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 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]|
|*Includes all available data at baseline/Week 48; ?Includes only paired data|
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
≥150mg/dL [1.69mmol/L]||68 (25.2)||85 (34.3)||0.0266|
≥200mg/dL [5.17mmol/L]||53 (19.6)||68 (27.4)||0.0382|
≥130mg/dL [3.36mmol/L]||55 (20.4)||62 (25.0)||0.2473|
≤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|
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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