Pharmacokinetics and virologic response of zidovudine/lopinavir/ritonavir initiated during the third trimester of pregnancy

Objective: To evaluate the pharmacokinetics and HIV viral load response following initiation during the third trimester of pregnancy of zidovudine plus standard-dose lopinavir boosted with ritonavir (LPV/r), twice daily, until delivery for the prevention of mother-to-child transmission of HIV. Desig...

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Main Authors: Cressey T., Jourdain G., Rawangban B., Varadisai S., Kongpanichkul R., Sabsanong P., Yuthavisuthi P., Chirayus S., Ngo-Giang-Huong N., Voramongkol N., Pattarakulwanich S., Lallemant M.
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Published: 2017
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http://cmuir.cmu.ac.th/jspui/handle/6653943832/43234
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Institution: Chiang Mai University
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spelling th-cmuir.6653943832-432342017-09-28T06:52:35Z Pharmacokinetics and virologic response of zidovudine/lopinavir/ritonavir initiated during the third trimester of pregnancy Cressey T. Jourdain G. Rawangban B. Varadisai S. Kongpanichkul R. Sabsanong P. Yuthavisuthi P. Chirayus S. Ngo-Giang-Huong N. Voramongkol N. Pattarakulwanich S. Lallemant M. Objective: To evaluate the pharmacokinetics and HIV viral load response following initiation during the third trimester of pregnancy of zidovudine plus standard-dose lopinavir boosted with ritonavir (LPV/r), twice daily, until delivery for the prevention of mother-to-child transmission of HIV. Design: Prospective study nested within a multicenter, three-arm, randomized, phase III prevention of mother-to-child transmission of HIV trial in Thailand (PHPT-5, ClinicalTrials.gov Identifier: NCT00409591). Methods: Women randomized to receive 300 mg zidovudine and 400/100 mg LPV/r twice daily from 28 weeks gestation, or as soon as possible thereafter, until delivery had intensive steady-state 12-h blood sampling performed. LPV/r pharmacokinetic parameters were calculated using noncompartmental analysis. Rules were defined a priori for a LPV/r dose escalation based on the proportion of women with an LPV area under the concentration-time curve (AUC) below 52 μg h/ml (10th percentile for LPV AUC in nonpregnant adults). HIV-1 RNA response was assessed during the third trimester. Results: Thirty-eight women were evaluable; at entry, median (range) gestational age was 29 (28-36) weeks, weight 59.5 (45.0-91.6) kg, CD4 cells count 442 (260-1327) cells/μl and HIV-1 RNA viral load 7818 ( < 40-402 015) copies/ml. Geometric mean (90% confidence interval) LPV AUC, Cmax and Cmin were 64.6 (59.7-69.8) μg h/ml, 8.1 (7.5-8.7) μg/ml and 2.7 (2.4-3.0) μg/ml, respectively. Thirty-one of 38 (81%) women had an LPV AUC above the AUC target. All women had a HIV-1 viral load less than 400 copies/ml at the time of delivery. Conclusion: A short course of zidovudine plus standard-dose LPV/r initiated during the third trimester of pregnancy achieved adequate LPV exposure and virologic response. © 2010 Wolters Kluwer Health | Lippincott Williams & Wilkins. 2017-09-28T06:52:35Z 2017-09-28T06:52:35Z 2010-09-10 Journal 02699370 2-s2.0-77956232308 10.1097/QAD.0b013e32833ce57d https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=77956232308&origin=inward http://cmuir.cmu.ac.th/jspui/handle/6653943832/43234
institution Chiang Mai University
building Chiang Mai University Library
country Thailand
collection CMU Intellectual Repository
description Objective: To evaluate the pharmacokinetics and HIV viral load response following initiation during the third trimester of pregnancy of zidovudine plus standard-dose lopinavir boosted with ritonavir (LPV/r), twice daily, until delivery for the prevention of mother-to-child transmission of HIV. Design: Prospective study nested within a multicenter, three-arm, randomized, phase III prevention of mother-to-child transmission of HIV trial in Thailand (PHPT-5, ClinicalTrials.gov Identifier: NCT00409591). Methods: Women randomized to receive 300 mg zidovudine and 400/100 mg LPV/r twice daily from 28 weeks gestation, or as soon as possible thereafter, until delivery had intensive steady-state 12-h blood sampling performed. LPV/r pharmacokinetic parameters were calculated using noncompartmental analysis. Rules were defined a priori for a LPV/r dose escalation based on the proportion of women with an LPV area under the concentration-time curve (AUC) below 52 μg h/ml (10th percentile for LPV AUC in nonpregnant adults). HIV-1 RNA response was assessed during the third trimester. Results: Thirty-eight women were evaluable; at entry, median (range) gestational age was 29 (28-36) weeks, weight 59.5 (45.0-91.6) kg, CD4 cells count 442 (260-1327) cells/μl and HIV-1 RNA viral load 7818 ( < 40-402 015) copies/ml. Geometric mean (90% confidence interval) LPV AUC, Cmax and Cmin were 64.6 (59.7-69.8) μg h/ml, 8.1 (7.5-8.7) μg/ml and 2.7 (2.4-3.0) μg/ml, respectively. Thirty-one of 38 (81%) women had an LPV AUC above the AUC target. All women had a HIV-1 viral load less than 400 copies/ml at the time of delivery. Conclusion: A short course of zidovudine plus standard-dose LPV/r initiated during the third trimester of pregnancy achieved adequate LPV exposure and virologic response. © 2010 Wolters Kluwer Health | Lippincott Williams & Wilkins.
format Journal
author Cressey T.
Jourdain G.
Rawangban B.
Varadisai S.
Kongpanichkul R.
Sabsanong P.
Yuthavisuthi P.
Chirayus S.
Ngo-Giang-Huong N.
Voramongkol N.
Pattarakulwanich S.
Lallemant M.
spellingShingle Cressey T.
Jourdain G.
Rawangban B.
Varadisai S.
Kongpanichkul R.
Sabsanong P.
Yuthavisuthi P.
Chirayus S.
Ngo-Giang-Huong N.
Voramongkol N.
Pattarakulwanich S.
Lallemant M.
Pharmacokinetics and virologic response of zidovudine/lopinavir/ritonavir initiated during the third trimester of pregnancy
author_facet Cressey T.
Jourdain G.
Rawangban B.
Varadisai S.
Kongpanichkul R.
Sabsanong P.
Yuthavisuthi P.
Chirayus S.
Ngo-Giang-Huong N.
Voramongkol N.
Pattarakulwanich S.
Lallemant M.
author_sort Cressey T.
title Pharmacokinetics and virologic response of zidovudine/lopinavir/ritonavir initiated during the third trimester of pregnancy
title_short Pharmacokinetics and virologic response of zidovudine/lopinavir/ritonavir initiated during the third trimester of pregnancy
title_full Pharmacokinetics and virologic response of zidovudine/lopinavir/ritonavir initiated during the third trimester of pregnancy
title_fullStr Pharmacokinetics and virologic response of zidovudine/lopinavir/ritonavir initiated during the third trimester of pregnancy
title_full_unstemmed Pharmacokinetics and virologic response of zidovudine/lopinavir/ritonavir initiated during the third trimester of pregnancy
title_sort pharmacokinetics and virologic response of zidovudine/lopinavir/ritonavir initiated during the third trimester of pregnancy
publishDate 2017
url https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=77956232308&origin=inward
http://cmuir.cmu.ac.th/jspui/handle/6653943832/43234
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