{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T02:14:45Z","timestamp":1792808085675,"version":"4.5.0"},"reference-count":32,"publisher":"BMJ","issue":"8","license":[{"start":{"date-parts":[[2024,8,22]],"date-time":"2024-08-22T00:00:00Z","timestamp":1724284800000},"content-version":"unspecified","delay-in-days":21,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"ANRS\/MIE Maladies Infectieuses Emergentes","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["J Immunother Cancer"],"accepted":{"date-parts":[[2024,8,6]]},"published-print":{"date-parts":[[2024,8]]},"abstract":"<jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>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).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>The ANRS CO24 OncoVIHAC study (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT03354936\">NCT03354936<\/jats:ext-link>) is an ongoing prospective observational cohort study in France of PWH with cancer treated with ICI. We assessed the incidence of grade \u22653 immune-related adverse events (irAEs). All grade \u22653 irAEs were reviewed by an event review.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>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\u201318.3), with a total of 126.2 person-years.<\/jats:p>\n                  <jats:p>Median age was 59 years (IQR: 54\u201364) and 111 (79.3%) were men. Median time since HIV diagnosis was 25 years (12\u201331), the median duration on antiretroviral (ARV) was 19.5 years (7.7\u201325.4), and the CD4 nadir was 117\/\u00b5L (51\u2013240). 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\u2019s lymphoma (n=9).<\/jats:p>\n                  <jats:p>During follow-up, a total of 34 grade \u22653 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 \u22653 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 &gt;17 years (incidence rate ratio (IRR)=4.66, p=0.002), with CD4&lt;200\u2009cells\/\u00b5L (IRR=4.39, p&lt;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 \u22653 irAEs.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>This study showed that the incidence of a first episode of grade \u22653\u2009irAE 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.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/jitc-2024-009728","type":"journal-article","created":{"date-parts":[[2024,8,23]],"date-time":"2024-08-23T01:01:12Z","timestamp":1724374872000},"page":"e009728","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":26,"title":["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"],"prefix":"10.1136","volume":"12","clinical-trial-number":[{"clinical-trial-number":"nct03354936","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03354936","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03354936","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5547-1796","authenticated-orcid":false,"given":"Lambert","family":"Assoumou","sequence":"first","affiliation":[{"name":"Sorbonne Universit\u00e9, INSERM, Institut Pierre Louis d\u2019Epid\u00e9miologie et de Sant\u00e9 Publique, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raghiatou","family":"Bald\u00e9","sequence":"additional","affiliation":[{"name":"Sorbonne Universit\u00e9, INSERM, Institut Pierre Louis d\u2019Epid\u00e9miologie et de Sant\u00e9 Publique, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christine","family":"Katlama","sequence":"additional","affiliation":[{"name":"Sorbonne Universit\u00e9, INSERM, Institut Pierre Louis d\u2019Epid\u00e9miologie et de Sant\u00e9 Publique, AP-HP, H\u00f4pital Piti\u00e9-Salp\u00eatri\u00e8re, service des maladies infectieuses, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Baptiste","family":"Abbar","sequence":"additional","affiliation":[{"name":"Sorbonne University, Department of Medical Oncology Assistance Publique - H\u00f4pitaux de Paris (AP-HP), Piti\u00e9-Salp\u00eatri\u00e8re Hospital, Institut Universitaire de Canc\u00e9rologie, CLIP\u00b2 Galil\u00e9e, INSERM U1135, Centre d'Immunologie et des Maladies Infectieuses (CIMI-Paris), Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pierre","family":"Delobel","sequence":"additional","affiliation":[{"name":"CHU de Toulouse, Service des Maladies Infectieuses et Tropicales, INSERM, UMR1291, Universit\u00e9 Toulouse III-Paul Sabatier, Toulouse, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thierry","family":"Allegre","sequence":"additional","affiliation":[{"name":"Department of Hematology Oncology & Internal M\u00e9dicine Centre Hospitalier d\u2019Aix en Provence, Centre Hospitalier du Pays d'Aix, Aix-en-Provence, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Armelle","family":"Lavole","sequence":"additional","affiliation":[{"name":"GRC#04 Theranoscan, D\u00e9partement de Pneumologie et Oncologie Thoracique, AP-HP, H\u00f4pital Tenon, Sorbonne Universit\u00e9, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alain","family":"Makinson","sequence":"additional","affiliation":[{"name":"INSERM U1175, D\u00e9partement de Maladies Infectieuses, Centre Hospitalier Universitaire de Montpellier, Universit\u00e9 de Montpellier, Montpellier, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olivia","family":"Zaegel-Faucher","sequence":"additional","affiliation":[{"name":"Aix-Marseille Universit\u00e9, APHM Sainte-Marguerite, Service d'immuno-h\u00e9matologie Clinique, Marseille, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laurent","family":"Greillier","sequence":"additional","affiliation":[{"name":"Multidisciplinary Oncology and Therapeutic Innovations Department, Assistance Publique\u2014H\u00f4pitaux de Marseille, Aix-Marseille University, Marseille, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cathia","family":"Soulie","sequence":"additional","affiliation":[{"name":"Sorbonne Universit\u00e9, INSERM, Institut Pierre Louis d\u2019Epid\u00e9miologie et de Sant\u00e9 Publique, AP-HP, H\u00f4pital Piti\u00e9-Salp\u00eatri\u00e8re, laboratoire de virologie, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marianne","family":"Veyri","sequence":"additional","affiliation":[{"name":"Sorbonne Universit\u00e9, INSERM, Institut Pierre Louis d\u2019Epid\u00e9miologie et de Sant\u00e9 Publique, AP-HP, H\u00f4pital Piti\u00e9-Salp\u00eatri\u00e8re, D\u00e9partement d\u2019Oncologie M\u00e9dicale, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mathilde","family":"Bertheau","sequence":"additional","affiliation":[{"name":"Inserm-ANRS MIE, clinical research department, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mich\u00e8le","family":"Algarte Genin","sequence":"additional","affiliation":[{"name":"Sorbonne Universit\u00e9, INSERM, Institut Pierre Louis d\u2019Epid\u00e9miologie et de Sant\u00e9 Publique, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S\u00e9verine","family":"Gibowski","sequence":"additional","affiliation":[{"name":"Inserm-ANRS MIE, safety department, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne-Genevi\u00e8ve","family":"Marcelin","sequence":"additional","affiliation":[{"name":"Sorbonne Universit\u00e9, INSERM, Institut Pierre Louis d\u2019Epid\u00e9miologie et de Sant\u00e9 Publique, AP-HP, H\u00f4pital Piti\u00e9-Salp\u00eatri\u00e8re, laboratoire de virologie, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin","family":"Bihan","sequence":"additional","affiliation":[{"name":"Sorbonne University, INSERM CIC Paris-Est, AP-HP, ICAN, Regional Pharmacovigilance Centre, Department of Pharmacology, AP-HP, Piti\u00e9-Salp\u00eatri\u00e8re Hospital, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marine","family":"Baron","sequence":"additional","affiliation":[{"name":"Sorbonne University, Department of Medical Oncology Assistance Publique - 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