{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,26]],"date-time":"2026-10-26T01:58:16Z","timestamp":1792979896964,"version":"4.5.0"},"reference-count":40,"publisher":"MDPI AG","issue":"11","license":[{"start":{"date-parts":[[2025,10,24]],"date-time":"2025-10-24T00:00:00Z","timestamp":1761264000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Viruses"],"abstract":"<jats:p>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 &lt; 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.<\/jats:p>","DOI":"10.3390\/v17111417","type":"journal-article","created":{"date-parts":[[2025,10,27]],"date-time":"2025-10-27T02:50:48Z","timestamp":1761533448000},"page":"1417","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Efficacy and Safety of Cabotegravir\u2013Rilpivirine in PLWH: A Real-World Study"],"prefix":"10.3390","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0009-0005-9069-5823","authenticated-orcid":false,"given":"Giuseppe Nicol\u00f2","family":"Conti","sequence":"first","affiliation":[{"name":"Department of Biomedical and Biotechnological Sciences, University of Catania, 95123 Catania, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-0149-2078","authenticated-orcid":false,"given":"Serena","family":"Spampinato","sequence":"additional","affiliation":[{"name":"Unit of Infectious Diseases, ARNAS \u201cGaribaldi Nesima\u201d Hospital, Department of Clinical and Experimental Medicine, University of Catania, 95122 Catania, Italy"},{"name":"Unit of Infectious Diseases, \u201cG. Martino\u201d University Hospital, Department of Clinical and Experimental Medicine, University of Messina, 98125 Messina, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8265-5400","authenticated-orcid":false,"given":"Andrea","family":"De Vito","sequence":"additional","affiliation":[{"name":"Unit of Infectious Diseases, Department of Medicine, Surgery and Pharmacy, University of Sassari, 07100 Sassari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5650-6911","authenticated-orcid":false,"given":"Andrea","family":"Marino","sequence":"additional","affiliation":[{"name":"Unit of Infectious Diseases, ARNAS \u201cGaribaldi Nesima\u201d Hospital, Department of Clinical and Experimental Medicine, University of Catania, 95122 Catania, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Teresa","family":"Cirelli","sequence":"additional","affiliation":[{"name":"Unit of Infectious Diseases, ARNAS \u201cGaribaldi Nesima\u201d Hospital, Department of Clinical and Experimental Medicine, University of Catania, 95122 Catania, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Viviana","family":"Coco","sequence":"additional","affiliation":[{"name":"Unit of Infectious Diseases, ARNAS \u201cGaribaldi Nesima\u201d Hospital, Department of Clinical and Experimental Medicine, University of Catania, 95122 Catania, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessia","family":"Mirabile","sequence":"additional","affiliation":[{"name":"Unit of Infectious Diseases, ARNAS \u201cGaribaldi Nesima\u201d Hospital, Department of Clinical and Experimental Medicine, University of Catania, 95122 Catania, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8251-9380","authenticated-orcid":false,"given":"Rossella","family":"Fontana del Vecchio","sequence":"additional","affiliation":[{"name":"Unit of Infectious Diseases, Umberto I Hospital, ASP, 96100 Siracusa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonina","family":"Franco","sequence":"additional","affiliation":[{"name":"Unit of Infectious Diseases, Umberto I Hospital, ASP, 96100 Siracusa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-9218-745X","authenticated-orcid":false,"given":"Arturo","family":"Montineri","sequence":"additional","affiliation":[{"name":"Unit of Infectious Diseases, \u201cG. Rodolico-S. Marco\u201d University Hospital, University of Catania, 95121 Catania, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chiara","family":"Fasca","sequence":"additional","affiliation":[{"name":"Unit of Infectious Diseases, \u201cG. Rodolico-S. Marco\u201d University Hospital, University of Catania, 95121 Catania, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9201-8659","authenticated-orcid":false,"given":"Chiara","family":"Gullotta","sequence":"additional","affiliation":[{"name":"Unit of Infectious Diseases, ARNAS \u201cGaribaldi Nesima\u201d Hospital, Department of Clinical and Experimental Medicine, University of Catania, 95122 Catania, Italy"},{"name":"Unit of Infectious Diseases, \u201cG. 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