Belgium-based Janssen Pharmaceutical has announced the phase three trial results for HIV drug SYMTUZA (darunavir 800mg, cobicistat 150mg, emtricitabine 200mg and tenofovir alafenamide 10mg D/C/F/TAF), it was reported on Friday.
The product indicated a high percentage of HIV patients recorded an undetectable viral load up to 48 weeks after rapid initiation of the drug.
The trial is called DIAMOND and is the first prospective phase three trial, which is assessing the rapid start of a single-tablet regimen product for the treatment of human immunodeficiency virus type one infection in adults. It included 109 patients who were enrolled within 14 days of going through an HIV diagnosis and then started on the once-daily single-tablet regimen of the drug before the release of laboratory or baseline resistance test results. According to the company, 97 of the enrolled patients completed the 48-week study, which represents around 90%. In the primary intent-to-treat analysis, 84% of patients registered undetectable viral loads, while 8% of patients had virologic failure at 48 weeks. Janssen said that the drug was well-tolerated with no serious related adverse events (AEs) recorded.
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