It’s been called, simultaneously, a medicine to “end the HIV epidemic” and a “party drug:” Pre-exposure prophylaxis, or PrEP for short, refers to a daily antiviral treatment that prevents HIV.
That’s right: People who don’t have the virus can take a pill a day to save themselves from getting infected.
Haven’t heard about PrEP? You’re probably not alone. The drug-maker, Gilead, doesn’t advertise Truvada (its brand name) for prevention, and the Centres for Disease Control and Prevention only endorsed it this past May—two years after it hit the market.
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Going forward, however, you’ll be hearing a lot more. On Friday, the World Health Organization backed the antiviral, recommending all HIV-negative men who have sex with men consider taking it as part of a strategy to reduce the global incidence of the disease. But there’s a lot more to the story. Here’s what you need to know:
1) Public health officials aren’t recommending this pill for “all gay men,” despite what the headlines say
The pill is “for people who do not have HIV but who are at substantial risk of getting it,” according to CDC guidance. “At substantial risk” means you regularly have unprotected sex with partners of unknown HIV status. This can include men who have sex with men, heterosexual men and women, injection drug users, sex workers, and people in couples with an HIV-positive partner. In other words, not simply “all gay men.”
The latest headlines about Truvada were so misleading that the WHO had to issue a clarification noting that they support PrEP “as an additional choice”—again, not for all men who have sex with men.
“We know from surveillance that condom use is not as high as is necessary to control the epidemic”
2) Truvada is not a condom replacement
Public-health officials are not endorsing Truvada as an alternative to other forms of protection. “We are suggesting that for people who are already not using condoms, we have another option to help protect them from HIV infection,” says the CDC’s Dawn Smith, biomedical interventions implementation officer. “It’s part of being practical and realistic.” So the hope is that those who get prescriptions are folks who just aren’t using anything to protect themselves. “We know from our surveillance systems that condom use is not as high as is necessary to control the epidemic,” Smith added.
3) We don’t yet know exactly how the drug will be used in real life
Still, this public-health message hasn’t stopped some activists and AIDS campaigners from worrying aloud that the pill will undermine traditional advocacy messages about condoms—especially at a time when HIV infections are on the rise among gay men. And the truth is, we don’t yet know what kind of impact PrEP will have on people’s behaviour.
To find out, there are now “demonstration trials” being run around the world. These will look at how Truvada works outside of clinical trials, the impact of non-daily use of the drug, and whether the antiviral encourages more risky sexual behaviour or leads to an increase in other sexually-transmitted infections.
4) We do know Truvada only works effectively when taken every day
A three-year clinical trial of PrEP in HIV-negative men who have sex with men found that users got much more protection when they took the drug every day. Participants who took the drug less than half the time had a 50 percent reduction in HIV acquisition; daily users cut their risk by more than 90 percent. These results have been supported by other studies in a range of populations—from injection-drug users to heterosexual men and women. The trouble is, most people don’t take their medications as their doctors prescribe.
Drug-resistant strains of HIV have emerged when people with acute, undetected infection were given Truvada
5) Truvada can cause drug-resistant HIV infection
Drug-resistant strains of HIV have emerged when people with acute, undetected infection were given PrEP. This means they were positive when they started the medicine, but levels of the virus in their blood were hardly detectable because their infections were so new. They hadn’t made enough antibodies to show up in a test and so they were prescribed the drug anyway.
There’s some question about how serious this risk is for individuals and public health. For now, doctors are asked to confirm the HIV status of patients and to do follow-up and re-testing throughout treatment.
When asked how much of a concern drug resistance is, Smith of the CDC said, “We don’t know yet. That’s one of the things we’ll learn as the first few demonstration projects begin telling us.”
6) Besides that, it’s pretty safe
Though Truvada for the prevention of HIV was only licensed by the Food and Drug Administration in 2012, it was first authorized in 2004 to treat HIV positive patients. That’s right: the same drug used for these two purposes. Since it has been on the market as a treatment for over a decade—with very minimal side effects and harms—doctors are pretty confident in its safety profile for preventative use. There seem to be few side-effects with Truvada for prevention, the most common one being nausea.
People have been slinging the term ‘Truvada whore’ around, and the head of the aids healthcare foundation called the pill a ‘party drug’
7) “Truvada whores” are a thing
Because of the questions about whether PrEP will cause people to have risky sex and ditch condoms, there’s some related stigma in the gay community. People have even been slinging the term “Truvada whore” around, and the head of the AIDS Healthcare Foundation called Truvada a “party drug.” In response, one PrEP activist created a #TruvadaWhore t-shirt campaign to reclaim the word.
Many have pointed out that this divide parallels the early days of the birth control pill and suggestions that the medication would encourage promiscuity.
8) Uptake has been slow—but that’s not the full story
According to data from the drug maker Gilead, by March 2013 there were approximately 1,774 people in the US taking the drug. But it’s important to put this number in context. First of all, these findings were not published and peer-reviewed; they were presented at a scientific conference last year. When studied, we’ll have a better picture of the PrEP landscape and it may look quite different. Secondly, Truvada has only been on the US market for prevention since 2012, a year after these numbers were gathered. It often takes decades for innovations to penetrate a market, especially in the conservative field of medicine.
9) The drug is expensive
Without insurance, Truvada can cost up to $14,000 a year, according to the CDC. But for most people, it is covered in their insurance programs and there’s only a co-pay. There are also medication assistance programs across the US for the uninsured that will cover the entire cost of the medication.
10) HIV remains a socio-economic crisis around the world
Globally, men who have sex with men, prisoners, injection-drug users, and sex workers are still the groups most affected by HIV.