Evidence map›Paper›PMID 38773606›Full record

ArticleAIDS research and therapy2024

Pharmacokinetics of tenofovir alafenamide, emtricitabine, and dolutegravir in a patient on peritoneal dialysis.

Sandra Abdul Massih, Mohamed G Atta, Chloe L Thio, Jeffrey A Tornheim, Edward J Fuchs, Rahul P Bakshi, Mark A Marzinke, Craig W Hendrix, Ethel D Weld

Abstract readCase Reports
PubMed Full text at PMC Publisher
In one paragraph

Article in AIDS research and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–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

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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

9 authors.

Sandra Abdul MassihDivision of Clinical Pharmacology, Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Mohamed G AttaDivision of Nephrology, Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Chloe L ThioDivision of Infectious Diseases, Department of Medicine, The Johns Hopkins University School of Medicine Baltimore, Baltimore, MD, USA.
Jeffrey A TornheimDivision of Infectious Diseases, Department of Medicine, The Johns Hopkins University School of Medicine Baltimore, Baltimore, MD, USA.
Edward J FuchsDivision of Clinical Pharmacology, Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Rahul P BakshiDivision of Clinical Pharmacology, Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Mark A MarzinkeDivision of Clinical Pharmacology, Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Craig W HendrixDivision of Clinical Pharmacology, Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Ethel D WeldDivision of Clinical Pharmacology, Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore, MD, USA. eweld@jhmi.edu.

Funding

Optimizing the Use of Long-Acting Antiretrovirals for Youth Living withHIVK23AI165290 · NIAID · JOHNS HOPKINS UNIVERSITY · PI WELD, ETHEL DERBY · 2021 to 2024
$702k
NIAID NIH HHS K23 AI165290NIH HHS K23 AI165290
6 · The paper itself

Abstract

introductionPeritoneal dialysis (PD) is an effective renal replacement modality in people with HIV (PWH) with end-stage kidney disease (ESKD), particularly those with residual kidney function. Data on pharmacokinetics (PK) of antiretrovirals in patients on peritoneal dialysis are limited.

methodsA single-participant study was performed on a 49-year-old gentleman with ESKD on PD and controlled HIV on once daily dolutegravir (DTG) 50 mg + tenofovir alafenamide (TAF) 25 mg / emtricitabine (FTC) 200 mg. He underwent serial blood plasma, peripheral blood mononuclear cell, and urine PK measurements over 24 h after an observed DTG + FTC/TAF dose.

resultsPlasma trough (Cmin) concentrations of TAF, tenofovir (TFV), FTC, and DTG were 0.05, 164, 1,006, and 718 ng/mL, respectively. Intracellular trough concentrations of TFV-DP and FTC-TP were 1142 and 11,201 fmol/million cells, respectively. Compared to published mean trough concentrations in PWH with normal kidney function, observed TFV and FTC trough concentrations were 15.5- and 20-fold higher, while intracellular trough concentrations of TFV-DP and FTC-TP were 2.2-fold and 5.4-fold higher, respectively. TFV and FTC urine levels were 20 times lower than in people with normal GFR.

conclusionsIn a single ESKD PWH on PD, daily TAF was associated with plasma TFV and intracellular TFV-DP trough concentrations 15-fold and 2-fold higher than those of people with uncompromised kidney function, potentially contributing to nephrotoxicity. This suggests that TFV accumulates on PD; thus, daily TAF in PD patients may require dose adjustment or regimen change to optimize treatment, minimize toxicity, and preserve residual kidney function.

Indexed as

AdenineAlanineAnti-HIV AgentsEmtricitabineHeterocyclic Compounds, 3-RingHIV InfectionsKidney Failure, ChronicOxazinesPeritoneal DialysisPiperazinesPyridonesTenofovirDolutegravirHumansMaleMiddle AgedAdenineAlanineAnti-HIV AgentsDolutegravirEmtricitabineHeterocyclic Compounds, 3-RingOxazinesPiperazinesPyridonesTenofovirtenofovir alafenamideEmtricitabineHIV treatmentNephrotoxicityPeritoneal dialysisTenofovirTrough concentration

Identifiers

PMID38773606
PMCPMC11110198

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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.