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AIDS. 2018 Feb 20;32(4):477-485. doi: 10.1097/QAD.0000000000001725.

Switch from tenofovir disoproxil fumarate combination to dolutegravir with rilpivirine improves parameters of bone health.

Author information

1
University Hospitals Cleveland Medical Center and Case Western Reserve University, Cleveland, Ohio, USA.
2
CAICA Institute, Rosario, Argentina.
3
Central West Clinical Research, St. Louis, Missouri, USA.
4
Medicina Nuclear, Hospital Universitario La Paz, IdiPAZ, Madrid, Spain.
5
Spectrum Health, Vancouver, British Columbia, Canada.
6
ViiV Healthcare, Brentford.
7
GlaxoSmithKline, Uxbridge, UK.
8
ViiV Healthcare, Collegeville, Pennsylvania, USA.
9
Janssen, Beerse, Belgium.
10
ViiV Healthcare, Research Triangle Park, North Carolina.
11
GlaxoSmithKline, Collegeville, Pennsylvania, USA.

Abstract

OBJECTIVE:

Bone mineral density (BMD) loss, a risk factor for osteoporosis, has been attributed to HIV infection and antiretroviral therapy (ART), including regimens containing tenofovir disoproxil fumarate.

DESIGN:

Study 202094 is an open-label, parallel-group, sub-study of the phase III SWORD-1 and SWORD-2 studies (ClinicalTrials.gov identifier, NCT02478632).

METHODS:

HIV-1-infected adults with HIV-1 RNA less than 50 copies/ml who received ART containing tenofovir disoproxil fumarate for at least 6 months were randomized to receive dolutegravir with rilpivirine or continue current ART regimen. Total hip and lumbar spine BMD were measured by dual-energy X-ray absorptiometry (DXA) scans. The primary endpoint was percentage change from baseline in total hip BMD.

RESULTS:

DXA scans were evaluable for 81 participants at baseline and Week 48. Percentage increase in total hip BMD was significantly greater in participants who switched to dolutegravir with rilpivirine (1.34%) compared with participants who continued current ART (0.05%; treatment difference, +1.29%; 95% CI 0.27-2.31; Pā€Š=ā€Š0.014). Lumbar spine BMD significantly increased in the dolutegravir with rilpivirine group by 1.46% (95% CI 0.65-2.28) compared with 0.15% (95% CI -0.79 to 1.09) in the current ART group (treatment difference, 1.32; 95% CI 0.07-2.57; Pā€Š=ā€Š0.039). Participants in the dolutegravir with rilpivirine group experienced significantly greater reductions in bone formation and resorption biomarkers compared with the current ART group.

CONCLUSION:

Switch to dolutegravir with rilpivirine was associated with significant improvement in BMD and bone turnover markers compared with tenofovir-based three-drug regimens, providing a robust option for preserving bone health while continuing suppressive ART.

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