Janssen Pharmaceutical said that a phase 3 trial evaluating SYMTUZA (darunavir 800mg, cobicistat 150mg, emtricitabine 200mg and tenofovir alafenamide 10mg D/C/F/TAF) showed that a high percentage of HIV patients recorded an undetectable viral load through 48 weeks after rapid initiation of the drug.
The trial, called DIAMOND, is the first prospective phase 3 trial which is assessing the rapid initiation of a single-tablet regimen (STR) SYMTUZA for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults.
The trial involved 109 patients who were enrolled within 14 days of going through an HIV diagnosis and then started on the once-daily STR of the drug before the release of laboratory or baseline resistance test results.
According to Janssen, 97 of the enrolled patients completed the 48-week study, which represents almost 90%. In the primary intent-to-treat (ITT) analysis, 84% of patients registered undetectable viral loads, while 8% of patients had virologic failure at 48 weeks.
The company said that, in an observed analysis, which excluded those with missing data, 96% of patients showed undetectable viral loads.
Janssen stated that 100% of patients registered viral loads of less than 200 c/mL at Week 48, with none of the patients having to stop SYMTUZA treatment based on efficacy reasons.
The company said that the drug was well-tolerated with no serious related adverse events (AEs) recorded.
Janssen Scientific Affairs, Janssen Infectious Diseases, medical affairs vice president Richard Nettles said: “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.”
The Janssen drug was approved in the US in July 2018 for the treatment of HIV-1 infection in treatment-naïve and certain virologically suppressed adults. In Europe, the drug was approved for the treatment of HIV-1 infection in adults and adolescents aged 12 years and over with body weight of at least 40kg.