Abstract

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-Guzman<sup>5

1</sup>Hospital 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 qd			DRV/r 600/100mg bid
Lipid-related laboratory abnormality	Baseline* 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?
Triglycerides	133 [1.50]	142 [1.60]	+4 [0.05]	133 [1.50]	159 [1.80]	+19 [0.22]
Total cholesterol	178 [4.60]	182 [4.71]	+3 [0.07]	178 [4.60]	189 [4.89]	+8 [0.21]
LDL	101 [2.61]	108 [2.79]	+3 [0.08]	104 [2.69]	108 [2.79]	+3 [0.09]
TC/HDL	4.2	4.3	0.2	4.2	4.5	0.3
*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 females	85 (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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