Durability of lenacapavir in viremic heavily treatment-experienced people with HIV: real-world data from the PRESTIGIO Registry

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Lenacapavir, the first-in-class capsid inhibitor, targets multiple stages of the HIV lifecycle, thereby inhibiting viral replication.1 Thanks to its new mechanism of action, lenacapavir is approved for use in people with HIV (PWH) who have limited treatment options.2,3 While its efficacy has been demonstrated in clinical trials,4–6 real-world data in PWH with extensive treatment experience remain scarce. We aimed to evaluate the durability and viro-immunological outcomes of lenacapavir-containing regimens in viremic PWH harbouring four-class drug-resistant (4DR) strains. This cohort study included 4DR-PWH from the PRESTIGIO Registry who initiated a lenacapavir-containing regimen with viral load (VL) ≥50 copies/mL. PRESTIGIO (NCT04098315; https://registroprestigio.org/) is an Italian multicenter registry of adults with HIV resistant to nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs) and integrase strand transfer inhibitors (INSTIs).7 Two non-viremic 4DR-PWH who initiated LEN were excluded (Table S1, available as Supplementary data at JAC Online). The primary outcome was lenacapavir durability; secondary outcomes included virological suppression [(VS) ≥ 1 VL <50 copies/mL] and immunological changes. Follow-up accrued from lenacapavir initiation (baseline) until discontinuation or last available VL (censoring date: 1 April 2025). Characteristics were described as median (interquartile range) or frequency (percentage). Lenacapavir retention and VS probabilities were estimated using Kaplan–Meier and cumulative incidence, respectively. FDA snapshot at Weeks 26 and 52 was also used. Changes in CD4+ and CD4+/CD8+ were assessed using the Wilcoxon signed-rank test.

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