A month after Symtuza's approval, Janssen announced new switch data on the treatment and a second study supporting its use in a rapid initiation scenario.
A month following the approval of Symtuza (darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg), the first darunavir-based single-tablet treatment regimen for HIV, Janssen has announced new data reaffirming the safety and efficacy of the treatment.
The treatment’s approval was based on the 48-week, noninferiority, pivotal phase 3 AMBER and EMERALD trials, which evaluated the safety and efficacy of Symtuza compared with control regimens in patients with no prior antiretroviral history in virologically suppressed adults.
In newly released data, analyses from the EMERALD trial further support the efficacy and safety of switching from boosted protease inhibitor-based regimens to Symtuza, regardless of prior treatment regimen in the patient population. Results of the study showed similar virologic response rates at week 48 for Symtuza compared with continuous treatment in controls (HIV RNA <50 copies/mL: 95% vs 94%; HIV RNA >50 copies/mL: 1% vs 1%). Researchers also observed similar rates of virologic rebound (2.5% vs 2.1%).
“Forty-eight week data from the pivotal EMERALD trial demonstrate continued virologic control following a switch to treatment with Symtuza regardless of the individual’s previous boosted protease inhibitor-based regimen,” said Gregory Huhn, MD, infectious disease specialist, Cook County Health System, in a statement. “These data add to the growing body of evidence that supports healthcare professionals to navigate treatment options.”
Janssen also released data from the DIAMOND trial, which provided evidence to support the use of a darunovir-based regimen when rapidly initiating treatment in newly diagnosed patients, as recommended by HHS. This is the first phase 3 trial for a single-tablet regimen in a rapid initiation scenario, Jassen noted.
“HIV drug resistance and rapid initiation of treatment are key issues in today’s HIV care landscape,” Brian Woodfall, MD, vice president, global head, infection diseases & vaccines, Janssen, said in a statement.
Those diagnosed with HIV within 14 days were immediately enrolled in the single-arm study and started on Symtuza without screening or baseline laboratory or HIV genotypic resistance information. Investigators reviewed screening and baseline laboratory and resistance findings as they became available, and patients not meeting predefined safety or resistance stopping rules continued treatment.
During the study, 81% of participants achieved virologic suppression—less than 50 copies/mL—at week 24 in an intent-to-treat analysis, and 90% of patients achieved virologic suppression at week 24 in an as-observed analysis. The primary endpoint will be a week 48. Thus far, no patients have stopped due to virologic failure, or lack of efficacy, and 1 patient discontinued due to an adverse event.