Evidence map›Paper›PMID 40599109›Full record

ArticleInternational journal of clinical pharmacology and therapeutics2025

Cabotegravir pharmacokinetics in Asians with and without HIV.

Kelong Han, Ahmed A Abulfathi, Rashmi S Mehta, Romina A Nand, Mark A Marzinke, Raphael J Landovitz, Ronald D D'Amico, Alex R Rinehart, William R Spreen, Susan L Ford

Abstract readComparative Study
In one paragraph

Article in International journal of clinical pharmacology and therapeutics, 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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1 · What the graph read from it

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3 · Its place in the literature

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4 · The record

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5 · Who and what money

Authors and funding

10 authors.

Kelong Han
Ahmed A Abulfathi
Rashmi S Mehta
Romina A Nand
Mark A Marzinke
Raphael J Landovitz
Ronald D D'Amico
Alex R Rinehart
William R Spreen
Susan L Ford

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveCabotegravir is approved for HIV treatment (with rilpivirine) and prevention. The established cabotegravir population pharmacokinetic (PPK) model included 1.2% Asian participants. We aimed to compare cabotegravir pharmacokinetics between Asian and non-Asian populations and across Asian countries. MATERIALS AND

methodsCabotegravir concentrations were collected from Asian participants in phase 1 and 3 studies. The applicability of the PPK model to Asian populations was validated by predicting the observed concentrations not included in model-building. Cabotegravir post-hoc pharmacokinetic parameters (long-acting absorption rate constant, weight-normalized apparent clearances and volumes of distribution) and exposures (trough and peak concentrations) following monthly and every-2-month regimens were estimated by fitting the PPK model to observed data. Non-Asian participants from the previous PPK dataset (1,697 males; 564 females) were used as comparator. Cabotegravir exposures in Asian and non-Asian were compared via simulations.

results2,034 cabotegravir concentrations were collected from 162 Asian males (assigned male at birth) in China (n = 47), Japan (n = 17), Korea (n = 25), Thailand (n = 53), and Vietnam (n = 20), and 35 concentrations from 2 Asian females (assigned female at birth) in Korea. Cabotegravir pharmacokinetic parameters were similar between Asian and non-Asian participants. Cabotegravir exposures in Asian populations largely overlapped with but tended to be higher than non-Asian populations, suggesting similar efficacy. Cabotegravir exposures in Asian and non-Asian populations remained below the safety threshold, suggesting similar safety profiles. Cabotegravir pharmacokinetic parameters and exposures were similar across Asian countries.

conclusionNo dose adjustment is recommended for Asian populations with and without HIV. Cabotegravir pharmacokinetic data from any Asian country/region may guide pharmacokinetic evaluation and regulatory considerations across Asian regions.

Indexed as

Anti-HIV AgentsAsian PeopleHIV InfectionsPyridonesAdultAsiaDiketopiperazinesFemaleHumansMaleMiddle AgedModels, BiologicalYoung AdultAnti-HIV AgentscabotegravirDiketopiperazinesPyridones

Identifiers

PMID40599109
PMCPMC12378465

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