In this episode we talk to Dr. Sean Kelly, Assistant Professor in the Division of Infectious Disease at VUMC, about pre-exposure prophylaxis (PrEP). PrEP is a medication regimen to prevent transmission of HIV in high risk populations.
Welcome to this edition of the Vanderbilt Health and Wellness Wellcast. I'm Shaina Farfel with Occupational Health. Today, we are speaking with Dr. Sean Kelly, Assistant Professor of Medicine in the Department of Infectious Disease. Hi, Dr. Kelly. Thanks so much for being with us today. There is a new acronym in town, "PrEP," which stands for pre-exposure prophylaxis. We are starting to hear about it in commercials, we are starting to read about it in magazines, but a lot of people may still be in the dark about what it means. So, can you explain to us what is pre-exposure prophylaxis?
Dr. Sean Kelly: Yeah, of course. So, it is actually not that new. It has been around for about six years, believe it or not. Pre-exposure prophylaxis, or PrEP, is a strategy to prevent HIV in those who are at high risk for HIV. The HIV prevention component is a medication. It's a combination of two medications that we have been using to treat HIV itself for many years now, but really found out that it was effective at preventing HIV and those who are at high risk since about 2012. So, it has been approved and available since then. The uptake has been pretty sluggish, I think especially here in the southeast.
Shaina Farfel: How does PrEP work? How does it prevent the spread of HIV?
Dr. Sean Kelly: Well, it works more on a population level. So, using these two medications to treat HIV, it can actually prevent the establishment of an HIV infection in somebody that is exposed to it. The drug has to be present in the system, though, at a therapeutic level. In other words, the patient has to be adherent to the medication and has to take it seven days a week to really get the fully benefit. By preventing patients at high risk from acquiring HIV, they can therefore not transmit HIV. It was estimated that, if we improved our PrEP uptake and covered up to 80% of patients who are at high risk for HIV in a high-risk area, we could probably reduce HIV in that area by 50% over a couple of decades.
Shaina Farfel: So, it sounds like PrEP is pretty effective at preventing the transmission of HIV. Does it prevent the spread of any other sexually-transmitted infections?
Dr. Sean Kelly: It doesn't and that is really a key concept for anybody that is going to go on PrEP. So, when it comes to HIV, it is phenomenally effective, more effective than any strategy we have ever had before. But true, it does not prevent the spread of gonorrhea, chlamydia, syphilis, HSV, and so barrier protection absolutely have to be employed to prevent the spread of those as well.
Shaina Farfel: What makes someone a good candidate for PrEP? Who would we give this medication to?
Dr. Sean Kelly: What I tell prospective PrEP providers, and patients, too, is that your common sense is one of the most important tools in deciding if a patient is a good PrEP candidate. You know, the Centers for Disease Control and Prevention have criteria for potential PrEP candidates. I think the criteria are a bit stringent, but, you know, in real life, there are patients that are at high risk for HIV but haven't met those criteria that, you know, need protection when it comes to preventing HIV. So, you know, I tell people that if you think your patient is at high risk or will be at high risk for HIV, that is the most effective tool in determining if the patient is a potential candidate, or similarly, if a patient comes to you worried about HIV, hasn't had any potential exposure in the past, you know, six months to a year, but may, I think that should be taken seriously as a good PrEP candidate.
Shaina Farfel: As we are thinking about PrEP, what are some of the potential side effects, some things that patients may need to weigh when deciding whether to take it?
Dr. Sean Kelly: So, the most common side effects are pretty self-limited, as you could imagine with any antibiotic - sort of GI intolerance, some low-level nausea, loose stools. Patients report fatigue, headaches, insomnia, or hyperinsomnia. I see that probably in about 2 out of 10 patients, any one of those, and some of the big PrEP studies reported these self-limited side effects occurring in 2 to 18% or so. Some important long-term side effects that are important for patients and providers to know about: The first is loss of kidney function. This is something that you should really be more concerned about in those who have underlying kidney disease or those who are on other medications that can affect kidney function. The second long-term side effect is loss of bone mineral density, and this is really due, and so is the kidney function issue,to one medication, the one drug in Truvada, tenofovir, or TDF. It is great for PrEP because it concentrates all over our bodies and concentrates in sites of HIV transmission, but it also concentrates in places we don't want it, like our kidneys and our bones, and so it can eventually lead to loss of bone mineral density in probably most patients. Coming off of Truvada, bone mineral density will recover 100% in most patients at any age group. So, it is another reversible side effect.
Shaina Farfel: One of the most important questions - where can patients access the PrEP treatment, and too, how much does it cost? Is it covered by insurance?
Dr. Sean Kelly: What I refer patients to is a website called preplocator.org. This is an Emory-powered website that PrEP providers nationally can register themselves onto and patients can put in their area code or their city and find a PrEP provider near them. Now, how much does PrEP cost? Now, that is sort of a complicated question. Like with any nongeneric medication, there is a reported average wholesale price that is astronomical but not actually realistic. So, that price for Truvada is about $25,000 per year, but that is not what patients actually pay for it. Virtually, all insurance does cover, including federal insurance. The co-pays, however, are sort of all over the board. The beauty of co-pay assistance programs, though, is that most patients pay nothing for it. You know, there are also resources for patients that don't have insurance. There are drug company programs, medication access programs, that are also pretty easy to roll into, that cover the entire cost of the drug for under or uninsured and undocumented patients, too.
Shaina Farfel: Finally, if there was a healthcare provider who was interested in maybe starting to prescribe PrEP, but felt like they needed a little bit more education or training, do you have any recommendations for them?
Dr. Sean Kelly: Reach out to me. You know, I do a lot of PrEP education with the Southeast AIDS Education and Training Center, which is based here in Vanderbilt, and we sort of run education in the surrounding states, and we would be absolutely happy to come to your clinic, come to you, invite you to an event, anything like that. But if you are looking for more online resources or printouts, I would recommend going to the CDC's PrEP Campaign. They updated this just a couple of months ago. If you Google "CDC Act Against AIDS," I believe it is "Prescribe HIV Prevention," it should take you to their program, which has sections for patients and providers. One thing I really like about it is if you go to the patient section, it has all the drug assistance programs listed in one spot, and so that would be a great go-to for you. There is also great infographics and I love infographics, especially for PrEP, that you can print out.
Shaina Farfel: Thank you so much for your time today. I think our listeners will benefit greatly from all of this information. We really appreciate it.
Dr. Sean Kelly: Absolutely. Thank you for having me.