Getting to Know PrEP (Pre-Exposure Prophylaxis)

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1 (Pre-Exposure Prophylaxis) What is PrEP? Prep stands for Pre-Exposure Prophylaxis: a medication that was recently approved by the FDA for daily use that can help high-risk patients who are HIV negative continue to stay negative by reducing the chances they could become infected with HIV, the virus that causes AIDS. How does PrEP work and what does it involve? Patients will be thoroughly screened to determine if they are a good candidate for PrEP. Those who qualify (see below) will be given a prescription to start taking a daily medication. This pill, called Truvada, is actually two different drugs combined into one pill, and has been used since 2004 to treat those who are HIV positive. It was approved by the FDA during the summer of 2012 for use in patients who are HIV negative but are at high risk of being exposed or infected. Research has shown that when Truvada is taken daily and combined with the use of other sexual safety precautions, it can significantly reduce a person s chances of being infected with HIV. In addition to the initial visit and taking the medication daily, PrEP patients will need to return to their provider about every three months (90 days) for follow-up care that will involve needed bloodwork, HIV and STD screenings, assessment of any negative side effects and providing patients with a new prescription to refill their medication. How do I know if I am someone who should get a prescription for PrEP? A medical provider who has a full understanding of your sexual risk can help you decide if PrEP is right for you. Based on current research, Truvada has only been approved to prevent infection among HIV negative adults (over age 18) who are considered very high risk for HIV infection through sexual contact. More specifically, the use of Truvada for PrEP is most recommended for key populations such as: HIV negative men who have sex with men (i.e. gay and bisexual men) HIV negative heterosexual men and women who are in a relationship with an HIV positive partner To make an appointment for PrEP, call and push 1 for Clinical Services. 1

2 Is PrEP safe? Are there any risks to consider? As previously mentioned, Truvada is not a new drug. It has been used globally and safely for a number of years. However, with any medication, there is a risk of medication side effects. Many patients who have taken Truvada have reported little to no significant side effects, but every patient s experience will be unique. A provider who is experienced with PrEP will be able to educate you about side effects and address any problems or questions you may have prior to and while you are taking the medication. For more information on side effects, visit: How long does a person have to take this medication? A patient taking PrEP medication should never stop taking their medication without first talking to their provider. Researchers current understanding is that a person who is taking PrEP should continue to do so daily for as long as they remain at high risk of sexual exposure and remain HIV negative. This is why it is important to have regular visits with the provider who prescribes PrEP for you. At some point, if they find you have become HIV positive, they can immediately stop your PrEP medications and assist you in transitioning into HIV care and treatment which can help control the HIV and keep you healthy. If you believe you no longer need to use PrEP after starting treatment (i.e. a change in relationship status or sexual behaviors/risks), your provider will be able to offer guidance about your options. After a person starts using PrEP is it safe to stop using condoms and or other forms of safer sex? It s very important for patients to know that all current recommendations suggest that patients interested in PrEP should strongly encourage them to take the medication and do one or more of the following to most effectively reduce their risk of HIV: Use barrier prevention (condoms, female condoms, etc.) consistently and especially for anal and/or vaginal sex. Reduce overall number of sexual partners. Get tested regularly for HIV and other STDs and encourage sexual partners to do so as well. Talk openly and honestly with sexual partners about HIV status and about past and present sexual risks. 2

3 If PrEP is effective, who do I still need to use condoms? Although they have not offered any guarantees, most of the findings on on PrEP have been very promising. We still recommend using both condoms and Truvada because the current research suggests that the highest level of protection was observed in HIV negative patients who were using PrEP with condoms. Condoms alone may not be 100% effective for everyone (i.e. breakage, incorrect use or forgetting to use one at all). For those at the highest risk of HIV infection, using just one or the other may not work as well as using both together. That is why the Food and Drug Administration, Centers for Disease Control, and the makers of Truvada have all recommended this medication only be prescribed when paired with patient counseling that supports consistent condom use. To be as safe and healthy as possible, the Community Health Initiatives Department at Trillium Health not only provides patients with safer sex supplies (i.e. condoms, lubricant, female condoms, etc.), but the staff is also happy to meet with patients who are interested in learning more about how to better protect themselves from HIV and other STDs. Contact: LGBThealth@TrilliumHealthNY.org for more information. What happens if I forget to use condoms or miss a pill? Will I get infected? Forgetting to use condoms, even some of the time, might increase your risk and like many other medications, missing doses can lower the drug s chance of working. These are both reasons why doing your best to combine medication and one or more risk reduction behaviors is the key to PrEP s success. Questions or concerns about your ability to take the medication correctly or to continue using safer sex methods are exactly the kinds of concerns where a medical provider who is experienced with PrEP can offer guidance. Talk openly and honestly with your provider so that you can decide together what is best for you and your health. Will my health insurance cover the cost of PrEP? Being a PrEP patient will involve not only the medications themselves, but also the cost of the initial appointment and regular follow up visits and labwork. Most insurance companies will cover the cost of the medical appointments and patient portions of the bill will vary depending on your insurance coverage. Prescription coverage can vary greatly between different insurance companies or plans. As a general rule, many providers will cover at least some portion of the cost of PrEP medications - especially if you have insurance that covers the cost of name brand drugs. Currently, there is no generic or less expensive prescription alternative, so all PrEP patients must take the name brand, Truvada. When insurance covers all or part of the cost you may pay nothing or only your copay. We work very closely with our on-site pharmacy, Pleasant Street Apothecary. Our pharmacists will help you determine if your insurance will cover PrEP. Or you can call your insurance company s pharmacy benefit manager directly to find out if Truvada is covered and at what cost. 3

4 How much does PrEP cost? Patients who do not have any form of insurance will need to pay out of pocket. Cost is an important consideration. We cannot quote an exact price due to medication pricing structures that are determined by a number of factors that can change over time. However, Truvada can currently retail at over $1000 per month. Therefore, any questions or concerns about insurance, ability to pay, etc. will need to be discussed fully with our providers and/or pharmacists. In addition, other options may be available for uninsured patients who are in financial need: A medical assistance program is offered through Gilead (the company that makes Truvada ) and this can help some patients with prescription costs. Patients must qualify and complete a formal application. For uninsured patients with demonstrated financial need, a sliding scale fee might be available for medical appointments only. * *Patients who feel they may require payment assistance or a sliding scale option should discuss that with reception staff and/or a provider before they make their first appointment. If I think PrEP would be a good option for me, where can I get it? Trillium Health has recently expanded our clinical services to provide PrEP services to qualifying high risk HIV-negative individuals. We do initial screening, determine eligibility, prescribe, and provide all ongoing follow-up care. Our onsite pharmacy, Pleasant Street Apothecary, can fill your prescription as well. Starting the process is easy. Simply call the Trillium Health office at When prompted, push 1 for Clinical Services and tell the receptionist you would like to make an appointment for PrEP. What does the PrEP experience at Trillium Health involve? If PrEP is right for you, you will need to have an initial appointment with a provider for screening and to start your prescription. You will then need to be seen every 2-3 months for follow-up appointments, labwork, and to renew your prescription. 4

5 What will happen at my first visit? At your first visit, you can expect: Rapid HIV test with results in 20 minutes (even if you have recently had one elsewhere) Female patients will be given a pregnancy test Meet with the clinical pharmacist to discuss how to take the drug, side effects, and to reinforce the need to take the medication exactly as prescribed Meet with a Trillium Health provider to - Discuss PrEP - Do a brief physical exam - Screen for sexually-transmitted infections - Assess whether PrEP is right for you - If warranted, you will be given a prescription for a 90 day supply of the drug What should I bring with me to my first visit? The receptionist who schedules your first visit can review this information with you, but you should bring the following: Photo ID Card Proof of medical insurance (insurance member benefit card) Prescription insurance card (if separate from medical insurance card) List of medications you currently take (both prescribed and otherwise) List of medication allergies Most recent chart note from primary care provider detailing the following lab results: - Labs including comprehensive metabolic panel and renal function - Immunizations - Hepatitis B status What will happen at the follow-up visits that I come to every 3 months? It is important to remember that follow-up visits are required at least every 90 days to be a patient enrolled in PrEP services. At these visits, you will have the opportunity to discuss how the treatment is going for you, ask any questions you have or address any concerns. You will always be asked to take a new rapid HIV test and have a screening done for other sexually transmitted diseases. Upon completion of your follow-up visits every 3 months, your provider will also renew your prescription for your next 90 day supply of medication if you and your provider determine it is appropriate to continue with PrEP. Additional PrEP info and links: Trillium PrEP information provided by: Erik Libey, Director of LGBT Health Initiatives, Ashley Zuppelli, PharmD, AAHIVP, Clinical Pharmacist, Clint Koenig, M.D., M.S.P.H., M.A. Chief Medical Officer, and William M. Valenti, M.D., Co-Founder and Senior Vice President for Organizational Advancement 259 Monroe Avenue Rochester, NY