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This is an early access version, the complete PDF, HTML, and XML versions will be available soon.
Article

Efficacy and Safety of Cabotegravir–Rilpivirine in PLWH: A Real-World Study

by
Giuseppe Nicolò Conti
1,†,
Serena Spampinato
2,3,†,
Andrea De Vito
4,
Andrea Marino
2,
Teresa Cirelli
2,
Viviana Coco
2,
Alessia Mirabile
2,
Rossella Fontana del Vecchio
5,
Antonina Franco
5,
Arturo Montineri
6,
Chiara Frasca
6,
Chiara Gullotta
2,3,
Michele Salvatore Paternò Raddusa
2,3,
Ylenia Russotto
3,
Sonia Sofia
7,
Grazia Pantò
7,
Claudia Calì
8,
Roberto Bruno
2,
Eugenia Pistarà
2,3,
Nunziatina Villari
2,
Carmelo Iacobello
7,
Bruno Cacopardo
2,
Benedetto Maurizio Celesia
2,
Giovanni F. Pellicanò
3,
Francesco P. Antonucci
9,
Sergio Lo Caputo
9,
Giordano Madeddu
4,
Giuseppe Nunnari
2,* and
Emmanuele Venanzi Rullo
3add Show full author list remove Hide full author list
1
Department of Biomedical and Biotechnological Sciences, University of Catania, 95123 Catania, Italy
2
Unit of Infectious Diseases, ARNAS “Garibaldi Nesima” Hospital, Department of Clinical and Experimental Medicine, University of Catania, 95122 Catania, Italy
3
Unit of Infectious Diseases, “G. Martino” University Hospital, Department of Clinical and Experimental Medicine, University of Messina, 98125 Messina, Italy
4
Unit of Infectious Diseases, Department of Medicine, Surgery and Pharmacy, University of Sassari, 07100 Sassari, Italy
5
Unit of Infectious Diseases, Umberto I Hospital, ASP, 96100 Siracusa, Italy
6
Unit of Infectious Diseases, “G. Rodolico-S. Marco” University Hospital, University of Catania, 95121 Catania, Italy
7
Unit of Infectious Diseases, AOE “Cannizzaro”, 95126 Catania, Italy
8
Unit of Infectious Diseases, ASP Ragusa, 97100 Ragusa, Italy
9
Unit of Infectious Diseases, Department of Medical and Surgical Sciences, University of Foggia, 71122 Foggia, Italy
*
Author to whom correspondence should be addressed.
†
These authors contributed equally to this work.
Viruses 2025, 17(11), 1417; https://doi.org/10.3390/v17111417 (registering DOI)
Submission received: 1 October 2025 / Revised: 20 October 2025 / Accepted: 24 October 2025 / Published: 24 October 2025
(This article belongs to the Special Issue Advances in Research on HIV Drug Resistance and Other Determinants of Treatment Success: 3rd Edition)
Versions Notes

Abstract

Background: Long-acting injectable antiretroviral therapy (LA-ART) with cabotegravir and rilpivirine (CAB + RPV) has emerged as a promising alternative to daily oral regimens for people living with HIV (PLWH), particularly those facing adherence challenges. While clinical trials have demonstrated its efficacy, real-world evidence remains limited. Methods: This retrospective, multicenter study evaluated the efficacy and safety of CAB + RPV in 160 virologically suppressed PLWH across eight Italian infectious disease units. Participants received intramuscular CAB (600 mg) and RPV (900 mg) every eight weeks without an oral lead-in phase. Clinical, immunological, and biochemical parameters were assessed at baseline and after 24 weeks. Results: At week 24, 96.25% of participants maintained virological suppression, and the proportion of individuals with target-not-detected viral load increased from 71% to 76%. Only one case of virological failure was observed. Significant immunological improvements included an increase in the CD4+/CD8+ ratio (p = 0.0038) and a reduction in CD8+ T-cell count (p = 0.0150). Biochemical analysis showed a decrease in serum creatinine (p < 0.0001) and an increase in HDL cholesterol (p = 0.0223). Treatment discontinuation occurred in 3.75% of participants, primarily due to adverse events or psychological factors. Conclusions: CAB + RPV demonstrated high efficacy and tolerability in a real-world setting, with favorable immunological and metabolic outcomes. These findings support its use as a viable therapeutic option for PLWH, especially those with adherence barriers. Further long-term studies are warranted to confirm these results across broader populations.
Keywords: long-acting antiretroviral therapy (LA-ART); cabotegravir–rilpivirine; virological suppression; real-world evidence; HIV treatment adherence long-acting antiretroviral therapy (LA-ART); cabotegravir–rilpivirine; virological suppression; real-world evidence; HIV treatment adherence

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MDPI and ACS Style

Conti, G.N.; Spampinato, S.; De Vito, A.; Marino, A.; Cirelli, T.; Coco, V.; Mirabile, A.; Fontana del Vecchio, R.; Franco, A.; Montineri, A.; et al. Efficacy and Safety of Cabotegravir–Rilpivirine in PLWH: A Real-World Study. Viruses 2025, 17, 1417. https://doi.org/10.3390/v17111417

AMA Style

Conti GN, Spampinato S, De Vito A, Marino A, Cirelli T, Coco V, Mirabile A, Fontana del Vecchio R, Franco A, Montineri A, et al. Efficacy and Safety of Cabotegravir–Rilpivirine in PLWH: A Real-World Study. Viruses. 2025; 17(11):1417. https://doi.org/10.3390/v17111417

Chicago/Turabian Style

Conti, Giuseppe Nicolò, Serena Spampinato, Andrea De Vito, Andrea Marino, Teresa Cirelli, Viviana Coco, Alessia Mirabile, Rossella Fontana del Vecchio, Antonina Franco, Arturo Montineri, and et al. 2025. "Efficacy and Safety of Cabotegravir–Rilpivirine in PLWH: A Real-World Study" Viruses 17, no. 11: 1417. https://doi.org/10.3390/v17111417

APA Style

Conti, G. N., Spampinato, S., De Vito, A., Marino, A., Cirelli, T., Coco, V., Mirabile, A., Fontana del Vecchio, R., Franco, A., Montineri, A., Frasca, C., Gullotta, C., Paternò Raddusa, M. S., Russotto, Y., Sofia, S., Pantò, G., Calì, C., Bruno, R., Pistarà, E., ... Venanzi Rullo, E. (2025). Efficacy and Safety of Cabotegravir–Rilpivirine in PLWH: A Real-World Study. Viruses, 17(11), 1417. https://doi.org/10.3390/v17111417

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