Bone Mineral Density and Vitamin D Levels in HIV Treatment-Naïve African American Individuals Randomized to Receive HIV Drug Regimens.
Treatment of human immunodeficiency virus (HIV)-infected patients with tenofovir disoproxil fumarate is associated with a decrease in bone mineral density (BMD). Treatment with efavirenz is associated with vitamin D deficiency. We compared the effects of efavirenz, emtricitabine, and tenofovir disoproxil fumarate (EFV/FTC/TDF) with the effects of raltegravir, darunavir, and ritonavir (RAL/DRV/r) on BMD and 25-hydroxyvitamin D (25[OH]D) levels in HIV-infected, antiretroviral treatment-naïve African American subjects.



This was a pilot study at a single HIV clinic. Forty HIV treatment-naïve African American subjects were screened, 35 of whom were randomized to receive either EFV/FTC/TDF or RAL/DRV/r. All of the subjects received supplemental vitamin D3and calcium. CD4 counts, HIV RNA, parathyroid hormone, osteocalcin, N-telopeptide, and 25(OH)D levels were obtained at baseline and at 8, 24, 36, and 48 weeks. Dual-energy x-ray absorptiometry of the spine and hip was performed at baseline and at week 48.



Of the 35 subjects enrolled, 10 patients receiving each regimen completed the study. Median baseline 25(OH)D levels were decreased and similar in both groups. All of the patients had plasma HIV RNA <50 copies per milliliter by week 24. By week 48, there was a sustained increase in 25(OH)D in the RAL/DRV/r group (P= 0.0004) but not in the EFV/FTC/TDF group (P= 0.78). There were reductions in BMD of the mean total hip (P= 0.002) and the mean femoral neck (P= 0.004) in the EFV/FTC/TDF group but not in the RAL/DRV/r group.



Treatment of African American patients with HIV using EFV/FTC/TDF is associated with a reduction in BMD of the hip and sustained reductions of 25(OH)D not seen in the group that received RAL/DRV/r. This phenomenon may have long-term consequences on bone integrity in this population.
From the Department of Medicine, Division of Infectious Diseases, the Department of Microbiology, and the Department of Medicine, Division of Endocrinology, Brody School of Medicine, East Carolina University, Greenville, North Carolina.
Paul P
PP
Cook
From the Department of Medicine, Division of Infectious Diseases, the Department of Microbiology, and the Department of Medicine, Division of Endocrinology, Brody School of Medicine, East Carolina University, Greenville, North Carolina.
Alexandra Te
AT
Stang
From the Department of Medicine, Division of Infectious Diseases, the Department of Microbiology, and the Department of Medicine, Division of Endocrinology, Brody School of Medicine, East Carolina University, Greenville, North Carolina.
Lia R
LR
Walker
From the Department of Medicine, Division of Infectious Diseases, the Department of Microbiology, and the Department of Medicine, Division of Endocrinology, Brody School of Medicine, East Carolina University, Greenville, North Carolina.
Shaw M
SM
Akula
From the Department of Medicine, Division of Infectious Diseases, the Department of Microbiology, and the Department of Medicine, Division of Endocrinology, Brody School of Medicine, East Carolina University, Greenville, North Carolina.
Fiona J
FJ
Cook
D015502:Absorptiometry, Photon; D000328:Adult; D001741:Black or African American; D000480:Alkynes; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D048588:Benzoxazines / Q000627:therapeutic use; D015519:Bone Density / Q000187:drug effects*; D050071:Bone Density Conservation Agents / Q000008:administration & dosage; D018791:CD4 Lymphocyte Count; D002136:Calcium, Dietary / Q000008:administration & dosage; D024042:Collagen Type I / Q000097:blood; D003521:Cyclopropanes; D000069454:Darunavir / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D000068679:Emtricitabine / Q000627:therapeutic use; D005260:Female; D005272:Femur Neck / Q000000981:diagnostic imaging; D015658:HIV Infections / Q000188:drug therapy*; D006621:Hip Joint / Q000000981:diagnostic imaging; D006801:Humans; D008297:Male; D015675:Osteocalcin / Q000097:blood; D010281:Parathyroid Hormone / Q000097:blood; D010455:Peptides / Q000097:blood; D010865:Pilot Projects; D012367:RNA, Viral / Q000097:blood; D000068898:Raltegravir Potassium / Q000627:therapeutic use; D019438:Ritonavir / Q000627:therapeutic use; D000068698:Tenofovir / Q000627:therapeutic use; D014807:Vitamin D / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000097:blood; D055815:Young Adult
D000480:Alkynes; D019380:Anti-HIV Agents; D048588:Benzoxazines; D050071:Bone Density Conservation Agents; D002136:Calcium, Dietary; D024042:Collagen Type I; D003521:Cyclopropanes; D010281:Parathyroid Hormone; D010455:Peptides; D012367:RNA, Viral; C052929:collagen type I trimeric cross-linked peptide; D015675:Osteocalcin; D014807:Vitamin D; D000068898:Raltegravir Potassium; D000068698:Tenofovir; C104450:25-hydroxyvitamin D; D000068679:Emtricitabine; C098320:efavirenz; D019438:Ritonavir; D000069454:Darunavir