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

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 thepaired t test or signed rank test. The multivariable analysis was performed using a general linear model, after rankingof 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 lipidprofile did not change significantly in either the global population or patients with HC. After a median observationof 17 months (IQR 13–20), 59 (25.3%) patients discontinued DRV/c, of which 13 were in DT. The durability DT resultedhigher than that of triple therapy (log-rank test p = 0.01). Main reasons for stopping DRV/c were simplification (15patients), adverse events (13 patients), planned discontinuation for treatment initiation with DAA (4 patients), treatmentfailure (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 longerdurability compared to triple therapies.