Early safety of tenofovir alafenamide in patients with a history of tubulopathy on tenofovir disoproxil fumarate: a randomized controlled clinical trial
| Autor: | Frank A. Post, Alexis Bailey, L Campbell, B Barbini, Fanconi-Tenofovir Alafenamide trial team, C G Musso, Keith Burling, Fowzia Ibrahim, Lisa Hamzah, David E. Williams, Rachael Jones |
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| Rok vydání: | 2019 |
| Předmět: |
Male
0301 basic medicine medicine.medical_specialty Urology Renal function HIV Infections Emtricitabine Tenofovir alafenamide Drug Administration Schedule Kidney Tubules Proximal 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Tubulopathy Humans Medicine media_common.cataloged_instance Pharmacology (medical) 030212 general & internal medicine European union Tenofovir media_common Creatinine Alanine Proteinuria business.industry Adenine Health Policy Middle Aged medicine.disease 030112 virology United Kingdom Retinol-Binding Proteins Treatment Outcome Infectious Diseases chemistry Linear Models Albuminuria Drug Therapy Combination Female Kidney Diseases medicine.symptom business Glomerular Filtration Rate medicine.drug |
| Zdroj: | HIV Medicine. 21:198-203 |
| ISSN: | 1468-1293 1464-2662 |
| DOI: | 10.1111/hiv.12819 |
| Popis: | Objectives The aim of the study was to assess the effect of tenofovir alafenamide (TAF) on kidney and bone biomarkers in patients who developed proximal renal tubulopathy (PRT) while receiving tenofovir disoproxil fumarate (TDF). Methods Individuals with a history of TDF-associated PRT and currently suppressed HIV infection on a tenofovir-sparing regimen were randomized 1:1 to continue current antiretroviral therapy or initiate emtricitabine (F)/TAF with discontinuation of nucleoside reverse transcriptase inhibitors (NRTIs) as appropriate. Renal and bone biomarkers were analysed at baseline, week 4 and week 12. The primary outcome was the mean difference between study arms in urine retinol-binding protein:creatinine ratio (RBPCR) change from baseline to week 12. Data were analysed using linear regression, with robust standard errors (primary outcome), and repeated measures mixed effects models (secondary outcomes). The trial was registered under European Union Drug Regulating Authorities Clinical Trials Database 2016-003345-29. Results We randomized 31 individuals [mean age 52.4 (standard deviation 0.3) years; 97% male; 90% white); all completed the study. At 12 weeks, there was no difference in change in RBPCR (β 19.6; 95% confidence interval -35.3, 74.5; P = 0.47), and no difference in change in estimated glomerular filtration rate (eGFR) (based on creatinine or cystatin C), albuminuria, proteinuria, renal phosphate or urea handling, (fasting) urine osmolality, parathyroid hormone and bone turnover markers in the control versus the F/TAF exposed groups. No cases of PRT were observed. Conclusions In people with a history of proximal renal tubulopathy while on TDF, 12-week exposure to TAF did not adversely affect renal tubular function. These data support continued evaluation of the long-term safety of TAF in this group of patients. |
| Databáze: | OpenAIRE |
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