Positioning of darunavir/cobicistat-containing antiretroviral regimens in real life: results from a large multicentre ob
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AIDS Research and Therapy Open Access
RESEARCH
Positioning of darunavir/ cobicistat‑containing antiretroviral regimens in real life: results from a large multicentre observational prospective cohort (SCOLTA) Lucia Taramasso1,2* , Elena Ricci3, Antonio Cascio4, Laura Valsecchi5, Barbara Menzaghi6, Nicola Squillace7, Paolo Maggi8, Giuseppe Vittorio De Socio9, Chiara Dentone10, Giordano Madeddu11, Giovanni F. Pellicanò12, Leonardo Calza13, Goffredo Angioni14, Paolo Bonfanti15 and Antonio Di Biagio16 on behalf of CISAI Study Group
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 LongTerm 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. Keywords: Darunavir/cobicistat, Dual, Durability, Tolerability, CISAI, Adverse events Background The first arrival of protease inhibitors (PI) in 1996 [1] has been one of the turning points in the history of AIDS. For years, PI have been the preferred third agents for combined antiretroviral therapies (cART) [2] but, in the more recent period, only darunavir (DRV) (boosted with *Correspondence: [email protected] 2 Infectious Diseases Unit, Department of Internal Medicine, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Via Francesco Sforza 35, 20122 Milan, Italy Full list of author information is available at the end of the article
either ritonavir or cobicistat) is the preferred PI in firstline cART, in combination with two nucleos(t)ide reverse transcriptase inhibitors (NRTI) in current EACS guidelines [3], and similarly, DRV is the preferred PI in certain clinical situations in DHHS and Italian guideli
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