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/dl. 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/dl in ATV/r arm and 342 mg/dl in DRV/r arm. TGs declined from baseline to week 24 by 108 mg/dl (p < 0.001) with a non-significant difference by arm: -88 mg/dl in the ATV/r arm and -126 mg/dl in the DRV/r arm. At week 24, 55% of ATV/r and 48% of DRV/r subjects had TGs <200 mg/dl (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.