Trial Demonstrates Safety and Efficacy of HIV Combination Therapy

Data from a recent clinical trial show that a high proportion of patients with human immunodeficiency virus (HIV) achieved an undetectable viral load through 48 weeks after rapidly starting Janssen’s single-tablet antiretroviral therapy (ART) containing darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg D/C/F/TAF.

The 4-drug combination tablet (Symtuza) was approved by the FDA in July 2018 for infection of HIV type 1 (HIV-1) in treatment-naïve and certain virologically suppressed adults.

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According to Janssen, a secondary endpoint of this study, DIAMOND, showed that 97% of patients enrolled in the trial reported they were satisfied with their treatment. Results of this 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.

"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, MD, Infectious Disease Director, Midway Immunology and Research Center, Fort Pierce, Florida., in a prepared statement.

DIAMOND is a Phase 3, single-arm, open-label, prospective, multicenter 48-week study evaluating the efficacy and safety of the once-daily STR for the treatment of HIV-1 infection in 109 adult patients who were enrolled within 14 days of receiving an HIV diagnosis and then started on this therapy before laboratory or baseline resistance test results were available.

The study’s 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 the combination therapy as a treatment for antiretroviral treatment (ART)-naïve adults with HIV-1, according to Jannsen.

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

Additionally, in an observed analysis — which excluded those with missing data – 96% of these 96 patients achieved undetectable viral loads, and 100% of these 96 of patients achieved viral loads of <200 c/mL at Week 48, with no patients discontinuing treatment due to lack of efficacy.

The combination therapy was well-tolerated with no serious related adverse events (AEs). Most AEs were grade 1 or 2 in severity, 2 patients experienced a grade 3 drug-related AE, and 1 patient discontinued the trial due to adverse events. The most common adverse drug reactions related to this STR (all grades, ≥2% of adults) were diarrhea, nausea, rash, vomiting and fatigue. Grade 3 and 4 laboratory abnormalities, occurring in ≥2% of patients, included increases in aspartate aminotransferase (5%), alanine aminotransferase (3%) or bilirubin (3%).

Reference

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 [news release]. Miami, FL; April 11, 2019: Janssen. https://prnmedia.prnewswire.com/news-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-300830670.html. Accessed April 11, 2019.