Lenacapavir use in France: a national, observational study (LENAddOn)
Jade Ghosn, Valérie Pourcher, Clotilde Allavena, Laurent Hocqueloux, Karine Lacombe, Eric Cua, Fabrice Bonnet, Claudine Duvivier, Alain Makinson, Christine Jacomet, Caroline Lascoux, Jean-Paul Viard, Olivier Robineau, Maxime Hentzien, Elina Teicher, Gilles Pialoux, Sophie Abgrall, Charles Cazanave, André Cabié, Yasmine Dudoit, Gilles Peytavin, Guillaume Barrière, Keith Dunn, Anne-Geneviève Marcelin, Lambert Assoumou, Romain Palich, , Charles Cazanave, Pauline Perreau, Tanguy Vincent, Fabrice Bonnet, Jean Delaune, Camille Krzyzanowsky, Sophie Abgrall, Agnès Cros, Laurent Richier, Alain Makinson, Corinne Merle, Célia Bouhnik, Laurent Hocqueloux, Barbara de Dieuleveult, Cécile Goujard, Yann Quertainmont, Sandrine Poirier, Elina Teicher, Véronique Godard, Jade Ghosn, Caroline Proux, Antoine Bachelard, Zélie Julia, Racha Ibrahim, Awa Ndiaye, André Cabié, Ornella Cabras, Lorry Facelina, Firouzé Bani-Sadr, Maxime Hentzien, Yohan Nguyen, Isabelle Kmiec, Jean-Paul Viard, Wiem Loghmari, Valérie Le Baut, Clotilde Allavena, Morane Cavallec, Soria Albane, Ernesto Paredes Manyari, Eric Cua, Sophie Breaud, Iris Touitou, Gilles Pialoux, Martin Siguier, Christia Palacios, Mouniya Mebarki, Anne Adda-Lievin, Christine Jacomet, Dilek Coban, Olivier Robineau, Véronique Baclet, Pauline Cornavin, Nathalie Viget, Marie-Christine Marien, Claudine Duvivier, Carole Louisin, Elisabete Gomes Pires, Jean-Michel Molina, Caroline Lascoux, Nadia Laradh, Karine Lacombe, Zineb Ouazene, Christian Tran, Rania Zemouri, Julie Lamarque, Ikrame Benyamina, Marc-Antoine Valantin, Afiya Nadour, Naïma Hamani, Malikhone ChansombatAbstract
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.