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Positioning of darunavir/cobicistat-containing antiretroviral regimens in real life: Results from a large multicentre observational prospective cohort (SCOLTA)

  • Autori: Taramasso, L.; Ricci, E.; Cascio, A.; Valsecchi, L.; Menzaghi, B.; Squillace, N.; Maggi, P.; De Socio, G.; Dentone, C.; Madeddu, G.; Pellicano, G.; Calza, L.; Angioni, G.; Bonfanti, P.; Di Biagio, A.; Sarchi, E.; Chichino, G.; Bellacosa, C.; Angarano, G.; Calza, L.; Menzaghi, B.; Farinazzo, M.; Angioni, G.; Gussio, M.; Celesia, B.; Falasca, K.; Mastroianni, A.; Guadagnino, G.; Vichi, F.; Salomoni, E.; Martinelli, C.; Di Biagio, A.; Nicolini, L.; Cenderello, G.; Bonfanti, P.; Molteni, C.; Pellicano, G.; Nunnari, G.; Valsecchi, L.; Cordier, L.; Parisini, A.; Rizzardini, G.; Rusconi, S.; Conti, F.; Bandera, A.; Taramasso, L.; Gori, A.; Motta, D.; Puoti, M.; Squillace, N.; Migliorino, G.; Maggi, P.; Martini, S.; Cascio, A.; Trizzino, M.; Gulminetti, R.; De Socio, G.; Cibelli, D.; Parruti, G.; Dentone, C.; Madeddu, G.; Mameli, M.; Orofino, G.; Guastavigna, M.
  • Anno di pubblicazione: 2019
  • Tipologia: Articolo in rivista
  • Parole Chiave: Adverse events; CISAI; Darunavir/cobicistat; Dual; Durability; Tolerability
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Background: Study aim was to evaluate the safety and durability of darunavir/cobicistat (DRV/c) in a real life setting. Methods: Multicentre prospective cohort study performed in the context of SCOLTA (Surveillance Cohort Long-Term Toxicity Antiretrovirals). Patients were evaluated at baseline, week 24 and 48. Changes were evaluated using the paired t test or signed rank test. The multivariable analysis was performed using a general linear model, after ranking of not normally distributed variables. Results: A total of 249 patients were included, 72 (29%) were in DRV/c-based dual therapies (DT). Hypercholesterolemia, HC, (total cholesterol (TC) ≥ 200 mg/dL or low density-C (LDL-C) ≥ 130 or statin use) was present in 121 (48.6%) and hypertriglyceridemia, (triglycerides (TG) ≥ 200 mg/dl or fibrate use) in 41 (16.5%) patients. Blood lipid profile did not change significantly in either the global population or patients with HC. After a median observation of 17 months (IQR 13-20), 59 (25.3%) patients discontinued DRV/c, of which 13 were in DT. The durability DT resulted higher than that of triple therapy (log-rank test p = 0.01). Main reasons for stopping DRV/c were simplification (15 patients), adverse events (13 patients), planned discontinuation for treatment initiation with DAA (4 patients), treatment failure (2 patients); death (2 patients), other causes (10 patients). Twenty-six were lost to follow-up. Conclusions: DRV/c was safe and well tolerated. Dual therapies showed a better profile of tolerability and a longer durability compared to triple therapies.