CD4/CD8 Ratio Increase in Female Living with HIV Switching to Cabotegravir-Rilpivirine: A Real-Life 24 Weeks Evaluation

In 2022, 20 million women globally were living with HIV, yet they remain underrepresented in clinical trials, including those for antiretroviral treatments (ART). This study assesses the safety and efficacy of the long-acting cabotegravir-rilpivirine (CAB-RPV) regimen in a cohort of 54 women living...

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Main Authors: Serena Spampinato, Emmanuele Venanzi Rullo, Giuseppe Nicolò Conti, Andrea De Vito, Andrea Marino, Teresa Cirelli, Viviana Coco, Alessia Mirabile, Rossella Fontana del Vecchio, Antonina Franco, Arturo Montineri, Chiara Frasca, Chiara Gullotta, Michele Salvatore Paternò Raddusa, Ylenia Russotto, Aakash Fugooah, Sarah Pulvirenti, Sonia Sofia, Grazia Pantò, Claudia Calì, Roberto Bruno, Eugenia Pistarà, Nunziatina Villari, Carmelo Iacobello, Bruno Cacopardo, Benedetto Maurizio Celesia, Giovanni F. Pellicanò, Francesco P. Antonucci, Giordano Madeddu, Sergio Lo Caputo, Giuseppe Nunnari
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Language:English
Published: MDPI AG 2025-06-01
Series:Pathogens
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Online Access:https://www.mdpi.com/2076-0817/14/7/633
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author Serena Spampinato
Emmanuele Venanzi Rullo
Giuseppe Nicolò Conti
Andrea De Vito
Andrea Marino
Teresa Cirelli
Viviana Coco
Alessia Mirabile
Rossella Fontana del Vecchio
Antonina Franco
Arturo Montineri
Chiara Frasca
Chiara Gullotta
Michele Salvatore Paternò Raddusa
Ylenia Russotto
Aakash Fugooah
Sarah Pulvirenti
Sonia Sofia
Grazia Pantò
Claudia Calì
Roberto Bruno
Eugenia Pistarà
Nunziatina Villari
Carmelo Iacobello
Bruno Cacopardo
Benedetto Maurizio Celesia
Giovanni F. Pellicanò
Francesco P. Antonucci
Giordano Madeddu
Sergio Lo Caputo
Giuseppe Nunnari
author_facet Serena Spampinato
Emmanuele Venanzi Rullo
Giuseppe Nicolò Conti
Andrea De Vito
Andrea Marino
Teresa Cirelli
Viviana Coco
Alessia Mirabile
Rossella Fontana del Vecchio
Antonina Franco
Arturo Montineri
Chiara Frasca
Chiara Gullotta
Michele Salvatore Paternò Raddusa
Ylenia Russotto
Aakash Fugooah
Sarah Pulvirenti
Sonia Sofia
Grazia Pantò
Claudia Calì
Roberto Bruno
Eugenia Pistarà
Nunziatina Villari
Carmelo Iacobello
Bruno Cacopardo
Benedetto Maurizio Celesia
Giovanni F. Pellicanò
Francesco P. Antonucci
Giordano Madeddu
Sergio Lo Caputo
Giuseppe Nunnari
author_sort Serena Spampinato
collection DOAJ
description In 2022, 20 million women globally were living with HIV, yet they remain underrepresented in clinical trials, including those for antiretroviral treatments (ART). This study assesses the safety and efficacy of the long-acting cabotegravir-rilpivirine (CAB-RPV) regimen in a cohort of 54 women living with HIV (WLWH) over 24 weeks. A retrospective cohort study from the Sardinian HIV Network and Sicilian HIV Cohort (SHiNe-SHiC) included WLWH who switched to CAB-RPV. Primary objectives were achieving and maintaining HIV RNA levels <50 copies/mL at 24 weeks. Secondary objectives included treatment safety, durability, and reasons for discontinuation. Data on demographics, viro-immunological markers, lipid profiles, and treatment interruptions were analyzed. Of 54 WLWH, 46 reached 24 weeks. The median age was 50 years. A total of 71.8% transitioned from dolutegravir (DTG) regimens. Virological suppression was 97.8% at baseline and 95.5% at 24 weeks. Significant increases in the CD4/CD8 ratio (<i>p</i> = 0.0076) and decreases in serum creatinine levels (<i>p</i> = 0.0109) were observed. Cholesterol, triglycerides, ALT, and AST levels remained unchanged. The CAB-RPV regimen demonstrated significant virological and immunological efficacy and safety in women living with HIV over 24 weeks. Notably, the improvement in the CD4/CD8 ratio and the increase in the percentage of women achieving target not detected (TND) status highlight the regimen’s effectiveness. These findings emphasize the importance of gender-focused research in HIV treatment and the need for equitable access to effective treatment options for women, which is crucial for global efforts to eliminate HIV.
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spelling doaj-art-1b78fe9395b0425399d55f38ee4e4dd72025-08-20T03:08:02ZengMDPI AGPathogens2076-08172025-06-0114763310.3390/pathogens14070633CD4/CD8 Ratio Increase in Female Living with HIV Switching to Cabotegravir-Rilpivirine: A Real-Life 24 Weeks EvaluationSerena Spampinato0Emmanuele Venanzi Rullo1Giuseppe Nicolò Conti2Andrea De Vito3Andrea Marino4Teresa Cirelli5Viviana Coco6Alessia Mirabile7Rossella Fontana del Vecchio8Antonina Franco9Arturo Montineri10Chiara Frasca11Chiara Gullotta12Michele Salvatore Paternò Raddusa13Ylenia Russotto14Aakash Fugooah15Sarah Pulvirenti16Sonia Sofia17Grazia Pantò18Claudia Calì19Roberto Bruno20Eugenia Pistarà21Nunziatina Villari22Carmelo Iacobello23Bruno Cacopardo24Benedetto Maurizio Celesia25Giovanni F. Pellicanò26Francesco P. Antonucci27Giordano Madeddu28Sergio Lo Caputo29Giuseppe Nunnari30Unit of Infectious Diseases, ARNAS “Garibaldi Nesima” Hospital, Department of Clinical and Experimental Medicine, University of Catania, 95122 Catania, ItalyUnit of Infectious Diseases, “G. Martino” University Hospital, Department of Clinical and Experimental Medicine, University of Messina, 98125 Messina, ItalyUnit of Infectious Diseases, ARNAS “Garibaldi Nesima” Hospital, Department of Clinical and Experimental Medicine, University of Catania, 95122 Catania, ItalyUnit of Infectious Diseases, Department of Medicine, Surgery and Pharmacy, University of Sassari, 07100 Sassari, ItalyUnit of Infectious Diseases, ARNAS “Garibaldi Nesima” Hospital, Department of Clinical and Experimental Medicine, University of Catania, 95122 Catania, ItalyUnit of Infectious Diseases, ARNAS “Garibaldi Nesima” Hospital, Department of Clinical and Experimental Medicine, University of Catania, 95122 Catania, ItalyUnit of Infectious Diseases, ARNAS “Garibaldi Nesima” Hospital, Department of Clinical and Experimental Medicine, University of Catania, 95122 Catania, ItalyUnit of Infectious Diseases, ARNAS “Garibaldi Nesima” Hospital, Department of Clinical and Experimental Medicine, University of Catania, 95122 Catania, ItalyUnit of Infectious Diseases, Umberto I Hospital, 96100 ASP Siracusa, ItalyUnit of Infectious Diseases, Umberto I Hospital, 96100 ASP Siracusa, ItalyUnit of Infectious Diseases, “G. Rodolico-S. Marco” University Hospital, University of Catania, 95121 Catania, ItalyUnit of Infectious Diseases, “G. Rodolico-S. Marco” University Hospital, University of Catania, 95121 Catania, ItalyUnit of Infectious Diseases, ARNAS “Garibaldi Nesima” Hospital, Department of Clinical and Experimental Medicine, University of Catania, 95122 Catania, ItalyUnit of Infectious Diseases, ARNAS “Garibaldi Nesima” Hospital, Department of Clinical and Experimental Medicine, University of Catania, 95122 Catania, ItalyUnit of Infectious Diseases, “G. Martino” University Hospital, Department of Clinical and Experimental Medicine, University of Messina, 98125 Messina, ItalyUnit of Infectious Diseases, ARNAS “Garibaldi Nesima” Hospital, Department of Clinical and Experimental Medicine, University of Catania, 95122 Catania, ItalyUnit of Infectious Diseases, ARNAS “Garibaldi Nesima” Hospital, Department of Clinical and Experimental Medicine, University of Catania, 95122 Catania, ItalyUnit of Infectious Diseases, AOE “Cannizzaro”, 95126 Catania, ItalyUnit of Infectious Diseases, AOE “Cannizzaro”, 95126 Catania, ItalyUnit of Infectious Diseases, ASP Ragusa, 97100 Ragusa, ItalyUnit of Infectious Diseases, ARNAS “Garibaldi Nesima” Hospital, Department of Clinical and Experimental Medicine, University of Catania, 95122 Catania, ItalyUnit of Infectious Diseases, ARNAS “Garibaldi Nesima” Hospital, Department of Clinical and Experimental Medicine, University of Catania, 95122 Catania, ItalyUnit of Infectious Diseases, ARNAS “Garibaldi Nesima” Hospital, Department of Clinical and Experimental Medicine, University of Catania, 95122 Catania, ItalyUnit of Infectious Diseases, AOE “Cannizzaro”, 95126 Catania, ItalyUnit of Infectious Diseases, ARNAS “Garibaldi Nesima” Hospital, Department of Clinical and Experimental Medicine, University of Catania, 95122 Catania, ItalyUnit of Infectious Diseases, ARNAS “Garibaldi Nesima” Hospital, Department of Clinical and Experimental Medicine, University of Catania, 95122 Catania, ItalyUnit of Infectious Diseases, “G. Martino” University Hospital, Department of Clinical and Experimental Medicine, University of Messina, 98125 Messina, ItalyUnit of Infectious Diseases, Department of Medical and Surgical Sciences, University of Foggia, 71122 Foggia, ItalyUnit of Infectious Diseases, Department of Medicine, Surgery and Pharmacy, University of Sassari, 07100 Sassari, ItalyUnit of Infectious Diseases, Department of Medical and Surgical Sciences, University of Foggia, 71122 Foggia, ItalyUnit of Infectious Diseases, ARNAS “Garibaldi Nesima” Hospital, Department of Clinical and Experimental Medicine, University of Catania, 95122 Catania, ItalyIn 2022, 20 million women globally were living with HIV, yet they remain underrepresented in clinical trials, including those for antiretroviral treatments (ART). This study assesses the safety and efficacy of the long-acting cabotegravir-rilpivirine (CAB-RPV) regimen in a cohort of 54 women living with HIV (WLWH) over 24 weeks. A retrospective cohort study from the Sardinian HIV Network and Sicilian HIV Cohort (SHiNe-SHiC) included WLWH who switched to CAB-RPV. Primary objectives were achieving and maintaining HIV RNA levels <50 copies/mL at 24 weeks. Secondary objectives included treatment safety, durability, and reasons for discontinuation. Data on demographics, viro-immunological markers, lipid profiles, and treatment interruptions were analyzed. Of 54 WLWH, 46 reached 24 weeks. The median age was 50 years. A total of 71.8% transitioned from dolutegravir (DTG) regimens. Virological suppression was 97.8% at baseline and 95.5% at 24 weeks. Significant increases in the CD4/CD8 ratio (<i>p</i> = 0.0076) and decreases in serum creatinine levels (<i>p</i> = 0.0109) were observed. Cholesterol, triglycerides, ALT, and AST levels remained unchanged. The CAB-RPV regimen demonstrated significant virological and immunological efficacy and safety in women living with HIV over 24 weeks. Notably, the improvement in the CD4/CD8 ratio and the increase in the percentage of women achieving target not detected (TND) status highlight the regimen’s effectiveness. These findings emphasize the importance of gender-focused research in HIV treatment and the need for equitable access to effective treatment options for women, which is crucial for global efforts to eliminate HIV.https://www.mdpi.com/2076-0817/14/7/633HIVlong actingCabotegravir-RilpivirineCD4/CD8 ratio
spellingShingle Serena Spampinato
Emmanuele Venanzi Rullo
Giuseppe Nicolò Conti
Andrea De Vito
Andrea Marino
Teresa Cirelli
Viviana Coco
Alessia Mirabile
Rossella Fontana del Vecchio
Antonina Franco
Arturo Montineri
Chiara Frasca
Chiara Gullotta
Michele Salvatore Paternò Raddusa
Ylenia Russotto
Aakash Fugooah
Sarah Pulvirenti
Sonia Sofia
Grazia Pantò
Claudia Calì
Roberto Bruno
Eugenia Pistarà
Nunziatina Villari
Carmelo Iacobello
Bruno Cacopardo
Benedetto Maurizio Celesia
Giovanni F. Pellicanò
Francesco P. Antonucci
Giordano Madeddu
Sergio Lo Caputo
Giuseppe Nunnari
CD4/CD8 Ratio Increase in Female Living with HIV Switching to Cabotegravir-Rilpivirine: A Real-Life 24 Weeks Evaluation
Pathogens
HIV
long acting
Cabotegravir-Rilpivirine
CD4/CD8 ratio
title CD4/CD8 Ratio Increase in Female Living with HIV Switching to Cabotegravir-Rilpivirine: A Real-Life 24 Weeks Evaluation
title_full CD4/CD8 Ratio Increase in Female Living with HIV Switching to Cabotegravir-Rilpivirine: A Real-Life 24 Weeks Evaluation
title_fullStr CD4/CD8 Ratio Increase in Female Living with HIV Switching to Cabotegravir-Rilpivirine: A Real-Life 24 Weeks Evaluation
title_full_unstemmed CD4/CD8 Ratio Increase in Female Living with HIV Switching to Cabotegravir-Rilpivirine: A Real-Life 24 Weeks Evaluation
title_short CD4/CD8 Ratio Increase in Female Living with HIV Switching to Cabotegravir-Rilpivirine: A Real-Life 24 Weeks Evaluation
title_sort cd4 cd8 ratio increase in female living with hiv switching to cabotegravir rilpivirine a real life 24 weeks evaluation
topic HIV
long acting
Cabotegravir-Rilpivirine
CD4/CD8 ratio
url https://www.mdpi.com/2076-0817/14/7/633
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