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HIV Oral Pre-exposure Prophylaxis Effectiveness, Adherence, and Discontinuation in an Italian Multicentric Access
Valentina Mazzotta1, Enrico Caruso2, Alessandro Tavelli3,4
1HIV/AIDS Unit, Department of Clinical Infectious Diseases, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy.
Open Forum Infectious Diseases
|September 22, 2025
Summary
Italian oral pre-exposure prophylaxis (PrEP) shows low HIV incidence in real-world data. Strategies must address adherence challenges and identify at-risk groups for effective implementation.
Area of Science:
- Public Health
- Infectious Diseases
- Clinical Pharmacology
Background:
- Oral pre-exposure prophylaxis (PrEP) implementation in Italy faced hurdles prior to 2023 drug reimbursement.
- Limited real-world data exists on the effectiveness of oral PrEP in Italy.
- This study addresses the need for national data on HIV and STI incidence, adherence, and discontinuation.
Purpose of the Study:
- To report incidence rates (IR) of HIV and other sexually transmitted infections (STIs) among oral PrEP users in Italy.
- To evaluate probabilities and predictors of poor adherence and PrEP discontinuation.
- To inform strategies for improving oral PrEP implementation in Italy.
Main Methods:
- Prospective national cohort study (ItaPrEP) involving 1758 oral PrEP users across eight Italian centers (September 2017-November 2023).
- Evaluation of HIV and STI incidence rates (IR) per 100 person-year follow-up (PYFU).
- Kaplan-Meier estimation for adherence and discontinuation probabilities; mixed-effect logistic models for risk factor analysis.
Main Results:
- Five HIV seroconversions observed (IR: 0.187/100 PYFU).
- High IRs for syphilis (13.1/100 PYFU), chlamydia (23.8/100 PYFU), and gonorrhea (24.2/100 PYFU).
- Two-year probabilities of poor adherence (57.9%) and discontinuation (37.1%); chemsex and switching schedules linked to poor adherence; age >40, free drugs, and monitoring associated with lower discontinuation risk.
Conclusions:
- Italian oral PrEP program demonstrates lower HIV incidence compared to clinical trials.
- Real-world effectiveness is comparable to other observational studies.
- Identifying vulnerable populations (young, low education, chemsex users) and addressing barriers (drug access, monitoring) are crucial for enhancing PrEP implementation.
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