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Reduced indinavir exposure during pregnancy.
MedLine Citation:
PMID:  23305215     Owner:  NLM     Status:  Publisher    
AIM: To describe the pharmacokinetics and safety of indinavir boosted with ritonavir (IDV/r) during the second and third trimesters of pregnancy and in the postpartum period. METHODS: IMPAACT P1026s is an on-going, prospective, non-blinded study of antiretroviral pharmacokinetics (PK) in HIV-infected pregnant women with a Thai cohort receiving IDV/r 400/100 mg twice daily during pregnancy through 6-12 weeks postpartum as part of clinical care. Steady-state PK profiles were performed during the second (optional) and third trimesters and at 6-12 weeks postpartum. PK targets were the estimated 10(th) percentile IDV AUC (12.9 μg.h/mL) in non-pregnant historical Thai adults and a trough concentration of 0.1 μg/mL, the suggested minimum target. RESULTS: Twenty-six pregnant women were enrolled; thirteen entered during the second trimester. Median (range) age was 29.8 (18.9-40.8) years and weight 60.5 (50.0-85.0) kg at the third trimester PK visit. The 90% confidence limits for the geometric mean ratio of the indinavir AUC(0-12) and Cmax during the second trimester and postpartum (ante/post ratios) were 0.58 (0.49-0.68) and 0.73 (0.59-0.91), respectively; third trimester/postpartum AUC(0-12) and Cmax ratios were 0.60 (0.53-0.68) and 0.63 (0.55-0.72), respectively. IDV/r was well tolerated and 21/26 women had a HIV-1 viral load <40 copies/mL at delivery. All twenty-six infants were confirmed HIV negative. CONCLUSION: IDV exposure during the second and third trimesters was significantly reduced compared to postpartum and ∼30% of women fail to achieve a target trough concentration. Increasing the dose of IDV/r during pregnancy to 600/100 mg twice daily may be preferable to ensure adequate drug concentrations.
Tim R Cressey; Brookie M Best; Jullapong Achalapong; Alice Stek; Jiajia Wang; Nantasak Chotivanich; Prapap Yuthavisuthi; Pornnapa Suriyachai; Sinart Prommas; David E Shapiro; D Heather Watts; Elizabeth Smith; Edmund Capparelli; Regis Kreitchmann; Mark Mirochnick;
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2013-1-11
Journal Detail:
Title:  British journal of clinical pharmacology     Volume:  -     ISSN:  1365-2125     ISO Abbreviation:  Br J Clin Pharmacol     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-1-11     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7503323     Medline TA:  Br J Clin Pharmacol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
© 2013 The Authors. British Journal of Clinical Pharmacology © 2013 The British Pharmacological Society.
Program for HIV Prevention and Treatment (IRD URI 174), Department of Medical Technology, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang, Mai, Thailand; Harvard School of Public Health, Boston, MA, USA; Institut de Recherché pour le Développement (IRD), UMI 174-PHPT, France.
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