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Randomized Controlled Trial
. 2024 Mar 15;38(4):521-529.
doi: 10.1097/QAD.0000000000003811. Epub 2024 Feb 1.

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

Amelia E B Moore  1   2 , James E Burns  3   4 , Deirdre Sally  3   4 , Ana Milinkovic  3   4 , Georgios Krokos  1 , Joemon John  1 , Christopher Rookyard  1 , Alessandro Borca  3   4 , Erica R M Pool  3   4 , Anna Tostevin  3 , Alyss Harman  1 , Dwight S Dulnoan  2 , Richard Gilson  3   4 , Alejandro Arenas-Pinto  3   4 , Gary J R Cook  1 , John Saunders  3   4 , David Dunn  3 , Glen M Blake  5 , Sarah L Pett  3   4
Affiliations
Randomized Controlled Trial

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

Amelia E B Moore et al. AIDS. .

Abstract

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.

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Conflict of interest statement

There are no conflicts of interest.

Figures

Fig. 1
Fig. 1
CONSORT diagram.
Fig. 2
Fig. 2
(a-d) Final versus baseline plots of standardized uptake values measured using [18F]NaF-PET/CT and bone mineral density using dual x-ray absorptiometry scans.
Fig. 3
Fig. 3
(a,b) Plots of bone turnover markers measured at final assessment versus baseline assessment.
See this image and copyright information in PMC

References

    1. Cassetti I. Study 903E Team. The safety and efficacy of tenofovir DF in combination with lamivudine and efavirenz through 6 years in antiretroviral-naïve HIV-1-infected patients. HIV Clin Trials 2007; 8:8164–8172. - PubMed
    1. Deeks SG, Overbaugh J, Phillips A, Buchbinder S. HIV infection. Nat Rev Dis Primers 2015; 1:15035. - PubMed
    1. Oster Y, Cohen MJ, Dresner-Pollak R, Szalat A, Elinav H. Increase in bone turnover markers in HIV patients treated with tenofovir disoproxil fumarate combined with raltegravir or efavirenz. Bone Rep 2020; 13:100727. - PMC - PubMed
    1. Grant PM, Cotter AG. Tenofovir and bone health. Curr Opin HIV AIDS 2016; 11:326–332. - PMC - PubMed
    1. Maggiolo F, Rizzardini G, Raffi F, et al. . Bone mineral density in virologically suppressed people aged 60 years or older with HIV-1 switching from a regimen containing tenofovir disoproxil fumarate to an elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide single-tablet regimen: a multicentre, open-label, phase 3b, randomised trial. Lancet HIV 2019; 6:e655–e666. - PubMed

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