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Background: Patients with prior failures, currently in complex suppressive ART, usually claim for an easier regimen. A combination of EVG/COBI/FTC/TDF (Quad) plus darunavir (DRV) 800 mg gives the opportunity of reducing significantly the number of pills while maintaining similar antiretroviral activity. Our objective is to assess the short term safety, efficacy of QUAD plus DRV and DRV levels.
Methods: All Quad plus DRV-treated subjects in our clinic were retrospectively collected since July 2014. Baseline and complete follow-up of each patient were entered into a database. Demographics, baseline CD4 cell count and viral load, reasons for new regimen use, change/end of QUAD plus DRV use and darunavir plasma levels while taking new regimen at least one month after initiating it were assessed. Paired analysis were explored.
Results: We included 20 participants, 47.9 years old, 75% men, 45% prior IDU, 66.7% AIDS stage, and 45% HCV co-infected. Median baseline and nadir CD4+ cell count were 539 and 122 cells/mm3, respectively. Median length of prior ART was 186 months with exposure to a median of 3.75 drug families. Six HIV strains (30%) presented darunavir-specific mutations (66% L33F and 33% I54L). Main reasons for prescribing new regimen were: simplification 55%, treatment intensification 20%, naive to ART and transmitted mutations 13.3%, and prior toxicity 6.7%. Only one (6%) was a treatment-naïve patient. 80% had HIV RNA level below 100 copies/mL. 30% of patients changed study therapy due to toxicity: 5 patients showed creatinine clearance worsening (4 ml/min mean decrease) and another person suffered from arthralgia. Daily number of pills decreased from 4.6 (SD 1.6) to 2. No significant changes were observed in lipid, hepatic, kidney profiles and CD4+ cell count after a median follow up of 10 months (4 months SD). 88% (15/17) of the patients with follow-up viral load data showed HIV-RNA below 50 copies/mL at week 24. Median darunavir concentrations were 4349 ± 3808 ng/mL in 14 patients. 85% showed adequate DRV concentrations (trough levels >400 ng/mL).
Conclusions: In clinical practice darunavir 800 mg once daily plus Quad Combo Tablet were used as a simplification regimen in highly treated patients, with adequate darunavir levels and viral response.

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