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

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.

Viraemic-time predicts mortality among people living with HIV on second-line antiretroviral treatment in Myanmar: A retrospective cohort study

“…This leads to a less effective second-line regimen and more-frequent secondline failures [54,55]. To overcome such challenges in the future, there is a need to scale up access to relatively new antiretrovirals, such as dolutegravir or darunavir/cobicistat, known to be safe and highly effective, and at the same time to have a higher genetic barrier and longevity in comparison with currently used treatments [56][57][58][59].…”

Viremia copy-years and risk of estimated glomerular filtration rate reduction in adults living with perinatal HIV infection

“…In the univariate analysis, we identified a relation between years of treatment with INI and eGFR reduction, while it was not observed in other ART regimens. Notably, both elvitegravir/cobicistat and dolutegravir have been associated with increased creatinine levels—though without a worsening of renal function—due to the inhibition of creatinine tubular secretion [ 20 , 27 – 29 ]. However, as shown in the multivariate analysis, higher VCY—and not years of exposure to INI—was retained as the predictor of eGFR reduction, thereby confirming the significant role of HIV replication in eGFR decline in the PHIV population studied.…”

Incident diabetes in course of antiretroviral therapy

“…Since routine evaluation of fasting glucose was introduced in SCOLTA in 2003, all people enrolled between January 2003 and November 2021 were included. PWH were enrolled and followed-up in different calendar periods according to the cohort: 2003-2008 for atazanavir/ritonavir (ATV/r) [28]; 2006-2008 for darunavir/ritonavir (DRV/r) [29]; 2016-2018 for darunavir/cobicistat (DRV/c) [30]; 2013-2017 for rilpivirine (RPV) [31]; 2007-2014 for raltegravir (RAL) [32]; 2014-2017 for elvitegravir (EVG) [33]; 2014-ongoing for DTG [2,26]; and 2019-ongoing for bictegravir (BIC).…”