Lenacapavir use in France: a national, observational study (LENAddOn)

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ID: 325593
2026
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Abstract
Abstract Context The LENAddOn study aimed to: characterize PWH initiating injectable lenacapavir (LEN) post-early access program in France; assess LEN continuation rates at W26 and W52; describe reasons for LEN discontinuation. Methods Observational, retrospective study across 19 centers, including people with HIV-1 who initiated LEN between 20/06/2023 and 30/06/2024. Socio-demographic, clinical, and laboratory data were extracted from medical records. The primary outcome was the proportion of PWH receiving a second and third set of LEN injections at W26 and W52. Results 77 PWH were included (median age 57 years [IQR 44-63]; duration of ART 25 years [17-29]), with a history of frequent adherence issues and vulnerability factors. At LEN initiation, 22 (28.6%) had a plasma HIV-1 viral load (pVL) ≥200 copies/mL and 43 (55.8%) a pVL <50 copies/mL; 42 (54.6%) had viral resistance to ≥2 drugs in ≥3 classes. 21 participants (27.3%) received injectable ART associating LEN plus cabotegravir ± rilpivirine. LEN continuation rate was 94.8% (95% CI 87.2-98.6) at W26, and 81.8% (71.4-89.7) at W52, with 4 LEN discontinuations between D0 and W26, and 10 between W26 and W52. Main reasons for LEN discontinuation were: death unrelated to LEN/lost-to-follow-up (n=5), persistence of viral replication (n=3) and injection site reactions (ISRs, n=2). Last measured pVL during the study period was <200 cp/mL in 72/77 participants (93.5%), and <50 cp/mL in 61/77 (79.2%). Conclusion LEN use allowed simplification of antiretroviral regimens, with the maintenance or achievement of virological suppression. Continuation of LEN at W26 and W52 remained high among a population with extensive treatment history.
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Authors Jade Ghosn, Valérie Pourcher, Clotilde Allavena, Laurent Hocqueloux, Karine Lacombe, Éric Cua, Fabrice Bonnet, Claudine Duvivier, Alain Makinson, Christine Jacomet, C. Lascoux, Jean‐Paul Viard, Olivier Robineau, Maxime Hentzien, Elina Teicher, Gilles Pialoux, Sophie Abgrall, Charles Cazanave, André Cabie, Yasmine Dudoit, Gilles Peytavin, Guillaume Barriere, Keith Dunn, Anne‐Geneviève Marcelin, L. Assoumou, Romain Palich, for the LENAddOn Study Group, Pauline Perreau, Tanguy Vincent, J. Delaune, Camille Krzyzanowsky, Agnès Cros, Laurent Richier, Corinne Merle, Célia Bouhnik, Barbara De Dieuleveult, Cécile Goujard, Yann Quertainmont, Sandrine Poirier, V Godard, Caroline Proux, Antoine Bachelard, Zélie Julia, Racha Ibrahim, Awa Ndiaye, Ornella Cabras, Lorry Facelina, Firouzé Bani‐Sadr, Yohan N'Guyen, I Kmiec, Wiem Loghmari, V. Le Baut, Morane Cavallec, Soria Albane, Ernesto Paredes Manyari, S Bréaud, Iris Touitou, Martin Siguier, Christia Palacios, Mouniya Mebarki, Anne Adda-Lievin, Dilek Çoban, V. Baclet, Pauline Cornavin, Nathalie Viget, Marie-Christine Marien, Carole Louisin, Elisabete Gomes Pires, Jean‐Michel Molina, Nadia Laradh, Zineb Ouazene, Christian Tran, Rania Zemouri, Julie Lamarque, Ikrame Benyamina, Marc‐Antoine Valantin, Afiya Nadour, Naïma Hamani, M Chansombat
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Journal Open forum infectious diseases
Year 2026
DOI
10.1093/ofid/ofag512
URL
https://doi.org/10.1093/ofid/ofag512
Keywords Keywords not found

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