Aussie-led research develops a cheaper HIV drug for developing countries
The US Food and Drug Administration (FDA) has tentatively approved a new combination of cheaper anti-retroviral drugs for use in its aid program in developing countries.
The announcement comes after research by the UNSW’s Kirby Institute found that a lower dose (400mg) of HIV drug component efavirenz was just as effective as the currently recommended higher dose (600mg).
Trials were held in 13 countries over three years to test the effectiveness of the reduced dose drug.
The research has served as the foundation for revisions to international treatment guidelines developed by the World Health Organization (WHO) that recommended 400mg of efavirenz as a valid treatment option in first line therapy.
Translation of these important findings into treatment programs was hampered by the absence of a pharmaceutical product that contained the lower dose of efavirenz in combination with other antiretroviral drugs.
In collaboration with Mylan Pharmaceuticals and colleagues at the Clinton Health Access Initiative, UNSW researchers can today confirm that a new product has been created and is now tentatively approved by the principal regulatory agency in the world.
Mylan announced the drug, called TLE400, in December 2016.
This will allow public sector procurement programs around the world to purchase and use this new medication.
Because the product costs less due to the lower amount of efavirenz in the medication, it is anticipated that more drug can be purchased and more people treated with the same amount of funding.
Estimates of the relative saving to these international procurement programs could be up to US$150 million per year.
“The direct translation of this body of research into international treatment guidelines and now its application in product development will change the way millions of people living with HIV receive treatment,” said Professor Sean Emery, Deputy Executive Dean and Research Dean at The University of Queensland, who led the study from the Kirby Institute.
“The biggest impact of this development will be felt in low and middle-income countries, where stagnating foreign aid investment results in reduced access to antiretroviral therapy for those who need it.”