title: Recovery of fat following a switch to nucleoside reverse transcriptase inhibitor-sparing therapy in patients with lipoatrophy: results from the 96-week randomized ANRS 108 NoNuke Trial.
abstract: OBJECTIVE
  To evaluate the impact on peripheral fat tissue of a nucleoside reverse transcriptase inhibitor (NRTI)-sparing regimen in lipoatrophic HIV-1 infected patients.
  
  
  METHODS
  This 96-week prospective, randomized study compared lipoatrophic patients switched to an NRTI-sparing regimen with patients remaining on an NRTI-containing regimen. The primary endpoint was the change in thigh subcutaneous fat tissue volume between baseline and week 48, as assessed by computerized tomography.
  
  
  RESULTS
  One hundred patients were included, 50 in each arm. At baseline, patients had been on highly active antiretroviral therapy (HAART) for a median time of 6.6 years (4.9-9.7); 71% of the patients had received thymidine analogues [stavudine (37%), zidovudine (34%)]. The mean change in fat volume between baseline and week 48 significantly favoured the NRTI-sparing arm over the NRTI-maintaining arm in the intent-to-treat analysis, with a last-observation-carried-forward approach [+34 cm(3); 95% confidence interval (CI) 5-63 cm(3); P=0.002]. This was confirmed in the intent-to-treat analysis of available data, with a mean difference of +109 cm(3) (95% CI 34-185 cm(3)) at week 96 (n=53; P=0.001). This corresponded to increases of 12 and 30% in fat volume at weeks 48 and 96, respectively, in the NRTI-sparing arm.
  
  
  CONCLUSIONS
  Switching from an effective NRTI-containing regimen to an NRTI-sparing regimen preserves immunovirological status and increases subcutaneous fat volume at weeks 48 and 96.
authors.affiliation: Department of Clinical Infectious and Tropical Diseases, Pitié-Salpêtrière Hospital, Paris, France. marc-antoine.valantin@psl.aphp.fr
authors.forename: M A
authors.initials: MA
authors.lastname: Valantin
authors.forename: E
authors.initials: E
authors.lastname: Lanoy
authors.forename: M
authors.initials: M
authors.lastname: Bentata
authors.forename: O
authors.initials: O
authors.lastname: Kalmykova
authors.forename: A
authors.initials: A
authors.lastname: Boutekadjirt
authors.forename: C
authors.initials: C
authors.lastname: Allavena
authors.forename: W
authors.initials: W
authors.lastname: Rozenbaum
authors.forename: G
authors.initials: G
authors.lastname: Peytavin
authors.forename: B
authors.initials: B
authors.lastname: Amellal
authors.forename: V
authors.initials: V
authors.lastname: Calvez
authors.forename: D
authors.initials: D
authors.lastname: Costagliola
authors.forename: C
authors.initials: C
authors.lastname: Katlama
mesh_terms: D050153:Abdominal Fat / Q000473:pathology; D000328:Adult; D000704:Analysis of Variance; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods; D001823:Body Composition / Q000187:drug effects; D018791:CD4 Lymphocyte Count; D004334:Drug Administration Schedule; D005260:Female; D017320:HIV Protease Inhibitors / Q000627:therapeutic use; D015497:HIV-1; D039682:HIV-Associated Lipodystrophy Syndrome / Q000188:drug therapy* / Q000276:immunology / Q000473:pathology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D018894:Reverse Transcriptase Inhibitors / Q000627:therapeutic use; D018709:Statistics, Nonparametric; D050151:Subcutaneous Fat / Q000473:pathology*; D013848:Thigh; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D017320:HIV Protease Inhibitors; D018894:Reverse Transcriptase Inhibitors