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PrEP: Red Flags

Posted on January 29, 2011 by in Left Field, Noteworthy

Left Field by Patricia Nell Warren

Media Exposure Surrounding Pre-Exposure Prophylaxis Needs a Life-or-Death Reality Check.

We can always count on many of the media to give us a rosy once-over-lightly about the latest in HIV products. Why do they do this, when they’re supposed to give us the pro-and-con analysis that has traditionally been expected of journalism? One reason why: In magazine and newspaper publishing, recession downsizing has led to hiring young low-salaried writers and editors who have little or no background in the screaming need to investigate medical stories.

The latest media burbling is all about PrEP. Pre-exposure prophylaxis is defined as the daily use of ARVs by HIV-negative persons who worry that their relationships or sex activities might expose them to HIV. They could be partnered with someone who is HIV-positive—or sex workers, or party animals who rack up hundreds of sex adventures a year. Right now, two ARVs are being scrutinized in clinical trials as candidates for oral PrEP against HIV-1: Viread (tenofovir disoproxil fumarate) and Truvada (a combination drug that contains emtricitabine and tenofovir). Some clinicians are already prescribing them for PrEP off-label.

Recently the New England Journal of Medicine published a report on the so-called iPrEX study, a clinical trial claiming that Truvada reduced the risk of HIV infection by 43.8 percent in a large cohort of men and transgender women who have sex with men. Right away, the babbling brooks of uncritical news stories were flowing. As I read through them, I noted that many garbled what the NEJM story said. Some omitted mention of the transgender women; others misquoted the final stats. A few publications even copycatted chunks of prose from one another. But few mentioned any downside to PrEP. Even the government’s NIH News announcement was slanted to the overwhelmingly positive—it quoted Anthony Fauci as saying that PrEP “has the potential to make a significant impact in the fight against HIV/AIDS.”

Few media mentioned that PrEP can impact a person’s wallet too. Given the implosion of our healthcare system, few U.S. service orgs and healthcare plans will likely cover PrEP. According to a 2008 study published in Journal of Acquired Immune Deficiency Syndrome, two-thirds of the gay and bisexual men surveyed said they would go for PrEP if they thought it was safe and effective. So daily Truvada treatment may cost each of these men as much as $14,000 per year. Even in developing countries, Viread can cost over $5,000 per person per year. No wonder the whole concept of using HIV drugs on HIV-negative persons is being viewed as a source of new profit for pharma companies.

Fortunately, some seasoned media experts did take a more skeptical look. One was Sean Strub, founder of POZ Magazine. In an 11/23 e-mail to commentator Rex Wockner that circulated widely on-line, Strub said, “What is noted in the New England Journal of Medicine article, but not in many of the glowing press releases from various AIDS, public health and government agencies, is that the finding of a 44% reduction in PrEP vs placebo has a pretty wide Confidence Interval (15% to 63%). If you don’t use a condom, allowing for the best statistical interpretation, a 44% reduction in infection (over only 1.2 years) is just nowhere near good enough….It is tragic that the tone and shallowness of the press coverage will almost certainly lead some to start using PrEP without understanding how risky it is as a stand-alone HIV prevention strategy.”

Red flags for PrEP can be seen waving right in the medical literature. For instance, some PrEP users will probably feel “safe” enough to push the envelope on personal risk. In a recent issue of AIDS Reviews, researchers at Rotterdam’s University Medical Centre pointed out: “Any efficacious HIV prevention strategy can lead to behavioral disinhibition, in which a reduced fear of HIV leads to increasing risk behaviour.” Some experts pooh-pooh this concern. Others are not so sure.

The risk route can also include self-medication. Technically, tenofovir and Truvada can be purchased only with a doctor’s prescription. But anybody who Googles can find both drugs sold from on-line pharmacies without a prescription. According to the blog Rod 2.0, tenofovir is available on the street as part of a “party pack” with Viagra and crystal meth. A single dose of tenofovir is popped by those who aim to have a good time but know that risk might happen before the night is out. They assume that one dose will protect them against HIV. Rod 2.0 calls these party packs “a trail mix that encourages unprotected sex.”

Burbling media stories often omit mention of possible side effects. But the medical literature links Truvada with kidney problems, bone problems, and lipodystrophy. Some can be fatal, including lactic acidosis, which happens when lactic acid builds up in the bloodstream faster than it can be removed. According to RxList (owned by WebMD), “Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness; numb or cold feeling in your arms.” True—other drugs can cause lactic acidosis as well. However, it’s important to get fully informed on the possible effects of each and every specific drug we put into our bodies.

The maker of both drugs, Gilead, adds this caution: “Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with HIV-1 and HBV who have discontinued Truvada.” Gilead also notes similar exacerbations with Viread, even though Viread has actually been FDA-approved for treating HBV. Translation: an HIV-negative MSM who leaps into self-PrEPing with Truvada without a doctor’s oversight, and happens to have undiagnosed hepatitis B, might be at risk for a monstrous HBV flare-up when he stops his self-treatment with Truvada.

The same MSM might be at risk if he self-medicates with PrEP while also taking other drugs with the same or similar ingredients, thus doubling his risk of side effects.

Last but not least, the media burblers seldom mention drug resistance. Conventional wisdom would insist that, if you aren’t HIV-positive, using HIV drugs won’t cause resistant strains to develop in your system. But according to the National Alliance for State and Territorial AIDS Directors (NASTAD): “Much is unknown (and will remain so until PrEP has been used for some time) about the possible development of drug resistance from its use.” The NIH News report mentioned some instances of Truvada resistance that surfaced during the iPrEX study.

So those who launch into long-term PrEP may be doing the same kind of borrowing, medically, as Americans who borrow financially against the equity in their home. It’s nice to have the extra money today—but tomorrow, when you may suddenly need your home equity, it may be reduced…or even gone.

The point is—how many people who self-medicate actually bother to read any medical literature before they leap? Given the thirty-second-sound-bite attention span of most Americans today, many are likely to zoom into PrEP after skimming the once-over-lightly in the news media.

Given the unknowns, people should be asking themselves these questions—and others as well—if they’re considering PrEP. And the media should be urging people to find that life-or-death information.

Further reading:

NIH News story on NEMJ article
http://www.niaid.nih.gov/news/newsreleases/2010/Pages/iPrEx.aspx

NASTAD info November 2010
http://nastad.org/Docs/Public/Resource/20101123_PrEP%20Issues%20for%20Consideration.pdf

Author of fiction bestsellers and provocative commentary, Patricia Nell Warren has her writings archived at www.patricianellwarren.com. Reach her by e-mail at patriciawarren@aol.com.

January 2011

Copyright © 2011 by Patricia Nell Warren. All rights reserved.

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