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Multicenter Study
. 2025 Oct;30(39):2500739.
doi: 10.2807/1560-7917.ES.2025.30.39.2500739.

Early results from implementation of HIV pre-exposure prophylaxis (PrEP) with long-acting injectable cabotegravir for people with barriers to oral strategies, Italy, December 2024 to August 2025

Davide Moschese  1 , Rozenn Esvan  2 , Chiara Fusetti  1 , Virginia Barchi  2 , Maria Vittoria Cossu  1 , Alessandro Giacinta  2 , Samuel Lazzarin  1 , Giulia Terracini  2 , Francesco Caruso  1 , Giulia Micheli  2 , Donatella Maddalena  1 , Giulia Del Duca  2 , Francesco Petri  1 , Gianluca Frate  2 , Maddalena Matone  1 , Damiano Farinacci  2 , Andrea Giacomelli  3   1 , Paolo Faccendini  4 , Debora Visigalli  5 , Sara Passacantilli  4 , Agostino Riva  1 , Andrea Antinori  6   2 , Andrea Gori  7   3   1 , Valentina Mazzotta  2
Affiliations
Multicenter Study

Early results from implementation of HIV pre-exposure prophylaxis (PrEP) with long-acting injectable cabotegravir for people with barriers to oral strategies, Italy, December 2024 to August 2025

Davide Moschese et al. Euro Surveill. 2025 Oct.

Abstract

Between December 2024 and August 2025, two Italian HIV/STI clinics offered long-acting injectable cabotegravir (CAB-LA) for HIV prevention in 265 individuals, representing the first European real-world implementation. Participants were prioritised based on vulnerabilities compromising oral pre-exposure prophylaxis (PrEP), such as poor adherence, comorbidities and behavioural barriers. Adherence to injections exceeded 95%, tolerability was favourable and only 1.5% discontinued for drug-related reasons. These findings demonstrate the feasibility of CAB-LA in European clinical services and support its use in specific populations.

Keywords: HIV; PrEP; cabotegravir; implementation; pre-exposure prophylaxis; real-world evidence.

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Conflict of interest statement

Conflict of interest: VM received fees for conference participation and institutional grants from Gilead Sciences and ViiV Healthcare; AA received personal fees for consultancy from AstraZeneca, Gilead Sciences, ViiV Healthcare, Merck, GSK, and institutional grants from AstraZeneca, Gilead Sciences, ViiV Healthcare; AGiacomelli received personal fees for consultancy from ViiV, Gilead and MSD and institutional grants from ViiV and Gilead. DM received fees for conference participation and institutional grants from Gilead Sciences and ViiV Healthcare. AGori reports grants or contracts from ViiV, Bristol-Myers Squibb, and Gilead; consulting fees from ViiV Healthcare, Gilead, Janssen-Cilag, Merck Sharp and Dohme, Bristol-Myers Squibb, Pfizer, and Novartis; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from ViiV Healthcare, Gilead, Janssen-Cilag, Merck Sharp and Dohme, Bristol-Myers Squibb, Pfizer, and Novartis; support for attending meetings and/or travel from ViiVHealthcare, Gilead, Janssen-Cilag, Merck Sharp and Dohme, Bristol-Myers Squibb, Pfizer, and Novartis.

Figures

Flow chart showing how individuals were assessed for cabotegravir eligibility: HIV-negative individuals underwent risk and clinical evaluation; due to limited supply, only those with barriers to oral PrEP were offered injectable CAB-LA, while others continued with oral PrEP.
Figure 1
Flow chart of the selection of study participants to receive long-acting injectable cabotegravir, Italy, December 2024–August 2025 (n = 265)
A Kaplan-Meier survival curve showing the probability of survival over a 24-week period. The x-axis represents time in weeks, and the y-axis represents survival probability. A solid line represents the survival estimate, while dashed lines indicate the 95% confidence interval. The curve remains high throughout the period, with a survival rate of 93% at 24 weeks.
Figure 2
Kaplan-Meier curve for the probability of participants remaining on long-acting injectable cabotegravir, Italy, December 2024–August 2025 (n = 265)
The graph displays five grouped bars representing doses 2 through 6. Each bar is divided into three segments showing the number of participants who received the dose on time, with a delay, or discontinued. The proportion of on-time injections decreases slightly across doses, while delayed doses increases just slightly. Participant discontinuations were noted at doses 2–4. Only seven participants had received the 6th dose during the study period.
Figure 3
Adherence to PrEP injection schedule and discontinuations of participants on long-acting injectable cabotegravir, Italy, December 2024–August 2025 (n = 265)
A graph shows four stacked bars the distribution of pain grades (0–3) at doses 1–4, revealing decreasing frequency and intensity over time. Nodules were reported in 21–45% of participants, with no clear trend across the four doses. Fever was uncommon, affecting ≤ 7% of participants, and typically occurred after the first dose.
Figure 4
Local adverse reactions to cabotegravir injections among participants, Italy, December 2024–August 2025 (n = 265)
See this image and copyright information in PMC

References

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