Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.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.
Image: Janssen said high proportion of patients achieved undetectable viral loads after rapidly starting SYMTUZA. Photo: courtesy of Darwin Laganzon/Pixabay.
Subscribe to our email newsletter
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.
