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Resistance Summary | SYMTUZA® (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) HCP

Resistance Summary

Lift the Virologic Burden With SYMTUZA®

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The protective barrier of darunavir was studied in >5500 patients in 14 clinical trials with data up to 192 weeks1-12*

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increase in darunavir RAMs over 10 years13,14

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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,

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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. 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.