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.
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.
Valantin
M A
MA
Department of Clinical Infectious and Tropical Diseases, Pitié-Salpêtrière Hospital, Paris, France. marc-antoine.valantin@psl.aphp.fr
Lanoy
E
E
Bentata
M
M
Kalmykova
O
O
Boutekadjirt
A
A
Allavena
C
C
Rozenbaum
W
W
Peytavin
G
G
Amellal
B
B
Calvez
V
V
Costagliola
D
D
Katlama
C
C
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
D019380:Anti-HIV Agents; D017320:HIV Protease Inhibitors; D018894:Reverse Transcriptase Inhibitors