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Clinical Trial
. 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

Grace A McComsey  1 , Sergio Lupo  2 , David Parks  3 , Mónica Coronado Poggio  4 , Joseph De Wet  5 , Lesley P Kahl  6 , Kostas Angelis  7 , Brian Wynne  8 , Kati Vandermeulen  9 , Martin Gartland  10 , Michael Cupo  11 , Michael Aboud  6 ; 202094 Sub-Study Investigators
Affiliations
Clinical Trial

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

Grace A McComsey et al. AIDS. .

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; P = 0.014). 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; P = 0.039). 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.

Trial registration: ClinicalTrials.gov NCT02478632 NCT02429791 NCT02422797.

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Figures

Fig. 1
Fig. 1
Disposition of participants.
Fig. 2
Fig. 2
Change from baseline in total hip and lumbar spine bone mineral density at Week 48.
Fig. 3
Fig. 3
Comparison of change in bone mineral density from baseline to 48 weeks by subgroup.
See this image and copyright information in PMC

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