title: Switching to lopinavir/ritonavir with or without abacavir/lamivudine in lipoatrophic patients treated with zidovudine/abacavir/lamivudine.
abstract: BACKGROUND
  Discontinuation of thymidine nucleoside reverse transcriptase inhibitors (tNRTIs) is the only proven strategy for improving lipoatrophy. It is unclear whether switching to NRTI-sparing or to non-thymidine NRTI-containing therapy has differential effects on body fat recovery.
  
  
  METHODS
  This was a 96 week, open-label, randomized study in suppressed patients with moderate/severe lipoatrophy and no prior virological failure while receiving a protease inhibitor and who had their triple NRTI regimen (zidovudine/lamivudine/abacavir) switched to lopinavir/ritonavir plus abacavir/lamivudine for a 1 month run-in period and then randomized to lopinavir/ritonavir plus abacavir/lamivudine versus lopinavir/ritonavir monotherapy. The KRETA trial is registered with ClinicalTrials.gov (number NCT00865007).
  
  
  RESULTS
  Of 95 patients included, 88 were randomized to lopinavir/ritonavir plus abacavir/lamivudine (n = 44) or lopinavir/ritonavir monotherapy (n = 44). Median (IQR) baseline limb fat was 2.5 (1.6-3.7) kg in the lopinavir/ritonavir plus abacavir/lamivudine group and 2.5 (2.0-5.4) kg in the lopinavir/ritonavir monotherapy group. Six patients in the triple therapy group and 13 in the monotherapy group had discontinued study drugs by week 96. Although there were limb fat gains in each group at weeks 48/96 (+324/+358 g in lopinavir/ritonavir plus abacavir/lamivudine, P = 0.09/0.07, versus +215/+416 g in the lopinavir/ritonavir monotherapy group, P = 0.28/0.16), differences between groups were not significant [difference +109 g (95% CI -442, +660)/-57 g (95% CI -740, +625)].
  
  
  CONCLUSIONS
  In lipoatrophic patients treated with zidovudine/lamivudine/abacavir, switching to lopinavir/ritonavir monotherapy had no additional benefit in limb fat recovery relative to switching to lopinavir/ritonavir with abacavir/lamivudine. These data suggest that non-thymidine nucleosides such as abacavir/lamivudine are not an obstacle to limb fat recovery.
authors: Hospital Universitario La Paz, IdiPAZ, Madrid, Spain. jibernardino.hulp@salud.madrid.org
authors: J I
authors: JI
authors: Bernardino
authors: F
authors: F
authors: Pulido
authors: E
authors: E
authors: Martinez
authors: J
authors: J
authors: Arrizabalaga
authors: P
authors: P
authors: Domingo
authors: J
authors: J
authors: Portilla
authors: A
authors: A
authors: Ocampo
authors: J
authors: J
authors: Muñoz
authors: R
authors: R
authors: Torres
authors: J R
authors: JR
authors: Arribas
mesh_terms: D015502:Absorptiometry, Photon; D000273:Adipose Tissue / Q000473:pathology*; D000328:Adult; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects / Q000379:methods*; D001284:Atrophy; D001823:Body Composition / Q000502:physiology; D002626:Chemistry, Pharmaceutical; D015224:Dideoxynucleosides / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D017320:HIV Protease Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D057194:Intention to Treat Analysis; D019259:Lamivudine / Q000009:adverse effects / Q000627:therapeutic use*; D008055:Lipids / Q000097:blood; D008060:Lipodystrophy / Q000150:complications*; D061466:Lopinavir / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D018894:Reverse Transcriptase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D019438:Ritonavir / Q000009:adverse effects / Q000627:therapeutic use*; D017211:Treatment Failure; D000099227:Abacavir
chemical_list: D015224:Dideoxynucleosides; D017320:HIV Protease Inhibitors; D019259:Lamivudine; D008055:Lipids; D061466:Lopinavir; D018894:Reverse Transcriptase Inhibitors; D019438:Ritonavir; D000099227:Abacavir
keywords: HIV; NRTI-sparing regimen; lipoatrophy; lopinavir/ritonavir monotherapy; thymidine nucleoside analogues