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Session 63 Poster Session Drug-Drug Interactions Session Time: 4:30-6:30 pm Room 4E-F

446-W. Pravastatin 40-mg qd Does not Alter Protease Inhibitor (PI) Exposure or Virological Efficacy over 24 Weeks Therapy G. J. Moyle*1, N. E. Buss2, and B. Gazzard1 1Chelsea and Westminster Hosp., London, UK and 2Roche, Basel, Switzerland Introduction: Amongst cholesterol-lowering statins, pravastatin is thought to have the least impact on cytochromes P450. We have recently demonstrated that the efficacy of pravastatin plus dietary advice in persons receiving Pis is similar to endogenous hyperlipidaemia, reducing LDL cholesterol by 20%. Methods: Patients on PI therapy with viral load <500copies/mL were randomised to either dietary advice alone or dietary advice plus pravastatin 40-mg qd. Samples for PI levels were taken pre-dose (trough) and 1 h post-observed dosing, before the commencement of pravastatin and at weeks 12 and 24. Results: 31 male patients were randomised, 15 to pravastatin. All patients remained <500 copies/mL throughout 24 weeks study. According to an analysis of variance model (ANOVA) levels of log transformed ritonavir (n=8), indinavir (n=5), and saquinavir (n=6) at both pre-dose and post-dose did not change significantly (p>0.05 for all comparisons) between baseline and week 24. Paired median pre-dose levels at baseline and week 24 were: ritonavir 1176 and 1439, indinavir 116 and 149, and saquinavir 247 and 386 ng/mL. Similarly, no changes in PI exposure were observed in the dietary advice alone arm. Conclusions: Consistent with studies in healthy volunteers, no impact of pravastatin on PI trough and post-dose exposures were seen in the study. Efficacy and lack of interactions with pravastatin suggest this agent to be first line choice in hypercholesterolaemia in persons receiving PI-based HAART.

©2002 9th Conference on Retroviruses and Opportunistic Infections