1,916
Views
5
CrossRef citations to date
0
Altmetric
Articles

Efficacy and safety of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide in Asian participants with human immunodeficiency virus 1 infection: A sub-analysis of phase 3 clinical trials

, , , ORCID Icon, , , , , , , , , , ORCID Icon, , ORCID Icon, & show all
Pages 73-81 | Received 19 Jun 2018, Accepted 30 Jan 2019, Published online: 08 Jul 2019

References

  • UNAIDS (2017) Data Book.
  • UNAIDS (2017) ‘Ending AIDS: Progress towards the 90-90-90 Targets’.
  • UNAIDS (2013) ‘HIV in Asia and the Pacific.
  • Department for Health and Human Services (DHHS). Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. March 2018. Available at: https://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-arv/0
  • European AIDS Clinical Society (EACS). Guidelines Version 9.0, October 2017. Available at http://www.eacsociety.org/guidelines/eacs-guidelines/eacs-guidelines.html
  • Sax PE, Wohl DA, Yin MT, et al. Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomized, double-blind, phase 3, non-inferiority trials. Lancet. 2015;385(9987):2606–2615.
  • Wohl DA, Oka S, Clumeck N, et al. A randomized, double-blind comparison of tenofovir alafenamide versus tenofovir disoproxil fumarate, each coformulated with elvitegravir, cobicistat, and emtricitabine for initial hiv-1 treatment: week 96 results. J Acquir Immune Defic Syndr 2016;72:58–64.
  • 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.
  • 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.
  • DeJesus E, Haas B, Segal-Maurer S, et al. Superior efficacy and improved renal and bone safety after switching from a tenofovir disoproxil fumarate regimen to a tenofovir alafenamide-based regimen through 96 weeks of treatment. AIDS Res Hum Retroviruses. 2016. 34(4):337–342.
  • Pozniak A, Arribas JR, Gathe J, et al. Switching to tenofovir alafenamide, coformulated with elvitegravir, cobicistat, and emtricitabine, in HIV-infected patients with renal impairment: 48-week results from a single-arm, multicenter, open-label phase 3 study. J Acquir Immune Defic Syndr. 2016;71(5):530–537.
  • Post F, Tebas P, Clarke A, et al. Longer-term safety of tenofovir alafenamide in renal impairment. HIV Med 2016;17:15.
  • Stein DK, Pozniak A, Gupta S, et al. Tenofovir alafenamide in participants with diabetes and renal impairment: renal safety through 96 weeks. American Society Microbe 2016. Oral presentation.
  • McDonald C, Khalsa A, Kerkar S, et al. Efficacy and Safety of Tenofovir Alafenamide in HIV-Infected Women with Renal Impairment: 96-Week Results. American Society Microbe 2016. Oral presentation.
  • Brown TT, Yin MT, Gupta S, et al. Switching from TDF To TAF in HIV-infected adults with low BMD: A pooled analysis. CROI 2017. Poster 683.
  • Nishijima T, Komatsu H, Gatanaga H, et al. Impact of small body weight on tenofovir-associated renal dysfunction in HIV-infected patients: a retrospective cohort study of Japanese patients. PLoS One. 2011;6(7):e22661.
  • Kim Y-S, Chin BS, Oka S, et al. Longer-term efficacy and safety of tenofovir alafenamide versus tenofovir disoproxil fumarate in treatment − Naïve Asian Adults. KoSAids 2016. Poster P-31.
  • Kim Y-S, Chetchotisakd P, Supparatpinyo K, et al. Efficacy and safety of switching from a tenofovir disoproxil fumarate-based regimen to co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in HIV-suppressed Asian adults. KoSAids 2016. Poster P-30.
  • Chin BS, Avihingsanon A, Chetchotisakd P, et al. Efficacy and safety of co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in virologically suppressed Asian adults with renal impairment. KoSAids 2016. Poster P-28.
  • Hall AM, Hendry BM, Nitsch D, et al. Tenofovir-associated kidney toxicity in HIV-infected patients: a review of the evidence. Am J Kidney Dis. 2011;57:773–780.
  • Post FA, Moyle GJ, Stellbrink HJ, et al. Randomized comparison of renal effects, efficacy, and safety with once-daily abacavir/lamivudine versus tenofovir/emtricitabine, administered with efavirenz, in antiretroviral naive, HIV-1-infected adults: 48-week results from the ASSERT study. J Acquir Immune Defic Syndr. 2010;55:49–57.
  • Stellbrink HJ, 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;51:963–972.
  • McComsey GA, Kitch D, Daar ES, et al. Bone mineral density and fractures in antiretroviral-naive persons randomized to receive abacavir-lamivudine or tenofovir disoproxil fumarate-emtricitabine along with efavirenz or atazanavir-ritonavir: Aids Clinical Trials Group A5224s, a substudy of ACTG A5202. J Infect Dis. 2011;203:1791–1801.
  • Tungsiripat M, Kitch D, Glesby MJ, et al. A pilot study to determine the impact on dyslipidemia of adding tenofovir to stable background antiretroviral therapy: ACTG 5206. AIDS. 2010;24:1781–1784.
  • Ruane PJ, DeJesus E, Berger D, et al. Antiviral activity, safety, and pharmacokinetics/pharmacodynamics of tenofovir alafenamide as 10-day monotherapy in HIV-1-positive adults. J Acquir Immune Defic Syndr. 2013;63(4):449–455.