Durability, safety, and efficacy of rilpivirine in clinical practice: results from the SCOLTA Project

Durability, safety, and efficacy of rilpivirine in clinical practice: results from the SCOLTA Project Paola Bagella,1 Giuseppe VL De Socio,2 Elena Ricci,3 Barbara Menzaghi,4 Canio Martinelli,5 Nicola Squillace,6 Paolo Maggi,7 Giancarlo Orofino,8 Leonardo Calza,9 Laura Carenzi,3 Benedetto Maurizio Celesia,10 Giovanni Penco,11 Antonio Di Biagio,12 Laura Valsecchi,3 Francesca Vichi,13 Valeria Colombo,14 Giustino Parruti,15 Chiara Dentone,16 Katia Falasca,17 Paolo Bonfanti,18 Giordano Madeddu1 On behalf of the C.I.S.A.I. Study Group, Italy 1Unit of Infectious Diseases, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy; 2Infectious Diseases Unit, Department of Medicine, Azienda Ospedaliero-Universitaria di Perugia, Santa Maria Hospital, Perugia, Italy; 3Department of Infectious Diseases, ASST Fatebenefratelli Sacco, Milan, Italy; 4Unit of Infectious Diseases, ASST della Valle Olona, Busto Arsizio, Italy; 5Unit of Infectious and Tropical Diseases, Careggi Hospital Florence, Florence, Italy; 6Infectious Diseases Unit, San Gerardo Hospital, University of Milano-Bicocca, Monza, Italy; 7Infectious Diseases Clinic, University of Bari, Policlinico Consorziale, Bari, Italy; 8Amedeo di Savoia Hospital Unit of Infectious Diseases, Torino, Italy; 9University of Bologna, Department of Infectious Diseases, S. Orsola Malpighi Hospital, Bologna, Italy; 10Unit of Infectious Diseases, Garibaldi Hospital, Catania, Italy; 11Infectious Diseases Unit, Galliera Hospital, Genoa, Italy; 12Unit of Infectious Diseases, IRCCS San Martino Hospital – IST, Genoa, Italy; 13Infectious Diseases Unit, Santa Maria Annunziata Hospital, Florence, Italy; 14Infectious Diseases Unit, University of Milan, DIBIC Luigi Sacco, Milan, Italy; 15Unit of Infectious Diseases, Pescara Hospital, Pescara, Italy; 16Unit of Infectious Diseases, Sanremo Hospital, Sanremo, Italy; 17Infectious Diseases Unit, University of Chieti, Chieti, Italy; 18Unit of Infectious Diseases, A. Manzoni Hospital, Lecco, Italy Abstract: Rilpivirine is associated with a good efficacy and safety profile. However, data from real-life settings are scarce. Methods: We investigated the durability, safety and efficacy of Rilpivirine-based antiretroviral therapy in a prospective, observational, multicenter study. Results: We enrolled 499 HIV-infected patients, 360 (72.1%) males, mean age 43.4 ± 10.5 years, mean CD4 600 ± 327 cell/μL, mean HIV-RNA 3.80 ± 1.15 log10 cp/mL. After a median follow up of 16 months, 81 (16.2%) interruptions were reported, 36 (7.2%) of which for adverse events (16 of grade ≥3), most commonly neurological and gastrointestinal. We observed virological failures in only 8 (1.6%) patients. Naive patients showed a significant reduction in eGFR at week 24, 48 and 72 and in total cholesterol (TC)/HDL ratio at week 48