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Foundations of ART Management in Heavily Treatment–Experienced Patients

Source: Strategies for Success: Optimizing Antiretroviral Therapy in Heavily Treatment–Experienced Patients
Eric S. Daar, MD
Released: October 6, 2022
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References

  1. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. Department of Health and Human Services. hiv.gov/en/guidelines/adult-and-adolescent-arv. Accessed September 28, 2022.
  2. gov. A timeline of the history of HIV and AIDS. hiv.gov/hiv-basics/overview/history/hiv-and-aids-timeline. Accessed September 28, 2022.
  3. Bajema KL, Nance RM, Delaney JAC, et al. Substantial decline in heavily treated therapy-experienced persons with HIV with limited antiretroviral treatment options. AIDS. 2020;34:2051-2059.
  4. Henegar CD, Underwood M, Ragone L, et al. Trends and characteristics of HIV-1 drug resistance in the United States (2012-2018). Presented at: 2020 Conference on Retroviruses and Opportunistic Infections; March 8-11, 2020. Abstract 521.
  5. Castagna A, Maggiolo F, Penco G, et al. Dolutegravir in antiretroviral-experienced patients with raltegravir- and/or elvitegravir-resistant HIV-1: 24-week results of the phase III VIKING-3 study. J Infect Dis. 2014;210:354-362.
  6. Darunavir [prescribing information]. Titusville, NJ: Janssen Therapeutics; 2022.
  7. Paton NI, Kityo C, Thompson J, et al. Nucleoside reverse-transcriptase inhibitor cross-resistance and outcomes from second-line antiretroviral therapy in the public health approach: an observational analysis within the randomised, open-label, EARNEST trial. Lancet HIV. 2017;4:e341-e348.
  8. Aboud M, Orkin C, Podzamczer D, et al. Efficacy and safety of dolutegravir-rilpivirine for maintenance of virological suppression in adults with HIV-1: 100-week data from the randomised, open-label, phase 3 SWORD-1 and SWORD-2 studies. Lancet HIV. 2019;6:e576-e587.
  9. Brown D, Kaplan R, Losso M, et al. Efficacy of second-line dolutegravir plus 2 nucleoside reverse transcriptase inhibitors by baseline nucleoside reverse transcriptase inhibitor resistance and nucleoside reverse transcriptase inhibitor use in the DAWNING study. Antivir Therapy. 2022:1-6.
  10. Paton NI, Musaazi J, Kityo C, et al. Dolutegravir or darunavir in combination with zidovudine or tenofovir to treat HIV. N Engl J Med. 2021;385:330-341.
  11. Paton NI, Musaazi J, Kityo C, et al. Efficacy and safety of dolutegravir or darunavir in combination with lamivudine plus either zidovudine or tenofovir for second-line treatment of HIV infection (NADIA): week 96 results from a prospective, multicentre, open-label, factorial, randomised, non-inferiority trial. Lancet HIV. 2022;9:e381-e393.
  12. Ibalizumab [prescribing information]. Montreal, Quebec: Theratechnologies.; 2021.
  13. Fostemsavir [prescribing information]. Research Triangle Park, NC: ViiV; 2022.
  14. gov. Study to evaluate the safety and efficacy of lenacapavir (GS-6207) in combination with an optimized background regimen (OBR) in heavily treatment experienced participants living with HIV-1 infection with multidrug resistance (CAPELLA). clinicaltrials.gov/ct2/show/NCT04150068. Accessed September 28, 2022.
  15. Emu B, Fessel J, Schrader S, et al. Phase 3 study of ibalizumab for multidrug-resistant HIV-1. N Engl J Med. 2018;379:645-654.
  16. Emu B, Fessel J, Schrader S, et al. 48-week safety and efficacy on-treatment analysis of ibalizumab in patients with multi-drug resistant HIV-1. Presented at: 2017 IDWeek; October 4-8, 2017. Abstract 1686.
  17. Emu B, Weinheimer S, Cohen Z, et al. Analysis of patients completing the ibalizumab phase III trial and expanded access program. Presented at: HIV Glasgow 2018; October 28-31, 2018. Abstract O345.
  18. DeJesusE, Emu B, Weinheimer S, et al. Outcomes of patients not achieving primary endpoint from an ibalizumab phase III trial. Presented at: HIV Glasgow 2018; October 28-31, 2018. Abstract P064.
  19. Emu B, Lalezari J, Kumar P, et al. Ibalizumab: 96-week data and efficacy in patients resistant to common antiretrovirals. Presented at: 2019 Conference on Retroviruses and Opportunistic Infections; March 4-7, 2019. Abstract 485.
  20. Kozal M, Aberg J, Pialoux G, et al. Fostemsavir in adults with multidrug-resistant HIV-1 infection. N Engl J Med. 2020;382:1232-1243.
  21. Pialoux G, Kozal M, Aberg J, et al. Phase 3 study of fostemsavir in heavily treatment-experienced HIV-1-infected participants: BRIGHTE week 24 subgroup analysis in randomized cohort subjects. Presented at: 2018 International AIDS Conference; July 23-27, 2018. Abstract THPEB045.
  22. Lataillade M, Lalezari J, Aberg J, et al. Week 96 safety and efficacy of the novel HIV-1 attachment inhibitor prodrug fostemsavir in heavily treatment-experienced participants infected with multi-drug resistant HIV-1 (BRIGHTE study). Presented at: 2019 International AIDS Society Conference on HIV Science; July 21-24, 2019. Abstract
  23. Ogbuagu O, Segal-Maurer S, Brinson C, et al. Long-acting lenacapavir in people with multidrug resistant HIV-1: Week 52 results. Presented at: 2022 Conference on Retroviruses and Opportunistic Infections; February 12-16, 2022. Abstract 491.
  24. Segal-Maurer S, DeJesus E, Stellbrink HJ, et al. Capsid inhibition with lenacapavir in multidrug-resistant HIV-1 infection. N Engl J Med. 2022;386:1793-1803. 
  25. Kumar P, Gupta S, Segal-Maurer S, et al. Injection site reaction experience in clinical studies of people using lenacapavir for HIV treatment. Presented at: 2022 International AIDS Conference; July 29-August 2, 2022. Abstract EPB184.
  26. Eron JJ, Young B, Cooper DA, et al. Switch to a raltegravir-based regimen versus continuation of a lopinavir-ritonavir-based regimen in stable HIV-infected patients with suppressed viraemia (SWITCHMRK 1 and 2): two multicentre, double-blind, randomised controlled trials. Lancet. 2010;375:396-407.
  27. Hagins D, Kumar P, Saag M, et al. Switching to bictegravir/emtricitabine/tenofovir alafenamide in black americans with HIV-1: a randomized phase 3b, multicenter, open-label study. J Acquir Immune Defic Syndr. 2021;88:86-95. 
  28. Sax PE, Andreatta K, Molina JM, et al. High efficacy of switching to bictegravir/emtricitabine/tenofovir alafenamide in people with suppressed HIV and preexisting M184V/I. AIDS. 2022;36:1511-1520. 
  29. Sax PE, Rockstroh JK, Luetkemeyer AF, et al. Switching to bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed adults With Human Immunodeficiency Virus. Clin Infect Dis. 2021;73:e485-e493.
  30. Sax PE, Rockstroh JK, Luetkemeyer AF, et al. Switching to a single-tablet regimen bictegravir, emtricitabine, and tenofovir alafenamide (B/F/TAF) from dolutegravir (DTG) plus emtricitabine and either tenofovir alafenamide or tenofovir disoproxil fumarate (F/TAF or F/TDF). Presented at: 2019 International AIDS Society Conference on HIV Science; July 21-24, 2019. Abstract MOAB0105.
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