Janssen has lifted the curtain on data from the first Phase 3 trial investigating the efficacy of Symtuza (darunavir 800mg, cobicistat 150mg, emtricitabine 200mg and tenofovir alafenamide 10mg D/C/F/TAF) in treating human immunodeficiency virus type 1 (HIV-1) infection when the regimen is started within 14 days of diagnosis, starting on the drug before laboratory or baseline resistance test results are available.

The study found that 84% of 109 participants achieved undetectable viral loads, measured as <50 c/mL; FDA-snapshot after 48 weeks of treatment, while 8% saw virologic failure, measured as ≥50 c/mL; FDA-snapshot.

In observed analysis excluding those with missing data, 96% achieved undetectable viral loads, with 100% achieving loads of <200 c/mL at Week 48, with no patients discontinuing treatment because of lack of efficacy.

Additionally, 97% of participants reported that they were satisfied with their treatment, meeting the trial’s secondary endpoint.

"When you’re first diagnosed with HIV, your entire world changes, and there are so many questions and uncertainties. However, one thing I did know was that getting on treatment as soon as possible was the most important thing for me to do so I could keep living," said Brandon B, a participant in the DIAMOND clinical trial. "As a participant in the DIAMOND trial, I was grateful for the opportunity to make treatment part of my daily routine with Symtuza."

Symtuza is already approved by the FDA in HIV-1 in treatment-naïve or certain virologically supressed patients.

"At Janssen, we’re committed to the research and development of medicines and solutions that have the potential to change the treatment paradigm for people living with HIV – across the care continuum," remarked Dr Richard Nettles, Vice President, Medical Affairs, Janssen Infectious Diseases. "The DIAMOND study mirrors real clinical scenarios that physicians face today – including the need to start treatment before lab or baseline resistance test results are available – and highlights the benefits this model of care can bring to those newly diagnosed with HIV. Symtuza is the only single-tablet regimen proven in a Phase 3 clinical trial studying the rapid initiation of treatment, further demonstrating it as a treatment option for people new to HIV therapy."

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