Spano11 To cite: Assoumou L, Baldé R, Katlama C, et al. Safety and tolerability of immune checkpoint inhibitors in people with HIV infection and cancer: insights from the national prospective real-world OncoVIHAC ANRS CO24 cohort study. Journal for ImmunoTherapy of Cancer 2024;12:e009728 . doi:10 . 1136/ jitc-2024-009728 ► Additional supplemental material is published online only. To view, please visit the journal online ([https://doi.org/10.1136/](https://doi.org/10.1136/)[ ](https://doi.org/10.1136/)[jitc-2024-009728](jitc-2024-009728)) . OL and J-PS contributed equally. OL and J-PS are joint senior authors. Accepted 06 August 2024 © 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. For numbered affiliations see end of article. Correspondence to Dr Lambert Assoumou; lambert.assoumou@iplesp. [upmc.fr](upmc.fr) ABSTRACT 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) . Methods TheANRS 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 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, antiprogrammed 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 antivascular 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 treatmentrelated 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 WHAT IS ALREADY KNOWN ON THIS TOPIC | ⇒ 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) .
WHAT THIS STUDY ADDS | | --- | | ⇒ The study showed that a low CD4 count, a longer time since HIV diagnosis, a history of cancer surgery and positive cytomegalovirus (CMV) serology at the star

FAQs

What was the primary focus of the OncoVIHAC study?

To evaluate the incidence of grade ≥3 immune-related adverse events (irAEs) in people with HIV infection (PWH) with cancer treated with immune checkpoint inhibitors (ICIs).

How many participants and grade ≥3 irAEs were observed?

140 participants were included in the analysis, with 34 grade ≥3 irAEs occurring in 20 participants, corresponding to an incidence rate of 26.9 per 100 person-years.

Which factors were associated with a higher risk of severe irAEs?

Lower CD4 counts (<200 cells/µL), positive CMV serology, history of cancer surgery, and a longer time since HIV diagnosis were associated with higher cumulative incidence of grade ≥3 irAEs.

Sep 21, 2026

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