Efficacy and safety of switching suppressed patients with elevated triglycerides from lopinavir/ritonavir or fosamprenavir/ritonavir to atazanavir/ritonavir or darunavir/ritonavir based therapy: The LARD study

Objectives: To determine if switching virologically suppressed patients on a regimen containing lopinavir/r (LPV/r) or fosamprenavir (FPV/r) to darunavir/r (DRV/r) or atazanavir/r (ATV/r) results in improved TGs while maintaining virological suppression.Methods: Eligibility criteria were undetectable HIV RNA >= 12 weeks, no PI resistance, receiving LPV/r (n=46) or FPV/r (n=3) plus nucleosides, and fasting TGs >200 mg/d1. Patients were randomized to either QD ATV/r or DRV/r (maintaining the same nucleosides). Primary endpoint was change in TGs from baseline to week 24.Results: 66 were screened, 51 enrolled and two withdrew consent after randomization. 24 patients received ATV/r; 25 received DRV/r. Baseline mean CD4 cell count was 569; HIV RNA was <50 copies/mL in 88% of subjects. Mean baseline TGs were 326 mg/di in ATV/r arm and 342 mg/di in DRV/r arm. TGs declined from baseline to week 24 by 108 mg/di (p < 0.001) with a non-significant difference by arm: 88 mg/di in the ATV/r arm and 126 mg/di in the DRV/r arm. At week 24, 55% of ATV/r and 48% of DRV/r subjects had TGs <200 mg/di (OR 1.3; Difference 7%, 95% CI: -22% to 35%). Total and HDL cholesterol decreased and LDL increased (non-significantly). Baseline quality of life (QOL) was 83% and remained high at week 24 (84%). No differences between the groups in CD4 cell counts or HIV RNA levels were noted.Conclusions: Patients with high TGs who switched from LPV/r or FPV/r to DRV/r or ATV/r had improved TGs, while maintaining virological suppression and high adherence and QOL. (C) 2012 Polish AIDS Research Society. Published by Elsevier Urban & Partner Sp. z o.o. All rights reserved.