Assessment of renal safety of tenofovir disoproxil fumarate in people living with HIV in Tunisia

Background: Tenofovir disoproxil fumarate (TDF) is a nucleotide reverse transcriptase inhibitor (NRTI). TDF is generally well tolerated. It is eliminated by the combination of glomerular filtration and active renal tubular secretion. Thus, it can be responsible, in the medium and long term, of renal toxicity. The aim of our study is to assess the prevalence of TDF nephrotoxicity and its factors risk in PLHIV treated in the Infectious Diseases Department at the University Hospital of Monastir, Tunisia.. Methods: An observational cross-sectional single-centre prospective study included 62 cases of HIV-infected patients taking antiretroviral therapy (ART) containing TDF was conducted between 1st August 2016 and 31 December 2016 at Fattouma Bourguiba University Hospital of Monastir, in Tunisia. During this period, patients were screened for renal dysfunction to detect renal toxicity, Tubular dysfunction or Fanconi syndrome. Results: 62 patients were included with female/male ratio at 1,52. The mean age was 39 years ± 8,5 years. Half of the patients were treated with TDF as first-line therapy. The average duration of TDF was 25 months, the duration was greater than 12 months in 40 (65%) patients. There was a decrease in creatinine clearance in 21 (33.8%) patients, the average of the decrease was 128,6 ±35,8 ml/min Proximal tubulopathy was noted in 1 patient (1.6%) and no patient had Fanconi syndrome.  No risk factors for renal impairment under TDF were found. This finding could be explained by the small sample size Conclusion: TDF-related renal toxicity is often asymptomatic, it require early detection. In ours patient cases, TD is rare, but creatinine clearance decrease is frequent and may inform of possible TD in these patient. In order to reduce TDFtoxicity, a new pro-drug, tenofovir alafenamide (TAF), is now available.