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Bone turnover change after randomized switch from tenofovir disoproxil to tenofovir alafenamide fumarate in men with HIV

Title: Bone turnover change after randomized switch from tenofovir disoproxil to tenofovir alafenamide fumarate in men with HIV
Authors: Moore, Amelia E.B.; Burns, James E.; Sally, Deirdre; Milinkovic, Ana; Krokos, Georgios; John, Joemon; Rookyard, Christopher; Borca, Alessandro; Pool, Erica R.M.; Tostevin, Anna; Harman, Alyss; Dulnoan, Dwight S.; Gilson, Richard; Arenas-Pinto, Alejandro; Cook, Gary J.R.; Saunders, John; Dunn, David; Blake, Glen M.; Pett, Sarah L.
Source: Moore, A E B, Burns, J E, Sally, D, Milinkovic, A, Krokos, G, John, J, Rookyard, C, Borca, A, Pool, E R M, Tostevin, A, Harman, A, Dulnoan, D S, Gilson, R, Arenas-Pinto, A, Cook, G J R, Saunders, J, Dunn, D, Blake, G M & Pett, S L 2024, 'Bone turnover change after randomized switch from tenofovir disoproxil to tenofovir alafenamide fumarate in men with HIV', AIDS, vol. 38, no. 4, pp. 521-529. https://doi.org/10.1097/QAD.0000000000003811
Publication Year: 2024
Collection: King's College, London: Research Portal
Subject Terms: bone density; bone turnover; HIV; PET/computed tomography; tenofovir
Description: Objective: Bone loss in people with HIV (PWH) is poorly understood. Switching tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) has yielded bone mineral density (BMD) increases. PETRAM (NCT#:03405012) investigated whether BMD and bone turnover changes correlate. Design: Open-label, randomized controlled trial. Setting: Single-site, outpatient, secondary care. Participants: Nonosteoporotic, virologically suppressed, cis-male PWH taking TDF/emtricitabine (FTC)/rilpivirine (RPV) for more than 24 weeks. Intervention: Continuing TDF/FTC/RPV versus switching to TAF/FTC/RPV (1 : 1 randomization). Main outcome measures: [ 18 F]NaF-PET/CT for bone turnover (standardized uptake values, SUV mean ) and dual-energy x-ray absorptiometry for lumbar spine and total hip BMD. Results: Thirty-two men, median age 51 years, 76% white, median duration TDF/FTC/RPV 49 months, were randomized between 31 August 2018 and 09 March 2020. Sixteen TAF:11 TDF were analyzed. Baseline-final scan range was 23-103 (median 55) weeks. LS-SUV mean decreased for both groups (TAF -7.9% [95% confidence interval -14.4, -1.5], TDF -5.3% [-12.1,1.5], P = 0.57). TH-SUV mean showed minimal changes (TAF +0.3% [-12.2,12.8], TDF +2.9% [-11.1,16.9], P = 0.77). LS-BMD changes were slightly more favorable with TAF but failed to reach significance (TAF +1.7% [0.3,3.1], TDF -0.3 [-1.8,1.2], P = 0.06). Bone turnover markers decreased more with TAF ([CTX -35.3% [-45.7, -24.9], P1NP -17.6% [-26.2, -8.5]) than TDF (-11.6% [-28.8, +5.6] and -6.9% [-19.2, +5.4] respectively); statistical significance was only observed for CTX (P = 0.02, P1NP, P = 0.17). Conclusion: Contrary to our hypothesis, lumbar spine and total hip regional bone formation (SUV mean ) and BMD did not differ postswitch to TAF. However, improved LS-BMD and CTX echo other TAF-switch studies. The lack of difference in SUV mean may be due to inadequate power.
Document Type: article in journal/newspaper
File Description: application/pdf
Language: English
Relation: info:eu-repo/semantics/altIdentifier/pmid/38061030
DOI: 10.1097/QAD.0000000000003811
Availability: https://kclpure.kcl.ac.uk/portal/en/publications/2deb7e9b-17fb-4717-94d1-ad2ad30a3f0c; https://doi.org/10.1097/QAD.0000000000003811; https://kclpure.kcl.ac.uk/ws/files/364441738/Bone_turnover_change_after_randomized_switch_from_tenofovir_disoproxil_to_tenofovir_alafenamide_fumarate_in_men_with_HIV_Version_of_Record.pdf; https://www.scopus.com/pages/publications/85186508492
Rights: info:eu-repo/semantics/openAccess ; http://creativecommons.org/licenses/by/4.0/
Accession Number: edsbas.2DDB13C
Database: BASE