Publications

30

Aug, 2016

Is pregnancy a barrier to the proposed lower dose of efavirenz?

 

Authors: Schalkwijk S, ter Heine R, Colbers A,  Huitema A, Denti P, Dooley K, Capparelli E, Best B, Cressey T, Greupink R, Russel F, Mirochnick M, Burger D.

Published: 17th edition of the International Workshop on Clinical Pharmacology of HIV & Hepatitis Therapy, June 8th-10th 2016, Washington DC.  P_26

 

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30

Aug, 2016

Timing of the postpartum curve in pharmacokinetic studies in pregnancy should not be too early

 

Authors: Colbers A, Schalkwijk S, Konopnicki D, Hawkins D, Hidalgo Tenorio C, Moltò J, Taylor G, Weizsacker K, van der Ende M, Burger D

Published: Oral presentation at 17th edition of the International Workshop on Clinical Pharmacology of HIV & Hepatitis Therapy, June 8th-10th 2016, Washington DC

 

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30

Aug, 2016

A Comparison of the Pharmacokinetics of Efavirenz During Pregnancy and Postpartum

 

Authors: Schalkwijk S, Best B, Colbers A, SteK A, Wang  J, Hawkins D, Mirochnick M, Burger D; for the The International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) P1026s Protocol Team, and the Pharmacokinetics of Newly Developed Antiretroviral Agents in HIV-infected Pregnant Women (PANNA) Study Network

Published: 23rd Conference on Retroviruses and Opportunistic Infections, February 22nd-25th 2016, Boston

 

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4

Aug, 2016

Etravirine Pharmacokinetics in HIV-Infected Pregnant Women

 

Authors: Blonk MI, Colbers AP, HidalgoTenorio C, et al.

Published inFront Pharmacol. 2016 Aug 4;7:239.

Background: The study goal was to describe etravirine pharmacokinetics during pregnancy and postpartum in HIV-infected women.

Methods: IMPAACT P1026s and PANNA are on-going, non-randomized, open-label, parallel-group, multi-center phase-IV prospective studies in HIV-infected pregnant women. Intensive steady-state 12-h pharmacokinetic profiles were performed from 2nd trimester through postpartum. Etravirine was measured at two labs using validated ultra performance liquid chromatography (detection limits: 0.020 and 0.026 mcg/mL).

Results: Fifteen women took etravirine 200 mg twice-daily. Etravirine AUC0–12 was higher in the 3rd trimester compared to paired postpartum data by 34% (median 8.3 vs. 5.3 mcg*h/mL, p = 0.068). Etravirine apparent oral clearance was significantly lower in the 3rd trimester of pregnancy compared to paired postpartum data by 52% (median 24 vs. 38 L/h, p = 0.025). The median ratio of cord blood to maternal plasma concentration at delivery was 0.52 (range: 0.19–4.25) and no perinatal transmission occurred.

Conclusion: Etravirine apparent oral clearance is reduced and exposure increased during the third trimester of pregnancy. Based on prior dose-ranging and safety data, no dose adjustment is necessary for maternal health but the effects of etravirine in utero are unknown. Maternal health and infant outcomes should be closely monitored until further infant safety data are available.

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