The Therapeutic Goods Administration (TGA) has approved the HIV prevention drug Truvada (also known as pre-exposure prophylaxis or PrEP) for use in Australia.
The approval of PrEP, which had previously been prescribed "off-label" by doctors for the purposes of HIV prevention, is another step towards what health advocates hope will be its eventual listing on the Pharmaceutical Benefits Scheme (PBS).
The once-a-day pill is an antiretroviral treatment taken by HIV negative people at high risk of acquiring HIV to prevent infection. Studies have shown that PrEP is extremely effective at preventing HIV transmission, with recent demonstration projects in Australia also showing strong results.
President of NSW HIV support organisation ACON, Dr Justin Koonin, said Friday’s announcement from the TGA was an important milestone.
“ACON congratulates the TGA on this significant outcome. PrEP works and alongside high HIV testing rates among gay men, strong treatment uptake among people with HIV and the continuing high rates of condom use, we have the tools to end transmission by 2020,” Dr Koonin said.
Victorian AIDS Council CEO Simon Ruth said the news brings Australia one step closer to affordable, accessible PrEP.
"Over the coming months we will be continuing our work with other community organisations and advocates to ensure PrEP is listed on the PBS, providing subsidised access for those who need it,” Ruth said.
In the past six months, several Australian state governments announced new schemes to make PrEP available to high-risk groups, such as men who have sex with men.
In New South Wales, a landmark clinical trial led by researchers from the Kirby Institute at UNSW hopes to reduce HIV infections to half the present rate within two years. The "Expanded PrEP Implementation in Communities" trial (EPIC) will see 3700 high-risk, mostly gay and bisexual men enrolled through the state-wide network of public sexual health clinics and selected GP practices.
PrEP has also been approved for use in the United States, Canada, France and South Africa.