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Original Research

Bone Safety of Dolutegravir-Containing Regimens in People Living with HIV: Results from a Real-World Cohort

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Pages 2291-2300 | Published online: 14 Jul 2020

References

  • Compston J. HIV infection and osteoporosis. Bonekey Rep. 2015;4:636. doi:10.1038/bonekey.2015.325709813
  • Shiau S, Broun EC, Arpadi SM, Yin MT. Incident fractures in HIV-infected individuals: a systematic review and meta-analysis. AIDS. 2013;27(12):1949–1957. doi:10.1097/QAD.0b013e328361d24124126140
  • Premaor MO, Compston JE. The hidden burden of fractures in people living with HIV. JBMR Plus. 2018;2(5):247–256. doi:10.1002/jbm4.1005530283906
  • Brown TT, Qaqish RB. Antiretroviral therapy and the prevalence of osteopenia and osteoporosis: A meta-analytic review. AIDS. 2006;20(17):2165–2174. doi:10.1097/QAD.0b013e32801022eb17086056
  • Ofotokun I, Titanji K, Vunnava A, et al. Antiretroviral therapy induces a rapid increase in bone resorption that is positively associated with the magnitude of immune reconstitution in HIV infection. AIDS. 2016;30(3):405–414. doi:10.1097/QAD.000000000000091826760232
  • Kung YY, Felge U, Sarosi I, et al. Activated T cells regulate bone loss and joint destruction in adjuvant arthritis through osteoprotegerin ligand. Nature. 1999;402(6759):304–309. doi:10.1038/4630310580503
  • Compston J. HIV infection and bone disease. J Intern Med. 2016;280(4):350–358. doi:10.1111/joim.1252027272530
  • Hidron AI, Hill B, Guest JL, Rimland D. Risk factors for vitamin D deficiency among veterans with and without HIV infection. PLoS One. 2015;10(4):e0124168. doi:10.1371/journal.pone.012416825898185
  • Dao CN, Patel P, Overton ET, et al. Low vitamin D among HIV-infected adults: prevalence of and risk factors for low vitamin D levels in a cohort of HIV-infected adults and comparison to prevalence among adults in the us general population. Clin Infect Dis. 2011;52(3):396–405. doi:10.1093/cid/ciq15821217186
  • Yin M, Stein E. The effect of antiretrovirals on vitamin D. Clin Infect Dis. 2011;52(3):406–408. doi:10.1093/cid/ciq16921217187
  • Madeddu G, Spanu A, Solinas P, et al. Bone mass loss and vitamin D metabolism impairment in HIV patients receiving highly active antiretroviral therapy. Q J Nucl Med Mol Imaging. 2004;48(1):39–48.15195003
  • Pinzone MR, Di Rosa M, Celesia BM, et al. LPS and HIV gp120 modulate monocyte/macrophage CYP27B1 and CYP24A1 expression leading to vitamin D consumption and hypovitaminosis D in HIV-infected individuals. Eur Rev Med Pharmacol Sci. 2013;17(14):1938–1950.23877860
  • Madeddu G, Spanu A, Solinas P, et al. Different impact of NNRTI and PI-including HAART on bone mineral density loss in HIV-infected patients. Eur Rev Med Pharmacol Sci. 2015;19(23):4576–4589.26698255
  • Rgen Stellbrink H-J, Orkin C, Arribas JR, et al. Comparison of changes in bone density and turnover with abacavir-lamivudine versus tenofovir-emtricitabine in HIV-infected adults: 48-week results from the ASSERT study. Clin Infect Dis. 2010;51(8):963–972. doi:10.1086/65641720828304
  • Hileman CO, Overton ET, McComsey GA. Vitamin D and bone loss in HIV. Curr Opin HIV AIDS. 2016;11(3):277–284. doi:10.1097/COH.000000000000027226890209
  • Sax PE, Wohl D, Yin MT, et al. Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, Phase 3, non-inferiority trials. Lancet. 2015;385(9987):2606–2615. doi:10.1016/S0140-6736(15)60616-X25890673
  • Mills A, Arribas JR, Andrade-Villanueva J, et al. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in antiretroviral regimens for virologically suppressed adults with HIV-1 infection: a randomised, active-controlled, multicentre, open-label, phase 3, non-inferiority study. Lancet Infect Dis. 2016;16(1):43–52. doi:10.1016/S1473-3099(15)00348-526538525
  • Post FA, Tebas P, Clarke A, et al. Switching to tenofovir alafenamide, coformulated with elvitegravir, cobicistat, and emtricitabine, in HIV-infected adults with renal impairment: 96-week results from a single-arm, multicenter, open-label phase 3 study. J Acquir Immune Defic Syndr. 2017;71(5):530–537. doi:10.1097/QAI.0000000000001186
  • Bedimo RJ, Drechsler H, Jain M, et al. The RADAR study: week 48 safety and efficacy of RAltegravir combined with boosted DARunavir compared to tenofovir/emtricitabine combined with boosted darunavir in antiretroviral-naive patients. Impact on bone health. PLoS One. 2014;9(8):e106221. doi:10.1371/journal.pone.010622125170938
  • Brown TT, Moser C, Currier JS, et al. Changes in bone mineral density after initiation of antiretroviral treatment with Tenofovir Disoproxil Fumarate/Emtricitabine Plus Atazanavir/ Ritonavir,Darunavir/ Ritonavir,or Raltegravir. J Infect Dis. 2015;212(8):1241–1249. doi:10.1093/infdis/jiv19425948863
  • Borghetti A, Baldin G, Capetti A, et al. Efficacy and tolerability of dolutegravir and two nucleos(t)ide reverse transcriptase inhibitors in HIV-1-positive, virologically suppressed patients. AIDS. 2017;31(3):457–459. doi:10.1097/QAD.000000000000135728079545
  • Rossetti B, Baldin G, Sterrantino G, et al. Efficacy and safety of dolutegravir-based regimens in advanced HIV-infected naïve patients: results from a multicenter cohort study. Antiviral Res. 2019;169. doi:10.1016/j.antiviral.2019.104552
  • Bagella P, Squillace N, Ricci E, et al. Lipid profile improvement in virologically suppressed HIV-1-infected patients switched to dolutegravir/abacavir/lamivudine: data from the SCOLTA project. Infect Drug Resist. 2019;12:1385–1391. doi:10.2147/IDR.S20381331213857
  • Trottier B, Lake JE, Logue K, et al. Dolutegravir/abacavir/lamivudine versus current ART in virally suppressed patients (STRIIVING): a 48-week, randomized, non-inferiority, open-label, Phase IIIb study. Antivir Ther. 2017;22(4):295–305. doi:10.3851/IMP316628401876
  • Gatell JM, Assoumou L, Moyle G, et al. Switching from a ritonavir-boosted protease inhibitor to a dolutegravir-based regimen for maintenance of HIV viral suppression in patients with high cardiovascular risk. AIDS. 2017;31(18):2503–2514. doi:10.1097/QAD.000000000000167529112070
  • Tebas P, Kumar P, Hicks C, et al. Greater change in bone turnover markers for efavirenz/emtricitabine/tenofovir disoproxil fumarate versus dolutegravir R abacavir/lamivudine in antiretroviral therapy-naive adults over 144 weeks. AIDS. 2015;29(18):2459–2464. doi:10.1097/QAD.000000000000086326355674
  • McComsey GA, Lupo S, Parks D, et al. Switch from tenofovir disoproxil fumarate combination to dolutegravir with rilpivirine improves parameters of bone health. AIDS. 2018;32(4):477–485. doi:10.1097/QAD.000000000000172529239893
  • Ciccullo A, Avino AD, Lassandro AP, et al. Changes in bone mineral density in HIV-positive, virologically suppressed patients switching to lamivudine/dolutegravir dual therapy: preliminary results from clinical practice. Infez Med. 2018;26(4):336–340.30555137
  • DAIDS. Division of aids table for grading the severity of adult and pediatric adverse events division of aids table for grading the severity of adult and pediatric adverse events. National Institute of Allergy and Infectious Diseases; 2017 Available from: https://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf. Accessed 73, 2020.
  • Madeddu G, De Socio GVL, Ricci E, et al. Muscle symptoms and creatine phosphokinase elevations in patients receiving raltegravir in clinical practice: results from the SCOLTA project long-term surveillance. Int J Antimicrob Agents. 2015;45(3):289–294. doi:10.1016/j.ijantimicag.2014.10.01325476452
  • Bonfanti P, Martinelli C, Ricci E, et al. An Italian approach to postmarketing monitoring: preliminary results from the SCOLTA (Surveillance Cohort Long-term Toxicity Antiretrovirals) project on the safety of lopinavir/ritonavir. J Acquir Immune Defic Syndr. 2005;39(3):317–320. doi:10.1097/01.qai.0000164248.56722.3c15980692
  • DHHS Panel on antiretroviral guidelines for adults and adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents Living with HIV developed. Department of Health and Human Services. doi:10.1108/14630010710742455
  • Wilson KE Practical consideration when replacing a DXA system. Available from: https://hologiced.com/wp-content/uploads/2018/06/Wilson-KE.-Practical-Considerations-When-Replacing-a-DXA-System.pdf. Accessed 73, 2020.
  • Pedrazzoni M, Girasole G, Bertoldo F, et al. Definition of a population-specific DXA reference standard in Italian women: the Densitometric Italian Normative Study (DINS). Osteoporos Int. 2003;14(12):978–982. doi:10.1007/s00198-003-1521-114530829
  • Kanis JA. Assessment of fracture risk and its application to screening for postmenopausal osteoporosis. Report of a WHO Study Group. World Health Organ - Tech Rep Ser. 1994;4(6):368–381.
  • De Socio GV, Maggi P, Ricci E, et al. Smoking habits in human immunodeficiency virus-infected people from Italy: a cross-sectional analysis of the STOPSHIV cohort. AIDS Res Hum Retroviruses. 2019;36(1):19–26. doi:10.1089/aid.2019.011531502468
  • Bernardino JI, Mocroft A, Mallon PW, et al. Bone mineral density and inflammatory and bone biomarkers after darunavir-ritonavir combined with either raltegravir or tenofovir-emtricitabine in antiretroviral-naive adults with HIV-1: a substudy of the NEAT001/ANRS143 randomised trial. Lancet HIV. 2015;2(11):464–473. doi:10.1016/S2352-3018(15)00181-2
  • Bloch M, Tong W, Hoy J, et al. Switch from tenofovir to raltegravir increases low bone mineral density and decreases markers of bone turnover over 48 weeks. HIV Med. 2014;15(6):373–380. doi:10.1111/hiv.1212324460797
  • Nia Negredo E, Domingo P, Pérez-Álvarez N, et al. Improvement in bone mineral density after switching from tenofovir to abacavir in HIV-1-infected patients with low bone mineral density: two-centre randomized pilot study (OsteoTDF study). J Antimicrob Chemother. 2014;69:3368–3371. doi:10.1093/jac/dku30025125679
  • Arribas JR, Thompson M, Sax PE, et al. Brief report: randomized, double-blind comparison of tenofovir alafenamide (TAF) vs Tenofovir Disoproxil Fumarate (TDF), Each Coformulated with Elvitegravir, Cobicistat, and Emtricitabine (E/C/F) for Initial HIV-1 treatment: week 144 results. J Acquir Immune Defic Syndr. 2017;75(2):211–218. doi:10.1097/QAI.000000000000135028282300
  • DeJesus E, Haas B, Segal-Mauer S, et al. Superior efficacy and improved renal and bone safety after switching from a tenofovir disoproxil fumarate (TDF)- to a Tenofovir Alafenamide (TAF)-based Regimen Through 96 Weeks of Treatment. AIDS Res Hum Retroviruses. 2018;34(4):337–342. doi:10.1089/aid.2017.020329368537
  • Gallant J, Lazzarin A, Mills A, et al. Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial. Lancet. 2017;390(10107):2063–2072. doi:10.1016/S0140-6736(17)32299-728867497
  • Molina JM, Ward D, Brar I, et al. Switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from dolutegravir plus abacavir and lamivudine in virologically suppressed adults with HIV-1: 48 week results of a randomised, double-blind, multicentre, active-controlled, phas. Lancet HIV. 2018;5(7):e357–e365. doi:10.1016/S2352-3018(18)30092-429925489
  • Wijting IEA, Rokx C, Zillikens MC, et al. Changes in renal, bone, lipid, and inflammation markers in HIV-1 patients after combination antiretroviral therapy simplification to dolutegravir monotherapy. Int J STD AIDS. 2019;30(11):1042–1048. doi:10.1177/095646241984896231431155
  • Vescini F, Cozzi-Lepri A, Borderi M, et al. Prevalence of hypovitaminosis D and factors associated with vitamin D deficiency and morbidity among HIV-infected patients enrolled in a large Italian cohort. J Acquir Immune Defic Syndr. 2011;58(2):163–172. doi:10.1097/QAI.0b013e31822e57e921826011
  • Brown TT, Hoy J, Borderi M, et al. Recommendations for evaluation and management of bone disease in HIV. Clin Infect Dis. 2015;60(8):1242–1251. doi:10.1093/cid/civ01025609682