Bone mineral density, kidney function and participant‐reported outcome measures in women who switch from tenofovir disoproxil emtricitabine and a nonnucleoside reverse transcriptase inhibitor to abacavir, lamivudine and dolutegravir

Objectives Tenofovir disoproxil fumarate (TDF) is associated with reduced bone mineral density (BMD). The aim of the study was to evaluate changes in BMD in women who switched from TDF, emtricitabine and a nonnucleoside reverse transcriptase inhibitor (TDF/FTC/NNRTI) to abacavir, lamivudine and dolu...

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Published in:	HIV medicine Vol. 23; no. 4; pp. 362 - 370
Main Authors:	Campbell, Lucy, Ibrahim, Fowzia, Barbini, Birgit, Samarawickrama, Amanda, Orkin, Chloe, Fox, Julie, Waters, Laura, Gilleece, Yvonne, Tariq, Shema, Post, Frank A., Post, Frank, Adegbaju, Oluwayomi, Hamzah, Lisa, Bhagwandin, Priya, Canoso, Ana, Kegg, Stephen, Moussaoui, Tarik, Lwanga, Julianne, Sharp, Alice, Aminata, Mohammed, John‐Baptiste, Ange, Prime, Katia, Okolo, Olanike, Waters, Anele, Cartier, Andrea, Johnson, Margaret, Nightingale, Alice, Edwards, Jonathan, Fernandez, Thomas, Hemat, Nargis, Ainsworth, Jonathan, Vincent, Rachel, Barbour, Lisa, Kirk, Sarah, Adams, Tanya, Knott, Alyson
Format:	Journal Article
Language:	English
Published:	England Wiley Subscription Services, Inc 01-04-2022
Subjects:	Abacavir Adult Albumins Anti-HIV Agents - adverse effects Antiretroviral agents Antiretroviral therapy Anxiety Biomedical materials Body mass Body mass index Body size Body weight gain bone Bone Density Bone mineral density Bone resorption Bone turnover Confidence intervals depression Dideoxynucleosides - therapeutic use dolutegravir Drug Combinations Drug therapy Emtricitabine Emtricitabine - pharmacology Emtricitabine - therapeutic use Female Femur Heterocyclic Compounds, 3-Ring Hip HIV HIV Infections - complications Human immunodeficiency virus Humans Inhibitors Kidney Kidneys Lamivudine Lamivudine - pharmacology Markers Mental depression Mental health Middle Aged Missing data Non-nucleoside reverse transcriptase inhibitors Oxazines Patient Reported Outcome Measures Piperazines Proteins Proteinuria Pyridones Reverse Transcriptase Inhibitors - pharmacology RNA-directed DNA polymerase Side effects Sleep Spine (lumbar) Statistical analysis Tenofovir Tenofovir - adverse effects Vitamin A women sleep kidney tenofovir bone depression dolutegravir women
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Summary:	Objectives Tenofovir disoproxil fumarate (TDF) is associated with reduced bone mineral density (BMD). The aim of the study was to evaluate changes in BMD in women who switched from TDF, emtricitabine and a nonnucleoside reverse transcriptase inhibitor (TDF/FTC/NNRTI) to abacavir, lamivudine and dolutegravir (ABC/3TC/DTG). Methods We conducted a randomized controlled trial in which women aged ≥ 40 years were randomized 1:2 to continue TDF/FTC/NNRTI or switch to ABC/3TC/DTG. We analysed changes in BMD at the hip and lumbar spine from baseline to week 96 using linear regression, and markers of bone turnover and kidney function using repeated measures mixed effects models with multiple imputation for missing data. We conducted exploratory analyses of weight, mental health, sleep and symptoms attributed to HIV infection and antiretroviral therapy. Results Ninety‐one women [mean (standard deviation) age 50.4 (6.6) years] were randomized. Women who switched to ABC/3TC/DTG maintained viral suppression and experienced improvements in BMD at the lumbar spine (but not the neck of the femur or the total hip), bone resorption markers and proteinuria (total protein, albumin and retinol‐binding protein) and modest weight gain without changes in body mass index. Although mean anxiety, depression and sleep scores did not differ between the two study arms, anxiety, depression and sleep disturbance at baseline predicted ABC/3TC/DTG discontinuation for neuropsychiatric side effects [odds ratios (95% confidence intervals) 11.9 (2.0–71.6), 16.0 (2.6–97.9) and 10.0 (1.8–56.0), respectively]. Conclusions Switching from TDF/FTC/NNRTI to ABC/3TC/DTG improved the BMD of the lumbar spine and kidney function. These benefits need to be balanced against modest weight gain and the need for antiretroviral therapy substitutions in a proportion of participants.
Bibliography:	Funding information section. Acknowledgements BESTT, Bone Evaluation in HIV positive women over 40 who Switch from TDF + 3TC/FTC + NNRTI to Triumeq. Funding was provided by ViiV Healthcare for this investigator‐sponsored study (204658). The funder provided study medication but was not involved in study design, data analysis or the decision to publish our findings. We notified the funder of our intention to submit this manuscript for publication, and the funder was provided with an opportunity to review and comment on the content of the manuscript. The members of the BESTT Trial Team are listed in the ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-News-1 ObjectType-Feature-3 content type line 23
ISSN:	1464-2662 1468-1293
DOI:	10.1111/hiv.13215