Why Aren't More People Using the HIV Prevention Pill?

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It has been shown that the daily use of the antiretroviral drug, Truvada, can significantly reduce the risk of infection in HIV-negative individuals in a serodiscordant relationship (i.e., where one partner is HIV-positive and the other is HIV-negative). The strategy, known as pre-exposure prophylaxis (or PrEP), has been shown to reduce transmission risk by anywhere from 62 percent to 75 percent if taken with consistent, uninterrupted adherence.

From a statistical viewpoint, the figures strongly support the use of PrEP as part of an overall HIV prevention strategy. However, from a real-life perspective, the numbers may not be all that convincing, with the words "consistent" and "uninterrupted" presenting potential barriers to those who might otherwise enlist.

In fact, according to industry research, only 1,774 people in the U.S. had filled prescriptions for Truvada for PrEP between January 2011 and March 2013. By July 2016, that figure had grown to around 76,000. That's still an arguably modest figure given that 50,000 new HIV infections are estimated to occur in the U.S. every year.

The figures bring into the spotlight many of the issues that make PrEP ideal in a research setting, but less so when placed in the context of the real world. And it's not simply an issue of education or awareness (although these are key factors). Clearly there's something else going on.

The Impact of Price and Adherence

A 2012 survey conducted by the U.S. Centers for Disease Control and Prevention (CDC) concluded that more than a third of the HIV-positive Americans on antiretroviral therapy (ART) are unable to maintain daily drug adherence—and this for a HIV population where adherence relates to directly to duration and quality of life.

Can we expect the barriers to be any less for people who take ART not for "survival" per se, but for HIV prevention? After all, while condoms are known to provide far greater protection, statistics show that they are used in only two out of three sexual acts at best.

So while some might ask, "How difficult can it be to take one little pill a day?", most research shows that daily adherence may be a too formidable hurdle to overcome. Consider that chronic medication for diabetes or heart disease requires as little as 70 percent adherence (or the equivalent of nine missed doses per month). By contrast, PrEP demands near-perfect adherence in order to achieve the protective goals.

Several recent studies confirm the challenges. In 2013, the VOICE Study—which looked at the use of PrEP among 5,029, at-risk African women—was declared futile when it was shown that only 30 percent were able to maintain daily adherence to therapy. Similar results were seen in the FEM-PrEP Study, which was also discontinued due to low adherence rates among those taking daily Truvada.

In light of these studies and the lower-than-expected numbers of PrEP registrants, greater emphasis may need to be placed on targeted education, whereby people in serodiscordant relationships (including those wanting to conceive) are advised about PrEP as a course of general family practice, rather than just in a specialized HIV setting.

Policy makers may also need to assess whether the cost of PrEP, estimated to be around $12,000 per year, may be a limiting factor for those with insurance plans that do not fully cover its use.

In a 2013 survey of U.S. and Canadian infectious disease specialists, 74 percent supported the use of PrEP on a population-wide basis. However, of this group, only 9% actually prescribed it to patients.

It is hoped that recommendations made by the CDC in May 2014, calling for the use of PrEP in populations considered at high risk of infection, will increase lagging enrollments in the U.S. Groups targeted by the CDC include:

  • men who have sex with men (MSM) who do not use condoms;
  • HIV-negative individuals who regularly have sex with an HIV-positive person;
  • injecting drug users (IDUs), and;
  • heterosexuals who have sex with high-risk partners.
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  • Microbicides Trial Network (MTN). "MTN Statement on Decision to Discontinue Use of Oral Tenofovir Tablets in VOICE, a Major HIV Prevention Study in Women." Press release issued September 28, 2011.
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