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

Author Department

Medicine

Document Type

Article, Peer-reviewed

Publication Date

12-2012

Abstract

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 >200mg/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 <50copies/mL in 88% of subjects. Mean baseline TGs were 326mg/dl in ATV/r arm and 342mg/dl in DRV/r arm. TGs declined from baseline to week 24 by 108mg/dl (p<0.001) with a non-significant difference by arm: −88mg/dl in the ATV/r arm and −126mg/dl in the DRV/r arm. At week 24, 55% of ATV/r and 48% of DRV/r subjects had TGs <200mg/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.

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