Janssen Presents New Data from 1st Phase 3 of Single-Tablet HIV Regimen

The Janssen Pharmaceutical Companies of Johnson & Johnson unveiled new 48-week data for SYMTUZA^® (darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg D/C/F/TAF) showing that a high proportion of HIV patients achieved an undetectable viral load through 48 weeks after rapidly starting SYMTUZA^®. A secondary endpoint of the study also showed that 97% of patients reported they were satisfied with their treatment.¹ The results from the DIAMOND study – the first prospective Phase 3 trial studying the rapid initiation of a single-tablet regimen (STR) – were presented at the 13^th Annual American Conference for the Treatment of HIV (ACTHIV 2019) in Miami, Florida.

The DIAMOND study evaluated the once-daily STR SYMTUZA^® for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult patients who were enrolled within 14 days of receiving an HIV diagnosis and then started on SYMTUZA^® before laboratory or baseline resistance test results were available.¹ SYMTUZA^® is approved by the U.S. Food & Drug Administration (FDA) for the treatment of HIV-1 infection in treatment-naïve and certain virologically suppressed adults.

“Rapid initiation of antiretroviral treatment is becoming the recognized standard of care for newly diagnosed HIV-1 patients, as it has the potential to improve treatment outcomes, including the probability of a person adhering to treatment and staying in care, and could be an additional strategy in our quest to achieve the 90/90/90 prevention and treatment goals as outlined by UNAIDS,” said Moti Ramgopal, M.D., Infectious Disease Director, Midway Immunology and Research Center, Fort Pierce, Florida.* “The DIAMOND study is the first evidence-based STR-specific trial in a rapid initiation model of care. SYMTUZA^® was well-tolerated, and a high proportion of patients achieved undetectable viral loads of less than 50 c/mL after 48 weeks.”

DIAMOND is a Phase 3, single-arm, open-label, prospective, multicenter 48-week study evaluating the efficacy and safety of rapidly initiating SYMTUZA^®.¹ These 48-week data, which follow on from the interim 24-week results presented at the 2018 International AIDS Conference (AIDS 2018), confirm the safety, efficacy and tolerability profile of rapidly starting SYMTUZA^® as a treatment for antiretroviral treatment (ART)-naïve adults with HIV-1.

Through 48 weeks, almost 90% (97/109) of patients enrolled in DIAMOND completed the study.¹In the primary intent-to-treat (ITT) analysis, 84% (92/109) of patients achieved undetectable viral loads (viral load <50 c/mL; FDA-snapshot), and 8% (9/109) of patients had virologic failure (viral load ≥50 c/mL; FDA-snapshot) at 48 weeks.

https://www.biospace.com/article/releases/janssen-presents-new-data-from-first-phase-3-trial-of-a-single-tablet-regimen-in-a-rapid-initiation-model-of-care-demonstrating-safety-and-efficacy-with-symtuza-through-48-weeks/