TY - JOUR
T1 - Bone turnover change after randomized switch from tenofovir disoproxil to tenofovir alafenamide fumarate in men with HIV
AU - Moore, Amelia E.B.
AU - Burns, James E.
AU - Sally, Deirdre
AU - Milinkovic, Ana
AU - Krokos, Georgios
AU - John, Joemon
AU - Rookyard, Christopher
AU - Borca, Alessandro
AU - Pool, Erica R.M.
AU - Tostevin, Anna
AU - Harman, Alyss
AU - Dulnoan, Dwight S.
AU - Gilson, Richard
AU - Arenas-Pinto, Alejandro
AU - Cook, Gary J.R.
AU - Saunders, John
AU - Dunn, David
AU - Blake, Glen M.
AU - Pett, Sarah L.
N1 - Publisher Copyright:
© 2024 Lippincott Williams and Wilkins. All rights reserved.
PY - 2024/3/15
Y1 - 2024/3/15
N2 - 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::[18F]NaF-PET/CT for bone turnover (standardized uptake values, SUVmean) 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-SUVmeandecreased for both groups (TAF -7.9% [95% confidence interval -14.4, -1.5], TDF -5.3% [-12.1,1.5], P = 0.57). TH-SUVmeanshowed 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 (SUVmean) and BMD did not differ postswitch to TAF. However, improved LS-BMD and CTX echo other TAF-switch studies. The lack of difference in SUVmeanmay be due to inadequate power.
AB - 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::[18F]NaF-PET/CT for bone turnover (standardized uptake values, SUVmean) 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-SUVmeandecreased for both groups (TAF -7.9% [95% confidence interval -14.4, -1.5], TDF -5.3% [-12.1,1.5], P = 0.57). TH-SUVmeanshowed 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 (SUVmean) and BMD did not differ postswitch to TAF. However, improved LS-BMD and CTX echo other TAF-switch studies. The lack of difference in SUVmeanmay be due to inadequate power.
KW - HIV
KW - PET/computed tomography
KW - bone density
KW - bone turnover
KW - tenofovir
UR - https://www.scopus.com/pages/publications/85186508492
U2 - 10.1097/QAD.0000000000003811
DO - 10.1097/QAD.0000000000003811
M3 - Article
C2 - 38061030
AN - SCOPUS:85186508492
SN - 0269-9370
VL - 38
SP - 521
EP - 529
JO - AIDS
JF - AIDS
IS - 4
ER -
