New Data Reinforce Efficacy of Symtuza for HIV-1 Treatment
Switching to Symtuza (darunavir, cobicistat, emtricitabine, tenofovir alafenamide; Janssen) was found to be safe and effective in virologically suppressed, treatment-experienced adults with HIV-1, regardless of prior treatment regimen, according to new data from the Phase 3 EMERALD trial.
In EMERALD (N=1141), Symtuza was compared with continued boosted protease inhibitor + emtricitabine/tenofovir disoproxil fumarate. The data showed low virologic failure rates (0.8% vs 0.5%) and high virologic suppression rates (94.9% vs 93.7%) at week 48; Symtuza was found to be non-inferior to the control (continuation of previous treatment) for virological rebound cumulative through week 48 (2.5% vs 2.1%). In the new subgroup analysis, these results were found to be consistent regardless of baseline regimen.
"These data add to the growing body of evidence that supports healthcare professionals to navigate treatment options," said Gregory Huhn, MD, Infectious Disease Specialist, Cook County Health System, Chicago, Illinois
Moreover, interim results from the single-arm Phase 3 DIAMOND study demonstrated that a darunavir-based regimen can be used for rapid initiation of treatment in newly diagnosed HIV-1 patients. At week 24, in an intent-to-treat analysis, 81% of enrolled patients had achieved HIV-1 RNA <50 copies/mL; none of the patients experienced virologic failure or discontinued treatment due to lack of efficacy.
Symtuza was approved earlier this month (July 2018) for the treatment of HIV-1 infection in treatment-naive and virologically suppressed adults (<50 copies/mL) on a stable antiretroviral regimen for at least 6 months who have no known substitutions associated with resistance to darunavir or tenofovir.
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