FANCONI-TAF (FANTA) study
Research type
Research Study
Full title
Safety of tenofovir alafenamide (TAF) in patients with a history of tubulopathy on tenofovir disoproxil fumarate (TDF)
IRAS ID
211705
Contact name
Frank Post
Contact email
Sponsor organisation
Kings College Hospital
Eudract number
2016-003345-29
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Summary of Research
Patients with a history of renal disorder on tenofovir disoproxil fumarate (TDF) are typically managed on TDF-sparing regimens with increased pill burden, suboptimal HIV/hepatitis B activity and potential adverse effects. A new formulation of tenofovir (Tenofovir alafenamide, TAF) was recently licensed and has a much improved renal safety profile. We wish to examine the safety of TAF in patients with a history of tubulopathy (a specific type of kidney injury) on TDF. We propose to conduct a clinical trial to examine the safety of TAF under careful monitoring of kidney function and with evaluation of bone mineral density. If the renal/bone safety of TAF is confirmed in patients with a history of renal disorder, many could switch to more convenient, better tolerated or more broadly active antiretroviral therapy regimens. It would also inform renal monitoring strategies for patients on TAF-based medications in clinical practice.Summary of Results
The purpose of the FANTA Study was to evaluate the effects of tenofovir alafenamide (TAF) on kidneys and bone in patients with a history of tubulopathy and FANCONI syndrome while receiving the antiretroviral medication tenofovir disoproxil fumarate (TDF). In summary, 31 patients with well-controlled HIV were enrolled and followed up for a duration of 5 years. The study results revealed that kidney function and bone turnover remained stable and no cases of recurrent tubulopathy were encountered, indicating that TAF is a safe, well-tolerated and effective treatment for individuals with HIV who experienced tubulopathy when taking TDF.REC name
London - Dulwich Research Ethics Committee
REC reference
16/LO/1812
Date of REC Opinion
14 Oct 2016
REC opinion
Favourable Opinion