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

AIDS Research and Therapy

José Valdez Madruga¹  Aline Alencar²  Monica Santos Valões²  Paulo R. Alencastro³  Esper G. Kallas⁴  Brenda Hoagland⁵  Ronaldo I. Moreira⁵  Sandra Wagner Cardoso⁵  Valdiléa Gonçalves Veloso Santos⁵  Iuri Costa Leite⁵  Rodrigo Carvalho Moreira⁵  Beatriz Grinsztejn⁵  Roberto Pecoits-Filho⁶  Karla Cristina Silva Petruccelli⁷  Nadia Cubas-Vega⁸  Alexandre Vilhena Silva-Neto⁹  Fernando Val⁹  Vanderson Sampaio^1,10  Marcus Vinícius Guimarães Lacerda^1,11  Djane Clarys Baía-da-Silva^1,11 

[1] Centro de Referência e Treinamento em DST/AIDS, São Paulo, Brazil;Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Av Pedro Teixeira, 25, 69040-000, Manaus, Amazonas, Brazil;Hospital Sanatório Partenon, SES/RS, Porto Alegre, Brazil;Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil;Instituto Nacional de Infectologia Evandro Chagas (INI), Fiocruz, Rio de Janeiro, Brazil;Pontifícia Universidade Católica do Paraná, Curitiba, Brazil;Universidade Federal do Amazonas, Manaus, Brazil;Universidade do Estado do Amazonas, Manaus, Brazil;Universidade do Estado do Amazonas, Manaus, Brazil;Universidade do Estado do Amazonas, Manaus, Brazil;Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Av Pedro Teixeira, 25, 69040-000, Manaus, Amazonas, Brazil;Universidade do Estado do Amazonas, Manaus, Brazil;Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Av Pedro Teixeira, 25, 69040-000, Manaus, Amazonas, Brazil;Fundação de Vigilância em Saúde do Amazonas, Manaus, Brazil;Universidade do Estado do Amazonas, Manaus, Brazil;Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Av Pedro Teixeira, 25, 69040-000, Manaus, Amazonas, Brazil;Instituto Leônidas and Maria Deane, Fiocruz, Manaus, Brazil;

关键词: PrEP;    Kidney function;    HIV;   

DOI  :  10.1186/s12981-022-00437-4

来源: Springer

【 摘 要 】

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/m2, without arterial hypertension. At screening, median eGFR was 93.0 mL/min/1.73 m2. At week 4 follow-up, 90 (23% of the study population) participants presented reductions in eGFR greater than 10 mL/min/1.73 m2 as compared to baseline eGFR, some as large as 59 mL/min/1.73 m2, 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).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.

【 授权许可】

CC BY