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

• Published in: Infection and drug resistance Vol. 11; pp. 615 - 623
• Main Authors: Bagella, Paola, De Socio, Giuseppe Vl, Ricci, Elena, Menzaghi, Barbara, Martinelli, Canio, Squillace, Nicola, Maggi, Paolo, Orofino, Giancarlo, Calza, Leonardo, Carenzi, Laura, Celesia, Benedetto Maurizio, Penco, Giovanni, Di Biagio, Antonio, Valsecchi, Laura, Vichi, Francesca, Colombo, Valeria, Parruti, Giustino, Dentone, Chiara, Falasca, Katia, Bonfanti, Paolo, Madeddu, Giordano
• Format: Journal Article
• Language: English
• Published: New Zealand Dove Medical Press Limited 01.01.2018; Taylor & Francis Ltd; Dove Medical Press
• Subjects: Acquired immune deficiency syndrome; AIDS; Antiretroviral agents; Antiretroviral drugs; Antiretroviral therapy; Cardiovascular disease; CD4 antigen; Cholesterol; Clinical medicine; Cohort analysis; combination antiretroviral therapy; Drug therapy; Efavirenz; efficacy; Emtricitabine; Epidermal growth factor receptors; High density lipoprotein; HIV; HIV infections; HIV patients; Hospitals; Human immunodeficiency virus; Infectious diseases; Lipids; Liver; Original Research; Patient outcomes; Pharmacological research; Protease inhibitors; Proteases; Proteinase inhibitors; Ribonucleic acid; Rifamycins; Rilpivirine; RNA; Safety; Statistical analysis; Triglycerides; Italy; HIV-1; experienced patients; NNRTI; cohort study; combination antiretroviral therapy; naive
• ISSN: 1178-6973; 1178-6973
• DOI: 10.2147/IDR.S152090

Rilpivirine is associated with a good efficacy and safety profile. However, data from real-life settings are scarce. We investigated the durability, safety and efficacy of Rilpivirine-based antiretroviral therapy in a prospective, observational, multicenter study. 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 log 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 ( =0.007). In patients switching from PI we found a significant decrease at week 24 and 48 in TC and triglycerides at week 24, 48 and 72. eGFR showed a significant decrease at week 48 and 72. TC/HDL ratio showed a statistically significant decrease at week 24 ( =0.0008) and 72 ( =0.04). A significant increase at week 24 and 48 in AST and ALT values was observed. Patients switching from TDF/FTC/EFV showed a reduction in HDL, total cholesterol and triglycerides at week 24 and 48 and in eGFR at all follow up times. TC/HDL ratio showed a significant decrease at week 48 ( =0.01). CDC stage C and antiretroviral-experience (especially Protease Inhibitors) were associated with RPV discontinuation. In conclusion, our data confirm Rilpivirine efficacy, safety and tolerability with improvement in lipid profile. Although hepatic and renal events rarely caused discontinuation, liver and kidney parameters should be monitored.