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. 2025 Aug 1;80(8):2169-2178.
doi: 10.1093/jac/dkaf184.

Effectiveness and predictors of treatment discontinuation of long-acting cabotegravir/rilpivirine in virologically suppressed people with HIV: real-life data from the Icona Cohort

Roberta Gagliardini  1 , Sara De Benedittis  2 , Alessandro Tavelli  2   3 , Giuseppe Lapadula  4 , Valentina Mazzotta  1 , Elena Bruzzesi  5 , Adriana Cervo  6 , Giorgia Carrozzo  7 , Annalisa Saracino  8 , Stefano Rusconi  9 , Giulia Marchetti  10 , Francesca Ceccherini-Silberstein  11 , Andrea Antinori  1 , Antonella d'Arminio Monforte  2 , Camilla Muccini  12 ; Icona Foundation Study Group
Collaborators, Affiliations

Effectiveness and predictors of treatment discontinuation of long-acting cabotegravir/rilpivirine in virologically suppressed people with HIV: real-life data from the Icona Cohort

Roberta Gagliardini et al. J Antimicrob Chemother. .

Abstract

Background: Phase 3 studies have shown long-acting (LA) cabotegravir/rilpivirine to be effective and tolerable as maintenance therapy in people with HIV (PWH). However, real-life data on their effectiveness are limited.

Methods: All PWH enrolled in the Icona Cohort who started LA cabotegravir/rilpivirine with HIV-RNA < 50 copies/mL were included. Times to treatment discontinuation (TD) and to virological failure (VF50, two consecutive HIV-RNA >50 copies/mL or one >1000 copies/mL followed by ART switch) were estimated by the Kaplan-Meier method. Cox regression models, adjusted for age, sex and mode of HIV transmission and stratified by the centre, were employed.

Results: Overall, 583 PWH started LA cabotegravir/rilpivirine. Six VF50 were observed, with a 1 year estimated cumulative probability of virological failure of 1.2% (95% CI, 0.5%-3.0%). Resistance-associated mutations for rilpivirine and cabotegravir were detected in 3/4 and 4/4 participants with VF50, respectively, for which the genotypic resistance test was performed.The 1 year cumulative probability of TD was 11.4% (95% CI, 8.6%-14.9%), mainly caused by toxicity/adverse events (73.2%). Multivariable analysis identified heterosexual intercourse and IV drug use as significant risk factors for TD compared with MSM.

Conclusions: This analysis demonstrated the short-term effectiveness of cabotegravir/rilpivirine in a real-life setting showing minimal incidence of virological failure but a notable probability of discontinuation due to toxicity or adverse events.

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Figures

Figure 1.
Figure 1.
Prevalence of previously detected resistance-associated mutations to NNRTIs or INSTIs.
See this image and copyright information in PMC

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