Abstract
BackgroundLopinavir/ritonavir (LPV/r) tablet compared to the soft gel capsule (SGC) formulation has no oleic acid or sorbitol, has no refrigeration or food-restriction requirements, and has less pharmacokinetic variability. We compared the tolerability, quality of life (QoL), and formulation preference after switching from LPV/r SGC to the tablet formulation.MethodsIn a prospective, single-arm, cohort study-design, 74 human immunodeficiency virus (HIV) infected subjects stable on LPV/r-based therapy were enrolled prior to (n = 25) or 8 weeks (n = 49) after switching from SGC to tablet. Baseline data included clinical laboratory tests, bowel habit survey (BHS) and QoL questionnaire (recalled if enrolled post-switch). Global Condition Improvement (GCI)-score, BHS-score, QoL-score, and formulation preference data were captured at weeks 4 and 12.ResultsAt week 12 post-enrollment; the tablet was preferred to the SGC (74% vs. 10%, p < 0.0001). GCI-overall-tolerability score was 2.46 ± 3.30 on a scale of -7 to +7, with 90% admitting to feeling better or about the same. Stool frequency, consistency, volume, and ± blood improved, however the improvement was significant in "consistency" only (p = 0.03). Aggregate Bowel Habit-Profile improved (BHS-score change = -0.227, p = 0.01). Inverse relationship existed between GCI and BHS (slope = -1.2, p = 0.02) at week-4, suggesting that improved overall-tolerability was related to better gastrointestinal (GI)-tolerance. QoL-scores were stable. Mean reductions in total cholesterol of 9.20 mg/dL (p = 0.02), in triglycerides of 33 mg/dL (p = 0.04), and in HDL of 4.50 mg/dL (p = 0.01) unrelated to lipid-lowering therapy, were observed at week 12.ConclusionsLPV/r-tablet was well tolerated and preferred to the SGC in HIV infected subjects, with stable QoL and appreciable improvement in GI-tolerability. The unexpected changes in lipid profile deserve further evaluation.
Highlights
Lopinavir/ritonavir (LPV/r) tablet compared to the soft gel capsule (SGC) formulation has no oleic acid or sorbitol, has no refrigeration or food-restriction requirements, and has less pharmacokinetic variability
Lopinavir/ritonavir (LPV/r) tablet is widely used in combination with other antiretroviral agents in place of the soft gel capsule (SGC) in the treatment of human immunodeficiency virus (HIV)-infection
Because the tablet formulation lacks oleic acid [1], an excipient believed to contribute to gastrointestinal (GI) intolerance in the SGC, it is expected for the tolerability of LPV/r to improve with the tablet formulation
Summary
Lopinavir/ritonavir (LPV/r) tablet compared to the soft gel capsule (SGC) formulation has no oleic acid or sorbitol, has no refrigeration or food-restriction requirements, and has less pharmacokinetic variability. Quality of life (QoL), and formulation preference after switching from LPV/r SGC to the tablet formulation. Lopinavir/ritonavir (LPV/r) tablet is widely used in combination with other antiretroviral agents in place of the soft gel capsule (SGC) in the treatment of HIV-infection. The overall tolerability, GI-tolerance profile, fasting lipid profile, quality of life (QoL), formulation preference and satisfaction were prospectively evaluated in a cohort of clinically stable HIV-infected subjects treated with LPV/r based antiretroviral therapy who were switched from the SGC to the tablet formulation. Because of the advantages of the tablet over the SCG, we hypothesized that the covariates evaluated, with the exception of fasting lipid profile and QoL, would improve within 12 weeks of the switch
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