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Bone Safety of Dolutegravir-Containing Regimens in People Living with HIV: Results from a Real-World Cohort

Authors Bonfanti P, De Vito A, Ricci E, Menzaghi B, Orofino G, Squillace N, Molteni C, De Socio GV, Salomoni E, Celesia BM, Dentone C, Colombo V, Madeddu G

Received 29 April 2020

Accepted for publication 27 June 2020

Published 14 July 2020 Volume 2020:13 Pages 2291—2300


Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 2

Editor who approved publication: Dr Sahil Khanna

Paolo Bonfanti,1 Andrea De Vito,2 Elena Ricci,3 Barbara Menzaghi,4 Giancarlo Orofino,5 Nicola Squillace,1 Chiara Molteni,6 Giuseppe Vittorio De Socio,7 Elena Salomoni,8 Benedetto Maurizio Celesia,9 Chiara Dentone,10 Valeria Colombo,11 Giordano Madeddu2

1Infectious Diseases Unit ASST-MONZA, San Gerardo Hospital-University of Milano-Bicocca, Milan, Italy; 2Unit of Infectious Diseases, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy; 3Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy; 4Unit of Infectious Diseases, ASST della Valle Olona – Busto Arsizio (VA), Busto Arsizio, Italy; 5Division I of Infectious and Tropical Diseases, ASL Città di Torino, Turin, Italy; 6Unit of Infectious Diseases, A. Manzoni Hospital, Lecco, Italy; 7Department of Internal Medicine 2, Infectious Diseases Unit, Perugia “Santa Maria della Misericordia” General Hospital, Perugia, Italy; 8Infectious Diseases Unit 1, Santa Maria Annunziata Hospital, Azienda USL Toscana Centro, Florence, Italy; 9Infectious Diseases University of Catania ARNAS Garibaldi Catania, Catania, Italy; 10Division of Infectious Diseases, Department of Health Sciences, IRCCS Ospedale Policlinico San Martino, Genova, Italy; 11Infectious Disease Unit, DIBC “Luigi Sacco”, University of Milan, Milan, Italy

Correspondence: Giordano Madeddu
Unit of Infectious Diseases, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Viale San Pietro 43, Sassari 07100, Italy
Tel +39 3403781734
Fax +39 079217620

Objective: Few data exist about the effect of dolutegravir (DTG) on bone mineral density (BMD) in real life. The aim of this study was to determine rates of change in BMD over time in people living with HIV (PLWH) treated with DTG.
Design: The SCOLTA project is a multicenter observational study enrolling HIV-infected people who start newly commercialized drugs prospectively, with the aim of identifying toxicities and adverse events (AE) in a real-life setting.
Methods: Dual-energy X-ray absorptiometry at the femoral neck (FN) and lumbar spine (LS) was performed at study entry (baseline, BL) and after 96 weeks. Percentage BMD change from BL was evaluated using a general linear model, including factors potentially associated with bone loss.
Results: One hundred and sixty PLWH were enrolled (26.3% female, mean age 49.9 ± 11.2 years) from April 2015 to April 2017. Overall, we could calculate BMD change from baseline, for at least one site, in 133 subjects (83.1%). After a median of 102 weeks (IQR: 90– 110), mean FN BMD increased, but not significantly, whereas LS BMD showed a significant mean increase of 13.1 (95% confidence interval, CI: 1.7– 24.6) mg/cm3 (+1.6%, 95% CI: 0.3%, 2.8%) after a median time of 102 weeks (IQR: 84– 110). As regards LS BMD, patients with osteopenia/osteoporosis at study entry experienced a high increase from baseline (20.6, 95% CI: 3.1, 38.1 mg/cm3), as well as experienced subjects (16.9, 95% CI: 4.7, 29.2 mg/cm3) and those on vitamin D supplementation (26.8, 95% CI: 7.7, 45.9 mg/cm3).
Conclusion: Dolutegravir-containing regimens could reduce the negative impact of antiretroviral therapy on bone, especially in patients with low BMD.

Keywords: HIV infection, dolutegravir, bone mineral density, real-life setting, adverse events, DXA scan

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