Evidence map›Paper›PMID 39332538›Full record

Trial reportAntiviral research2024

Evaluation of pharmacokinetics of Tenofovir Alafenamide (TAF) and Tenofovir Disoproxil (TDF) in pregnant and postpartum women in South Africa: PrEP-PP PK study.

Dvora Joseph Davey, Sumaya Dadan, Kalisha Bheemraj, Catriona Waitt, Saye Khoo, Landon Myer, Lubbe Wiesner, Laura Else, Beth Thompson, Sandra Castel and 3 more

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Antiviral research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Dvora Joseph DaveyDivision of Epidemiology & Biostatistics, School of Public Health, University of Cape Town, Cape Town, South Africa; Division of Infectious Diseases, Department of Medicine, University of California, Los Angeles, California, USA. Electronic address: dvoradavey@ucla.edu.
Sumaya DadanDivision of Epidemiology & Biostatistics, School of Public Health, University of Cape Town, Cape Town, South Africa.
Kalisha BheemrajDivision of Epidemiology & Biostatistics, School of Public Health, University of Cape Town, Cape Town, South Africa.
Catriona WaittDepartment of Pharmacology and Therapeutics, University of Liverpool, England, UK; Infectious Diseases Institute, Makerere University College of Health Sciences, Uganda.
Saye KhooDepartment of Pharmacology and Therapeutics, University of Liverpool, England, UK.
Landon MyerDivision of Epidemiology & Biostatistics, School of Public Health, University of Cape Town, Cape Town, South Africa.
Lubbe WiesnerDivision of Clinical Pharmacology, University of Cape Town, Cape Town, South Africa.
Laura ElseDepartment of Pharmacology and Therapeutics, University of Liverpool, England, UK.
Beth ThompsonDepartment of Pharmacology and Therapeutics, University of Liverpool, England, UK.
Sandra CastelDivision of Clinical Pharmacology, University of Cape Town, Cape Town, South Africa.
Nafisa WaraDivision of Infectious Diseases, Department of Medicine, University of California, Los Angeles, California, USA.
Peter L AndersonDepartment of Pharmaceutical Sciences, University of Colorado - Anschutz Medical Campus, Aurora, Colorado, USA.
Catherine OrrellDesmond Tutu HIV Centre, Cape Town, South Africa.

Funding

Stepped care to optimize PrEP effectiveness in pregnant and postpartum women (SCOPE-PP) in South AfricaR01HD106862 · NICHD · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI DVORA Leah JOSEPH DAVEY · 2021 to 2026
$2.7M
Evaluating the PrEP cascade in HIV-negative pregnant and breastfeeding women in South Africa (PrEP-PP)R01MH116771 · NIMH · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI JOSEPH DAVEY, DVORA LEAH, MYER, BENJAMIN LANDON · 2018 to 2022
$2.5M
NICHD NIH HHS R01 HD106862NIMH NIH HHS R01 MH116771
6 · The paper itself

Abstract

backgroundThere are few data on tenofovir-diphosphate (TFV-DP) concentrations in pregnant and postpartum women on Tenofovir Disoproxil Fumarate-Emtricitabine (TDF-FTC) or Tenofovir Alafenamide-Emtricitabine (TAF-FTC).

methodsEligible pregnant women were randomized to TDF-FTC or TAF-FTC and followed for 16 weeks (8-weeks pregnant, 8-weeks postpartum) with weekly collection of dried blood spot (DBS) and 4-weekly peripheral blood mononuclear cells (PBMC). PrEP dosing was observed daily via asynchronous videos sent via cell phone. We report geometric means (GM) and their ratios (GMR) with 95% confidence intervals (CIs) for TFV-DP in PBMC and DBS from pregnancy and postpartum.

resultsWe enrolled N = 39 participants (n = 19 TDF-FTC, n = 20 TAF-FTC): median age was 28 years (IQR:25-34); median gestational age was 24-weeks (IQR:21-28). For TDF-FTC, TFV-DP DBS concentrations at 8-weeks did not differ significantly between pregnancy (GM: 675; 95%CI:537-849) and postpartum (GM: 583; 95%CI:471-722; GMR-TDF = 1.16; 95%CI:0.74-1.80). For TAF-FTC, TFV-DP DBS concentrations at 8-weeks were 44% higher in postpartum (GM: 1199; 95%CI:929-1549) versus pregnancy (GM: 832; 95%CI:751-922; GMR-TAF = 1.44; 95% CI: 1.01-2.06). In PBMC analysis of TDF-FTC, 8-week median TFV-DP (pmol/10^6 cell) was 71 (IQR 44-112) in pregnancy and 73 (IQR 50-102) in postpartum (GMR = 1.04; 95%CI:0.44-2.44). In TAF-FTC, median PBMC at 8-weeks was 580 (IQR:341-985) in pregnancy and 666 (IQR:396-1123) in postpartum (GMR = 1.15; 95%CI:0.30-2.49).

conclusionTFV-DP concentrations were overall lower during pregnancy than postpartum for TAF-FTC. We found high concentrations of TFV-DP in PBMC in pregnancy and postpartum on TAF-FTC, suggesting PrEP efficacy is maintained. Efficacy and safety studies are warranted to evaluate TAF-FTC for PrEP in pregnant and postpartum women.

Indexed as

AdenineAlanineAnti-HIV AgentsHIV InfectionsPostpartum PeriodPre-Exposure ProphylaxisTenofovirAdultEmtricitabineFemaleHumansLeukocytes, MononuclearOrganophosphatesPregnancyPregnancy Complications, InfectiousSouth AfricaAdenineAlanineAnti-HIV AgentsEmtricitabineOrganophosphatesTenofovirtenofovir alafenamidetenofovir diphosphatePharmacokineticsPregnancyPrEPPreventionTAF/FTCTDF/FTC

Identifiers

PMID39332538
PMCPMC13312342

What OpenQuestion holds

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Registered trials

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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 OpenQuestion graph.