Phase III DIAMOND study of Symtuza shows rapid initiation benefits in HIV patients

Janssen Pharmaceutical 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.

The results from the DIAMOND study – the first prospective Phase III trial studying the rapid initiation of a single-tablet regimen (STR) found that through 48 weeks, almost 90% (97/109) of patients enrolled in DIAMOND completed the study. In the primary intent-to-treat (ITT) analysis, 84% (92/109) of patients achieved undetectable viral loads (viral load less than 50 c/mL; FDA-snapshot), and 8% (9/109) of patients had virologic failure (viral load at least 50 c/mL; FDA-snapshot) at 48 weeks. Additionally, in an observed analysis – which excluded those with missing data – 96% (92/96) of patients achieved undetectable viral loads, and 100% (96/96) of patients achieved viral loads of less than 200 c/mL at Week 48, with no patients discontinuing treatment with Symtuza due to lack of efficacy.

Symtuza was well-tolerated with no serious related adverse events (AEs). Data were presented at the 13th Annual American Conference for the Treatment of HIV (ACTHIV 2019).

Comment: Several studies examining rapid initiation in newly diagnosed adults with HIV-1 have previously underscored the benefits of linking people with HIV to treatment services soon after diagnosis, including improved virologic outcomes, retention in care and decreased morbidity/mortality. While achieving viral suppression is always a main goal of treatment for individuals, these studies have also found that rapid initiation may get patients to undetectable viral loads more quickly and sustain them over time.