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Session 152 Poster Abstracts
Dyslipidemia: Role of ART and Interventions for Management
Session Day and Time: Monday, 1-4 pm
Room: Hall B


934    
Differences in Lopinavir Plasma Concentrations Comparing Kaletra Film Coated Tablets and Soft Gelatin Capsules Translate into Distinct Lipid Abnormalities
Judit Morello*, S Rodriguez-Novoa, F Blanco, A Rubio, I Jimenez-Nacher, and V Soriano
Hosp Carlos III, Madrid, Spain

Background:  A new formulation of lopinavir/ritonavir (LPV/r) as film-coated tablets has recently replaced the formulation of LPV/r soft gelatin capsules. Although the new formulation may show several advantages—such as no food requirements, reduced pill count, and no refrigeration required—few data are available about the bioequivalence of the 2 formulations, specially regarding effects on lipids.

Methods:  All HIV patients at our institution, who had been treated with LPV/r capsules for at least 6 months and switched in 2007 to the newer LPV/r tablets, were retrospectively analyzed. Lipid values and LPV plasma trough concentrations were examined before switching and 12 weeks thereafter. LPV plasma concentrations were measured by a validated high-performance liquid chromatography with ultraviolet detector (HPLC-UV) method. Patients taking lipid-lowering agents were excluded from this analysis.

Results:  A total of 40 patients were identified (83% male; median age, 44 years old [IQR 41 to 48], 95.1% Caucasian). LPV plasma trough concentrations were significantly higher with LPV/r tablets than with the old LPV/r capsules. No significant differences were seen for total cholesterol and LDL cholesterol when comparing both LPV/r formulations. In contrast, triglycerides were significantly increased and HDL cholesterol reduced with LPV/r tablets compared to capsules. The ratio of total cholesterol (TC) to HDL cholesterol was significantly higher with tablets than capsules.

 

 

Capsules

Tablets

p

LPV plasma levels (mg/mL)

3.2, 2.3 to 5.2

4, 3.2 to 5.7

0.008

TC (mg/dL)

189, 162.7 to 219.2

193.5, 153.7 to 219.2

0.889

LDL (mg/dL)

121.6, 95.4 to 133.8

110.1, 82.3 to 141.4

0.512

HDL (mg/dL)

42.5, 33.5 to 57.5

39, 32 to 53

0.008

TC:HDL ratio

4.4, 3.3 to 5.2

4.7, 3.7 to 5.5

0.014

Triglycerides (mg/dL)

110, 84.2 to 145.2

147, 99 to 207

0.016

 

Conclusions:  Higher LPV plasma trough concentrations with the new formulation of LPV/r tablets compared with the old capsules are associated with increases in triglycerides and reductions in the TC:HDL ratio, which may be relevant in patients with cardiovascular risk.