期刊
JOURNAL OF INFECTIOUS DISEASES
卷 203, 期 12, 页码 1791-1801出版社
OXFORD UNIV PRESS INC
DOI: 10.1093/infdis/jir188
关键词
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资金
- National Institute of Allergy and Infectious Diseases, National Institutes of Health [U01AI068636, AI68634, AI38855, AI069501]
- GlaxoSmithKline
- Gilead
- Bristol Myers Squibb
- Abbott
- Merck
- Gilead Sciences
- Abbott Laboratories
- Pfizer
- Tibotec
- GCRC [UL1 RR024992, M01 RR00750, UL1 RR 024160]
- UNC CFAR [P30 AI050410(-11)]
- UNC CTRC [UL 1RR 025747]
- CTSA [UL1 RR025005]
- CFAR [UO1-AI069467-04]
- CTU [AI069424, RR00425, AI069474, U01AI069495, U01 AI069452, AI069434, UL1 RR025014, 5 U0I AI069415-03, AI069513, AI69501, 5 - U01 AI069423-03, AI69432, AI 27661, 1 U01 AI069494-01, 5U01AI025859, AI27668, AI27665, AI069532, AI69450, 3U01AI046376-05S4, RR025780, P30-AI0450008-11, U01 AI069472-04, UOI AI 069472, U01AI069511-02, N01 AI72626, UO1Al69418-01, AI27658, U01 AI069471, AI34853, 1U01AI069424-01, UL1RR024979, 5U01 AI069 484-02, AI32782, U01 AI069419, AI46339-01, MO1 RR 00095]
- ACTG [5U01AI069494]
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/mu L. 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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