Evidence map›Paper›PMID 40323543›Full record

ArticleClinical pharmacokinetics2025

Maternal-Fetal Physiologically Based Population Pharmacokinetics Model Development of Lopinavir/Ritonavir in HIV/HBV Co-infected Pregnant Women to Quantitatively Describe the Gestational PK Characteristics and Predict the Potential Disease-Drug-Drug Interaction (DDDI).

Ling Song, Xuan Guo, Wei Yang, Jie Song, Dongyang Liu

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Article in Clinical pharmacokinetics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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5 · Who and what money

Authors and funding

5 authors.

Ling Song *Department of Obstetrics and Gynecology, Peking University Third Hospital, Beijing, 100191, China.
Xuan Guo *Drug Clinical Trial Center, Peking University Third Hospital, Beijing, 100191, China.
Wei YangDrug Clinical Trial Center, Peking University Third Hospital, Beijing, 100191, China.
Jie SongDrug Clinical Trial Center, Peking University Third Hospital, Beijing, 100191, China.
Dongyang LiuDrug Clinical Trial Center, Peking University Third Hospital, Beijing, 100191, China. liudongyang@vip.sina.com.ORCID 0000-0002-0608-8192

Funding

Gates Foundation INV-007625Innovative Research Group Project of the National Natural Science Foundation of China 82373954National Key Research and Development Program of China 2023YFC2705900National Natural Science Foundation of China 82173895
6 · The paper itself

Abstract

BACKGROUND AND

objectiveLopinavir/ritonavir (LPV/r) has been widely used in HIV/HBV co-infected pregnant-women. We aim to characterize the maternal-fetal (m-f) pharmacokinetic (PK) of LPV/r and support the dose optimization and potential drug-drug interaction (DDI) evaluation in this population.

methodsLopinavir PK characteristics in human immunodeficiency virus/hepatitis B virus (HIV/HBV) co-infected pregnant women (n = 35) and fetus were calculated using non-compartmental analysis followed by quantification of maternal PK characteristics using population PK (PopPK) analysis. A maternal-fetal lopinavir physiologically based pharmacokinetic (PBPK) model was developed by incorporating trans-placental transfer, disease- and pregnancy-related physiological changes. This final population PBPK model was applied to simulate different dose regimens of LPV/r and potential DDI risks under different drug combination scenarios.

results(AUC

conclusionsThis work successfully applied model-informed approaches to quantitatively assess lopinavir m-f PK and also provided a novel strategy for DDI risk evaluation and dosing optimization for other P-gp substrates in HIV/HBV co-infected pregnant women.

Indexed as

Hepatitis BHIV InfectionsLopinavirModels, BiologicalPregnancy Complications, InfectiousRitonavirAdultAnti-HIV AgentsCoinfectionDrug CombinationsDrug InteractionsFemaleHIV Protease InhibitorsHumansMaternal-Fetal ExchangePregnancyAnti-HIV AgentsDrug CombinationsHIV Protease InhibitorsLopinavirlopinavir-ritonavir drug combinationRitonavirHIV/HBV co-infected pregnant womenLPV/rmaternal-fetal PKmodel-informed DDDI study

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.