Lenacapavir Use in France: A National, Observational Study (LENAddOn)
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.
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BibTeX
@article{ghosn2026lenacapavir,
title = {{Lenacapavir Use in France: A National, Observational Study (LENAddOn)}},
author = {Jade Ghosn and Valérie Pourcher and Clotilde Allavena and Laurent Hocqueloux and Karine Lacombe and Eric Cua and Fabrice Bonnet and Claudine Duvivier and Alain Makinson and Christine Jacomet and Caroline Lascoux and Jean-Paul Viard and Olivier Robineau and Maxime Hentzien and Elina Teicher and Gilles Pialoux and Sophie Abgrall and Charles Cazanave and André Cabié and Yasmine Dudoit and Gilles Peytavin and Guillaume Barrière and Keith Dunn and Anne-Geneviève Marcelin and Lambert Assoumou and Pauline Perreau and Tanguy Vincent and Jean Delaune and Camille Krzyzanowsky and Agnès Cros and Laurent Richier and Corinne Merle and Célia Bouhnik and Barbara de Dieuleveult and Cécile Goujard and Yann Quertainmont and Sandrine Poirier and Véronique Godard and Caroline Proux and Antoine Bachelard and Zélie Julia and Racha Ibrahim and Awa Ndiaye and Ornella Cabras and Lorry Facelina and Firouzé Bani-Sadr and Yohan Nguyen and Isabelle Kmiec and Wiem Loghmari and Valérie Le Baut and Morane Cavallec and Soria Albane and Ernesto Paredes Manyari and Sophie Breaud and Iris Touitou and Martin Siguier and Christia Palacios and Mouniya Mebarki and Anne Adda-Lievin and Dilek Coban},
journal = {Open Forum Infectious Diseases},
year = {2026},
month = aug,
doi = {10.1093/ofid/ofag512},
url = {https://u-bordeaux.hal.science/hal-05744307v1},
note = {CC BY-NC-ND 4.0},
}
RIS
TY - JOUR
TI - Lenacapavir Use in France: A National, Observational Study (LENAddOn)
AU - Jade Ghosn
AU - Valérie Pourcher
AU - Clotilde Allavena
AU - Laurent Hocqueloux
AU - Karine Lacombe
AU - Eric Cua
AU - Fabrice Bonnet
AU - Claudine Duvivier
AU - Alain Makinson
AU - Christine Jacomet
AU - Caroline Lascoux
AU - Jean-Paul Viard
AU - Olivier Robineau
AU - Maxime Hentzien
AU - Elina Teicher
AU - Gilles Pialoux
AU - Sophie Abgrall
AU - Charles Cazanave
AU - André Cabié
AU - Yasmine Dudoit
AU - Gilles Peytavin
AU - Guillaume Barrière
AU - Keith Dunn
AU - Anne-Geneviève Marcelin
AU - Lambert Assoumou
AU - Pauline Perreau
AU - Tanguy Vincent
AU - Jean Delaune
AU - Camille Krzyzanowsky
AU - Agnès Cros
AU - Laurent Richier
AU - Corinne Merle
AU - Célia Bouhnik
AU - Barbara de Dieuleveult
AU - Cécile Goujard
AU - Yann Quertainmont
AU - Sandrine Poirier
AU - Véronique Godard
AU - Caroline Proux
AU - Antoine Bachelard
AU - Zélie Julia
AU - Racha Ibrahim
AU - Awa Ndiaye
AU - Ornella Cabras
AU - Lorry Facelina
AU - Firouzé Bani-Sadr
AU - Yohan Nguyen
AU - Isabelle Kmiec
AU - Wiem Loghmari
AU - Valérie Le Baut
AU - Morane Cavallec
AU - Soria Albane
AU - Ernesto Paredes Manyari
AU - Sophie Breaud
AU - Iris Touitou
AU - Martin Siguier
AU - Christia Palacios
AU - Mouniya Mebarki
AU - Anne Adda-Lievin
AU - Dilek Coban
PY - 2026
DA - 2026/08/19
JO - Open Forum Infectious Diseases
DO - 10.1093/ofid/ofag512
UR - https://u-bordeaux.hal.science/hal-05744307v1
AB - 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.
SN - 2328-8957
SN - 2328-8957
ER -