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Predicting Optimal Dihydroartemisinin-Piperaquine Regimens to Prevent Malaria During Pregnancy for Human Immunodeficiency Virus-Infected Women Receiving Efavirenz

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2018
3175.pdf (1.701Mb)
Authors
Wallender, Erika
Vučićević, Katarina
Jagannathan, Prasanna
Huang, Liusheng
Natureeba, Paul
Kakuru, Abel
Muhindo, Mary
Nakalembe, Mirium
Havlir, Diane
Kamya, Moses
Aweeka, Francesca
Dorsey, Grant
Rosenthal, Philip J.
Savić, Radojka M.
Article (Published version)
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Abstract
Background. A monthly treatment course of dihydroartemisinin-piperaquine (DHA-PQ) effectively prevents malaria during pregnancy. However, a drug-drug interaction pharmacokinetic (PK) study found that pregnant human immunodeficiency virus (HIV)-infected women receiving efavirenz-based antiretroviral therapy (ART) had markedly reduced piperaquine (PQ) exposure. This suggests the need for alternative DHA-PQ chemoprevention regimens in this population. Methods. Eighty-three HIV-infected pregnant women who received monthly DHA-PQ and efavirenz contributed longitudinal PK and corrected QT interval (QTc) (n = 25) data. Population PK and PK-QTc models for PQ were developed to consider the benefits (protective PQ coverage) and risks (QTc prolongation) of alternative DHA-PQ chemoprevention regimens. Protective PQ coverage was defined as maintaining a concentration > 10 ng/mL for > 95% of the chemoprevention period. Results. PQ clearance was 4540 L/day. With monthly DHA-PQ (2880 mg PQ), lt 1% o...f women achieved defined protective PQ coverage. Weekly (960 mg PQ) or low-dose daily (320 or 160 mg PQ) regimens achieved protective PQ coverage for 34% and > 96% of women, respectively. All regimens were safe, with lt = 2% of women predicted to have >= 30 msec QTc increase. Conclusions. For HIV-infected pregnant women receiving efavirenz, low daily DHA-PQ dosing was predicted to improve protection against parasitemia and reduce risk of toxicity compared to monthly dosing.

Keywords:
intermittent preventive treatment during pregnancy / dihydroartemisinin-piperaquine / HIV infection / drug-drug interaction
Source:
Journal of Infectious Diseases, 2018, 217, 6, 964-972
Publisher:
  • Oxford Univ Press Inc, Cary
Projects:
  • National Natural Science Foundation of China - 31372466

DOI: 10.1093/infdis/jix660

ISSN: 0022-1899

PubMed: 29272443

WoS: 000427131300015

Scopus: 2-s2.0-85042947997
[ Google Scholar ]
7
7
URI
http://farfar.pharmacy.bg.ac.rs/handle/123456789/3177
Collections
  • Radovi istraživača / Researchers’ publications
Institution
Pharmacy
TY  - JOUR
AU  - Wallender, Erika
AU  - Vučićević, Katarina
AU  - Jagannathan, Prasanna
AU  - Huang, Liusheng
AU  - Natureeba, Paul
AU  - Kakuru, Abel
AU  - Muhindo, Mary
AU  - Nakalembe, Mirium
AU  - Havlir, Diane
AU  - Kamya, Moses
AU  - Aweeka, Francesca
AU  - Dorsey, Grant
AU  - Rosenthal, Philip J.
AU  - Savić, Radojka M.
PY  - 2018
UR  - http://farfar.pharmacy.bg.ac.rs/handle/123456789/3177
AB  - Background. A monthly treatment course of dihydroartemisinin-piperaquine (DHA-PQ) effectively prevents malaria during pregnancy. However, a drug-drug interaction pharmacokinetic (PK) study found that pregnant human immunodeficiency virus (HIV)-infected women receiving efavirenz-based antiretroviral therapy (ART) had markedly reduced piperaquine (PQ) exposure. This suggests the need for alternative DHA-PQ chemoprevention regimens in this population. Methods. Eighty-three HIV-infected pregnant women who received monthly DHA-PQ and efavirenz contributed longitudinal PK and corrected QT interval (QTc) (n = 25) data. Population PK and PK-QTc models for PQ were developed to consider the benefits (protective PQ coverage) and risks (QTc prolongation) of alternative DHA-PQ chemoprevention regimens. Protective PQ coverage was defined as maintaining a concentration > 10 ng/mL for > 95% of the chemoprevention period. Results. PQ clearance was 4540 L/day. With monthly DHA-PQ (2880 mg PQ),  lt  1% of women achieved defined protective PQ coverage. Weekly (960 mg PQ) or low-dose daily (320 or 160 mg PQ) regimens achieved protective PQ coverage for 34% and > 96% of women, respectively. All regimens were safe, with  lt = 2% of women predicted to have >= 30 msec QTc increase. Conclusions. For HIV-infected pregnant women receiving efavirenz, low daily DHA-PQ dosing was predicted to improve protection against parasitemia and reduce risk of toxicity compared to monthly dosing.
PB  - Oxford Univ Press Inc, Cary
T2  - Journal of Infectious Diseases
T1  - Predicting Optimal Dihydroartemisinin-Piperaquine Regimens to Prevent Malaria During Pregnancy for Human Immunodeficiency Virus-Infected Women Receiving Efavirenz
VL  - 217
IS  - 6
SP  - 964
EP  - 972
DO  - 10.1093/infdis/jix660
ER  - 
@article{
author = "Wallender, Erika and Vučićević, Katarina and Jagannathan, Prasanna and Huang, Liusheng and Natureeba, Paul and Kakuru, Abel and Muhindo, Mary and Nakalembe, Mirium and Havlir, Diane and Kamya, Moses and Aweeka, Francesca and Dorsey, Grant and Rosenthal, Philip J. and Savić, Radojka M.",
year = "2018",
url = "http://farfar.pharmacy.bg.ac.rs/handle/123456789/3177",
abstract = "Background. A monthly treatment course of dihydroartemisinin-piperaquine (DHA-PQ) effectively prevents malaria during pregnancy. However, a drug-drug interaction pharmacokinetic (PK) study found that pregnant human immunodeficiency virus (HIV)-infected women receiving efavirenz-based antiretroviral therapy (ART) had markedly reduced piperaquine (PQ) exposure. This suggests the need for alternative DHA-PQ chemoprevention regimens in this population. Methods. Eighty-three HIV-infected pregnant women who received monthly DHA-PQ and efavirenz contributed longitudinal PK and corrected QT interval (QTc) (n = 25) data. Population PK and PK-QTc models for PQ were developed to consider the benefits (protective PQ coverage) and risks (QTc prolongation) of alternative DHA-PQ chemoprevention regimens. Protective PQ coverage was defined as maintaining a concentration > 10 ng/mL for > 95% of the chemoprevention period. Results. PQ clearance was 4540 L/day. With monthly DHA-PQ (2880 mg PQ),  lt  1% of women achieved defined protective PQ coverage. Weekly (960 mg PQ) or low-dose daily (320 or 160 mg PQ) regimens achieved protective PQ coverage for 34% and > 96% of women, respectively. All regimens were safe, with  lt = 2% of women predicted to have >= 30 msec QTc increase. Conclusions. For HIV-infected pregnant women receiving efavirenz, low daily DHA-PQ dosing was predicted to improve protection against parasitemia and reduce risk of toxicity compared to monthly dosing.",
publisher = "Oxford Univ Press Inc, Cary",
journal = "Journal of Infectious Diseases",
title = "Predicting Optimal Dihydroartemisinin-Piperaquine Regimens to Prevent Malaria During Pregnancy for Human Immunodeficiency Virus-Infected Women Receiving Efavirenz",
volume = "217",
number = "6",
pages = "964-972",
doi = "10.1093/infdis/jix660"
}
Wallender E, Vučićević K, Jagannathan P, Huang L, Natureeba P, Kakuru A, Muhindo M, Nakalembe M, Havlir D, Kamya M, Aweeka F, Dorsey G, Rosenthal PJ, Savić RM. Predicting Optimal Dihydroartemisinin-Piperaquine Regimens to Prevent Malaria During Pregnancy for Human Immunodeficiency Virus-Infected Women Receiving Efavirenz. Journal of Infectious Diseases. 2018;217(6):964-972
Wallender, E., Vučićević, K., Jagannathan, P., Huang, L., Natureeba, P., Kakuru, A., Muhindo, M., Nakalembe, M., Havlir, D., Kamya, M., Aweeka, F., Dorsey, G., Rosenthal, P. J.,& Savić, R. M. (2018). Predicting Optimal Dihydroartemisinin-Piperaquine Regimens to Prevent Malaria During Pregnancy for Human Immunodeficiency Virus-Infected Women Receiving Efavirenz.
Journal of Infectious DiseasesOxford Univ Press Inc, Cary., 217(6), 964-972.
https://doi.org/10.1093/infdis/jix660
Wallender Erika, Vučićević Katarina, Jagannathan Prasanna, Huang Liusheng, Natureeba Paul, Kakuru Abel, Muhindo Mary, Nakalembe Mirium, Havlir Diane, Kamya Moses, Aweeka Francesca, Dorsey Grant, Rosenthal Philip J., Savić Radojka M., "Predicting Optimal Dihydroartemisinin-Piperaquine Regimens to Prevent Malaria During Pregnancy for Human Immunodeficiency Virus-Infected Women Receiving Efavirenz" 217, no. 6 (2018):964-972,
https://doi.org/10.1093/infdis/jix660 .

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