Resistance Summary
Lift the Virologic Burden With SYMTUZA®
The protective barrier of darunavir was studied in >5500 patients in 14 clinical trials with data up to 192 weeks1-12*
increase in darunavir RAMs over 10 years13,14†
treatment-emergent darunavir, primary PI, or TAF mutations with SYMTUZA® across rapid initiation and treatment-naïve and virologically suppressed clinical trial populations1,2‡
In the EMERALD study of virologically suppressed patients,
of patients across both treatment arms with archived emtricitabine RAMs (n=53), mainly at reverse transcriptase position M184, maintained virologic suppression at Week 48 or at latest time point assessed2
The DHHS guidelines recommend darunavir-based regimens like SYMTUZA® for use in rapid initiation, as well as in patients with unknown resistance testing records or adherence concerns15
*AMBER (n=362); AMBER CONTROL (n=363); EMERALD (n=763); EMERALD CONTROL (n=266); DIAMOND (n=109); STUDY 130 (n=313); ARTEMIS (n=343); ODIN QD (n=294); ODIN BID (n=296); POWER 1 (n=65); POWER 2 (n=66); POWER 3 (n=336); METABOLIK (n=34); GRACE (n=429); DUET (n=599); DUET CONTROL (n=604); TITAN (n=298); PHASE 2 (n=103); PHASE 2 CONTROL (n=50)=5693.1-12
†The absence of darunavir RAMS does not imply clinical results.
‡In a Phase 3 registration trial of treatment-naïve patients (AMBER), only 1 patient receiving SYMTUZA® was found to have M184I/V. This patient also had a transmitted K103N mutation at screening. M184V was detected pretreatment by deep sequencing (Illumina MiSeq) as a minority variant (9.4%).16
BID=twice-daily; DHHS=Department of Health and Human Services; PI=protease inhibitor; QD=once-daily; RAM=resistance-associated mutation; TAF=tenofovir alafenamide.
References: 1. Huhn GD, Crofoot G, Ramgopal M, et al. Darunavir/cobicistat/emtricitabine/tenofovir alafenamide in a rapid-initiation model of care for human immunodeficiency virus type 1 infection: primary analysis of the DIAMOND study. Clin Infect Dis. 2020;71(12):3110-3117. 2. SYMTUZA® [package insert]. Titusville, NJ: Janssen Therapeutics, Division of Janssen Products, LP. 3. Orkin C, Molina JM, Negredo E, et al; EMERALD Study Group. Efficacy and safety of switching from boosted protease inhibitors plus emtricitabine and tenofovir disoproxil fumarate regimens to single-tablet darunavir, cobicistat, emtricitabine, and tenofovir alafenamide at 48 weeks in adults with virologically suppressed HIV-1 (EMERALD): a phase 3, randomised, non-inferiority trial. Lancet HIV. 2018;5(1):e23-e34. 4. Tashima K, Crofoot G, Tomaka FL, et al. Cobicistat-boosted darunavir in HIV-1-infected adults: week 48 results of a phase lllb, open-label single-arm trial. AIDS Res Ther. 2014;11:39. 5. Orkin C, DeJesus E, Khanlou H, et al. Final 192-week efficacy and safety of once-daily darunavir/ritonavir compared with lopinavir/ritonavir in HIV-1-infected treatment-naïve patients in the ARTEMIS trial. HIV Med. 2013;14(1):49-59. 6. Cahn P, Fourie J, Grinsztejn B, et al. Week 48 analysis of once-daily vs. twice-daily darunavir/ritonavir in treatment-experienced HIV-1-infected patients. AIDS. 2011;25(7):929-939. 7. Arastéh K, Yeni P, Pozniak A, et al. Efficacy and safety of darunavir/ritonavir in treatment-experienced HIV type-1 patients in the POWER 1, 2 and 3 trials at week 96. Antivir Ther. 2009;14(6):859-864. 8. Aberg JA, Tebas P, Overton ET, et al. Metabolic effects of darunavir/ritonavir versus atazanavir/ritonavir in treatment-naive, HIV type-1 infected subjects over 48 weeks. AIDS Res Hum Retroviruses. 2012;28(10):1184-1195. 9. Currier J, Averitt Bridge D, Hagins D, et al; GRACE (Gender, Race, and Clinical Experience) Study Group. Sex-based outcomes of darunavir–ritonavir therapy: a single-group trial. Ann Intern Med. 2010;153(6):349-357. 10. Katlama C, Clotet B, Mills A, et al. Efficacy and safety of etravirine at week 96 in treatment-experienced HIV type-1-infected patients in the DUET-1 and DUET-2 trials. Antivir Ther. 2010;15(7):1045-1052. 11. Madruga JV, Berger D, McMurchie M, et al; TITAN Study Group. Efficacy and safety of darunavir-ritonavir compared with that of lopinavir-ritonavir at 48 weeks in treatment-experienced, HIV-infected patients in TITAN: a randomised controlled phase III trial. Lancet. 2007;370(9581):49-58. 12. Mills A, Crofoot G Jr, McDonald C, et al. Tenofovir alafenamide versus tenofovir disoproxil fumarate in the first protease inhibitor-based single-tablet regimen for initial HIV-1 therapy: a randomized phase 2 study. J Acquir Immune Defic Syndr. 2015;69(4):439-445. 13. Lathouwers E, Gupta S, Haddad M, et al. Trends in darunavir resistance-associated mutations and phenotypic resistance in commercially tested United States clinical samples between 2006 and 2012. AIDS Res Hum Retroviruses. 2015;31(6):628-635. 14. Brown K, Stewart L, Whitcomb JM, et al. Prevalence of darunavir resistance in the United States from 2010 to 2017. AIDS Res Hum Retroviruses. 2018;34(12):1036-1043. 15. Department of Health and Human Services. Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. Updated January 20, 2022. Accessed March 8, 2022. https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-arv/whats-new-guidelines 16. Eron JJ, Orkin C, Gallant J, et al; AMBER Study Group. A week-48 randomized phase-3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naive HIV-1 patients. AIDS. 2018;32(11):1431-1442.