Lenacapavir Use in France: A National, Observational Study (LENAddOn)
Year: 2026
Type: article
Study design: Observational Study
Abstract: Background: The LENAddOn study aimed to characterize people with HIV (PWH) initiating injectable lenacapavir (LEN) post-early access program in France, assess LEN continuation rates at W26 and W52, and describe reasons for LEN discontinuation. Methods: Observational, retrospective study across 19 centers, including people with HIV-1 who initiated LEN between 20 June 2023 and 30 June 2024. Sociodemographic, 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: Seventy-seven PWH were included (median age, 57 years [IQR, 44-63]; duration of antiretroviral therapy (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%) had a pVL <50 copies/mL; 42 (54.6%) had viral resistance to ≥2 drugs in ≥3 classes. Twenty-one participants (27.3%) received injectable ART associating LEN plus cabotegravir ± rilpivirine. Lenacapavir 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 (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%). Conclusions: Lenacapavir 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.
Source: Open Forum Infectious Diseases
DOI: 10.1093/ofid/ofag512
Authors: 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, for the LENAddOn Study Group, Pauline Perreau, Tanguy Vincent, Jean Delaune, Camille Krzyzanowsky, Agnès Cros, Laurent Richier, Corinne Merle, Célia Bouhnik, Barbara de Dieuleveult, Cécile Goujard, Yann Quertainmont, Sandrine Poirier, Véronique Godard, Caroline Proux, Antoine Bachelard, Zélie Julia, Racha Ibrahim, Awa Ndiaye, Ornella Cabras, Lorry Facelina, Firouzé Bani-Sadr, Yohan Nguyen, Isabelle Kmiec, Wiem Loghmari, Valérie Le Baut, Morane Cavallec, Soria Albane, Ernesto Paredes Manyari, Sophie Breaud, Iris Touitou, Martin Siguier, Christia Palacios, Mouniya Mebarki, Anne Adda-Lievin, Dilek Coban, Véronique 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, Malikhone Chansombat
Institutions: Inserm, Université Paris Cité, Hôpital Bichat-Claude-Bernard, Infection, Anti-microbiens, Modélisation, Evolution, Sorbonne Université, Assistance Publique – Hôpitaux de Paris, Pitié-Salpêtrière Hospital, Institut Pierre Louis d‘Épidémiologie et de Santé Publique, Nantes Université, Université d'Orléans, Centre hospitalier universitaire d'Orléans, Hôpital Saint-Antoine, Centre Hospitalier Universitaire de Nice, Bordeaux Population Health, Hôpital Saint-André, Institut des Maladies Génétiques Imagine, Centre Hospitalier Universitaire de Montpellier, Centre Hospitalier Universitaire de Clermont-Ferrand, Hôtel-Dieu de Paris, Centre Hospitalier de Tourcoing, Centre Hospitalier Universitaire de Reims, Vieillissement, Fragilité, Université de Reims Champagne-Ardenne, Bicêtre Hospital, Hôpital Tenon, Hôpital Antoine-Béclère, Centre National de la Recherche Scientifique, Hôpital Pellegrin, Laboratoire de Microbiologie Fondamentale et Pathogénicité, Université de Montpellier, Centre Hospitalier Universitaire de Martinique, Université Sorbonne Paris Nord, Gilead Sciences (United States)
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $4,053
Funder: Gilead Sciences
OpenAlex ID: W7203792536