ArticleJournal of acquired immune deficiency syndromes (1999)2014
Pharmacokinetics and safety of tenofovir in HIV-infected women during labor and their infants during the first week of life.
Article in Journal of acquired immune deficiency syndromes (1999), 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers, 5 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
37 citing papers in PubMed, 5 syntheses or guidelines pooled it, 65 citations in OpenAlex.
- KASL clinical practice guidelines for management of chronic hepatitis B.Clinical and molecular hepatology · 2019Guideline
- Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance.Hepatology (Baltimore, Md.) · 2018Guideline
- Efficacy and safety of tenofovir disoproxil fumarate in preventing vertical transmission of hepatitis B in pregnancies with high viral load.Scientific reports · 2017Pooled it
- Is infant exposure to antiretroviral drugs during breastfeeding quantitatively important? A systematic review and meta-analysis of pharmacokinetic studies.The Journal of antimicrobial chemotherapy · 2015Pooled it
- Protecting the fetus against HIV infection: a systematic review of placental transfer of antiretrovirals.Clinical pharmacokinetics · 2014Pooled it
- Use of tenofovir disoproxil fumarate in highly viremic, hepatitis B mono-infected pregnant women.Digestive diseases and sciences · 2014Trial
- KASL clinical practice guidelines for management of chronic hepatitis B Endorsed by the East Asia Liver Alliance (EALA).Clinical and molecular hepatology · 2026Article
- Application of a Physiologically Based Pharmacokinetic Approach to Predict Tenofovir Pharmacokinetics During Pregnancy.The AAPS journal · 2025Article
- A Review of the Systemic Manifestations of Hepatitis B Virus Infection, Hepatitis D Virus, Hepatocellular Carcinoma, and Emerging Therapies.Gastro hep advances · 2024Review
- Clinical trial simulation to evaluate tenofovir disoproxil fumarate/emtricitabine HIV pre-exposure prophylaxis dosing during pregnancy.Frontiers in reproductive health · 2023Article
- Development and application of a pediatric mechanistic kidney model.CPT: pharmacometrics & systems pharmacology · 2022Article
- Where are the pregnant and breastfeeding women in new pre-exposure prophylaxis trials? The imperative to overcome the evidence gap.The lancet. HIV · 2022Review
- Awareness, acceptability, and intention to initiate HIV pre-exposure prophylaxis among pregnant women.AIDS care · 2022Article
- Systematic Review of Early Phase Pediatric Clinical Pharmacology Trials.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2022Article
- Safety review of tenofovir disoproxil fumarate/emtricitabine pre-exposure prophylaxis for pregnant women at risk of HIV infection.Expert opinion on drug safety · 2021Review
- Plasma and Breast Milk Pharmacokinetics of Tenofovir Disoproxil Fumarate in Nursing Mother with Chronic Hepatitis B-Infant Pairs.Antimicrobial agents and chemotherapy · 2021Article
- Factors associated with non-compliance with breastfeeding recommendation: a retrospective survey in hepatitis B virus-infected mothers who had taken Nucleos(t)ide analogs during pregnancy.BMC pregnancy and childbirth · 2021Article
- Prevention of Mother-to-Child Transmission of Hepatitis B Virus in the Western Pacific Region.Clinical liver disease · 2021Review
- Benefits and Risks of Antiviral Treatment during Pregnancy in Patients with Chronic Hepatitis B.Journal of clinical medicine · 2021Review
- Extent of In Utero Transfer of Tenofovir From Mother to Fetus: A Paired Analysis of Hair Specimens Collected at Birth From a Cohort in the United States.The Journal of infectious diseases · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors at 8 institutions in 4 countries.
Funding
Abstract
backgroundData describing the pharmacokinetics and safety of tenofovir in neonates are lacking.
methodsThe HIV Prevention Trials Network 057 protocol was a phase 1, open-label study of the pharmacokinetics and safety of tenofovir disoproxil fumarate (TDF) in HIV-infected women during labor and their infants during the first week of life with 4 dosing cohorts: maternal 600 mg doses/no infant dosing; no maternal dosing/infant 4 mg/kg doses on days 0, 3, and 5; maternal 900 mg doses/infant 6 mg/kg doses on days 0, 3, and 5; maternal 600 mg doses/infant 6 mg/kg daily for 7 doses. Pharmacokinetic sampling was performed on cohort 1 and 3 mothers and all infants. Plasma, amniotic fluid, and breast milk tenofovir concentrations were determined by liquid chromatographic-tandem mass spectrometric assay. The pharmacokinetic target was for infant tenofovir concentration throughout the first week of life to exceed 50 ng/mL, the median trough tenofovir concentration in adults receiving standard chronic TDF dosing.
resultsOne hundred twenty-two mother-infant pairs from Malawi and Brazil were studied. Tenofovir exposure in mothers receiving 600 and 900 mg exceeded that in nonpregnant adults receiving standard 300 mg doses. Tenofovir elimination in the infants was equivalent to that in older children and adults, and trough tenofovir plasma concentrations exceeded 50 ng/mL in 74%-97% of infants receiving daily dosing.
conclusionsA TDF dosing regimen of 600 mg during labor and daily infant doses of 6 mg/kg maintains infant tenofovir plasma concentration above 50 ng/mL throughout the first week of life and should be used in the studies of TDF efficacy for HIV prevention of mother-to-child transmission and early infant treatment.
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Registered trials
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