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Previous preventative measures, such as using condoms for sex, have not been sufficient to stop the spread of HIV & AIDS. PrEP, a new medical option for HIV/AIDS prevention available in the form of a pill, may be available here in Europe sometime soon. That’s good news for people at greater risk of HIV infection, since they now have additional options for protecting themselves.
This flyer aims to help you decide whether PrEP is the right choice for you and which form is best. Even if you’re simply interested in the topic, you will find relevant information here.
WHAT IS PrEP?
PrEP is the use of anti-viral agents to prevent an HIV infection (only the HIV-1 subtype, which occurs almost entirely in Europe and the USA).
When using PrEP, substances are taken regularly or on a case-by-case base before any possible sexual contact. This is a combination of the same substances that are taken during treatment by people with HIV. One currently very widespread combination of these active agents is Truvada®, which combines two active agents in one pill and only rarely causes any significant side effects.
PrEP is not a morning after pill, a vaccination against HIV, or a cure. It should not be confused with post-exposure prophylaxis (PEP), which is taken after a situation in which unprotected contact occurs in order to attempt to prevent an infection.
Currently, no medical compound for PrEP has been approved or been submitted for approval in the EU or Switzerland. However, in France public health insurances cover the cost from 1st Jan 2016. In the USA, public health authorities and some insurance companies have assessed PrEP to be effective, thus promoting its use and covering the costs of the medication. The FDA (Food and Drug Administration) officially approved Truvada® for preventative use in 2012. Even though it may yet be a while before it becomes available here in the EU, a small but growing number of people have already started using PrEP. At the same time, knowledge of it is not particularly widespread. What’s certain is that PrEP will soon be used more frequently – with or without official approval – by individuals who want to protect themselves against HIV both in combination with and without condoms.
PrEP can be taken regularly (daily) or for just a few days. Studies have shown that both methods are effective. You are safely protected if you take PrEP every 24 hours. A planned, short-term use before possibly risky situations, like special weekends, can also be a practical and affordable form of protection.
For both kinds of PrEP, it is important to remember that for every dose you forget, protection is reduced!
HOW EXACTLY DOES PrEP WORK?
In order for the HIV virus to reproduce in the body, it has to constantly replicate its genetic material (RNA) in the genetic material of human cells (DNA). The virus must first rewrite its genetic information in human form in order to do that. That’s done with a tool that HIV brings with it: the reverse transcriptase enzyme. The active agents in PrEP block this process by integrating false components into the DNA. That prevents the virus from reproducing. Because the active agents remain in the blood and anal mucosa along with other places for longer periods of time, the virus is no longer able to integrate its genetic information into human cells and disappears from the body, unsuccessful in its attempt to convert its genetic information into human DNA.
WHY IS EVERYONE TALKING ABOUT TRUVADA® FOR PrEP?
Truvada®, which contains the active agents known as emtricitabine FTC and tenofovir TDF (manufactured by Gilead), is currently the most widely available medication for PrEP. Since all studies until now have only been done with Truvada®, information is only available for this specific medication, however we intend to discuss the results of these studies without advertising or endorsing a specific pharma-ceutical product. In the coming years, Truvada® (or a generic, pharmaceutically reproduced pill) will be used, even if other combination preparations (medications with more than one active agent) that are also potentially effective against HIV would work as PrEP.
HOW SAFE IS PrEP?
Long-term use of PrEP has been proven to be effective. When taken daily over long periods of time, the risk of HIV transmission is reduced by 90% to 99% (based on the average risk of infection during unprotected anal intercourse). Although this value varies somewhat from study to study, it indicates that consistent use of PrEP offers as much protection as the correct use of condoms (risk re-duction of about 95%) or protection through treatment (virus at undetectable levels: 96% risk reduction). What’s important to remember is that every time a dose is forgotten, the protection that PrEP provides is reduced. A short-term PrEP dose (see below for details) statistically reduces the risk of HIV transmission by about 86%, which is still a considerable amount. This number may sound relatively low, but if you don’t use condoms or don’t use them all the time, it’s still a better option than no protection against HIV at all.
HOW IS PrEP TAKEN?
The manufacturer of Truvada® recommends the following for long-term use as PrEP. Take one pill at the same time daily:
For short-term PrEP, participants of the IPER-GAY study took two pills between 2-24 hours before potentially being exposed to HIV, and then one pill every 24 hours for up to two days after.
Dosage recommendation for Truvada®, short-term PrEP (IPERGAY Study with male participants, who have sex with other men.)
Before starting PrEP, you must be sure that you’re not already infected with HIV by being tested regularly! It is also important that you have your blood levels checked beforehand and every three months after starting treatment. The creatinine levels in your blood are the most important to pay attention to, because they indicate how well your kidneys are functioning (see Side Effects below).
You should have yourself tested for other sexually transmitted infections (STIs) at the same time. If you take Truvada® during meals, you can increase the intake of contained tenofovir in your body by about a third.
Once again: Taking the medication regularly is the decisive factor in its effectiveness! Taking it daily will likely be the most practical and effective form of PrEP. Only you will be able to find the right variation that works best for you.
SIDE EFFECTS INTERACTIONS
When Truvada® is taken for PrEP, it may cause nausea, fatigue and headache. When its use is discontinued, any side effects experienced will completely disappear over time. In rare cases, Truvada® can reduce bone density or cause kidney damage. You should never take it without consulting a doctor, especially if you have a history of kidney problems. Additionally, the lactose contained in the medication may also cause a problem for those with lactose intolerance.
You can learn about interactions with other medications by consulting a doctor, or from the package leaflet. Truvada® cannot be taken in combination with adefovir dipivoxil (Hepsera®).
Alcohol and other drugs do not limit the effectiveness of PrEP with Truvada®. However, consuming them simultaneously can put further strain on your metabolism, liver and kidneys.
There are claims that HIV can be more easily transmitted when another STI is already present. PrEP also effectively inhibits the transmission of HIV in this case.
WHERE CAN I ACTUALLY GET PrEP?
Truvada® for PrEP is only available in the EU with a private prescription (off-label use) because insurance companies will not cover the costs. Due to the current lack of official approval, doctors will prescribe PrEP at their own risk (and even then only rarely).
Nevertheless, people continue to find creative ways of getting the medications. Truvada® or generic medications with the same active agents, like Tenvir EM® (licensed by Gilead), are purchased inexpensively while on vacation. Allegedly they can be purchased in Indian pharmacies for less than 10EUR for a month’s supply. Tenvir EM® can also be purchased online for 60EUR and sent to Western European countries. But be careful: Problems may arise with customs due to patent protections, even for amounts intended for personal use only. Pills prescribed for PEP are also taken as PrEP though this is actually not permitted.
Aside from the danger of receiving placebos, fraud or problems with customs, the fundamental problem remains: getting pills in the necessary amounts for long-term use is very difficult. Approving medicines for PrEP and covering their costs would allow people with average or low incomes to use PrEP as well.
WHAT ARE THE ACTUAL COSTS?
The costs for PrEP are the combined costs of medical consultation, lab tests and the medication itself. A monthly supply (for long-term PrEP) of the medication costs about 820EUR a month in Germany and about 900CHF in Switzerland. When Gilead loses its patent protection, prices could fall by as much as 20%, which would still be too expensive for private purchase. The savings for insurance companies when financing PrEP would still be quite significant. Just think about the costs of a lifelong HIV treatment.
WHAT ARE THE PROS AND CONS OF PrEP?
If you’re thinking about starting PrEP, then you have to be fully aware of the decision you are taking.
PrEP only works correctly if you take it regularly. Condoms also only work if you choose to use them. What’s certain is that condoms don’t work at all if you forget to use them. If you forget to take your PrEP for a day, the chance for protection is not completely gone, although it is reduced.
The use of a condom may be neglected while under the influence of alcohol, other drugs or if you’re just lost in a moment of love – but a PrEP that was taken, when you were sober still works!
Unlike condoms, PrEP offers no protection against other STIs. However, condoms (during oral intercourse or other contact with bodily fluids) don’t protect against all STIs either. PrEP is also a good method for people who already don’t use condoms or who use them irregularly or incorrectly, and therefore may not be protected from other STIs anyway. An important advantage of a regular PrEP treatment is that during the necessary regular lab test (every three months) you can also be tested for any other STIs (which doesn’t always happen automatically). That way they can be detected and treated early.
With PrEP, you have control over your own protection from HIV because you’re the one who’s responsible for using it correctly. Talking about safe sex beforehand is still important.
You may have had a hard time addressing the topic of safe sex in the past and ended up taking risks without proper protection. Trying PrEP may allow you to have more enjoyable sex without feelings of fear and guilt afterwards. This kind of psychological relief may allow you to speak more openly about protection from HIV and other STIs. It may even make certain situations with condoms less stressful! The different options for safe sex shouldn’t be in competition with one another. They can be combined and in many situations, just one method is enough.
There’s no reason, whether political, financial, or other, to prevent people from deciding to use PrEP, and taking control of their health and well-being. For that reason, many institutions have recommended introducing PrEP to the EU, such as the WHO World Health Organization, the ECDC European Center for Disease Prevention and Control, the association of German HIV specialists (dagnä) and the national German AIDS organization (Deutsche Aids-Hilfe), just to name a few.
WHAT HAPPENS IF I UNKNOWINGLY HAVE HIV AND TAKE PrEP?
If you’re HIV positive and take PrEP, you’re not getting all you need to successfully treat HIV, as the virus may not be kept at undetectable levels (currently the measurement for a successful HIV treatment). Taking Truvada®, which combines two active agents, is sufficient for an effective PrEP treatment, but an HIV treatment requires additional medication. That’s why having an HIV test is absolutely necessary before starting PrEP! That means a dependable (and anonymous) test at a healthcare institute or a community testing station. A home test alone is not enough.
It’s also possible that resistance to medicine used for PrEP may form, though this has not been frequently observed in studies. Truvada® is not associated with this sort of resistance. Both of the active agents present in the medicine have a particularly long half-life period in the body and display a high level of protection, even when doses are occasionally forgotten. However, this is not particularly relevant for people who are HIV negative because no virus is present that could form a resistance.
WHO REALLY NEEDS PrEP?
PrEP is recommended for people who are at a high risk for HIV infection. Only you can answer the question of whether or not you belong to this group. If you can’t or don’t want to use condoms, if you’ve had an STI in the last year or an anal STI, if you find the topic of safe sex scary or hard to talk about, or if you’ve found yourself doing things during sex under the influence of drugs that you wouldn’t otherwise do, then PrEP is a good option for you to consider, if only to increase your chances of protection for exposure. In the end, that question can only be answered by you personally: Simply wanting to have more fun and enjoyment during sex – without a condom – is a legitimate enough reason to decide to start taking PrEP. Everyone should have the right to expand his/her possibilities for their personal freedom.
WHAT WILL HAPPEN WITH PrEP IN THE NEAR FUTURE?
Fundamental research on medications will undoubtedly open up new possibilities in the near future. In this way, monthly or quarterly PrEP treatments in the form of an injection may be developed. Research is also being done on a local version of PrEP that can be applied as a gel in the places that the virus can enter the body (vaginal or anal area). We can expect more effective active agents with less side effects on the market soon, though they might be more expensive. Because PrEP is such an important building block for ending the HIV crisis for good, we’re calling for the immediate approval of suitable medications!
WHERE DOES THIS INFORMATION COME FROM?
The two large European studies, the PROUD study based in England and the IPERGAY study based in France, provide us with the first important findings. You can read more about that in our link list. We also have collected available info about PrEP from the Internet and events.
We’ve had intense discussions about what this new information means for our lives and future. We believe that it’s so important that we have made it available for anyone at a high risk of HIV infection and anyone else who may be interested. You can find all links to studies and sources on our website.
WHERE CAN I FIND MORE INFORMATION?
and in German:
and the ‚PrEP 2015‘ pdf:
“Effectiveness & Availability” at hivreport.de (02/2015) and information about the PROUD, IPERGAY and IPREX studies on the Internet.
If you want to talk to someone about PrEP, contact the following (english speaking):
Mancheck in Berlin
+49 30 44668870
Checkpoint in Zurich
+41 44 455 59 10
or your local AIDS Service Organization (Aids-Hilfe).