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.
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