Evidence map›Paper›PMID 35209929›Full record

ArticleAIDS research and therapy2022

Kidney function and daily emtricitabine/tenofovir disoproxil fumarate pre-exposure prophylaxis against HIV: results from the real-life multicentric demonstrative project PrEP Brazil.

Karla Cristina Silva Petruccelli, Djane Clarys Baía-da-Silva, Fernando Val, Monica Santos Valões, Nadia Cubas-Vega, Alexandre Vilhena Silva-Neto, Vanderson Sampaio, Aline Alencar, Roberto Pecoits-Filho, Rodrigo Carvalho Moreira and 10 more

Abstract readMulticenter Study
In one paragraph

Article in AIDS research and therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. 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

20 authors.

Karla Cristina Silva PetruccelliUniversidade Federal do Amazonas, Manaus, Brazil.
Djane Clarys Baía-da-SilvaUniversidade do Estado do Amazonas, Manaus, Brazil.
Fernando ValUniversidade do Estado do Amazonas, Manaus, Brazil.
Monica Santos ValõesFundação de Medicina Tropical Dr Heitor Vieira Dourado, Av Pedro Teixeira, 25, Manaus, Amazonas, 69040-000, Brazil.
Nadia Cubas-VegaUniversidade do Estado do Amazonas, Manaus, Brazil.
Alexandre Vilhena Silva-NetoUniversidade do Estado do Amazonas, Manaus, Brazil.
Vanderson SampaioUniversidade do Estado do Amazonas, Manaus, Brazil.
Aline AlencarFundação de Medicina Tropical Dr Heitor Vieira Dourado, Av Pedro Teixeira, 25, Manaus, Amazonas, 69040-000, Brazil.
Roberto Pecoits-FilhoPontifícia Universidade Católica do Paraná, Curitiba, Brazil.
Rodrigo Carvalho MoreiraInstituto Nacional de Infectologia Evandro Chagas (INI), Fiocruz, Rio de Janeiro, Brazil.
Sandra Wagner CardosoInstituto Nacional de Infectologia Evandro Chagas (INI), Fiocruz, Rio de Janeiro, Brazil.
Ronaldo I MoreiraInstituto Nacional de Infectologia Evandro Chagas (INI), Fiocruz, Rio de Janeiro, Brazil.
Iuri Costa LeiteInstituto Nacional de Infectologia Evandro Chagas (INI), Fiocruz, Rio de Janeiro, Brazil.
José Valdez MadrugaCentro de Referência e Treinamento em DST/AIDS, São Paulo, Brazil.
Esper G KallasHospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.
Paulo R AlencastroHospital Sanatório Partenon, SES/RS, Porto Alegre, Brazil.
Brenda HoaglandInstituto Nacional de Infectologia Evandro Chagas (INI), Fiocruz, Rio de Janeiro, Brazil.
Beatriz GrinsztejnInstituto Nacional de Infectologia Evandro Chagas (INI), Fiocruz, Rio de Janeiro, Brazil.
Valdiléa Gonçalves Veloso SantosInstituto Nacional de Infectologia Evandro Chagas (INI), Fiocruz, Rio de Janeiro, Brazil.
Marcus Vinícius Guimarães LacerdaUniversidade do Estado do Amazonas, Manaus, Brazil. marcuslacerda.br@gmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPre-Exposure Prophylaxis (PrEP) has demonstrated efficacy in the reduction of sexually transmitted HIV infections. The prolonged use of tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) co-formulation (TDF/FTC), however, may result in augmented risk of renal toxicity. We aimed to evaluate changes in the estimated Glomerular Filtration Rate (eGFR) in a real-world population setting of participants enrolled in PrEP Brazil, a 48-week prospective, open-label, demonstration study to assess the feasibility of daily oral TDF/FTC used by men who have sex with men and transgender women at high-risk of HIV infection, all over 18 years old.

methodsKidney function was assessed by serial measurement of serum creatinine and eGFR with the Modification of Diet in Renal Disease Study (MDRD) formula on weeks 4, 12, 24, 36 and 48. Adherence to PrEP was assessed by dosing TDF concentration in dried blood spots at weeks 4 and 48, measured by liquid chromatography-mass spectrometry or mass spectrometry.

resultsOf 392 participants completing the 48-week follow-up protocol with TDF blood detectable levels and eGFR measures, 43.1% were young adults, of Caucasian ethnic background (57.9%), with BMI below 30 kg/m

conclusionsThese results suggest that the renal function profile in individuals on TDF/FTC may be assessed on week 4 and then only annually, allowing a more flexible medical follow-up in primary care centers.

Indexed as

Anti-HIV AgentsHIV InfectionsPre-Exposure ProphylaxisSexual and Gender MinoritiesAdolescentBrazilEmtricitabineFemaleHomosexuality, MaleHumansKidneyMaleProspective StudiesReverse Transcriptase InhibitorsTenofovirYoung AdultAnti-HIV AgentsEmtricitabineReverse Transcriptase InhibitorsTenofovirHIVKidney functionPrEP

Identifiers

PMID35209929
PMCPMC8867642

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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.