I recently read an article published at Aidsmap about the Centers for Disease Prevention and Control (CDC) releasing guidelines for gay and bisexual men in the United States using Pre-Exposure Prophylaxis (PrEP) and I wanted to share this information with you. You might find this article especially interesting if you are an HIV-negative barebacker who is wanting to remain HIV negative for as long as possible. It’s important to state that Pre-Exposure Prophylaxis (PrEP) cannot completely protect someone from HIV transmission because clinical trials found that it may reduce the risk of infection by only 44% and not 100%.

If you’re not sure what Pre-Exposure Prophylaxis (PrEP) is, here is a brief introduction. You may have heard of Post-Exposure Prophylaxis (PEP) which is a program of medication which must be taken within 72 hours of a person being exposed to Human Immunodeficiency Virus (HIV). Pre-Exposure Prophylaxis (PrEP) uses a combination of two drugs (Tenofovir and Emtricitabine) combined into one pill called Truvada, which is taken daily before possible exposure to HIV. In a study which took place in November 2010, it was found that Pre-Exposure Prophylaxis (PrEP) may reduce the risk of infection by 44%.

The Centers for Disease Prevention and Control (CDC) advice is that they are releasing these guidelines at this time because “Concerns exist that without early guidance, various unsafe and potentially less effective PrEP-related practices could develop among health-care providers and MSM beginning to use PrEP in the coming weeks and months.” The interim guidance has been released just a couple of months after the first positive results of a research trial into the approach.

An important note highlighted by the Centers for Disease Prevention and Control (CDC) is that antiretrovirals other than Truvada should not be used for PrEP and that the same daily dosing schedule that was employed in the trial must be followed. The reason for this is that the Centers for Disease Prevention and Control (CDC) is endorsing a model which is very close to the model carried out in the trial setting. This means that a consistent daily dose is required and that irregular dosing is not endorsed. Candidates for PrEP are HIV-negative gay and bisexual men classified as being high-risk.

If you think you might be interested in trying PrEP to reduce your risk of acquiring HIV, then there are a few things you need to know, because it’s not a simple process to obtain the Truvada. The Centers for Disease Prevention and Control (CDC) guidelines state that Pre-Exposure Prophylaxis (PrEP) should only be provided for men who have sex with men, specifically those who are “at substantial, ongoing, high risk for acquiring HIV infection”. It gets more complicated because the guidelines also state that prescriptions should only be given for 90 days at a time, with HIV testing, adherence counseling, sexually transmitted infection check-ups, sexual risk counseling and condoms provided before new prescriptions are issued.

If reading the previous paragraph makes this program seem complicated, read on, because you’re about to find out how much Truvada costs. As Truvada is only approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV and not its prevention, insurance companies are unlikely to pay for PrEP, but doctors are allowed to prescribe Truvada if men have the means to pay for it themselves. The cost for a one month supply of the drug is around $1000, which is in addition to the costs of counseling, side-effects monitoring and medical appointments.

So the cost is a major consideration and you also need to remember that the study found a 44% reduction in the risk of infection and not a 100% reduction. In addition to these factors, clinicians are required to check that the patient is HIV-negative and screened for sexually transmitted infections (STI’s) and have kidney function assessed, as Truvada can sometimes harm the kidneys. This is required every 90 days before a new prescription can be issued including the risk-reduction counseling and ready access to condoms, not just the first time.

As this article only provides a summary of the Centers for Disease Prevention and Control (CDC) findings, please ensure that you read the source document and additional references before making any decisions about whether Pre-Exposure Prophylaxis (PrEP) is something you want to consider. You may also be interested in reading the AIDS Healthcare Foundation’s (AHF) views in their article AHF to Gilead: ‘No Magic Pill’ Ads Warn Against AIDS Drug as HIV Prevention. Gilead Sciences Inc. is the manufacturer of Truvada.

References:

  1. Aidsmap
    http://www.aidsmap.com/page/1625361/
  2. Centers for Disease Prevention and Control (CDC)
    http://www.cdc.gov/hiv/prep/
  3. PrEP Clinical Trial
    http://www.globaliprex.net
  4. Truvada
    http://www.truvada.com
  5. U.S. Food and Drug Administration (FDA)
    http://www.fda.gov/Drugs/default.htm
6 Comments
Red_Phillip March 20, 2011 at 4:26 pm Reply

I am taking Truvada and Isentress for control of HIV. My pharmacy, part of a largish grocery store chain, lists the retail price of my 30 tablets of Truvada as $1,382.99.

The point of view advanced by the AIDS Healthcare Foundation rather significantly distorts the science behind the existing Truvada PreP recommendations, and before making up your mind, I suggest you might find these two posts from Crowolf worth considering:

http://sayencrowolf.net/2011/03/the-truvadaprep-debate-wont-go-away-so-im-going-to-sort-it-out-for-you-hiv-aids/

http://sayencrowolf.net/2011/03/the-mounting-struggle-around-prep-hiv-aids/

Brad Berrigan March 20, 2011 at 5:14 am Reply

Thanks for this information Red_Phillip, I appreciate you sharing both the cost of Truvada at your pharmacy, along with the two links to the Crowolf website on this particular topic. The links you have provided are both excellent articles and I also encourage everyone to read these articles to help get a balanced viewpoint about Truvada and Pre-Exposure Prophylaxis (PrEP).

Daniel March 21, 2011 at 5:49 am Reply

I wrote the above articles, as well as many more on PrEP and Truvada, and AHF isn’t doing much more than fear mongering with their “No Magic Pill” campaign. They don’t present the facts in a proper context, nor do they make a single case for people who could actually benefit from the drug.

Yes, it’s a pill and you REALLY don’t want to forget it, lest you create complications down the road. It’s A pill, not 18 of them. People are not being given the credit for having brains enough to work taking a daily pill into their normal routines.

Yes, there could be physical side effects. Please find me a single pill in all of your doctor’s bag of tricks that doesn’t have the risk of some unintended side effect.

Doctors are well aware that counseling and discussion around risk factors needs to take place when dispensing a prescription for Truvada. It’s not cheap by any means (as pointed out above), and it’s not a bulletproof shield. It’s not being billed as a Magic Pill by anybody other than those against it. If it were foolproof, there’d be scores of people cracking open their piggy banks to come up with the loot to pay for it.

AHF needs to dial it way the hell down and let the studies on this move forward. If there’s even a chance that this can reduce seroconversions, we owe it to ourselves to have it fully examined.

Brad Berrigan March 22, 2011 at 2:43 am Reply

Daniel, thanks for writing the above articles, they are excellent and I encourage all visitors to Brad Bare to visit your site and read them, along with the other articles you have written. You are very passionate about what you write and you also provide balanced viewpoints, which makes your articles even more valuable to readers. I appreciate you visiting and providing your comments here.

Matthew October 26, 2013 at 8:35 pm Reply

Brad, I wanted to give you some updated information about the effectiveness of PrEP. As it turns out, part of the reason for the lower levels of efficacy during the trial turned out to be that people weren’t actually always taking the drug. The results you posted were based solely on the first results and not on the analysis afterward. If people are taking the drug 7 days a week, then PrEP is 99% effective against HIV infection, similar to or actually a tiny bit more effective than condoms (also only when used properly). PrEP 4 days a week yields a 96% effectiveness. But, of course, taking it fewer days starts to get to where people forget to take it on a regular schedule.

Here’s some of the information about this. There’s more out there. http://www.natap.org/2012/CROI/croi_10.htm. I hope you’ll continue to talk about this since I’m sure there are barebackers on your site who are HIV negative. And you have a platform to help continue getting the word out about this potentially health-saving information.

Brad Berrigan October 26, 2013 at 9:41 am Reply

Thank you for sharing this updated information Matthew. I need to update my articles to keep them current and this information if very helpful. I also appreciate the link and I will definitely continue to discuss sexual health articles here, because I agree that it’s important to discuss sexual health and share this important information. I have created a dedicated section at my blog for sexual health articles and shortly these articles will be updated and expanded. Thanks again for this information Matthew, I really appreciate it. 🙂

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