ArticleBritish journal of clinical pharmacology2026
Physiologically based pharmacokinetic model combined with a clinical lactation study to determine doravirine concentrations in human breastmilk.
Article in British journal of clinical pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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Who cites it
1 citing paper in PubMed.
- Physiologically based pharmacokinetic model combined with a clinical lactation study to determine doravirine concentrations in human breastmilk.British journal of clinical pharmacology · 2026Article
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4 authors.
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Abstract
aimsTo determine breastmilk concentrations of doravirine via PBPK modelling in combination with a clinical lactation study. As women living with HIV are not able to cease antiretroviral therapy during lactation, it is necessary to establish drug transfer into breastmilk to determine exposure of the infant to antiretroviral drugs and potential risk of drug-induced toxicity.
methodsPBPK modelling was performed with Simcyp v22 with the lactation module as an add-on. Model predictions were compared with observed data, and model performance was considered adequate if predicted: observed ratios for AUC
resultsThe lactation model predicted a geometric mean (CV%) breastmilk to maternal plasma ratio of 0.39,
conclusionsWe present in silico and clinical evidence of the transfer of doravirine into breastmilk. However, based on these data, the infant's exposure to doravirine through breastmilk is not expected to be hazardous.
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