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Clin Infect Dis. 2015 Oct 1;61(7):1179-88. doi: 10.1093/cid/civ455. Epub 2015 Jun 9.

Less Bone Loss With Maraviroc- Versus Tenofovir-Containing Antiretroviral Therapy in the AIDS Clinical Trials Group A5303 Study.

Author information

1
Division of Infectious Diseases, Northwestern University, Chicago, Illinois.
2
Statistical and Data Analysis Center, Harvard School of Public Health, Boston, Massachusetts.
3
Division of Infectious Diseases, University of Cincinnati, Ohio.
4
Division of Infectious Diseases, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
5
HIV Research Branch, Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland.
6
Departments of Infectious Diseases.
7
Neurology, University of North Carolina at Chapel Hill.
8
Department of Immunology/Microbiology, Rush University Medical Center, Chicago, Illinois.
9
Division of Infectious Diseases, Department of Medicine, Emory University, Atlanta, Georgia.
10
Division of Endocrinology, Diabetes, and Metabolism, Johns Hopkins University, Baltimore, Maryland.

Abstract

BACKGROUND:

There is a need to prevent or minimize bone loss associated with antiretroviral treatment (ART) initiation. We compared maraviroc (MVC)- to tenofovir disoproxil fumarate (TDF)-containing ART.

METHODS:

This was a double-blind, placebo-controlled trial. ART-naive subjects with human immunodeficiency virus type 1 RNA load (viral load [VL]) >1000 copies/mL and R5 tropism were randomized to MVC 150 mg or TDF 300 mg once daily (1:1), stratified by VL <100 000 or ≥100 000 copies/mL and age <30 or ≥30 years. All subjects received darunavir 800 mg, ritonavir 100 mg, and emtricitabine 200 mg daily. Dual-energy X-ray absorptiometry scanning was done at baseline and week 48. The primary endpoint was percentage change in total hip bone mineral density (BMD) from baseline to week 48 in the as-treated population.

RESULTS:

We enrolled 262 subjects. A total of 259 subjects (130 MVC, 129 TDF) contributed to the analyses (91% male; median age, 33 years; 45% white, 30% black, 22% Hispanic). Baseline median VL was 4.5 log10 copies/mL and CD4 count was 390 cells/µL. The decline in hip BMD (n = 115 for MVC, n = 109 for TDF) at week 48 was less with MVC (median [Q1, Q3] of -1.51% [-2.93%, -0.11%] vs -2.40% [-4.30%, -1.32%] for TDF (P < .001). Lumbar spine BMD decline was also less with MVC (median -0.88% vs -2.35%; P < .001). Similar proportions of subjects in both arms achieved VL ≤50 copies/mL in as-treated and ITT analyses.

CONCLUSIONS:

MVC was associated with less bone loss at the hip and lumbar spine compared with TDF. MVC may be an option to attenuate ART-associated bone loss.

CLINICAL TRIALS REGISTRATION:

NCT01400412.

KEYWORDS:

bone; darunavir; maraviroc; tenofovir

PMID:
26060295
PMCID:
PMC4560904
DOI:
10.1093/cid/civ455
[Indexed for MEDLINE]
Free PMC Article

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