AIDS (London, England) 2017 12 12() doi 10.1097/QAD.0000000000001725
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.
Study 202094 is an open-label, parallel-group, sub-study of the phase III SWORD-1 and SWORD-2 studies (ClincialTrials.gov identifier, NCT02478632).
HIV-1-infected adults with HIV-1 RNA < 50 copies per mL who received ART containing tenofovir disoproxil fumarate for ≥6 months were randomized to receive dolutegravir+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+rilpivirine (1.34%) compared with participants who continued current ART (0.05%; treatment difference, +1.29%; 95% CI, 0.27 to 2.31; P = 0.014). Lumbar spine BMD significantly increased in the dolutegravir+rilpivirine group by 1.46% (95% CI, 0.65 to 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 to 2.57; P = 0.039). Participants in the dolutegravir+rilpivirine group experienced significantly greater reductions in bone formation and resorption biomarkers compared with the current ART group.
Switch to dolutegravir+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.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0.