title: Less lipoatrophy and better lipid profile with abacavir as compared to stavudine: 96-week results of a randomized study.
abstract: OBJECTIVE
  To assess lipoatrophy, other toxicities, and efficacy associated with abacavir as compared with stavudine in HIV-infected antiretroviral-naive patients.
  
  
  METHODS
  This was a prospective, randomized, open trial, stratified by viral load and CD4 cell count, conducted January 2001 to July 2004. Two hundred thirty-seven adult patients with HIV infection initiating antiretroviral therapy were assigned to receive abacavir (n = 115) or stavudine (n = 122), both combined with lamivudine and efavirenz. The primary endpoint was the proportion of patients with lipoatrophy as assessed by physician and patient observation at 96 weeks.
  
  
  RESULTS
  A lower proportion of patients assigned to abacavir developed clinical signs of lipoatrophy (4.8% vs. 38.3%; P < 0.001). These observations were confirmed by anthropometric data. Dual energy x-ray absorptiometry (DEXA) scans performed in 57 patients showed significantly greater total limb fat loss in the stavudine arm (-1579 vs. 913 g; P < 0.001). The lipid profile in abacavir patients presented more favorable changes in the levels of triglycerides (P = 0.03), high-density lipoprotein cholesterol (HDLc; P < 0.001), and apolipoprotein A1 (P < 0.001) as well as in the ratio between total cholesterol and HDLc (P = 0.005). Throughout the study, a higher proportion of patients in the stavudine group received lipid-lowering agents as compared to the abacavir group (17% vs. 4%; P = 0.002). Similar virologic and immunologic responses were observed.
  
  
  CONCLUSIONS
  Assuming the limitations inherent to clinical assessment, this study shows a notably weaker association of abacavir with lipoatrophy than stavudine. DEXA scans and anthropometric measurements supported the clinical findings. In addition, the lipid changes that occurred were more favorable in patients receiving abacavir.
authors.affiliation: Infectious Disease Service, Hospital Universitari de Bellvitge, Barcelona, Spain. dpodzamczer@csub.scs.es
authors.forename: Daniel
authors.initials: D
authors.lastname: Podzamczer
authors.forename: Elena
authors.initials: E
authors.lastname: Ferrer
authors.forename: Pochita
authors.initials: P
authors.lastname: Sanchez
authors.forename: José M
authors.initials: JM
authors.lastname: Gatell
authors.forename: Manel
authors.initials: M
authors.lastname: Crespo
authors.forename: Cesar
authors.initials: C
authors.lastname: Fisac
authors.forename: Montse
authors.initials: M
authors.lastname: Lonca
authors.forename: Jose
authors.initials: J
authors.lastname: Sanz
authors.forename: Jordi
authors.initials: J
authors.lastname: Niubo
authors.forename: Sergio
authors.initials: S
authors.lastname: Veloso
authors.forename: Josep M
authors.initials: JM
authors.lastname: Llibre
authors.forename: Pilar
authors.initials: P
authors.lastname: Barrufet
authors.forename: María A
authors.initials: MA
authors.lastname: Ribas
authors.forename: Esperanza
authors.initials: E
authors.lastname: Merino
authors.forename: Esteban
authors.initials: E
authors.lastname: Ribera
authors.forename: Javier
authors.initials: J
authors.lastname: Martínez-Lacasa
authors.forename: Carlos
authors.initials: C
authors.lastname: Alonso
authors.forename: Miquel
authors.initials: M
authors.lastname: Aranda
authors.forename: Federico
authors.initials: F
authors.lastname: Pulido
authors.forename: Juan
authors.initials: J
authors.lastname: Berenguer
authors.forename: Antonio
authors.initials: A
authors.lastname: Delegido
authors.forename: Juan D
authors.initials: JD
authors.lastname: Pedreira
authors.forename: Ana
authors.initials: A
authors.lastname: Lérida
authors.forename: Rafael
authors.initials: R
authors.lastname: Rubio
authors.forename: Luis
authors.initials: L
authors.lastname: del Río
mesh_terms: D015502:Absorptiometry, Photon; D000273:Adipose Tissue / Q000000981:diagnostic imaging; D000328:Adult; D000368:Aged; D000480:Alkynes; D048588:Benzoxazines; D018791:CD4 Lymphocyte Count; D003521:Cyclopropanes; D015224:Dideoxynucleosides / Q000009:adverse effects* / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005121:Extremities / Q000000981:diagnostic imaging; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D039682:HIV-Associated Lipodystrophy Syndrome / Q000139:chemically induced*; D006801:Humans; D019259:Lamivudine / Q000627:therapeutic use; D050356:Lipid Metabolism / Q000187:drug effects*; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D010078:Oxazines / Q000627:therapeutic use; D018119:Stavudine / Q000009:adverse effects* / Q000627:therapeutic use*; D019562:Viral Load; D000099227:Abacavir
chemical_list: D000480:Alkynes; D048588:Benzoxazines; D003521:Cyclopropanes; D015224:Dideoxynucleosides; D019259:Lamivudine; D008055:Lipids; D010078:Oxazines; D018119:Stavudine; D000099227:Abacavir; C098320:efavirenz