Positioning of darunavir/cobicistat-containing antiretroviral regimens in real life: Results from a large multicentre observational prospective cohort (SCOLTA)
- Authors: Taramasso L.; Ricci E.; Cascio A.; Valsecchi L.; Menzaghi B.; Squillace N.; Maggi P.; De Socio G.V.; Dentone C.; Madeddu G.; Pellicano G.F.; 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.M.; 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.F.; 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.M.; Maggi P.; Martini S.; Cascio A.; Trizzino M.; Gulminetti R.; De Socio G.V.; Cibelli D.; Parruti G.; Dentone C.; Madeddu G.; Mameli M.S.; Orofino G.; Guastavigna M.
- Publication year: 2019
- Type: Articolo in rivista
- OA Link: http://hdl.handle.net/10447/387357
Abstract
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.