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Peer-reviewedCC BYOpen Forum Infectious Diseases

A French National Real-World Survey of People With Multiresistant HIV-1 Viruses Receiving an Antiretroviral Regimen Including Fostemsavir or Ibalizumab

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Abstract

Background Attachment inhibitor fostemsavir (FTR) and postattachment inhibitor ibalizumab (IBA) are used in people with HIV-1 (PWH) who are highly treatment experienced and harboring multidrug-resistant viruses, and real-world data remain limited. We describe population characteristics and pharmacovirologic outcomes of PWH initiating FTR- or IBA-based regimens. Methods We conducted a French retrospective observational study within the AIDS Research National Agency | Emerging Infectious Diseases virology and pharmacology network. Virologic failure (VF) was defined as 2 consecutive plasma viral loads (VLs) ≥50 copies/mL; nonvirologic response was considered a VL decrease <1 log10 copies/mL or failure to achieve virologic suppression. Results Among 70 PWH receiving FTR-based treatment, 50% were virologically suppressed at initiation; median VL among viremic cases was 3.6 log10 copies/mL. Resistance to at least 2 antiretrovirals was observed among participants by inhibitor class: 96%, nucleoside reverse transcriptase inhibitor; 94%, nonnucleoside reverse transcriptase inhibitor; 74%, protease inhibitor; and 64%, integrase strand transfer inhibitor. The genotypic susceptibility score was ≤1 in 47%, and median follow-up was 20 months. Eight VFs and 8 nonvirologic responses occurred. At failure, emergence of FTR resistance-associated mutations occurred in 1 case. Suboptimal temsavir concentrations were observed in 2 of 8 participants in failure. Eleven PWH who were viremic initiated IBA-based treatment: the genotypic susceptibility score was ≤1 in 4, and median follow-up was 7 months with 5 VFs and 2 nonvirologic responses. One new resistance mutation (N74D, capsid) was detected at VF; suboptimal plasma concentrations of oral antiretrovirals were observed in 3 of 5 participants. Conclusions PWH receiving FTR or IBA had extensive multidrug resistance and limited therapeutic options. Among PWH who were viremic and initiating FTR- and IBA-based regimens, virologic success was achieved in 63% and 36%, respectively, and maintained in 91% who were virologically suppressed and starting an FTR-based regimen.

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BibTeX
@article{stefic2026french,
  title = {{A French National Real-World Survey of People With Multiresistant HIV-1 Viruses Receiving an Antiretroviral Regimen Including Fostemsavir or Ibalizumab}},
  author = {Karl Stefic and Camille Tumiotto and Anne de Monte and Marc Wirden and Audrey Rodallec and Djeneba Bocar Fofana and Marie-Laure Chaix and Pantxika Bellecave and Elisabeth André-Garnier and Justine Sourice and Camille Vellas and Stéphanie Raymond and Sidonie Lambert-Niclot and Enagnon Kazali Alidjinou and Pauline Coulon and Véronique Avettand-Fenoel and Gilbert Mchantaf and Lynda Handala and Elodie Alessandri-Gradt and Alice Moisan and Minh Lê and Constance Delaugerre and Anne-Geneviève Marcelin and Gilles Peytavin and Vincent Calvez and Diane Descamps and Charlotte Charpentier and Kevin Alexandre and Clotilde Allavena and Antoine Bachelard and Fabrice Bonnet and Charles Cazanave and David Chirio and Yoann Conan and Eric Cua and Pierre Delobel and Jade Ghosn and Laurent Hocqueloux and Karine Lacombe and Estibalitz Lazaro and Adrien Lemaignen and Guillaume Martin-Blondel and Jean-Michel Molina and Bao Phung and Valérie Pourcher and Caroline Proux and Pascal Pugliese and Mayda Rahi and Christophe Rioux and Olivier Robineau},
  journal = {Open Forum Infectious Diseases},
  year = {2026},
  month = aug,
  doi = {10.1093/ofid/ofag495},
  url = {https://u-bordeaux.hal.science/hal-05732452v1},
  note = {CC BY},
}
RIS
TY  - JOUR
TI  - A French National Real-World Survey of People With Multiresistant HIV-1 Viruses Receiving an Antiretroviral Regimen Including Fostemsavir or Ibalizumab
AU  - Karl Stefic
AU  - Camille Tumiotto
AU  - Anne de Monte
AU  - Marc Wirden
AU  - Audrey Rodallec
AU  - Djeneba Bocar Fofana
AU  - Marie-Laure Chaix
AU  - Pantxika Bellecave
AU  - Elisabeth André-Garnier
AU  - Justine Sourice
AU  - Camille Vellas
AU  - Stéphanie Raymond
AU  - Sidonie Lambert-Niclot
AU  - Enagnon Kazali Alidjinou
AU  - Pauline Coulon
AU  - Véronique Avettand-Fenoel
AU  - Gilbert Mchantaf
AU  - Lynda Handala
AU  - Elodie Alessandri-Gradt
AU  - Alice Moisan
AU  - Minh Lê
AU  - Constance Delaugerre
AU  - Anne-Geneviève Marcelin
AU  - Gilles Peytavin
AU  - Vincent Calvez
AU  - Diane Descamps
AU  - Charlotte Charpentier
AU  - Kevin Alexandre
AU  - Clotilde Allavena
AU  - Antoine Bachelard
AU  - Fabrice Bonnet
AU  - Charles Cazanave
AU  - David Chirio
AU  - Yoann Conan
AU  - Eric Cua
AU  - Pierre Delobel
AU  - Jade Ghosn
AU  - Laurent Hocqueloux
AU  - Karine Lacombe
AU  - Estibalitz Lazaro
AU  - Adrien Lemaignen
AU  - Guillaume Martin-Blondel
AU  - Jean-Michel Molina
AU  - Bao Phung
AU  - Valérie Pourcher
AU  - Caroline Proux
AU  - Pascal Pugliese
AU  - Mayda Rahi
AU  - Christophe Rioux
AU  - Olivier Robineau
PY  - 2026
DA  - 2026/08/14
JO  - Open Forum Infectious Diseases
DO  - 10.1093/ofid/ofag495
UR  - https://u-bordeaux.hal.science/hal-05732452v1
AB  - Background Attachment inhibitor fostemsavir (FTR) and postattachment inhibitor ibalizumab (IBA) are used in people with HIV-1 (PWH) who are highly treatment experienced and harboring multidrug-resistant viruses, and real-world data remain limited. We describe population characteristics and pharmacovirologic outcomes of PWH initiating FTR- or IBA-based regimens. Methods We conducted a French retrospective observational study within the AIDS Research National Agency | Emerging Infectious Diseases virology and pharmacology network. Virologic failure (VF) was defined as 2 consecutive plasma viral loads (VLs) ≥50 copies/mL; nonvirologic response was considered a VL decrease <1 log10 copies/mL or failure to achieve virologic suppression. Results Among 70 PWH receiving FTR-based treatment, 50% were virologically suppressed at initiation; median VL among viremic cases was 3.6 log10 copies/mL. Resistance to at least 2 antiretrovirals was observed among participants by inhibitor class: 96%, nucleoside reverse transcriptase inhibitor; 94%, nonnucleoside reverse transcriptase inhibitor; 74%, protease inhibitor; and 64%, integrase strand transfer inhibitor. The genotypic susceptibility score was ≤1 in 47%, and median follow-up was 20 months. Eight VFs and 8 nonvirologic responses occurred. At failure, emergence of FTR resistance-associated mutations occurred in 1 case. Suboptimal temsavir concentrations were observed in 2 of 8 participants in failure. Eleven PWH who were viremic initiated IBA-based treatment: the genotypic susceptibility score was ≤1 in 4, and median follow-up was 7 months with 5 VFs and 2 nonvirologic responses. One new resistance mutation (N74D, capsid) was detected at VF; suboptimal plasma concentrations of oral antiretrovirals were observed in 3 of 5 participants. Conclusions PWH receiving FTR or IBA had extensive multidrug resistance and limited therapeutic options. Among PWH who were viremic and initiating FTR- and IBA-based regimens, virologic success was achieved in 63% and 36%, respectively, and maintained in 91% who were virologically suppressed and starting an FTR-based regimen.
SN  - 2328-8957
SN  - 2328-8957
ER  -