World AIDS Day in Australia has been dominated by demands for greater access to the HIV prevention pill, also known as pre-exposure prophylaxis or PrEP. Several state governments have announced new schemes and guidelines to make PrEP available to high-risk groups, such as men who have sex with men. PrEP is not currently approved by the Therapeutic Goods Administration (TGA) in Australia, it can be prescribed ‘off-label’ for the purposes of HIV prevention.
In New South Wales, state health minister Jillian Skinner has announced a landmark clinical trial, led by researchers from the Kirby Institute at UNSW, designed 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.
“This trial presents an exciting opportunity to dramatically reduce HIV diagnoses in New South Wales,” Kirby Institute director and principal investigator Professor David Cooper said.
“Rapid enrolment, high coverage and precision targeting are crucial to the success of this trial and if done properly, it will bring about the rapid reduction of HIV transmission in NSW, and the virtual elimination of new HIV infections by 2020.”
NSW will become the first state in Australia to implement a PrEP trial of this magnitude. Minister Skinner said it's a game changer.
“PrEP is recommended by the World Health Organisation and other international and national expert bodies for people who are at high risk of acquiring HIV infection. It has been shown to be very effective in preventing HIV infection," Mrs Skinner said.
The Victorian government has also announced plans to develop new guidelines providing information and clinical guidance to doctors to inform discussions with patients requesting PrEP.
Victorian AIDS Council CEO Simon Ruth said he welcomed the new guidelines.
"The guidelines will increase access to this vital HIV prevention tool by giving prescribers the security and confidence they need to prescribe PrEP to those in our community who need it the most," Mr Ruth said.
The Australian AIDS Councils and the National Association of People Living with HIV released a joint statement to coincide with World AIDS Day demanding immediate access to PrEP, which they say could dramatically drive down HIV infections in Australia.
The organisations claim there is no documented case of a person getting HIV when they are taking PrEP daily. Recent research showed no new HIV infections with increasing use of PrEP in a clinical practice setting.
"Although PrEP is not yet licensed in Australia, gay men, some people in relationships with people living with HIV, trans people and other people at high risk of becoming HIV infected are already asking their doctors for prescriptions to enable them to import PrEP from overseas," the statement read.
"We call on all Australian and state/territory governments to urgently provide PrEP access programs now and for the Commonwealth government to fast track licensing of [PrEP drug] Truvada through the Australian regulatory system and the PBS."
Yesterday, the federal Senate passed a motion by Greens Senator Robert Simms calling on the government to increase the accessibility of PrEP in the lead up to World AIDS Day. Simms said he wanted to see an increase in the roll-out of trials for those most at-risk of HIV transmission and speed up the process of getting PrEP approved by the TGA.
“The current process for getting PrEP approved by the TGA is moving at a glacial pace. With countries like France and the US providing wide-scale access to this drug, Australians have a right to ask why they are being denied access to this effective HIV prevention tool," Simms said in a statement following the vote yesterday.
Recruitment for the NSW PrEP trial is expected to commence during Mardi Gras 2016. Those interested in taking part can register for information at: www.endinghiv.org.au/nsw/epic