On 9 February 2018 the Pharmaceutical Benefit Advisory Committee (PBAC) recommended pre-exposure prophylaxis (PrEP), a program that combines daily anti-retroviral medications with regular sexual health testing, be listed on the Pharmaceutical Benefits Scheme (PBS) — making this game changing HIV prevention tool accessible across Australia. Globally, PrEP has proved to be highly effective at preventing the acquisition of HIV and its addition to the PBS has been greatly anticipated by community and health professionals alike.
Announced by Minister Greg Hunt on 21 March 2018, PrEP will be added to the PBS this April 1 2018, and is expected to come in at under $40 a month or $6.40 for those with a concession, and to be dispensable from any pharmacy in Australia with a script from your GP, though it may take a few days for some pharmacies to order in the initial medication.
In May 2016, the Therapeutic Goods Administration approved PrEP for use in Australia, but the drug remained expensive to acquire with many community members turning to personal importation minimise these costs. Meanwhile, demonstration trials launched across Australia to make PrEP available to those communities most at risk of acquiring HIV. These trials have played an important role in making PrEP accessible until it could be listed on the PBS, but with each state independently launching trials, access has been inconsistent nationally. It is hoped by advocates and services a like that the addition of PrEP to the PBS will alleviate many of these accessibility issues.
PrEP (Pre-Exposure Prophylaxis) is a HIV prevention program that makes use of medication and regular sexual health testing to prevent HIV. By taking PrEP, people who are HIV-negative (meaning they do not have HIV) can reduce the chance of getting HIV by up to 99%. The drugs used in PrEP are also often used in treating HIV.
In 2009, a large study showed not only were these drugs effective at treating HIV, but also at preventing HIV when taken every day. Since then, several studies have confirmed that it is incredibly effective at preventing HIV.
PrEPX-SA will monitor how providing large-scale access to Pre-Exposure Prophylaxis (PrEP) medication impacts the rate of new infections across the state. SA Health, SAHMRI and the Alfred have partnered together to deliver PrEPX-SA the South Australian PrEP trial, modelled on the PrEPX study in Victoria.
To learn more about the trial please visit the Alfred's PrEPX-SA trial information page.
PrEP is for HIV-negative people who may be at risk of HIV. The level of risk is different for every person, but people who are at highest risk are men who have sex with men, injection drug users, and transgender people. Women can also be at high risk if they or any of their sexual partners are injection drug users, or if any of their sexual partners are men who have sex with men.
Many other factors can affect your personal risk, including:
Whether PrEP is right for you depends on your individual circumstances, and your risk of being exposed to HIV. In figuring out whether you should go on PrEP, you should ask yourself the following questions:
For example, if you are a gay man who has multiple sex partners and you don’t always use condoms, PrEP is a very good idea for you. Even if your risk is relatively low, you might want to consider PrEP as a supplementary or an extra prevention tool.
PrEP works by stopping HIV from duplicating inside the body. Without the ability to duplicate, the virus eventually dies off, and can no longer infect you.
Normally when a person is exposed to HIV, the virus attaches to immune cells and uses them to make more HIV. The newly made HIV then spreads and attaches to more immune cells, ultimately damaging the immune cells until they can no longer fight off illnesses and infections. PrEP stops this process before it starts, preventing HIV from making more copies of itself, and preventing HIV infection.
In order to be effective, there has to be enough Truvada (the drug used as PrEP) in your body to prevent HIV. If there isn’t enough Truvada in your body, then there’s a chance you could be infected. This is why it’s important to take PrEP every day. This ensures high levels of Truvada in your body, providing maximum protection from the virus.
PrEP is the most effective HIV prevention tool by far. When taken daily, PrEP is up to 99% effective at preventing HIV. By comparison, condoms are approximately 70% effective at preventing HIV when used all the time.
Many different figures have been thrown around about how effective PrEP is. When we say something is effective to a certain percentage, it means that out of all the times it’s been used that it worked that percentage of the time.
Some have heard 42%, some have heard 86% or 92%. The reason for these different figures is because a drug’s effectiveness is a measure of how successful it might be in real world circumstances. This takes into account things like missed doses, interactions with other medications a person might be taking, or other illnesses that might be present.
When we say PrEP is 99% effective, that means that when PrEP is taken every day as prescribed, it prevents 99% of the cases of HIV that would have occurred otherwise. If doses are missed, however, then PrEP is not as effective.
PrEP has very few side effects, and very few people ever experience them. The most common side effects were headache, nausea, unintentional weight loss, and depression. Some people experience sleeplessness, while others may experience fatigue. In almost all cases, these were very mild and for most people they disappeared just a few weeks after starting PrEP. Most people don’t have any side effects at all.
In a handful of people, Truvada may lead to a loss of bone mineral density, or a decrease in kidney function. These side effects aren’t problematic in and of themselves, but it is important to visit your PrEP doctor every three months to keep track of them if they pop up.
There are no known common long-term side effects from taking Truvada as PrEP. In a handful of people, Truvada may lead to a loss of bone mineral density, or a decrease in kidney function. Most of the side effects that people ever experience (like nausea and headaches) disappear within a few weeks of starting it.
Truvada has been around since 2004, and used to treat HIV in HIV-positive people. In very rare cases, people on Truvada have experienced a build-up of lactic acid in the bloodstream, and sometimes developed serious liver problems. These side effects were very rare, and were in part caused by the underlying HIV infection in the people who experienced them. An HIV-negative person is unlikely to develop such side effects while taking Truvada, even over the long-term.
If you’ve just started PrEP and you’re noticing any symptoms out of the ordinary (like nausea, headache, or diarrhoea), you probably just need to wait a few weeks. Such side effects aren’t unheard of, but they almost always go away on their own. Essentially they’re just signs that your body is getting used to the medication.
That said, it’s important to pay attention to them, how severe they are, and how long they last. If you experience side effects that are particularly serious, or last longer than 3-4 weeks, you should contact your doctor for further advice.
There are a number of reasons people can’t, don’t, or won’t use condoms. Ultimately the decision whether or not to use condoms is a very personal one, and depends on each person’s particular circumstances. Instead of focusing on what other people do – or what you think they should do – it’s best to focus on your own individual sexual practices. Informing yourself about your own personal risk and the different ways you can reduce that risk will help you make decisions that improve your own wellbeing.
For some HIV-negative people, the simplest way of avoiding HIV would be to have sex only with other HIV-negative people. This practice, known as serosorting, is only somewhat effective, and is one of the least reliable HIV prevention strategies. The main drawback of serosorting is that a large proportion of people don’t know their HIV status. In Australia, An estimated 10-20% of people living with HIV are unaware they have the virus. Simply assuming a person is negative, or relying on their belief that they are negative is not a safe prevention strategy.
Serosorting does not make sense especially given what we now know about treatment as prevention (TasP) and undetectable viral load. We’ve long known that HIV-positive people on treatment can reach undetectable viral load, meaning the amount of virus in their body is so low that current tests can’t detect it. What scientists have recently discovered is that people who are undetectable are all but incapable of passing on the virus. In other words, it’s safer to have condomless sex with an HIV-positive undetectable person than it is with a person who thinks they are negative.
It’s important to take PrEP every day, and you should try to never miss a dose. If you accidentally forget to take it, though, take it as soon as you possibly can. However, if you’re close to taking your next regular dose, it’s fine to wait until then to pick up where you left off. If this happens, take only one pill as prescribed. Taking two pills to make up for the missed dose, or double dosing, isn’t necessary as it doesn’t give you any added benefits.
Where PrEP is taken before you’re potentially exposed to HIV, PEP is taken after a suspected exposure. PEP stands for post-exposure prophylaxis, and is taken only if someone thinks they have already been exposed to HIV, either through sex without condoms, injection drug use, or needlestick injury. PEP must be started within 72 hours of the exposure, and is taken for 28 days.
PrEP does not prevent any STIs other than HIV. The best way to prevent other STIs is by going in for regular sexual health checks at least every three months and by using condoms.
Because PrEP does not prevent or protect against other STIs, condoms are still a very good idea. When used properly and regularly condoms are the most effective method for preventing STIs like gonorrhoea, chlamydia, syphilis, hepatitis, and herpes.
PrEP can be prescribed by any GP. Your doctor does not need to go undertake any specialist training in order to prescribe you PrEP. However if they have never heard of or prescribed PrEP before then they may not be confident in providing you with advice or a prescription. You can send them to websites such as PrEP Access Now or refer them to ASHM (the Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine) which are the body governing the best practice guidelines on how PrEP is prescribed, and taken.
Alternatively, you can get into contact with PrEP Access Now (www.pan.org.au) yourself to find a list of doctors who are located closest to you who already prescribe PrEP and make an appointment with one of them. This way you can ensure that your new PrEP doctor will know the ins and outs of prescribing and taking PrEP.
Now that PrEP has been listed on the PBS, there will be a short time in between being able to get a script and then being able to get PrEP from your local pharmacy. Details on the date of when you can walk in and get PrEP from your local pharmacy will be updated when we know them.
The cost of PrEP depends on where you get it. When buying from an online pharmacy or what we call ‘self importing’, the cost ranges from about $95 - $290 for a three month supply, depending on which pharmacy you use and which generic you choose. Community activists have set up a group called PrEP Access Now (www.pan.org.au) to help you buy PrEP from online pharmacies with specific instructions and guidance. If can’t afford the cost of buying online, one of the pharmacies has made a deal with PrEP Access Now to provide subsidies for some people who cannot financially afford to access PrEP.
Now that PrEP has been listed on the PBS, you will soon be able to get if from your local pharmacy. The estimated cost will be $39.50 for a bottle of 30 pills, so the total cost will be $118.50 for a three month supply. The price is significantly reduced if you have a concession card or identify as Aboriginal or Torres Strait Islander.
There is no difference between name-brand Truvada and its generic versions other than their manufacturer. Both contain the same ingredients and both are effective at preventing HIV.
Truvada, the drug used as PrEP, is manufactured by Gilead Sciences. Gilead has given permission to other companies in India and South Africa to manufacture generic versions, but with the exact same composition, mainly so they can provide affordable and low cost drugs to the people living there. These generics have been tested for safety and effectiveness by several agencies, including the US Food and Drug Administration, the World Health Organisation, and the South African Medicines Control Council.
Talking to a doctor about PrEP might be very difficult as many doctors may not be aware of it. Also, talking to your doctor about your sex life isn’t always easy, and may bring up some uncomfortable topics. It’s important to remember that your doctor’s job is to provide you with the best possible care. It’s best to simply be honest: tell them you believe you are at risk for HIV, and that you believe PrEP would be a great way to help you prevent HIV. They may ask you questions about many things discussed here: your overall health, your knowledge of HIV and PrEP, your sexual practices, and other potential risk factors.
If your doctor is unfamiliar with PrEP, it may help to refer them to the current Australian guidelines for it, provided by ASHM. There is also a section of the PrEP Access Now (www.pan.org.au/doctors) website that provides information on PrEP that you can refer your doctor to, and also a list of doctors who currently prescribe PrEP and you may want to see one of them instead.
Your doctor will need to see you at least twice before prescribing you PrEP. During the first appointment you’ll talk about PrEP, its potential side effects, and how it might impact your overall health. The doctor will give you an HIV test, to confirm that you’re HIV negative, as PrEP is only for HIV-negative people. The doctor will also test your kidneys to help reduce the chance of any side effects.
At the second appointment the doctor will discuss your test results, and if you’re negative, provide you with a prescription for Truvada PrEP. They will also do HIV and STI tests a second time, just to be certain you are not HIV-positive.
After that, you will have to visit the doctor every three months to get a new prescription. The doctor will test you for HIV and STIs at every appointment, as well as asking you about any side-effects you may be having.
If you decide to stop taking PrEP, your doctor will ask you to take it for an extra 28 days after the last time you had sex, just in case you were exposed to HIV.
Many doctors still don’t know about PrEP, or may be uncomfortable with prescribing it. You can encourage them to look into it and consider changing their mind, but in the meantime it’s important to find a doctor who’s willing to prescribe it. You can ask your original GP for a referral to a doctor who does prescribe PrEP, or to an HIV specialist. You can also visit the website for PrEPaccessNOW. It lists doctors throughout Australia who will prescribe PrEP. You can also visit the Facebook pages for either PrEPaccessNOW or PrEPd for Change. These groups provide peer support for PrEP users, and often contain up-to-date information on where to access PrEP.
PrEP has been listed on the PBS and this is a fantastic step forward, however there are a range of considerations that need to be made. For example, if you are on one of the access clinical trials what happens now? If you are using ‘self importation’ should you change over to local purchase?
If you are on one of the access clinical trials, the trial will contact you in time to inform you of what the next steps are. Don’t worry though, you will always have access to PrEP one way or another. The important thing to remember is to NOT stop taking it.
PrEP Access Now has information that can help answer the questions you may have if you are currently taking PrEP either through the trial or through importation.
In order to be listed on the PBS, PrEP has to go through a number of government approval processes. Though it’s received the first approval it needs, it’s not yet clear if or when PrEP will be available on the PBS. Gilead, the company that makes Truvada for PrEP, is in the middle of getting the final approvals, and hopes to have a better idea of the timeframe in mid-2017.
You may have heard that in August 2016 the government rejected Gilead’s application to have PrEP put on the PBS. This does not mean PrEP is not effective. It also does not mean that PrEP will never be listed on the PBS. PBAC, the government body in charge of looking at applications for this sort of thing, said they know that PrEP is effective and that it will help prevent new cases of HIV in Australia. The application was rejected due to some inaccurate information that it contained, and also because Gilead was asking the government to pay too much money. Gilead has said they are going to submit another application in the near future, and that they will work with the government to find a fair price for PrEP.
Once PrEP is on the PBS, there will be a wait of several months before it is actually available. Once more details become available about how and when to access PrEP on the PBS, VAC and other groups will work to publicise those details.
Because there’s still a lot of confusion about PrEP, it may help to talk to others who are interested in it or already taking it. Fortunately, there are several groups that have sprung up in Victoria that can help answer some of your questions about PrEP, as well as providing information on how to get it.
PrEPd for Change provides extensive information about PrEP, including how it works, how to get it, and how to talk about the stigma and misconceptions a lot of people have about it. There’s also a section for prescribers to help them provide better information and care to people who want to get PrEP.
PrEPaccessNOW also provides information, and has set up an easy system for importing PrEP from overseas.
If you’re a trans guy who has sex with guys, the group PASH.tm provides extensive information about PrEP specifically for trans guys. They also have information about safer sex and HIV prevention on their website.