A French national real-world survey of people with multi-resistant HIV-1 viruses receiving an antiretroviral regimen including fostemsavir or ibalizumab

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ID: 325044
2026
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Abstract
Abstract Background Attachment inhibitor fostemsavir (FTR) and post-attachment inhibitor ibalizumab (IBA), are used in highly treatment-experienced people with HIV-1 (PWH) harboring multidrug-resistant viruses, and real-world data remain limited. We describe population characteristics and pharmaco-virological outcomes of PWH initiating FTR- or IBA-based regimens. Methods We conducted a French retrospective observational study within the ANRS|MIE virology&pharmacology network. Virological failure (VF) was defined as two consecutive plasma viral loads (VL) ≥50 c/mL; non-virological response as a VL decrease <1 log10 c/mL or failure to achieve virological suppression. Results Among 70 PWH receiving FTR-based treatment, 50% were virologically-suppressed at initiation; median VL among viremic individuals was 3.6 log10 c/mL. Resistance to at least two ARVs was observed in 96%, 94%, 74%, and 64% of participants for NRTI, NNRTI, PI, and INSTI classes, respectively. Genotypic susceptibility score (GSS) was ≤1 in 47%, and median follow-up was 20 months. Eight VFs and eight non-virological responses occurred. At failure, emergence of FTR resistance-associated mutations occurred in one case. Suboptimal temsavir concentrations were observed in 2/8 participants in failure. Eleven viremic PWH initiated IBA-based treatment, GSS was ≤1 in four, and median follow-up was 7 months, with five VF and two non-virological responses. One new resistance mutation (N74D, capsid) was detected at VF; suboptimal plasma concentrations of oral ARV were observed in 3/5 participants. Conclusions PWH receiving FTR or IBA had extensive multidrug-resistance and limited therapeutic options. Virological success was achieved in 63% and 36% of viremic PWH initiating FTR- and IBA-based regimens, respectively, and maintained in 91% of virologically-suppressed PWH starting FTR-based regimen.
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Authors Karl Stéfic, Camille Tumiotto, Anne De Monte, Marc Wirden, Audrey Rodallec, Djeneba Fofana, Marie‐Laure Chaix, Pantxika Bellecave, Elisabeth Garnier, Justine Sourice, Camille Vellas, Stéphanie Raymond, Sidonie Lambert-Niclot, Enagnon Kazali Alidjinou, Pauline Coulon, Véronique Avettand-Fènoël, Gilbert Mchantaf, Lynda Handala, Élodie Alessandri-Gradt, Alice Moisan, Minh Lê, Constance Delaugerre, Anne‐Geneviève Marcelin, Gilles Peytavin, Vincent Cálvez, Diane Descamps, Charlotte Charpentier, the Entry Inhibitors Observatory Study Group, Kévin Alexandre, Clotilde Allavena, Antoine Bachelard, Fabrice Bonnet, Charles Cazanave, David Chirio, Yoann Conan, Éric Cua, Pierre Delobel, Jade Ghosn, Laurent Hocqueloux, Karine Lacombe, Estibalitz Lazaro, Adrien Lemaignen, G Martin-Blondel, Jean‐Michel Molina, Bao Phung, Valérie Pourcher, Caroline Proux, Pascal Puglièse, Mayda Rahi, C. Rioux, Olivier Robineau
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Journal Open forum infectious diseases
Year 2026
DOI
10.1093/ofid/ofag495
URL
https://doi.org/10.1093/ofid/ofag495
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