Applying the CONSENSUS ‐ LAI virological failure definition in real‐world practice: Evidence from the multicentre LAHIV cohort
Year: 2026
Type: article
Study design: Observational Study
Abstract: OBJECTIVES: Definitions of virological failure (VF) for long-acting cabotegravir plus rilpivirine (CAB+RPV) remain inconsistent across real-world cohorts. The CONSENSUS-LAI Delphi process (September 2025) set a shared plasma threshold of ≥200 copies/mL. We evaluated its impact on VF classification and whether its publication influenced prescriber behaviour. METHODS: Retrospective analysis of virologically suppressed adults initiating CAB+RPV across 11 centres in Tuscany, Italy. Switches attributed to VF by the treating physician were reclassified as meeting CONSENSUS-LAI plasma criteria or as sub-threshold. Rates were calculated per 100 person-years (PY); switches before and after September 2025 were compared with Fisher's exact test. RESULTS: Among 297 participants (418 PY), 11 switches were attributed to VF (2.63/100 PY, 95% CI 1.31-4.71). Six (54.5%) met CONSENSUS-LAI plasma criteria (1.44/100 PY, 95% CI 0.53-3.12), five with a single value >1000 copies/mL, one with confirmed values ≥200 copies/mL; 4 were sub-threshold and one was cerebrospinal fluid viral escape with undetectable plasma HIV-1 RNA. Emergent resistance occurred in three cases, all CONSENSUS-LAI-defined failures. No resistance was detected in the two sub-threshold cases tested; all four sub-threshold VF re-suppressed, although two of four were switched to a protease inhibitor-based regimen. Sub-threshold switches were 1/6 before and 3/5 after CONSENSUS-LAI publication (p = 0.24). CONCLUSIONS: The CONSENSUS-LAI definition nearly halves the VF rate, aligning it with cohorts using a ≥200 copies/mL threshold. Emergent resistance was confined to CONSENSUS-LAI-defined failures, whereas sub-threshold viraemia, without detected resistance, still drove most post-consensus switches, highlighting the challenges of translating consensus recommendations into routine practice.
Source: HIV Medicine
DOI: 10.1111/hiv.70363
Institutions: Azienda Ospedaliero-Universitaria Careggi, University of Florence, Ospedale Misericordia - Grosseto, University of Siena, Azienda Ospedaliera Universitaria Senese, Ospedale Santa Maria Annunziata, Azienda Usl Toscana Centro, Azienda USL Toscana Nord Ovest, Hospital of Prato, Ospedale di Livorno, Ospedale Piero Palagi
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W7225468594