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Session 142 Poster Abstracts
Renal and Bone Abnormalities
Thursday, 1:30 - 3:30 pm
Hall B


823    
Similar Incidence of Osteopenia and Osteoporosis in ART-naïve Patients Treated with Tenofovir DF or Stavudine in Combination with Lamivudine and Efavirenz over 144 Weeks
William Powderly*1, C Cohen2, J Gallant3, B Lu4, J Enejosa4, A Cheng4, and Study 903 Team
1Univ Coll, Dublin, Ireland; 2Community Res Initiative New England, Boston, MA, USA; 3Johns Hopkins Univ Sch of Med, Baltimore, MD, USA; and 4Gilead Sci, Foster City, CA, USA

Background:  Incidence of osteopenia and osteoporosis is high in HIV-infected patients and is seen more frequently in patients receiving potent ART. Over 144 weeks in Study 903, both arms experienced decreases in bone mineral density, which were similar at the hip but greater at the spine, for the tenofovir (TDF) arm. However, more patients experienced bone fractures on the stavudine (d4T) arm.

Methods:  Study 903 was a phase III, 144 week, multicenter, randomized, double-blind, active-controlled trial in ARV-naïve patients with HIV-1 RNA > 5000 copies/mL and any CD4 count. Patients were randomized to receive either TDF (n = 299) or d4T (n = 301) plus lamivudine (3TC) and efavirenz (EFV). All patients underwent bone mineral density measurements of spine and hip by dual X-ray absorptiometry (DXA) at baseline and every 24 weeks. WHO criteria for osteopenia (T-score:  –2.5 to –1.0 SD) and osteoporosis (≤ 2.5 SD) were used for this analysis.

Results:  At the lumbar spine, baseline osteopenia and osteoporosis were seen in 26% (TDF = 23%, d4T = 28%) and 3% (TDF = 3%, d4T = 4%) of patients, respectively. Among the patients who were osteopenic at baseline and with week 144 data, 76% (TDF = 74%, d4T = 78%) remained osteopenic, 10% (TDF = 12%, d4T = 8%) moved from osteopenia to osteoporosis, while 14% (TDF = 14%, d4T = 14%) moved from osteopenia to a normal T-score. Among the patients who were osteoporotic at baseline and with week 144 data, most (TDF = 5, d4T =  4) remained osteoporotic, while a minority (TDF = 1, d4T = 2) moved from osteoporosis to osteopenia. Among the patients who were normal at baseline and with week 144 data, 90% (TDF = 87%, d4T = 92%) remained normal, while 10% (TDF = 13%, d4T = 8%) moved from normal to osteopenia and < 1% (TDF = 0, d4T = <1%) moved from normal to osteoporosis. None of the above comparisons between arms achieved statistical significance. In the overall study population, 5 fractures were seen in the TDF arm compared to 11 in the d4T arm. None occurred in patients with osteoporosis.

Conclusions:  Despite the small differences in bone mineral density decreases over 144 weeks at the lumbar spine favoring the d4T arm, the incidence of osteopenia and osteoporosis was similar between the treatment arms.

 

Keywords: osteoporosis; tenofovir DF; antiretroviral naive