A multicentre real-life prospective cohort study on effectiveness, durability and safety of long-acting injectable cabotegravir and rilpivirine in northern Italy: the LONGITUDE study
Year: 2025
Type: article
Study design: Observational Study
Abstract: OBJECTIVES: We herein present a prospective multicentre experience of long-acting injectable (LAI) cabotegravir/rilpivirine from 11 different HIV clinics in northern Italy, focusing on the regimen's effectiveness, durability and safety in a real-life setting. METHODS: We included all people who received at least one dose of LAI cabotegravir/rilpivirine, recording clinical data, and assessing factors associated with treatment discontinuation (TD) for any cause. Kaplan-Meier curves were used to estimate the probability of TD, and Cox regression models identified significant predictors of TD. A sub-analysis was conducted focusing on TD due to virological failure (VF, defined as two consecutive HIV-RNA values >200 copies/mL or a single value over 200 copies/mL leading to treatment withdrawal). RESULTS: We included 483 participants (81.6% males) with a median age of 49 (IQR: 40-58) years. In 74.1% of participants, the LA regimen was started by choice, with 51.8% coming from a dual oral antiretroviral regimen. During a median follow-up time of 22 (IQR: 13-26) months, 54 (11.1%) participants had TD (incidence = 0.627 per 100 person-months of follow-up), mostly due to side effects (31, 6.4%) but with 7 (1.4%) due to VF [with people reporting major integrase strand transfer inhibitor (INSTI) and NNRTI resistance mutations in 71.4% cases]. When multivariable analysis was performed, age, years with HIV, CD4/CD8 ratio and BMI were significantly associated with TD. Also, we detected that the number of previous antiretroviral regimens was significantly associated with VF. CONCLUSIONS: Despite the overall effectiveness, TD was observed in a specific subset of people, primarily due to side effects, with a smaller proportion experiencing VF. Factors associated with both TD and VF underscore the importance of personalized selection to optimize LAI cabotegravir/rilpivirine outcomes and to improve regimen persistence.
DOI: 10.1093/jac/dkaf281
Authors: Maria Mazzitelli, Claudia Cozzolino, Dina Yaacoub, Angela Pieri, Elke Erne, Cinzia Puzzolante, Beatrice Fontana, Maddalena Giglia, Claudio Rigamonti, Maddalena Cordioli, Chiara Zanchi, Giada Fasani, Emanuela Lattuada, Giuliana Battagin, Stefano Nicolè, Marina Malena, Maria Cristina Rossi, Daniela Piacentini, Francesca Raumer, Vincenzo Scaglione, Massimiliano Lanzafame, Leonardo Calza, Cristina Mussini, Annamaria Cattelan, the LONGITUDE Study Group, Annamaria Cattelan, Maria Mazzitelli, Claudia Cozzolino, Vincenzo Baldo, Annamaria Cattelan, Maria Mazzitelli, Lolita Sasset, Davide Leoni, Samuele Gardin, Anna Ferrari, Nadia Monteforte, Monia Luciano, Leonardo Calza, Maddalena Giglia, Claudio Rigamonti, Domenico Marzolla, Alberto Zuppiroli, Silvia Cretella, Renzo Scaggiante, Daniela Piacentini, Cristina Putaggio, Cristina Mussini, Cinzia Puzzolante, Beatrice Fontana, Federico Romani, Alessandro Tili, Maddalena Cordioli, Chiara Zanchi, Giada Fasani, Maria Teresa Giordani, Francesca Raumer, Marina Malena, Maria Cristina Rossi, Giuliana Battagin, Stefano Nicolè, Vinicio Manfrin
Institutions: Azienda Ospedale - Università Padova, University of Padua, University of Modena and Reggio Emilia, IRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola, University of Verona, Azienda Ospedaliera Universitaria Integrata Verona, Ospedale San Bortolo, Ospedale Santa Maria della Misericordia di Rovigo, University of Trento
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: green
Funders: Gilead Sciences, ViiV Healthcare
OpenAlex ID: W4413109677