Journal Article

P15 Changes in bone mineral density and bone turnover markers in antiretroviral therapy-naïve people with HIV starting bictegravir/emtricitabine/tenofovir alafenamide or doravirine/lamivudine/tenofovir disoproxil fumarate

Rigamonti, C, Marzolla, D, Calza, L, Bon, I, Zuppiroli, A, Viale, P, Giglia, M

2025

Overview

BackgroundAntiretroviral therapy (ART) including tenofovir disoproxil fumarate (TDF) has been associated with an increased risk of bone loss in people with HIV (PWH) compared to tenofovir alafenamide (TAF). However there is no a direct comparison about changes in bone mineral density (BMD) between naive PWH starting bictegravir/emtricitabine/TAF (BIC/F/TAF) or doravirine/lamivudine/TDF (DOR/3TC/TDF).MethodsWe performed a retrospective, observational, cohort study on adult PWH in our Division of Infectious Diseases who started as initial antiretroviral therapy (ART) the single tablet regimen BIC/F/TAF or DOR/3TC/TDF between January 2020 and December 2022. The inclusion criteria were as follows: individuals naïve to ART; age >40 years; individuals who had a dual-energy X-ray absorptiometry (DXA) scan before ART initiation and had at least one follow-up DXA scan 12 months or more after ART initiation. BMD changes and variations in bone turnover markers [bone alkaline phosphatase (ALP) and beta-crosslaps (cLP)] were evaluated in participants who had follow-up DXA scans after >12 months of ART.ResultsAs a whole, 65 patients (59 males, mean age 48.5 years) were enrolled: 35 starting BIC/F/TAF and 30 DOR/3TC/TDF. Baseline characteristics were comparable between groups: median HIV RNA was 4.35 log10, median CD4 T lymphocyte count was 379 cells/mm3, and 6 patients (9.2%) had AIDS diagnosis. At baseline, 11 subjects (17%) were diagnosed with low BMD (T-score <-1.0 or Z-score <-2.0), without significant differences between groups. After a median follow-up of 14.4 months, decrease in median absolute BMD and changes in bone turnover markers were comparable between groups. The median reduction (IQR) in BMD at femur neck was -0.04 (-0.07, 0.00) g/cm2 in BIC/F/TAF group and -0.05 (-0.08, -0–01) g/cm2 in DOR/3TC/TDF group (p=0.198). The median change (IQR) in BMD at lumbar spine was -0.06 (-0.09, -0.01) g/cm2 in BIC/F/TAF group and -0.07 (-1.0, -0–02) g/cm2 in DOR/3TC/TDF group (p=0.276). The median changes (IQR) in bone turnover markers were: +7.2 (+4.9, +9.3) ng/mL in BIC/F/TAF group and +8.1 (+4.2, +10.7) ng/mL in DOR/3TC/TDF group for ALP (p=0.403), and +115 (+82, +153) ng/L in BIC/F/TAF group and +106 (+77, +141) ng/L in DOR/3TC/TDF group for cLP (p=0.552). After the median follow-up, virological efficacy was comparable: HIV RNA <50 copies/mL was obtained in 32 patients (91.4%) in BIC/F/TAF group and in 27 (90%) in the DOR/3TC/TDF group. The median increase in CD4 T lymphocyte count was comparable between groups (+156 and + 132 cells/mm3, respectively), such as incidence of adverse events (<10% in each group). However, weight gain was significantly greater in the BIC/F/TAF group (weight change: +1.86 Kg vs +0.81 Kg; p=0.008).ConclusionsIn our study, initial antiretroviral regimen with BIC/F/TAF or DOR/3TC/TDF caused comparable reduction in BMD and similar changes in bone turnover markers after a median follow-up of 14 months.

• Publisher: BMJ Publishing Group LTD
• Subject: Antiretroviral drugs / Bone density / Drug therapy / HIV / Human immunodeficiency virus