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Randomized, Controlled, 48-Week Study of Switching Stavudine and/or Protease Inhibitors to Combivir/Abacavir to Prevent or Reverse Lipoatrophy in HIV-Infected Patients.

John, Mina; McKinnon, Elizabeth J.; James, Ian R.; Nolan, David A.; Herrmann, Susan E.; Moore, Corey B.; White, Alex J.; Mallal, Simon A.
JAIDS Journal of Acquired Immune Deficiency Syndromes: May 1, 2003

Objective: HIV-1 protease inhibitors (versus no protease inhibitors) and stavudine (versus zidovudine) are independently associated with a higher risk of lipoatrophy in HIV-infected patients. We sought to determine whether the revision of stavudine and/or protease inhibitor-containing regimens to combivir/abacavir would result in prevention and/or reversibility of lipoatrophy in HIV-1-infected patients.

Design: The investigation was a prospective, randomized, controlled, open-label study.

Subjects: The subjects included 37 HIV-1-infected individuals with stable undetectable HIV-1 loads who were taking a regimen containing either stavudine or zidovudine with lamivudine and a protease inhibitor.

Intervention: Subjects were randomized to continue therapy or switch stavudine to zidovudine and protease inhibitor to abacavir, such that the universal switch regimen was combivir (zidovudine/lamivudine) and abacavir.

Main Outcome Measures: Total body, leg, and arm fat mass was measured at baseline, 24 weeks, and 48 weeks using whole-body dual-energy x-ray absorptiometry. Single-cut L4 computed tomography and assays of multiple metabolic parameters were also performed.

Results: There was an average gain in fat mass of 0.009 kg/(leg[middle dot]mo) in switch patients versus a loss of 0.010 kg/(leg[middle dot]mo) in controls (p = .04, on-treatment analysis) over 48 weeks. Significant arm fat restoration was observed in patients who switched regimens, with an average gain of 0.014 kg/(arm[middle dot]mo) (p = .004), whereas controls did not have a significant change from baseline. Analyses of percentage changes in arm and leg fat masses showed similar findings. No significant effects on intra-abdominal fat, blood lipid levels, glycemic indices, and lactate levels were detected, although most baseline mean values were normal in study subjects. Combivir/abacavir maintained virological control in all but one case, and three (13.6%) of 22 individuals had adverse reactions to abacavir therapy.

Conclusions: A switch to combivir/abacavir therapy was associated with objective evidence of limb fat-sparing and fat restoration compared with continued treatment with stavudine and/or protease inhibitor.

(C) 2003 Lippincott Williams & Wilkins, Inc.