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

Autor: Petruccelli KCS; Universidade Federal do Amazonas, Manaus, Brazil.; Universidade do Estado do Amazonas, Manaus, Brazil., Baía-da-Silva DC; Universidade do Estado do Amazonas, Manaus, Brazil.; Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Av Pedro Teixeira, 25, Manaus, Amazonas, 69040-000, Brazil.; Instituto Leônidas and Maria Deane, Fiocruz, Manaus, Brazil., Val F; Universidade do Estado do Amazonas, Manaus, Brazil.; Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Av Pedro Teixeira, 25, Manaus, Amazonas, 69040-000, Brazil., Valões MS; Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Av Pedro Teixeira, 25, Manaus, Amazonas, 69040-000, Brazil., Cubas-Vega N; Universidade do Estado do Amazonas, Manaus, Brazil., Silva-Neto AV; Universidade do Estado do Amazonas, Manaus, Brazil.; Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Av Pedro Teixeira, 25, Manaus, Amazonas, 69040-000, Brazil., Sampaio V; Universidade do Estado do Amazonas, Manaus, Brazil.; Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Av Pedro Teixeira, 25, Manaus, Amazonas, 69040-000, Brazil.; Fundação de Vigilância em Saúde do Amazonas, Manaus, Brazil., Alencar A; Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Av Pedro Teixeira, 25, Manaus, Amazonas, 69040-000, Brazil., Pecoits-Filho R; Pontifícia Universidade Católica do Paraná, Curitiba, Brazil., Moreira RC; Instituto Nacional de Infectologia Evandro Chagas (INI), Fiocruz, Rio de Janeiro, Brazil., Cardoso SW; Instituto Nacional de Infectologia Evandro Chagas (INI), Fiocruz, Rio de Janeiro, Brazil., Moreira RI; Instituto Nacional de Infectologia Evandro Chagas (INI), Fiocruz, Rio de Janeiro, Brazil., Leite IC; Instituto Nacional de Infectologia Evandro Chagas (INI), Fiocruz, Rio de Janeiro, Brazil., Madruga JV; Centro de Referência e Treinamento em DST/AIDS, São Paulo, Brazil., Kallas EG; Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil., Alencastro PR; Hospital Sanatório Partenon, SES/RS, Porto Alegre, Brazil., Hoagland B; Instituto Nacional de Infectologia Evandro Chagas (INI), Fiocruz, Rio de Janeiro, Brazil., Grinsztejn B; Instituto Nacional de Infectologia Evandro Chagas (INI), Fiocruz, Rio de Janeiro, Brazil., Santos VGV; Instituto Nacional de Infectologia Evandro Chagas (INI), Fiocruz, Rio de Janeiro, Brazil., Lacerda MVG; Universidade do Estado do Amazonas, Manaus, Brazil. marcuslacerda.br@gmail.com.; Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Av Pedro Teixeira, 25, Manaus, Amazonas, 69040-000, Brazil. marcuslacerda.br@gmail.com.; Instituto Leônidas and Maria Deane, Fiocruz, Manaus, Brazil. marcuslacerda.br@gmail.com.
Jazyk: angličtina
Zdroj: AIDS research and therapy [AIDS Res Ther] 2022 Feb 24; Vol. 19 (1), pp. 12. Date of Electronic Publication: 2022 Feb 24.
DOI: 10.1186/s12981-022-00437-4
Abstrakt: Background: Pre-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.
Methods: Kidney 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.
Results: Of 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 2 , without arterial hypertension. At screening, median eGFR was 93.0 mL/min/1.73 m 2 . At week 4 follow-up, 90 (23% of the study population) participants presented reductions in eGFR greater than 10 mL/min/1.73 m 2 as compared to baseline eGFR, some as large as 59 mL/min/1.73 m 2 , but with no clinical outcomes (adverse events and renal adverse events) severe enough to demand TDF/FTC discontinuation. A negative relationship was observed between TDF blood levels and eGFR at weeks 4 (r = - 0.005; p < 0.01) and 48 (r = - 0.006; p < 0.01).
Conclusions: These 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.
(© 2022. The Author(s).)
Databáze: MEDLINE
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