A randomized study of pharmacokinetics, efficacy, and safety of 2 raltegravir plus atazanavir strategies in ART-treated adults

Carey, Dianne, Pett, Sarah L., Bloch, Mark, Wand, Handan, MacRae, Karen, Beileiter, Kate, Ray, John E., Boyd, Mark A., Emery, Sean and Cooper, David A. (2012) A randomized study of pharmacokinetics, efficacy, and safety of 2 raltegravir plus atazanavir strategies in ART-treated adults. Journal of Acquired Immune Deficiency Syndromes, 60 2: 143-149. doi:10.1097/QAI.0b013e318252f97e


Author Carey, Dianne
Pett, Sarah L.
Bloch, Mark
Wand, Handan
MacRae, Karen
Beileiter, Kate
Ray, John E.
Boyd, Mark A.
Emery, Sean
Cooper, David A.
Title A randomized study of pharmacokinetics, efficacy, and safety of 2 raltegravir plus atazanavir strategies in ART-treated adults
Journal name Journal of Acquired Immune Deficiency Syndromes   Check publisher's open access policy
ISSN 1525-4135
1944-7884
Publication date 2012-06-01
Sub-type Article (original research)
DOI 10.1097/QAI.0b013e318252f97e
Open Access Status Not yet assessed
Volume 60
Issue 2
Start page 143
End page 149
Total pages 7
Place of publication Philadelphia, PA, United States
Publisher Lippincott Williams & Wilkins
Language eng
Formatted abstract
Background: New antiretroviral drug classes provide opportunities to explore novel regimens.

Methods: HIV+ adults (<50 copies/mL) receiving atazanavir (ATV) were randomized to raltegravir (RAL) 400 mg + ATV 300 mg twice daily (q12h) for 4 weeks followed by RAL 800 mg + ATV/ritonavir 300/100 mg once daily (q24h) for 4 weeks or vice versa. Validated assays quantitated RAL and ATV plasma concentrations. Primary endpoint was geometric mean ratio (GMR) of ATV minimum concentration (Cmin) for q24h/q12h. Equivalence was 90% confidence interval (CI) of GMR lying between 0.80 and 1.25. Participants could consent to a total 48-week follow-up.

Results: Twenty-five men, mean age 45 (range, 35-57) years, were evaluated. ATV and RAL demonstrated considerable pharmacokinetic variability. There was no period or sequence effect for pharmacokinetic parameters (P > 0.1 all measures). Ninety percent CIs of ATV GMR Cmin [1.30 (90% CI: 1.08 to 1.58)] and RAL GMR Cmin [0.48 (90% CI: 0.31 to 0.75)] demonstrated nonequivalence. Seventy-six percent consented to follow-up. There were no serious adverse events and no discontinuations due to adverse events over 48 weeks; HIV RNA remained undetectable.

Conclusions: In virologically suppressed adults, regimens comprising ATV plus RAL were efficacious and safe. ATV q12h troughs were lower than ritonavir-boosted atazanavir q24h; RAL q24h troughs were lower than q12h.
Keyword Antiretroviral therapy
Atazanavir
HIV
Raltegravir
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collection: School of Medicine Publications
 
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