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

摘要

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. Open-label, randomized controlled trial. Single-site, outpatient, secondary care. Nonosteoporotic, virologically suppressed, cis-male PWH taking TDF/emtricitabine (FTC)/rilpivirine (RPV) for more than 24?weeks. Continuing TDF/FTC/RPV versus switching to TAF/FTC/RPV (1?:?1 randomization). : 18 FNaF-PET/CT for bone turnover (standardized uptake values, SUV mean ) and dual-energy x-ray absorptiometry for lumbar spine and total hip BMD. 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). 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.