What is PrEP?
PrEP is a new HIV prevention method in which people who do not have HIV infection take a pill daily to reduce their risk of becoming HIV infected.
The pill is called Truvada and it contains two antiviral medicines that are also used to treat people who already have HIV infection. These are the same drugs used to suppress the virus in people living with HIV. “PrEP” stands for Pre-Exposure Prophylaxis, with “prophylaxis” meaning “to prevent or control the spread of an infection or disease.”
Who should take PrEP?
The effectiveness of using HIV antiretroviral drugs as PrEP has been established by clinical trials conducted in gay men, heterosexual adults and injecting drug users. PrEP can be considered for people in these populations who are at high risk of acquiring HIV, such as gay and other homosexually active men who are having multiple events of condomless sex.
How does Truvada work?
If you take Truvada and you are exposed to HIV through sex or injecting drug use, this medicine can work to prevent HIV infection. Along with other prevention methods like condoms, PrEP can offer effective protection against HIV if taken every day. Truvada (a dual combination of the antiviral drugs tenofovir and emtricitabine) has been investigated in several major clinical trials and has shown to be highly effective as HIV pre-exposure prophylaxis, provided the medication is taken correctly.
Is Truvada available in Australia?
Truvada has been licensed for use as PrEP in the USA, but it is not yet licensed for PrEP in Australia by the Therapeutic Goods Administration (TGA) and is not therefore available at a subsidised price through Australia’s Pharmaceutical Benefits Scheme (PBS). Community and medical organisations are urging Gilead Pharmaceuticals, who manufacture Truvada, to apply for TGA licensing and PBS listing as soon as possible. However, a decision on any such applications would be unlikely until at least 12 months after lodgement.
What are the options for obtaining PrEP?
If you are considering PrEP, you should discuss this with a doctor with experience in HIV or sexual health to help decide if PrEP is right for you. This fact sheet explains your options for obtaining PrEP through the Australian health system, and how to go about obtaining generic Truvada via the internet if you and your doctor decide that is your best access option.
Ask your doctor about the possibility of getting Truvada through access programs operating in NSW, Victoria and Queensland. Places in these programs are limited and only available for residents of these three States. Truvada is free in these access programs – although a dispensing fee may be charged as for most other PBS medicines.
Your doctor can also prescribe Truvada “off label”, even though it is not yet licensed in Australia. This would involve asking the local supplier, Gilead Sciences Australia, to supply the drug via your doctor’s “off label” prescription. The cost is approximately $13,500 for a year’s supply of Truvada, which will be too expensive for many people.
Another option is to purchase a generic version of Truvada from a reliable overseas supplier and import it to Australia. Generics are copies of brandname drugs. The cost of generic Truvada is much less than the brand-name and would be approximately $1300 per year, which will still be too expensive for some, but an option for others.
Australia's personal importation scheme for medicines (IPU)
You can legally import most medicines for your personal use under Australia’s personal importation scheme. This involves arranging from within Australia for a medicine to be sent to you from an overseas supplier or family/friend. The medicines are only to be used by you (or a member of your immediate family) and must not be supplied to any other person. It is important to note that such medicines may not be approved for supply in Australia by the TGA; and the TGA warns there are no guarantees about their safety or quality. Subject to satisfying various conditions you may import a 3 month supply (at the maximum dose recommended by the manufacturer) of an unapproved medicine without any prior approval required by the TGA.
Medicines ordered over the internet require an Australian-issued prescription from your doctor. To purchase or import a generic version of Truvada into Australia, you must first get a valid Australianissued prescription to accompany the medicine being imported.
Obtaining generic Truvada online for PrEP?
If you and your doctor decide that obtaining generic Truvada via online is the best option for you, then your local HIV clinic or organisation can provide additional information to assist you and your doctor. A step by step guide to ordering generic Truvada for PrEP online is attached. The site used in this information sheet is AIDS Drugs Online (www.aidsdrugsonline.netnet ), which a number of Australian’s and their doctors are using to obtain generic versions of HIV medications from various overseas manufacturers.
Buying medicines online
The internet can offer consumers a convenient and less expensive way to access medicines. However, online purchases of medicines must be approached with caution. Medicines available on international websites are not regulated by the TGA. You need to ensure that the website is legitimate, otherwise consumers face risks, including that medicines are fake, past their use-by date or not manufactured to appropriate standards. Medical guidance from the internet should never replace consultation with your doctor and should be interpreted with caution.
Where can I find out more?
For more information on importing medicines for personal see the Australian Government’s Therapeutic Goods Administration (TGA) website:
www.tga.gov.au/importing-mail-or-courier For more information on Truvada for PrEP, talk to your local HIV organisation, your doctor or sexual health clinic. In NSW, the community based organisations who can assist with information about PrEP, eligibility and steps to access PrEP are:
Positive Life NSW
9206 2177 or 1800 245 677 (freecall) or http://prep.positivelife.org.au/