AIDS Healthcare Foundation, one of the world's largest HIV/AIDS healthcare organizations, announced Friday it is rolling out a campaign to highlight concerns it has over the use of a daily pill for pre-exposure prophylaxis (PrEP) to prevent HIV infection as a public health strategy against the spread of the virus.
The organization will run advertisements with information from studies about adherence to the pill's daily regimen in several publications within the next week.
The pill, marketed as Truvada by Gilead Sciences, has been shown to reduce HIV infection when taken daily as directed along with using condoms and was recently recommended for populations at high risk of HIV infection by the Centers for Disease Control and Prevention and the World Health Organization.
But AHF cautions individuals who may be interested in taking PrEP, community organizations, and public health officials in government against the widespread use of the PrEP pill for HIV prevention efforts, saying people will fail to take the pill every day as directed for the drugs to work.
"The bottom line is that people won't adhere and take the pill," Michael Weinstein, president of AHF, told BuzzFeed. "That's what studies have shown. If this catches on as a public health strategy, that means there are going to be people who will take Truvada irregularly and some will be infected, and some develop drug resistance."
AHF cites studies showing that due to issues with adherence among people taking the drug in clinical trials, PrEP efficacy is about 50%, Weinstein said. Because of this, he said "a government-sanctioned widespread scale up of PrEP appears to be a public health disaster in the making." Additionally, there is no research showing PrEP's effectiveness as a public health strategy, he told BuzzFeed.
The AHF campaign comes just months after New York Gov. Andrew Cuomo announced the state's new strategy in its fight against HIV/AIDS, which includes increasing access to Truvada through the state's Medicaid program and its own public information campaign to raise awareness about PrEP — in addition to identifying people who may not not know they're HIV positive so that they are linked to treatment, and working to ensure that people who are HIV-positive are getting the care and treatment they need. AHF condemned Cuomo's inclusion of PrEP in the plan.
But New York public health officials are not alone in considering PrEP as part of HIV prevention strategy.
In May, the CDC issued clinical guidelines on PrEP to prevent HIV transmission, saying that if taken daily as directed along with using condoms, it is over 90% effective in preventing HIV infection. The government health agency recommended that doctors with patients at high risk of infection should consider PrEP as part of their HIV prevention strategy, including regular HIV and STD testing and condom use. In July, the WHO announced a similar recommendation, saying men who have sex with men should consider PrEP as an additional method of preventing HIV infection. These recommendations, according to AHF, were "misguided."
Advocates at GMHC, an HIV/AIDS healthcare and advocacy group in New York City, agreed with AHF's point that adherence to the drug is crucial to it being effective in protecting people from HIV, but said that discouraging people to consider PrEP is problematic.
"The only disaster would be to stop encouraging people to explore taking PrEP if they are at high-risk for contracting HIV," said Anthony Hayes, GMHC's managing director of public affairs and policy, in a statement to BuzzFeed. "The fact is adherence is key to any drug regimen, including [antiretroviral drugs], and we are not going to tell people who are HIV-positive to stop taking ARVs because some do not practice strict adherence."
Hayes said GMHC disagrees with the position that PrEP should not be included in public health strategies. "We believe more people should explore being on PrEP to reduce the risk of contracting HIV and it should absolutely be included in the strategy along with comprehensive education that includes emphasizing that adherence is key to effectiveness."
Weinstein said that AHF is not alone in its reservations about PrEP, as many doctors and people in general question using it. With that, he emphasized that the conversation around PrEP has shifted from suggested it be used along with condoms to using it instead of condoms, which he said will expose people to other STDs such as syphilis, among others. People have become "cavalier" when it comes to STDs, he said.
Fewer than 10,000 prescriptions have been written for Truvada to be used as PrEP, the CDC said when it announced its recommendations. It's price tag, at about $1,300 per month, is also a factor in access, although insurance plans cover it and there are assistance programs, such as one through Gilead.
Despite the campaign, Weinstein said AHF is not opposed to individuals and doctors considering and ultimately moving forward with using PrEP. "We don't tell our doctors not to prescribe it or doctors in general not to prescribe it," he said. "But as for a public health measure, you have to look at the data from the studies. This is not a question of my opinion."