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Efficacy and durability of Fostemsavir-, Ibalizumab-, or Lenacapavir-including regimens in people living with a Multidrug Resistant HIV: results from the PRESTIGIO Registry

Purpose: To describe the efficacy and durability of fostemsavir (FTR), ibalizumab (IBA) or lenacapavir (LEN)-including regimens in people living with 4-drug class resistant HIV (4DR-PLWH) in a real-life setting.

Methods: We included 4DR-PLWH from the PRESTIGIO Registry, treated with a FTR-, IBA- or LEN-including regimen and with a documented resistance to NRTIs/NNRTIs/PIs/INSTIs.

Discontinuation of FTR, IBA or LEN was defined as interruption of the drug for any cause. Follow-up (FU) started from the date of FTR, LEN or IBA start (baseline; BL) until discontinuation of FTR/IBA/LEN or death/freezing date (30/June/2023). Descriptions by median (IQR) or frequency (%). Genotypic susceptibility score for the optimized background therapy introduced with FTR/LEN/IBA was estimated according to the cumulative data of the available plasma genotyping resistance tests recorded for each patient.

Results: Among 35 4DR-PLWH, we considered 27, 11 and 10 FTR-, IBA- and LEN-including regimens, respectively (Table 1).
FTR-including regimens: at the end of FU [median duration 18.7 (5.6-82.7) months], virological efficacy (VE; HIV-RNA <200 copies/mL) was 66.7% (18/27); 8/27 (29.6%) regimens had been discontinued. Among those still in a FTR-including regimen, the median change in CD4+ was +97 (-38/+182) cells/mm3(p=0.064).
IBA-including regimens: median FU 14.1 (5.6 -39.1) months, VE was 63.6% (7/11); 4/11 (36%) regimens had been discontinued. Median CD4+ change, in those still on treatment with IBA, was +63 (-38/+122) cells/mm3(p=0.109).
LEN including regimens: median FU 30.3 (18.7-33.5) months, VE was 90% (9/10); 2/10 (20%) regimens had been discontinued. Median CD4+ change was +5 (-48/+101) cells/mm3(p=0.742).
Regimens including a concomitant administration of FTR, IBA or LEN (n=4) are described in Table 2.

Conclusions: In 4DR-PLWH, the overall efficacy and durability of FTR, IBA or LEN-including regimens were good. Efficacy and safety data on combination regimens including entry and capsid inhibitors are urgently needed in this fragile population.

Dated Thu Oct 19 2023

Authors: G.Torkjazi, L.Galli, R.Gagliardini, M.Feasi, S.Bonora, F.Lagi, E.Focà, G.Marchetti, A.Cervo, F.Maggiolo, R.Gulminetti, F Vichi, R.Papaioannu Borjesson, A.Castagna, V.Spagnuolo

Affiliations: Faculty of Medicine and Surgery, Vita-Salute San Raffaele University, Milan Infectious Diseases, IRCCS San Raffaele Scientific Institute, Milan National Institute for Infectious Diseases ‘L. Spallanzani’ IRCCS, Rome Ente Ospedaliero Ospedali Galliera, Genova Unit of Infectious Diseases, Department of Medical Sciences, University of Torino Department of Clinical and Experimental Medicine, University of Florence Division of Infectious and Tropical Diseases, ASST Spedali Civili Hospital, University of Brescia, Brescia, Italy Clinic of Infectious Diseases and Tropical Medicine, San Paolo Hospital, ASST Santi Paolo e Carlo, Department of Health Sciences, University of Milan Department of Infectious Diseases, Azienda Ospedaliero-Universitaria of Modena Department of Infectious Diseases, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo Department of Medical Sciences and Infectious Diseases, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy Infectious Diseases Unit, Santa Maria Annunziata Hospital, Bagno a Ripoli, Italy