108
Views
0
CrossRef citations to date
0
Altmetric
Original Research

Efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide fumarate for adult patients with human immunodeficiency virus-1 in China: a retrospective real-world cohort study

, , , , , & show all
Pages 211-217 | Received 25 May 2023, Accepted 01 Nov 2023, Published online: 12 Dec 2023

References

  • Broder S. The development of anti-retroviral therapy and its impact on the HIV-1/AIDS pandemic. Antiviral Res. 2010;85(1):1–18. doi: 10.1016/j.antiviral.2009.10.002
  • Deeks SG, Lewin SR, Havlir DV. The end of AIDS: HIV infection as a chronic disease. Lancet. 2013;382(9903):1525–1533. doi: 10.1016/S0140-6736(13)61809-7
  • Scarsi KK, Havens JP, Podany AT, et al. HIV-1 integrase inhibitors: a comparative review of efficacy and safety. Drugs. 2020;80(16):1649–1676. doi: 10.1007/s40265-020-01379-9
  • Smith SJ, Zhao XZ, Passos DO, et al. Integrase strand transfer inhibitors are effective anti-HIV drugs. Viruses. 2021;13(2):205. doi: 10.3390/v13020205
  • Yang LL, Li Q, Zhou LB, et al. Meta-analysis and systematic review of the efficacy and resistance for human immunodeficiency virus type 1 integrase strand transfer inhibitors. Int J Antimicrob Agents. 2019;54(5):547–555. doi: 10.1016/j.ijantimicag.2019.08.008
  • Wu J, Lu AD, Zhang LP, et al. Study of clinical outcome and prognosis in pediatric core binding factor-acute myeloid leukemia. Zhonghua Xueyexue Za Zhi. 2019;40(1):52–57. doi: 10.3760/cma.j.issn.0253-2727.2019.01.010
  • 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)32299-7
  • Sax PE, Pozniak A, Montes ML, et al. Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US-380-1490): a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet. 2017;390(10107):2073–2082. doi: 10.1016/S0140-6736(17)32340-1
  • Stellbrink HJ, Arribas JR, Stephens JL, et al. Co-formulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet HIV. 2019;6(6):e364–e372. doi: 10.1016/S2352-3018(19)30080-3
  • Maggiolo F, Rizzardini G, Molina JM, et al. Bictegravir/Emtricitabine/Tenofovir alafenamide in virologically suppressed people with HIV aged ≥ 65 years: week 48 results of a phase 3b, Open-label trial. Infect Dis Ther. 2021;10(2):775–788. doi: 10.1007/s40121-021-00419-5
  • AIDS and Hepatitis C Professional Group. Society of infectious diseases, Chinese medical association; Chinese center for disease control and prevention. [Chinese guidelines for diagnosis and treatment of HIV/AIDS (2021 edition). Zhonghua Nei Ke Za Zhi. 2021;60(12):1106–1128. Chinese. doi: 10.3760/cma.j.cn112138-20211006-00676
  • Chang HM, Chou PY, Chou CH, et al. Outcomes after switching to BIC/FTC/TAF in patients with virological failure to protease inhibitors or non-nucleoside reverse transcriptase inhibitors: a real-world cohort study. Infect Drug Resist. 2021;14:4877–4886. doi: 10.2147/IDR.S331647
  • Stephan C, Hill A, Sawyer W, et al. Impact of baseline HIV-1 RNA levels on initial highly active antiretroviral therapy outcome: a meta-analysis of 12,370 patients in 21 clinical trials*. HIV Med. 2013;14(5):284–292. doi: 10.1111/hiv.12004
  • Ramgopal M, Wurapa A, Baumgarten A, et al. 5-year outcomes of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) as initial treatment of HIV-1 in adults with high baseline HIV-1 RNA and/or low CD4 count in two phase 3 randomized clinical trials. Open Forum Infect Dis. 2022;9(Supplement_2):ofac492–1082. doi: 10.1093/ofid/ofac492.1082
  • Lundgren JD, Babiker AG, INSIGHT START Study Group. Initiation of anti-retroviral therapy in early asymptomatic HIV infection. N Engl J Med. 2015;373(9):795–807. doi: 10.1056/NEJMoa1506816.
  • Danel C, Moh R, EMPRANO ANRS 12136 Study Group. A trial of early anti-retrovirals and isoniazid preventive therapy in Africa. N Engl J Med. 2015;373(9):808–822. doi: 10.1056/NEJMoa1507198.
  • Pilcher CD, Ospina-Norvell C, Dasgupta A, et al. The effect of same-day observed initiation of anti-retroviral therapy on HIV viral load and treatment outcomes in a US public health setting. J Acquir Immune Defic Syndr. 2017;74(1):44–51. doi: 10.1097/QAI.0000000000001134
  • Serrano-Villar S, Sainz T, Lee SA, et al. HIV-infected individuals with low CD4/CD8 ratio despite effective anti-retroviral therapy exhibit altered T cell subsets, heightened CD8+ T cell activation, and increased risk of non-AIDS morbidity and mortality. PLOS Pathog. 2014;10(5):e1004078. doi: 10.1371/journal.ppat.1004078
  • Lazzaro A, Cacciola EG, Borrazzo C, et al. Switching to a bictegravir single tablet regimen in elderly people living with HIV-1: data analysis from the BICTEL cohort. Diagnostics. 2021;12(1):76. doi: 10.3390/diagnostics12010076
  • Lazerwith SE, Cai R, Chen X, et al. Discovery of GS-9883, an HIV-1 integrase strand transfer inhibitor (INSTI) with improved pharmacokinetics and in vitro resistance profile. American Society for Microbiology. Boston, MA, USA; 2016 Jun 16–20. Abstract 414.
  • Sax PE, Erlandson KM, Lake JE, et al. Weight gain following initiation of antiretroviral therapy: risk factors in randomized comparative clinical trials. Clin Infect Dis. 2020;71(6):1379–1389. doi: 10.1093/cid/ciz999
  • Kumar S, Samaras K. The impact of weight gain during HIV treatment on risk of pre-diabetes, diabetes mellitus, cardiovascular disease, and mortality. Front Endocrinol. 2018;9:705. doi: 10.3389/fendo.2018.00705
  • Bakal DR, Coelho LE, Luz PM, et al. Obesity following ART initiation is common and influenced by both traditional and HIV−/ART-specific risk factors. J Antimicrob Chemother. 2018;73(8):2177–2185. doi: 10.1093/jac/dky145
  • Yuh B, Tate J, Butt AA, et al. Weight change after antiretroviral therapy and mortality. Clin Infect Dis. 2015;60(12):1852–1859. doi: 10.1093/cid/civ192
  • Koethe JR, Jenkins CA, Shepherd BE, et al. An optimal body mass index range associated with improved immune reconstitution among HIV-infected adults initiating antiretroviral therapy. Clin Infect Dis. 2011;53(9):952–960. doi: 10.1093/cid/cir606
  • Halcox JP, Banegas JR, Roy C, et al. Prevalence and treatment of atherogenic dyslipidemia in the primary prevention of cardiovascular disease in Europe: EURIKA, a cross-sectional observational study. BMC Cardiovasc Disord. 2017;17(1):160. doi: 10.1186/s12872-017-0591-5
  • Sax PE, Arribas JR, Orkin C, et al. Bictegravir/Emtricitabine/Tenofovir alafenamide as initial treatment for HIV-1: five-year follow-up from two randomized trials. EClinicalMedicine. 2023;59:101991. doi: 10.1016/j.eclinm.2023.101991
  • Hayes E, Derrick C, Smalls D, et al. Short-term adverse events with BIC/FTC/TAF: postmarketing study. Open Forum Infect Dis. 2020;7(9):ofaa285. doi: 10.1093/ofid/ofaa285

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.