title: Incidence and risk factors for tenofovir-associated renal toxicity in HIV-infected patients.
abstract: BACKGROUND
  Since the beginning of highly active antiretroviral therapy utilization, the association of renal impairment with treatment toxicity is more prevalent. Tenofovir disoproxil fumarate (TDF) side effects include renal toxicity.
  
  
  OBJECTIVE
  To assess the incidence of renal damage in human immunodeficiency virus (HIV)-positive patients treated with TDF and to identify associated potential risk factors.
  
  
  METHODS
  A public university tertiary 450-beds hospital in Spain.
  
  
  METHODS
  Retrospective, longitudinal observational study that included adult HIV-1-infected patients treated with TDF. Patient´s treated with TDF from January 2010 to December 2012 were included. Patient follow-up started when initiating treatment with TDF up until either end of treatment or end of study (July 31, 2013). The estimated glomerular filtration rate was calculated using the four-variable modification of diet in renal disease. Renal toxicity was classified as moderate [estimated glomerular filtration rate (eGFR) < 60 ml/min] or severe (eGFR < 30 ml/min). The incidence rate for moderate and severe renal insufficiency was calculated as number of cases per 1000 patient-year. A univariate analysis and binary logistic regression was carried out in order to identify risk factors associated with renal toxicity by using the forward stepwise method (likelihood ratio)
  
  
  METHODS
  Incidence rate for moderate and severe renal insufficiency (RI) RESULTS: 451 patients were included in the study. The incidence rate of moderate RI was 29.2 cases per 1000 person-year (95% CI 22.1-36.3), whereas the incidence of severe RI was 2.2 cases per 1000 person-year (95% CI 0.3-4.1). Multivariate analysis confirmed an independent association with the risk of kidney damage for age (OR 1.08 95% CI 1.05-1.12), time on treatment with TDF (OR 1.16 95% CI 1.04-1.30), baseline creatinine (OR 49.80 95% CI 7.90-311.92) and treatment with NNRTIs (OR 0.45 95% CI 0.24-0.83).
  
  
  CONCLUSIONS
  Mild to moderate renal failure is a frequent complication during treatment with TDF although severe renal impairment is scarce. Risk factors include age, duration of treatment with TDF, elevated baseline creatinine levels, and treatment with protease inhibitor boosted with ritonavir combinations.
authors.affiliation: Pharmacy Department, University Hospital of Getafe, Getafe, Madrid, Spain. pedroprq@gmail.com.
authors.forename: Pedro Rodríguez
authors.identifier: http://orcid.org/0000-0003-1296-8476
authors.initials: PR
authors.lastname: Quesada
authors.affiliation: Pharmacy Department, University Hospital of Getafe, Getafe, Madrid, Spain.
authors.forename: Laura López
authors.initials: LL
authors.lastname: Esteban
authors.affiliation: Pharmacy Department, University Hospital of Getafe, Getafe, Madrid, Spain.
authors.forename: Jimena Ramón
authors.initials: JR
authors.lastname: García
authors.affiliation: Pharmacy Department, University Hospital of Getafe, Getafe, Madrid, Spain.
authors.forename: Rocío Vázquez
authors.initials: RV
authors.lastname: Sánchez
authors.affiliation: Pharmacy Department, University Hospital of Getafe, Getafe, Madrid, Spain.
authors.forename: Teresa Molina
authors.initials: TM
authors.lastname: García
authors.affiliation: Internal Medicine Department, University Hospital of Getafe, Getafe, Madrid, Spain.
authors.forename: Gabriel Gaspar
authors.initials: GG
authors.lastname: Alonso-Vega
authors.affiliation: Pharmacy Department, University Hospital of Getafe, Getafe, Madrid, Spain.
authors.forename: Javier Sánchez-Rubio
authors.initials: JS
authors.lastname: Ferrández
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects* / Q000627:therapeutic use; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects*; D005260:Female; D005919:Glomerular Filtration Rate / Q000187:drug effects; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D015994:Incidence; D008137:Longitudinal Studies; D008297:Male; D051437:Renal Insufficiency / Q000139:chemically induced* / Q000453:epidemiology*; D012189:Retrospective Studies; D012307:Risk Factors; D013030:Spain / Q000453:epidemiology; D000068698:Tenofovir / Q000009:adverse effects* / Q000627:therapeutic use
chemical_list: D019380:Anti-HIV Agents; D000068698:Tenofovir
keywords: HAART; HIV; Renal impairment; Tenofovir