| Peripheral and Central Fat Changes in Subjects Randomized to Abacavir-Lamivudine or Tenofovir-Emtricitabine With Atazanavir-Ritonavir or Efavirenz: ACTG Study A5224s. | |
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MedLine Citation:
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PMID: 21690627 Owner: NLM Status: In-Data-Review |
Abstract/OtherAbstract:
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Background. We compare the effect of 4 different antiretroviral regimens on limb and visceral fat. Methods. A5224s was a substudy of A5202, a trial of human immunodeficiency virus type 1 (HIV-1)-infected, treatment-naive subjects randomized to blinded abacavir-lamivudine (ABC-3TC) or tenofovir DF-emtricitabine (TDF-FTC) with open-label efavirenz (EFV) or atazanavir-ritonavir (ATV-r). The primary endpoint was the presence of lipoatrophy (≥10% loss of limb fat) at week 96 by intent-to-treat (ITT) analysis. Secondary endpoints included changes in limb and visceral fat. Statistical tests included linear regression, binomial, two-sample t test, and Fisher's exact test. Results. A5224s enrolled 269 subjects; 85% were male, and 47% were white non-Hispanic. The subjects had a median baseline HIV-1 RNA level of 4.6 log(10) copies/mL, a median age of 38 years, a median CD4+ cell count of 233 cells/μL, median limb fat of 7.4 kg, median visceral adipose tissue (VAT) of 84.1 cm(2), and VAT: total adipose tissue (TAT) ratio of 0.31. At week 96, estimated prevalence of lipoatrophy (upper 95% confidence interval [CI]) was 18% (25%) for ABC-3TC and 15% (22%) for TDF-FTC (P = .70); this was not significantly less than the hypothesized 15% for both (P ≥ .55 for both). The secondary as-treated (AT) analysis showed similar results. At week 96, the estimated mean percentage change from baseline in VAT was higher for the ATV-r group than for the EFV group (26.6% vs 12.4%; P = .090 in ITT analysis and 30.0% vs 14.5%; P = .10 in AT analysis); however, the percentage change in VAT:TAT was similar by ITT and AT analysis (P ≥ .60 for both). Results were similar for absolute changes in VAT and VAT:TAT. Conclusions. ABC-3TC- and TDF-FTC-based regimens increased limb and visceral fat at week 96, with a similar prevalence of lipoatrophy. Compared to the EFV group, subjects assigned to ATV-r had a trend towards higher mean percentage increase in VAT. Clinical Trials Registration. NCT00118898. |
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Authors:
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Grace A McComsey; Douglas Kitch; Paul E Sax; Pablo Tebas; Camlin Tierney; Nasreen C Jahed; Laurie Myers; Kathleen Melbourne; Belinda Ha; Eric S Daar |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America Volume: 53 ISSN: 1537-6591 ISO Abbreviation: Clin. Infect. Dis. Publication Date: 2011 Jul |
Date Detail:
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Created Date: 2011-06-21 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9203213 Medline TA: Clin Infect Dis Country: United States |
Other Details:
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Languages: eng Pagination: 185-96 Citation Subset: IM |
Affiliation:
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Departments of Pediatrics and Medicine, Case Western Reserve University and Rainbow Babies and Children's Hospital, Cleveland, Ohio. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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