Janssen single tablet regimen shows Phase 3 success in HIV
The latest Phase 3 data investigating Janssen’s darunivir in the treatment of human immunodeficiency virus (HIV-1) showed that the drug was effective and safe, Janssen has announced.
The study focused on the effects of darunivir as part of a single tablet regimen including darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg in virologically suppressed adult patients who switched from a standard boosted protease inhibitor (PI) regimen. After 24 weeks of treatment, it was found that the combination led to a high virologic suppression rate and a low virologic rebound rate
The regimen, also known by brand name Symtuza, is currently undergoing assessment for approval in the EU, and could soon become the first darunivir-based treatment authorised for use.
“The complexity and high pill burden of some HIV treatment regimens can result in non-adherence, which is one of the major contributors to the development of HIV drug resistance,” said Professor Jean-Michel Molina, Professor of Infectious Diseases, Department of Infectious Diseases, St-Louis Hospital at the University of Paris Diderot. “These promising results show that the darunavir-based STR was highly effective and well tolerated, providing a complete treatment regimen with a high genetic barrier to resistance with just one single daily tablet. If we can help to reduce the treatment burden for patients living with HIV-1, this can help to improve adherence which we know is essential for achieving viral suppression and reducing the emergence of resistance mutations.”
Lawrence Blatt, Global Therapeutic Area Head, Infectious Disease Therapeutics at Janssen, also commented: “Over the past decade, Janssen has developed a broad range of therapies for people living with HIV that have helped to transform the management of patients living with the disease. Darunavir is one of the most widely used HIV medicines in the US and EMEA and it offers a high genetic barrier to resistance. We remain dedicated to fulfilling our mission of delivering transformational innovations to meet the diverse needs of the HIV community and are excited to be bringing forward an evolved therapy with darunavir as its backbone. If approved, it has the potential to not only offer the benefits of darunavir but could also reduce the treatment burden faced by those taking life-long HIV therapy, which may help to address the issues of both adherence and resistance.”
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