Ritonavir boosting dose reduction from 100 to 50 mg does not change the atazanavir steady-state exposure in healthy volunteers

The Journal of Antimicrobial Chemotherapy
Javier A EstévezMarta Valle

Abstract

To evaluate the pharmacokinetics, tolerability and safety of 300 mg of atazanavir boosted with 100 or 50 mg of ritonavir, both once daily, at steady state. This was a single-blind, multiple-dose, crossover, sequence-randomized trial. Thirteen healthy HIV-1-negative men received witnessed once-daily doses of atazanavir (300 mg) and 100 or 50 mg of ritonavir for 10 days (15 day washout). Atazanavir and ritonavir plasma concentrations were determined for 24 h on day 10. Log-transformed individual pharmacokinetic parameters were compared between treatments (analysis of variance); the difference between treatments on the log scale and 95% CIs were calculated. Fasting cholesterol, triglycerides, glucose and bilirubin plasma levels were measured at the beginning and end of each period and compared (Wilcoxon signed rank test). Gastrointestinal symptoms and other events were recorded. Ritonavir C(max) and the AUC₀₋₂₄ were lower after the 50 mg booster dose than after 100 mg [geometric mean ratio (GMR) (95% CI), 0.40 (0.31-0.51) and 0.35 (0.29-0.42), respectively]. No differences were observed in atazanavir exposure with 50 or 100 mg of ritonavir [GMR C(max) (95% CI), 1.00 (0.79-1.28); GMR AUC₀₋₂₄ (95% CI), 0.98 (0.79-1.21)]. Atazanavir ...Continue Reading

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Citations

May 14, 2014·The Journal of Antimicrobial Chemotherapy·M Arab-AlameddineUNKNOWN Swiss HIV Cohort Study
Nov 1, 2016·The Journal of Antimicrobial Chemotherapy·E J SmoldersD M Burger
Apr 27, 2021·Frontiers in Cardiovascular Medicine·Shiridhar KashyapManish K Gupta

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