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

Rossella Fontana Del Vecchio, Francesco P Antonucci, Carmelo Iacobello, Nunziatina Villari, Eugenia Pistarà, Roberto Bruno, Claudia Calì, Grazia Pantò, Sonia Sofia, Sarah Pulvirenti, Aakash Fugooah, Ylenia Russotto, Michele Salvatore Paternò Raddusa, Chiara Gullotta, Chiara Frasca, Antonina Franco, Serena Spampinato, Alessia Mirabile, Viviana Coco, Teresa Cirelli, Giuseppe Nicolò Conti, Giordano Madeddu, Benedetto Maurizio Celesia, Sergio Lo Caputo, Giuseppe Nunnari, Giovanni F Pellicanò, Bruno Cacopardo, Andrea De Vito, Andrea Marino, Arturo Montineri, Emmanuele Venanzi Rullo

Journal: Pathogens (Basel, Switzerland) 2025;14(7):

PMID: 40732681

Abstract

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 ( = 0.0076) and decreases in serum creatinine levels ( = 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.

Address: Unit of Infectious Diseases, ARNAS "Garibaldi Nesima" Hospital, Department of Clinical and Experimental Medicine, University of Catania, 95122 Catania, Italy.; Unit of Infectious Diseases, "G. Martino" University Hospital, Department of Clinical and Experimental Medicine, University of Messina, 98125 Messina, Italy.; Unit of Infectious Diseases, "G. Martino" University Hospital, Department of Clinical and Experimental Medicine, University of Messina, 98125 Messina, Italy.; Unit of Infectious Diseases, Department of Medicine, Surgery and Pharmacy, University of Sassari, 07100 Sassari, Italy.; Unit of Infectious Diseases, ARNAS "Garibaldi Nesima" Hospital, Department of Clinical and Experimental Medicine, University of Catania, 95122 Catania, Italy.; Unit of Infectious Diseases, Umberto I Hospital, 96100 ASP Siracusa, Italy.; Unit of Infectious Diseases, "G. Rodolico-S. Marco" University Hospital, University of Catania, 95121 Catania, Italy.; Unit of Infectious Diseases, AOE "Cannizzaro", 95126 Catania, Italy.; Unit of Infectious Diseases, ASP Ragusa, 97100 Ragusa, Italy.; Unit of Infectious Diseases, Department of Medical and Surgical Sciences, University of Foggia, 71122 Foggia, Italy.
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