XVIII International AIDS Conference

Abstract

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Effects of once-daily (qd) versus twice-daily (bid) darunavir/ritonavir (DRV/r) on lipid parameters at week 48 in treatment-experienced, HIV-1-infected patients with no DRV resistance-associated mutations (RAMs) in the ODIN study

J. Arribas1, E. Arathoon2, C.R. Gonsalez3, G.H. Latiff4, T. Van de Casteele5, P. De Doncker5, S. Spinosa-Guzman5

1Hospital La Paz, HIV Unit, Madrid, Spain, 2Clinica Familiar Luis Angel Garcia, Guatemala City, Guatemala, 3Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, Pinheiros, Brazil, 4203 Maxwell Centre, Durban, South Africa, 5Tibotec BVBA, Mechelen, Belgium

Background: In the 48-week analysis of ODIN, a Phase IIIb, randomised, open-label study, DRV/r 800/100mg qd was non-inferior to DRV/r 600/100mg bid and showed favourable overall tolerability. The 48-week lipid profile of ODIN patients is reported.
Methods: Fasting (≥8 hours) lipids were assessed throughout the study (intent-to-treat population). Lipid levels were classified above or below NCEP cut-offs at any time during the observation period (between baseline and a mean of 44.8 [DRV/r qd] or 43.1 [DRV/r bid] weeks). Lipid-lowering agents (except lovastatin and simvastatin) were allowed. In the DRV/r qd and DRV/r bid arms, 5.4% and 11.1% of patients received lipid-lowering agents.
Results: Median lipid concentrations showed small increases (Table 1).

 DRV/r 800/100mg qdDRV/r 600/100mg bid
Lipid-related laboratory abnormalityBaseline* mg/dL [mmol/L]Week 48* mg/dL [mmol/L]Median change?Baseline* mg/dL [mmol/L]Week 48* mg/dL [mmol/L]Median change?
Triglycerides133 [1.50]142 [1.60]+4 [0.05]133 [1.50]159 [1.80]+19 [0.22]
Total cholesterol178 [4.60]182 [4.71]+3 [0.07]178 [4.60]189 [4.89]+8 [0.21]
LDL101 [2.61]108 [2.79]+3 [0.08]104 [2.69]108 [2.79]+3 [0.09]
TC/HDL4.24.30.24.24.50.3
*Includes all available data at baseline/Week 48; ?Includes only paired data
[Table 1]

Treatment-emergent abnormalities (NCEP criteria) in triglycerides and total cholesterol were lower with DRV/r qd than DRV/r bid to Week 48 in patients not receiving lipid-lowering agents (Table 2).

Lipid-related laboratory abnormality based on NCEP criteria, n (%)DRV/r 800/100mg qd (n=270)DRV/r 600/100mg bid (n=248)p value*
Triglycerides ≥150mg/dL [1.69mmol/L]68 (25.2)85 (34.3)0.0266
Total cholesterol ≥200mg/dL [5.17mmol/L]53 (19.6)68 (27.4)0.0382
LDL (calculated) ≥130mg/dL [3.36mmol/L]55 (20.4)62 (25.0)0.2473
HDL ≤40mg/dL [1.03mmol/L] for males or ≤50mg/dL [1.29mmol/L] for females85 (31.5)68 (27.4)0.3357
*Comparison of DRV/r qd vs DRV/r bid at Week 48
[Table 2]


Conclusions: At Week 48 in the ODIN study, the incidence of NCEP treatment-emergent abnormalities in triglycerides and total cholesterol was significantly lower with once-daily DRV/r 800/100mg compared with DRV/r 600/100mg bid.


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