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.

Positioning of darunavir/cobicistat-containing antiretroviral regimens in real life: Results from a large multicentre observational prospective cohort (SCOLTA) / L. Taramasso, E. Ricci, A. Cascio, L. Valsecchi, B. Menzaghi, N. Squillace, P. Maggi, G.V. De Socio, C. Dentone, G. Madeddu, G.F. Pellicano, L. Calza, G. Angioni, P. Bonfanti, A. Di Biagio, E. Sarchi, G. Chichino, C. Bellacosa, G. Angarano, L. Calza, B. Menzaghi, M. Farinazzo, G. Angioni, M. Gussio, B.M. Celesia, K. Falasca, A. Mastroianni, G. Guadagnino, F. Vichi, E. Salomoni, C. Martinelli, A. Di Biagio, L. Nicolini, G. Cenderello, P. Bonfanti, C. Molteni, G.F. Pellicano, G. Nunnari, L. Valsecchi, L. Cordier, A. Parisini, G. Rizzardini, S. Rusconi, F. Conti, A. Bandera, L. Taramasso, A. Gori, D. Motta, M. Puoti, N. Squillace, G.M. Migliorino, P. Maggi, S. Martini, A. Cascio, M. Trizzino, R. Gulminetti, G.V. De Socio, D. Cibelli, G. Parruti, C. Dentone, G. Madeddu, M.S. Mameli, G. Orofino, M. Guastavigna. - In: AIDS RESEARCH AND THERAPY. - ISSN 1742-6405. - 16:1(2019 Aug 26).

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

Taramasso L.;Menzaghi B.;Bonfanti P.;SARCHI, ELENA;Angarano G.;Menzaghi B.;MASTROIANNI, ANTONIO;Bonfanti P.;Rusconi S.;Bandera A.;Gori A.;Motta D.;
2019-08-26

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.
adverse events; CISAI; Darunavir/cobicistat; dual; durability; tolerability; Cobicistat;
Settore MED/17 - Malattie Infettive
AIDS RESEARCH AND THERAPY
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/2434/678418
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