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dc.contributor.authorMarieke Bierhoffen_US
dc.contributor.authorElise J. Smoldersen_US
dc.contributor.authorJoel Tarningen_US
dc.contributor.authorDavid M. Burgeren_US
dc.contributor.authorRene Spijkeren_US
dc.contributor.authorMarcus J. Rijkenen_US
dc.contributor.authorChaisiri Angkurawaranonen_US
dc.contributor.authorRose McGreadyen_US
dc.contributor.authorNicholas J. Whiteen_US
dc.contributor.authorFrancois Nostenen_US
dc.contributor.authorMichèle van Vugten_US
dc.description.abstractBACKGROUND: Tenofovir disoproxil fumarate (TDF), the oral prodrug of tenofovir (TFV), is advocated in pregnancy for prevention of mother-to-child transmission (PMCT) with failure of hepatitis B immunoglobulin and vaccination. The pharmacokinetics of TDF monotherapy for PMCT-HBV is important if deployment is to emulate the success of multiple antiretrovirals (ARVs) for PMCT-HIV in resource-constrained settings. METHODS: This systematic review followed a protocol and is reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement (PRISMA) guidelines. We included studies that enrolled pregnant women who received oral TDF therapy as monotherapy or in combination with other ARVs: irrespective of the reason for receiving the drug (for example, HIV, HBV or pre-exposure prophylaxis); and reported pharmacokinetics. RESULTS: The area under the concentration-time curve (AUC), maximum plasma concentrations (Cmax) and last measurable plasma concentration (Clast) of TFV were decreased in the second and third trimester compared with first trimester or post-partum. In none of the manuscripts was the non-pregnant HBV threshold of Cmax of 300 ng/ml reached, but the 50% effective concentration (EC50) of TFV is lower for treatment of HBV compared with HIV. The TFV concentration in breastfed infants was 0.03% of the recommended infant dose. CONCLUSIONS: Most knowledge of pharmacokinetics of TFV in pregnancy results from studies on HIV involving multiple ARVs. Increased TFV clearance occurred in the second and third trimester when optimal TFV concentrations are required to maximize suppression of HBV in the window before birth. Dose or duration adjustments will be better conceptualized with concurrent analysis of the pharmacokinetics of TFV monotherapy and hepatitis B pharmacodynamics in pregnancy.en_US
dc.subjectPharmacology, Toxicology and Pharmaceuticsen_US
dc.titlePharmacokinetics of oral tenofovir disoproxil fumarate in pregnancy and lactation: a systematic reviewen_US
article.title.sourcetitleAntiviral therapyen_US
article.volume24en_US Medical Center Utrechten_US Universityen_US Department of Clinical Medicineen_US Clinicsen_US University Nijmegen Medical Centreen_US UMC - University of Amsterdamen_US Mai Universityen_US Global Healthen_US
Appears in Collections:CMUL: Journal Articles

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