title: Evolution of renal function in African patients initiating second-line antiretroviral treatment: findings from the ANRS 12169 2LADY trial.
abstract: To investigate change in renal function in African patients initiating second-line antiretroviral therapy (ART) including ritonavir-boosted protease inhibitor (PI/r) with or without tenofovir disoproxil fumarate (TDF).
  
  
  
  HIV-1-positive adults, failing standard first-line ART were randomized to either TDF/emtricitabine (FTC)+LPV/r, abacavir + didanosine +LPV/r or TDF/FTC+ darunavir (DRV)/r and followed for 18 months. Patients with an estimated glomerular filtration rate (eGFR) ≥60 ml/min/1.73 m2at baseline were included in this analysis.
  
  
  
  Data from 438 out of 454 randomized patients were analysed. Median age was 38 years and 72% were women. Initiation of PI/r-based second-line regimen induced a marked eGFR decline of -10.5 ml/min/1.73 m2at week 4 in all treatment groups with a greater decrease in TDF/FTC+LPV/r arm (-15.1 ml/min/1.73 m2). At month 18, mean eGFR in the non-TDF containing regimen recovered its baseline level and was significantly greater than eGFR 18-month levels in the TDF-containing regimens that experienced only partial recovery (difference: -10.7; CI -16.8, -4.6; P=0.001 in TDF/FTC+LPV/r and -6.4; CI -12.5, -0.3; P=0.04 in TDF/FTC+DRV/r). At 18 months, prevalence of stage 3 chronic kidney disease was low (<3%) and not associated with treatment. One treatment discontinuation and five TDF dosage reductions for renal toxicities were reported in TDF-containing arms.
  
  
  
  Overall, these results suggest a reasonable renal tolerance of a regimen associating TDF/FTC+PI/r in African patients with eGFR>60 ml/ml/1.73 m2at baseline. They also support the recommendation of reassessing renal function 1 month after initiation of treatment including ritonavir to account for the ritonavir-related artefactual decrease of eGFR and determine the new reference baseline value.
authors.affiliation: Unité Mixte Internationale 233, Institut de Recherche pour le Développement, U1175-INSERM, University of Montpellier, Montpellier, France.
authors.forename: Amandine
authors.initials: A
authors.lastname: Cournil
authors.affiliation: Day Care Unit, University Hospital Souro Sanou, Bobo-Dioulasso, Burkina Faso.
authors.forename: Arsène
authors.initials: A
authors.lastname: Hema
authors.affiliation: Unité Mixte Internationale 233, Institut de Recherche pour le Développement, U1175-INSERM, University of Montpellier, Montpellier, France.
authors.forename: Sabrina
authors.initials: S
authors.lastname: Eymard-Duvernay
authors.affiliation: Unité Mixte Internationale 233, Institut de Recherche pour le Développement, U1175-INSERM, University of Montpellier, Montpellier, France.
authors.forename: Laura
authors.initials: L
authors.lastname: Ciaffi
authors.affiliation: Biochemistry Department, University Hospital, Montpellier, France.
authors.forename: Stéphanie
authors.initials: S
authors.lastname: Badiou
authors.affiliation: Day Care Unit, University Hospital Souro Sanou, Bobo-Dioulasso, Burkina Faso.
authors.forename: Firmin N
authors.initials: FN
authors.lastname: Kabore
authors.affiliation: CRCF, Dakar, Senegal.
authors.forename: Assane
authors.initials: A
authors.lastname: Diouf
authors.affiliation: Yaoundé Military Hospital, Yaoundé, Cameroon.
authors.forename: Liliane
authors.initials: L
authors.lastname: Ayangma
authors.affiliation: Unité Mixte Internationale 233, Institut de Recherche pour le Développement, U1175-INSERM, University of Montpellier, Montpellier, France.|Department of Infectious Diseases, University Hospital, Montpellier, France.
authors.forename: Vincent
authors.initials: V
authors.lastname: Le Moing
authors.affiliation: Unité Mixte Internationale 233, Institut de Recherche pour le Développement, U1175-INSERM, University of Montpellier, Montpellier, France.|Department of Infectious Diseases, University Hospital, Montpellier, France.
authors.forename: Jacques
authors.initials: J
authors.lastname: Reynes
authors.affiliation: Faculté de Médecine et des Sciences Biomédicales, University of Yaoundé 1, Yaoundé, Cameroon.
authors.forename: Sinata
authors.initials: S
authors.lastname: Koulla-Shiro
authors.affiliation: Unité Mixte Internationale 233, Institut de Recherche pour le Développement, U1175-INSERM, University of Montpellier, Montpellier, France.|Department of Infectious Diseases, University Hospital, Montpellier, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Delaporte
mesh_terms: D000328:Adult; D000368:Aged; D019380:Anti-HIV Agents / Q000009:adverse effects* / Q000627:therapeutic use; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects / Q000379:methods; D044383:Black People; D018791:CD4 Lymphocyte Count; D005260:Female; D005500:Follow-Up Studies; D005919:Glomerular Filtration Rate / Q000187:drug effects; D015658:HIV Infections / Q000150:complications* / Q000188:drug therapy / Q000276:immunology / Q000821:virology; D006801:Humans; D007674:Kidney Diseases / Q000175:diagnosis* / Q000209:etiology*; D007677:Kidney Function Tests; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D016032:Randomized Controlled Trials as Topic; D019233:Retreatment; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents