Zoledronic acid is superior to tenofovir DF-switching for low bone mineral density in adults with HIV: a randomised trial

Hoy, Jennifer F.a; Richardson, Robynb; Ebeling, Peter R.c; Rojas, Jhond; Pocock, Nicholasb; Kerr, Stephen J.b; Martinez, Esteband; Carr, Andrewb for the ZEST Study Investigators.

 

AIDS: June 20, 2018 – Volume Publish Ahead of Print – Issue – p

doi: 10.1097/QAD.0000000000001911

 

Abstract

 

Objective: To compare the effects of switching tenofovir disoproxil fumarate (TDF) or treatment with an intravenous bisphosphonate on bone mineral density (BMD) in HIV-positive adults with low bone mass.

 

Design: Two-year, randomised, open-label study at 10 sites in Australia and Spain.

 

Participants: Of 112 adults on TDF-based antiretroviral therapy (ART) screened, 87 with low BMD (T-score < -1.0 at hip or spine by dual-energy x-ray absorptiometry) and undetectable plasma HIV viral load were randomised to either switch TDF to another active antiretroviral drug or to continue TDF-based ART and receive intravenous zoledronic acid (ZOL) 5 mg annually for 2 years.

 

Primary Outcome Measure: Change in lumbar spine BMD at 24 months by intention-to-treat analysis. Secondary outcomes included changes in femoral neck and total hip BMD, fractures, safety, and virological failure.

 

Results: 44 subjects were randomised to TDF switch and 43 to ZOL, mean age 50 years (SD 11), 96% men, mean TDF duration 5.9 years (SD 3.1), and mean spine and hip T-scores -1.6 and -1.3, respectively. At 24 months, mean spine BMD increased by 7.4% (SD 4.3%) with ZOL vs. 2.9% (SD 4.5%) with TDF-switch (mean difference 4.4%, 95%CI 2.6–6.3; p < 0.001). Mean total hip BMD increased by 4.6% (2.6%) and 2.6% (4.0%), respectively (mean difference 1.9%, 95%CI 0.5–3.4; p = 0.009). There was 1 fracture in the ZOL group versus 7 fractures in 4 TDF-switch subjects. Virological failure occurred in 1 TDF-switch subject. Other safety endpoints were similar.

 

Conclusions: ZOL is more effective than switching TDF at increasing BMD in HIV-positive adults with low bone mass.

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