title: Tenofovir renal safety in HIV-infected patients: results from the SCOLTA Project.
abstract: OBJECTIVE
  To evaluate the prevalence and incidence of nephrotoxicity in HIV-infected patients enrolled in the SCOLTA Project tenofovir cohort and to identify possible risk factors.
  
  
  METHODS
  The SCOLTA Project is a prospective, observational, multicenter study involving 25 infectious disease departments in Italy created to assess the incidence of severe adverse events in patients receiving new antiretroviral drugs.
  
  
  METHODS
  The SCOLTA Project tenofovir cohort includes a total of 754 HIV infected patients.
  
  
  RESULTS
  Data including grade II-IV creatinine elevations according to ACTG scale were available in 354 patients, 237 (67%) males with a mean age of 40.1+/-7.6 years enrolled in the SCOLTA Project tenofovir cohort. During a mean follow up of 19.5+/-11.5 months creatinine elevations were reported in 9/354 (2.5%) patients, all males. Mean duration of tenofovir therapy at the event was 9.5+/-5 months. The overall incidence was 1.6 (95% CI 1.5-1.7) per 100 person-years (p-y) and 0.5 (95% CI 0.4-0.6) p-y for grade III. No grade IV creatinine elevations were reported. Patients with nephrotoxicity were older and more frequently male, HCV infected, in CDC stage C and their CD4 cell count was significantly lower than those without nephrotoxicity. No significant difference was found between tenofovir co-administered antiretroviral drugs.
  
  
  CONCLUSIONS
  Both prevalence and incidence of nephrotoxicity were low in patients receiving tenofovir in a non-selected clinical setting. Renal injury in patients receiving tenofovir seems associated with the presence of co-morbidities and with advanced HIV infection.
authors.affiliation: Department of Infectious Diseases, University of Sassari, Via De Nicola 1, Sassari, Italy. giordano.madeddu@uniss.it
authors.forename: Giordano
authors.initials: G
authors.lastname: Madeddu
authors.forename: Paolo
authors.initials: P
authors.lastname: Bonfanti
authors.forename: Giuseppe V
authors.initials: GV
authors.lastname: De Socio
authors.forename: Silvia
authors.initials: S
authors.lastname: Carradori
authors.forename: Carmela
authors.initials: C
authors.lastname: Grosso
authors.forename: Patrizia
authors.initials: P
authors.lastname: Marconi
authors.forename: Giovanni
authors.initials: G
authors.lastname: Penco
authors.forename: Elena
authors.initials: E
authors.lastname: Rosella
authors.forename: Sebastiano
authors.initials: S
authors.lastname: Miccolis
authors.forename: Sara
authors.initials: S
authors.lastname: Melzi
authors.forename: Maria Stella
authors.initials: MS
authors.lastname: Mura
authors.forename: Simona
authors.initials: S
authors.lastname: Landonio
authors.forename: Elena
authors.initials: E
authors.lastname: Ricci
authors.forename: Tiziana
authors.initials: T
authors.lastname: Quirino
mesh_terms: D000225:Adenine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D000367:Age Factors; D019380:Anti-HIV Agents / Q000009:adverse effects* / Q000627:therapeutic use; D015331:Cohort Studies; D015897:Comorbidity; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D015994:Incidence; D007558:Italy; D007674:Kidney Diseases / Q000139:chemically induced* / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D063065:Organophosphonates / Q000009:adverse effects* / Q000627:therapeutic use; D015995:Prevalence; D011446:Prospective Studies; D012307:Risk Factors; D012720:Severity of Illness Index; D012737:Sex Factors; D000068698:Tenofovir
chemical_list: D019380:Anti-HIV Agents; D063065:Organophosphonates; D000068698:Tenofovir; D000225:Adenine