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OC25 Identifying the eligibility gap for long-acting injectable PrEP in the Italian PrIDE cohort

sextrans · 2026-06-05 · canonical JSON source

6 visible annotations · policy: published · automated confidence ≥ 75.00%

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Background Long-acting cabotegravir (CAB-LA) is a key addition to HIV prevention but requires more resources than oral PrEP. To guide sustainable use, we estimated the proportion of users in Italy who may truly need CAB-LA.Methods We analyzed PrEP users from the Italian PrIDE cohort, a nationwide observational study. Participants were enrolled July 2024-August 2025 in 14 hospitals and 3 community sites. The ‘active oral PrEP’ population excluded definitive discontinuation, CAB-experience, and those lost to follow-up (no visit ≥6 months). Observation spanned from first post-enrolment visit to last visit plus 90 days.Eligibility criteria (≥1 for inclusion): renal impairment (eGFR ≤60 mL/min/1.73m2, contraindicated if <60), proximal tubular dysfunction, proteinuria, or decline >20 mL/min; poor self-reported adherence, defined as <60% on a 0–100 visual analog scale for daily users or ‘sometimes/never’ correct 2+1+1 on-demand (including chemsex-induced); drug intolerance required both side effects and ≥1 suspension for adverse events (excluding intermediate suspensions); psychiatric comorbidities; malabsorption syndromes; and being a cis or transgender women. Renal decline was assessed over ≥6 months. Time on PrEP was described but not modeled to avoid time-dependent bias. Predictors were tested with logistic regression and Cox models (censoring at last visit plus 90 days).Results Among 2,368 PrEP users, 337 (14.2%) met ≥1 one strict eligibility criterion. Specifically, 156 (6.6%) reported poor adherence, 61 (2.6%) psychiatric comorbidities, 38 (1.6%) suboptimal renal function, 32 (1.4%) drug intolerance, 27 (1.1%) malabsorption, and 23 (1.0%) were cisgender or transgender women ( table 1). In univariable logistic regression, higher education was linked with lower odds of eligibility (OR 0.60; 95% CI 0.39–0.93). In the multivariable logistic model, receiving care in a community-based setting was significantly associated with a lower risk of LA-PrEP eligibility (OR 0.65; 95%CI: 0.47 – 0.88; p=0.007), likely due to referral of complex PrEP cases to hospitals.Conclusions In our nationally representative cohort, 14.2% of oral PrEP users met strict clinical or behavioral criteria for CAB-LA. Only a minority would therefore require LA PrEP, supporting a targeted rather than universal rollout. Restricting access to those with clear needs would increase feasibility and sustainability while directing resources to those most likely to benefit.Abstract OC25 Table 1Proportion of active PrEP users meeting CAB-LA eligibility criteria in the Italian PrIDE Cohort (N =2368)