Body Composition Changes After Initiation of Raltegravir or Protease Inhibitors: ACTG A5260s.

TitleBody Composition Changes After Initiation of Raltegravir or Protease Inhibitors: ACTG A5260s.
Publication TypeJournal Article
Year of Publication2016
AuthorsMcComsey GA, Moser C, Currier J, Ribaudo HJ, Paczuski P, Dubé MP, Kelesidis T, Rothenberg J, Stein JH, Brown TT
JournalClin Infect Dis
Volume62
Issue7
Pagination853-62
Date Published2016 Apr 1
ISSN1537-6591
Abstract

BACKGROUND: Fat gain after antiretroviral therapy (ART) occurs, and its association with protease inhibitors (PIs) is unclear.

METHODS: Peripheral and central fat depots and lean mass were measured using standardized and centrally read abdominal CT scans and whole-body dual-energy absorptiometry scans over a 96-week period in human immunodeficiency virus (HIV)-infected treatment-naive participants. The patients were randomized to tenofovir-emtricitabine (TDF/FTC) plus atazanavir-ritonavir (ATV/r), darunavir-ritonavir (DRV/r), or raltegravir (RAL) in ACTG A5260s, a substudy of A5257. Within arm changes were assessed with signed-rank tests. The 96-week percentage changes in fat and lean mass in the 2 PI arms were not different, thus the PI arms were combined and compared to the RAL arm. Associations between baseline biomarkers and changes in body composition were assessed. All analyses used linear regression models.

RESULTS: 328 patients were randomized (90% male, 44% white non-Hispanic). The median age was 36 years, HIV-1 RNA 4.6 log10 copies/mL, and CD4 349 cells/μL. Overall, at week 96, increases in limb fat (13.4%), subcutaneous (19.9%) and visceral abdominal fat (25.8%), trunk fat (18%), and lean mass (1.8%) were apparent (P < .001 for changes within each arm). Changes for all fat and lean outcomes were not different between the PI arms or between the RAL and the combined PI arms. Higher baseline HIV-1 RNA levels were associated with greater gains in peripheral and central fat.

CONCLUSIONS: In treatment-naive participants initiating ART with TDF/FTC, no differences in lean mass and regional fat were found with RAL when compared with ATV/r or DRV/r over 96 weeks.

CLINICAL TRIALS REGISTRATION: NCT00811954 and NCT00851799.

DOI10.1093/cid/ciw017
Alternate JournalClin. Infect. Dis.
PubMed ID26797215
PubMed Central IDPMC4787610
Grant ListAI068634 / AI / NIAID NIH HHS / United States
AI068636 / AI / NIAID NIH HHS / United States
AI069501 / AI / NIAID NIH HHS / United States
AI56933 / AI / NIAID NIH HHS / United States
AI69471 / AI / NIAID NIH HHS / United States
HL095126 / HL / NHLBI NIH HHS / United States
HL095132 / HL / NHLBI NIH HHS / United States
UM1 AI068634 / AI / NIAID NIH HHS / United States
UM1 AI068636 / AI / NIAID NIH HHS / United States