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Bone mineral density and fractures in antiretroviral-naive persons randomized to receive abacavir-lamivudine or tenofovir disoproxil fumarate-emtricitabine along with efavirenz or atazanavir-ritonavir: Aids Clinical Trials Group A5224s, a substudy of ACTG A5202.

Abstract

BACKGROUND

Long-term effects of abacavir (ABC)-lamivudine (3TC), compared with tenofovir (TDF)-emtricitabine (FTC) with efavirenz (EFV) or atazanavir plus ritonavir (ATV/r), on bone mineral density (BMD) have not been analyzed.

METHODS

A5224s was a substudy of A5202, in which HIV-infected treatment-naive participants were randomized and blinded to receive ABC-3TC or TDF-FTC with open-label EFV or ATV/r. Primary bone end points included Dual-emission X-ray absorbtiometry (DXA)-measured percent changes in spine and hip BMD at week 96. Primary analyses were intent-to-treat. Statistical tests used the factorial design and included linear regression, 2-sample t, log-rank, and Fisher's exact tests.

RESULTS

Two hundred sixty-nine persons randomized to 4 arms of ABC-3TC or TDF-FTC with EFV or ATV/r. At baseline, 85% were male, and 47% were white non-Hispanic; the median HIV-1 RNA load was 4.6 log(10) copies/mL, the median age was 38 years, the median weight was 76 kg, and the median CD4 cell count was 233 cells/μL. At week 96, the mean percentage changes from baseline in spine and hip BMD for ABC-3TC versus TDF-FTC were -1.3% and -3.3% (P = .004) and -2.6% and -4.0% (P = .024), respectively; and for EFV versus ATV/r were -1.7% and -3.1% (P = .035) and -3.1% and -3.4% (P = .61), respectively. Bone fracture was observed in 5.6% of participants. The probability of bone fractures and time to first fracture were not different across components.

CONCLUSIONS

Compared with ABC-3TC, TDF-FTC-treated participants had significantly greater decreases in spine and hip BMD, whereas ATV/r led to more significant losses in spine, but not hip, BMD than EFV. Clinical Trials Registration. NCT00118898.

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  • Authors+Show Affiliations

    ,

    Departments of Pediatrics and Medicine, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland, OH 44106, USA. grace.mccomsey@case.edu

    , , , , , , , ,

    Source

    The Journal of infectious diseases 203:12 2011 Jun 15 pg 1791-801

    MeSH

    Absorptiometry, Photon
    Adenine
    Adult
    Anti-HIV Agents
    Antiretroviral Therapy, Highly Active
    Atazanavir Sulfate
    Benzoxazines
    Bone Density
    CD4 Lymphocyte Count
    Deoxycytidine
    Dideoxynucleosides
    Drug Combinations
    Drug Therapy, Combination
    Emtricitabine
    Female
    Fractures, Bone
    HIV Infections
    Humans
    Intention to Treat Analysis
    Lamivudine
    Male
    Middle Aged
    Oligopeptides
    Organophosphonates
    Osteoporosis
    Pyridines
    Risk Factors
    Ritonavir
    Tenofovir
    Viral Load

    Pub Type(s)

    Journal Article
    Randomized Controlled Trial
    Research Support, N.I.H., Extramural
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    21606537

    Citation

    McComsey, Grace A., et al. "Bone Mineral Density and Fractures in Antiretroviral-naive Persons Randomized to Receive Abacavir-lamivudine or Tenofovir Disoproxil Fumarate-emtricitabine Along With Efavirenz or Atazanavir-ritonavir: Aids Clinical Trials Group A5224s, a Substudy of ACTG A5202." The Journal of Infectious Diseases, vol. 203, no. 12, 2011, pp. 1791-801.
    McComsey GA, Kitch D, Daar ES, et al. Bone mineral density and fractures in antiretroviral-naive persons randomized to receive abacavir-lamivudine or tenofovir disoproxil fumarate-emtricitabine along with efavirenz or atazanavir-ritonavir: Aids Clinical Trials Group A5224s, a substudy of ACTG A5202. J Infect Dis. 2011;203(12):1791-801.
    McComsey, G. A., Kitch, D., Daar, E. S., Tierney, C., Jahed, N. C., Tebas, P., ... Sax, P. E. (2011). Bone mineral density and fractures in antiretroviral-naive persons randomized to receive abacavir-lamivudine or tenofovir disoproxil fumarate-emtricitabine along with efavirenz or atazanavir-ritonavir: Aids Clinical Trials Group A5224s, a substudy of ACTG A5202. The Journal of Infectious Diseases, 203(12), pp. 1791-801. doi:10.1093/infdis/jir188.
    McComsey GA, et al. Bone Mineral Density and Fractures in Antiretroviral-naive Persons Randomized to Receive Abacavir-lamivudine or Tenofovir Disoproxil Fumarate-emtricitabine Along With Efavirenz or Atazanavir-ritonavir: Aids Clinical Trials Group A5224s, a Substudy of ACTG A5202. J Infect Dis. 2011 Jun 15;203(12):1791-801. PubMed PMID: 21606537.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Bone mineral density and fractures in antiretroviral-naive persons randomized to receive abacavir-lamivudine or tenofovir disoproxil fumarate-emtricitabine along with efavirenz or atazanavir-ritonavir: Aids Clinical Trials Group A5224s, a substudy of ACTG A5202. AU - McComsey,Grace A, AU - Kitch,Douglas, AU - Daar,Eric S, AU - Tierney,Camlin, AU - Jahed,Nasreen C, AU - Tebas,Pablo, AU - Myers,Laurie, AU - Melbourne,Kathleen, AU - Ha,Belinda, AU - Sax,Paul E, PY - 2011/5/25/entrez PY - 2011/5/25/pubmed PY - 2011/7/29/medline SP - 1791 EP - 801 JF - The Journal of infectious diseases JO - J. Infect. Dis. VL - 203 IS - 12 N2 - BACKGROUND: Long-term effects of abacavir (ABC)-lamivudine (3TC), compared with tenofovir (TDF)-emtricitabine (FTC) with efavirenz (EFV) or atazanavir plus ritonavir (ATV/r), on bone mineral density (BMD) have not been analyzed. METHODS: A5224s was a substudy of A5202, in which HIV-infected treatment-naive participants were randomized and blinded to receive ABC-3TC or TDF-FTC with open-label EFV or ATV/r. Primary bone end points included Dual-emission X-ray absorbtiometry (DXA)-measured percent changes in spine and hip BMD at week 96. Primary analyses were intent-to-treat. Statistical tests used the factorial design and included linear regression, 2-sample t, log-rank, and Fisher's exact tests. RESULTS: Two hundred sixty-nine persons randomized to 4 arms of ABC-3TC or TDF-FTC with EFV or ATV/r. At baseline, 85% were male, and 47% were white non-Hispanic; the median HIV-1 RNA load was 4.6 log(10) copies/mL, the median age was 38 years, the median weight was 76 kg, and the median CD4 cell count was 233 cells/μL. At week 96, the mean percentage changes from baseline in spine and hip BMD for ABC-3TC versus TDF-FTC were -1.3% and -3.3% (P = .004) and -2.6% and -4.0% (P = .024), respectively; and for EFV versus ATV/r were -1.7% and -3.1% (P = .035) and -3.1% and -3.4% (P = .61), respectively. Bone fracture was observed in 5.6% of participants. The probability of bone fractures and time to first fracture were not different across components. CONCLUSIONS: Compared with ABC-3TC, TDF-FTC-treated participants had significantly greater decreases in spine and hip BMD, whereas ATV/r led to more significant losses in spine, but not hip, BMD than EFV. Clinical Trials Registration. NCT00118898. SN - 1537-6613 UR - https://www.unboundmedicine.com/medline/citation/21606537/Bone_mineral_density_and_fractures_in_antiretroviral_naive_persons_randomized_to_receive_abacavir_lamivudine_or_tenofovir_disoproxil_fumarate_emtricitabine_along_with_efavirenz_or_atazanavir_ritonavir:_Aids_Clinical_Trials_Group_A5224s_a_substudy_of_ACTG_A5202_ L2 - https://academic.oup.com/jid/article-lookup/doi/10.1093/infdis/jir188 DB - PRIME DP - Unbound Medicine ER -