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

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 an...

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Detalles Bibliográficos
Autores principales: McComsey, Grace A., Lupo, Sergio, Parks, David, Poggio, Mónica Coronado, De Wet, Joseph, Kahl, Lesley P., Angelis, Kostas, Wynne, Brian, Vandermeulen, Kati, Gartland, Martin, Cupo, Michael, Aboud, Michael
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Lippincott Williams & Wilkins 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5802259/
https://www.ncbi.nlm.nih.gov/pubmed/29239893
http://dx.doi.org/10.1097/QAD.0000000000001725
Descripción
Sumario: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.