The AIDS Healthcare Foundation has never been a fan of Gilead Sciences, which makes the AIDS drug Truvada. It has held protests outside of Gilead's offices, and has consistently criticized the drug maker, mainly over the cost of its medications. Truvada, of course, is the drug that people can take as pre-exposure prophylaxis, or PrEP. And yes, it is expensive. The cost of taking the pill once a day as an HIV prevention tool can run about $1,300 a month. While Gilead has a patient assistance program to help those who can't afford Truvada, the high cost of the drug has been the subject of ongoing debate among PrEP advocates and others for several years.
The Food and Drug Administration approved Gilead's Truvada combination pill for PrEP in July 2012. The two drugs in Truvada, tenofovir and emtricitabine, have been approved for HIV treatment for more than a decade and are considered safe and well tolerated. Tenofovir can cause impaired kidney function and bone loss in some people, but so far it has shown minimal side effects in PrEP studies.
PrEP got a major boost when a drug trial revealed significant results. The international iPrEx trial found that daily use of Truvada reduced the risk of HIV infection for gay and bisexual men and transgender women by 42 percent overall, rising to more than 90 percent among participants with blood drug levels indicating regular daily use. That last part is important, because as we know, not everyone remembers to take their medications as prescribed. And that's where AHF is resorting to scare tactics and misinformation in an effort to discourage gay men from taking Truvada.
AHF is running an ad in several gay publications – it appears on the back page of this week's Bay Area Reporter – skewing the scientific results. As AIDS reporter Todd Heywood wrote in a piece for HIVPlus.com, AHF wants people to believe that Truvada is "only as effective as baseline results from various studies."
"A baseline finding combines all the results together to come up with an overall efficacy result," Heywood noted. "But those studies found substantial differences between participants with detectable levels of the drug in their blood and those who did not. But science requires that we combine all the groups – adherent and nonadherent – for one overall efficacy rate. AHF would like folks to believe those low numbers are the top line of efficacy, when in fact they are the bottom line of efficacy." In other words, AHF is cherry-picking data from the low end of various studies to try and show Truvada isn't as effective as it is.
There are legitimate discussions going on, largely in the HIV/AIDS and gay male communities, about PrEP. Some men don't want to have to take a pill everyday, some men would rather use condoms. In developing countries, access to PrEP is marginal at best. AHF's misleading ad does nothing to further this conversation. And while condoms, unlike Truvada, are effective at preventing HIV and other sexually transmitted diseases like syphilis, the reality today is that some gay men aren't using condoms. For those men, PrEP is an alternative. (It should be noted that agencies like the World Health Organization, which last month came out with an advisory that people at high risk for HIV should consider PrEP, also state that Truvada should be used with condoms as an additional method of protection.)
AHF has long promoted condoms, and that's a good thing. But it doesn't have to advocate condom use at the expense of new prevention tools that have proven to be effective. These days, our community needs more HIV prevention strategies, not fewer. As we reported last month, mathematical models estimate that widespread use of PrEP could reduce HIV incidence among men who have sex with men by 20-25 percent worldwide, preventing up to 1 million new infections.
Agencies like the WHO and the Centers for Disease Control and Prevention, which in May also recommended PrEP for at-risk individuals, need to fight AHF's ad shenanigans. So does Gilead. San Francisco has one of the country's first PrEP demonstration projects, and as more studies are done, more information will become available.
If AHF wants to have a conversation about PrEP we're all for that. But AHF's ad is wrong by saying that "there is a major debate going on about the efficacy of the drug Truvada to prevent HIV." The efficacy has been established, AHF just doesn't like the results. AHF must be honest with the community and acknowledge that so far, the research in support of Truvada is in – it works.