title: A randomized, pilot trial to evaluate glomerular filtration rate by creatinine or cystatin C in naive HIV-infected patients after tenofovir/emtricitabine in combination with atazanavir/ritonavir or efavirenz.
abstract: BACKGROUND
  Glomerular filtration rate (GFR) estimated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation based on creatinine or cystatine C may be more accurate methods especially in patients without chronic kidney disease. There is lack of data on GFR estimated by these methods in patients on highly active antiretroviral therapy.
  
  
  METHODS
  Antiretroviral-naive HIV-infected patients were randomized to tenofovir/emtricitabine in association with atazanavir/ritonavir (ATV/r) or efavirenz (EFV) Patients had to have an actual creatinine clearance >50 mL/minute (24-hour urine collection) and were followed for 48 weeks.
  
  
  RESULTS
  Ninety-one patients (48 ATV/r, 43 EFV) were recruited. Using the CKD-EPI creatinine formula, there was a significant decrease in GFR up to week 48 in patients receiving ATV/r (4.9 mL/minute/m(2), P = 0.02) compared with a not statistically significant increment in patients prescribed EFV. Using the cystatin C-based equation, we found greater decrease in GFR in both arms, although, in the EFV arm, the decrease was not statistically significant (5.8 mL/minute/m(2), P = 0.92). At multivariable analysis, ATV/r was a significant predictor of greater decrease in estimated glomerular filtration rate (eGFR) (P = 0.0046) only with CKD-EPI creatinine.
  
  
  CONCLUSIONS
  ATV/r plus tenofovir caused greater GFR decreases compared with EFV. The evaluation of eGFR by cystatin C confirmed this result, but this method seemed to be more stringent, probably precluding the possibility to detect a significant difference in the pattern of eGFR evolution between the two arms over time. More studies are needed to understand the clinical relevance of these alterations and whether cystatin C is a more appropriate method for monitoring GFR in clinical practice.
authors: Department of Materno Infantile e Tecnologie Biomediche, Institute of Infectious and Tropical Diseases, University of Brescia, Italy.
authors: Laura
authors: L
authors: Albini
authors: Bruno Mario
authors: BM
authors: Cesana
authors: Davide
authors: D
authors: Motta
authors: Emanuele
authors: E
authors: Focà
authors: Daria
authors: D
authors: Gotti
authors: Alessandra
authors: A
authors: Calabresi
authors: Ilaria
authors: I
authors: Izzo
authors: Rita
authors: R
authors: Bellagamba
authors: Rita
authors: R
authors: Fezza
authors: Pasquale
authors: P
authors: Narciso
authors: Laura
authors: L
authors: Sighinolfi
authors: Paolo
authors: P
authors: Maggi
authors: Eugenia
authors: E
authors: Quiros-Roldan
authors: Luigi
authors: L
authors: Manili
authors: Giovanni
authors: G
authors: Guaraldi
authors: Giuseppe
authors: G
authors: Lapadula
authors: Carlo
authors: C
authors: Torti
mesh_terms: D000225:Adenine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000328:Adult; D000480:Alkynes; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000009:adverse effects* / Q000627:therapeutic use; D000069446:Atazanavir Sulfate; D048588:Benzoxazines / Q000008:administration & dosage / Q000009:adverse effects; D003404:Creatinine / Q000378:metabolism*; D003521:Cyclopropanes; D055316:Cystatin C / Q000378:metabolism*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000068679:Emtricitabine; D005260:Female; D005919:Glomerular Filtration Rate / Q000187:drug effects* / Q000502:physiology; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009842:Oligopeptides / Q000008:administration & dosage / Q000009:adverse effects; D063065:Organophosphonates / Q000008:administration & dosage / Q000009:adverse effects; D010865:Pilot Projects; D011725:Pyridines / Q000008:administration & dosage / Q000009:adverse effects; D019438:Ritonavir / Q000008:administration & dosage / Q000009:adverse effects; D000068698:Tenofovir
chemical_list: D000480:Alkynes; D019380:Anti-HIV Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D055316:Cystatin C; D009842:Oligopeptides; D063065:Organophosphonates; D011725:Pyridines; D003841:Deoxycytidine; D000069446:Atazanavir Sulfate; D000068698:Tenofovir; D003404:Creatinine; D000068679:Emtricitabine; D000225:Adenine; C098320:efavirenz; D019438:Ritonavir