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              <p>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 &amp;gt;17 years (incidence rate ratio [IRR] 4.66, p = 0.002), with CD4 &amp;lt;200 cells/µl (IRR 4.39, p &amp;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 ≥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.</p>
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          <orgName>Pôle Inflammation, infection, immunologie et loco-moteur [CHU Toulouse]</orgName>
          <orgName type="acronym">Pôle I3LM Toulouse</orgName>
          <desc>
            <address>
              <addrLine>Toulouse</addrLine>
              <country key="FR"/>
            </address>
          </desc>
          <listRelation>
            <relation active="#struct-300075" type="direct"/>
          </listRelation>
        </org>
        <org type="institution" xml:id="struct-300075" status="VALID">
          <orgName>Centre Hospitalier Universitaire de Toulouse</orgName>
          <orgName type="acronym">CHU Toulouse</orgName>
          <desc>
            <address>
              <addrLine>regroupe les hôpitaux  Purpan, Rangueil, Pierre-Paul Riquet, Larey, Paule de Viguier, Hôtel Dieu Saint-Jacques, La Grave, etc.</addrLine>
              <country key="FR"/>
            </address>
            <ref type="url">https://www.chu-toulouse.fr</ref>
          </desc>
        </org>
        <org type="institution" xml:id="struct-67872" status="VALID">
          <idno type="IdRef">050165224</idno>
          <idno type="ROR">https://ror.org/05q3vnk25</idno>
          <orgName>Institut de Recherche pour le Développement</orgName>
          <orgName type="acronym">IRD</orgName>
          <desc>
            <address>
              <addrLine>SiègeLe Sextant 44, bd de DunkerqueCS 9000913572 Marseille cedex 02</addrLine>
              <country key="FR"/>
            </address>
            <ref type="url">http://www.ird.fr/</ref>
          </desc>
        </org>
        <org type="regroupinstitution" xml:id="struct-1100589" status="VALID">
          <idno type="ROR">https://ror.org/051escj72</idno>
          <orgName>Université de Montpellier</orgName>
          <orgName type="acronym">UM</orgName>
          <date type="start">2022-01-01</date>
          <desc>
            <address>
              <addrLine>163 rue Auguste Broussonnet - 34090 Montpellier</addrLine>
              <country key="FR"/>
            </address>
            <ref type="url">http://www.umontpellier.fr/</ref>
          </desc>
        </org>
        <org type="regroupinstitution" xml:id="struct-258773" status="VALID">
          <idno type="ISNI">000000009961060X</idno>
          <idno type="ROR">https://ror.org/04m6sq715</idno>
          <orgName>Centre Hospitalier Régional Universitaire [Montpellier]</orgName>
          <orgName type="acronym">CHRU Montpellier</orgName>
          <desc>
            <address>
              <addrLine>191 avenue du doyen Gaston Giraud 34295 Montpellier</addrLine>
              <country key="FR"/>
            </address>
            <ref type="url">https://www.chu-montpellier.fr/fr/</ref>
          </desc>
        </org>
        <org type="regroupinstitution" xml:id="struct-300073" status="VALID">
          <idno type="ROR">https://ror.org/002cp4060</idno>
          <orgName>Assistance Publique - Hôpitaux de Marseille</orgName>
          <orgName type="acronym">APHM</orgName>
          <desc>
            <address>
              <addrLine>Direction générale AP-HM80, rue Brochier13 354 Marseille Cedex 5</addrLine>
              <country key="FR"/>
            </address>
            <ref type="url">http://fr.ap-hm.fr/</ref>
          </desc>
        </org>
        <org type="institution" xml:id="struct-300889" status="VALID">
          <idno type="ROR">https://ror.org/0338wkj94</idno>
          <orgName>Hôpital Sainte-Marguerite [CHU - APHM]</orgName>
          <orgName type="acronym">Hôpitaux Sud</orgName>
          <desc>
            <address>
              <addrLine>270, boulevard de Sainte-Marguerite13274 Marseille cedex 9</addrLine>
              <country key="FR"/>
            </address>
            <ref type="url">http://fr.ap-hm.fr/nos-hopitaux/hopitaux-sud</ref>
          </desc>
        </org>
        <org type="institution" xml:id="struct-301315" status="VALID">
          <idno type="ISNI">0000 0001 0304 0719 </idno>
          <idno type="ROR">https://ror.org/029a4pp87</idno>
          <orgName>Hôpital Nord [CHU - APHM]</orgName>
          <date type="start">1964</date>
          <desc>
            <address>
              <addrLine>Hôpital Nord - Chemin des Bourrely13915Marseille cedex 20</addrLine>
              <country key="FR"/>
            </address>
            <ref type="url">http://fr.ap-hm.fr/nos-hopitaux/hopital-nord</ref>
          </desc>
        </org>
        <org type="institution" xml:id="struct-312432" status="VALID">
          <orgName>Hôpital Bicêtre [AP-HP, Le Kremlin-Bicêtre]</orgName>
          <desc>
            <address>
              <addrLine>78 Rue du Général Leclerc 94270 Le Kremlin-Bicêtre</addrLine>
              <country key="FR"/>
            </address>
            <ref type="url">https://hopital-bicetre.aphp.fr/</ref>
          </desc>
          <listRelation>
            <relation active="#struct-300068" type="direct"/>
          </listRelation>
        </org>
      </listOrg>
    </back>
  </text>
</TEI>