The call of “Step up. Get tested.” rang out at a recent World AIDs Day event. Illinois plans to add one-a-day pill prevention as another layer of protection starting in January.
The young saga of pre-exposure prophylaxis (PrEP), a one-a-day medication that prevents HIV infection, reads much like the old story of the birth control pill.
Though it was approved by the FDA in 2012, PrEP continues to be stigmatic and little-prescribed despite endorsement from the Centers for Disease Control and Prevention (CDC), World Health Organization and Human Rights Campaign. The monthly cost of $1,539.90 can also place it out of reach. Early next year, the Illinois Department of Public Health (IDPH) plans to change all of that.
In January, Illinois is on track to become the second state to initiate a widespread program that will increase the affordability and accessibility of PrEP, manufactured by Gilead under the brand name Truvada. The IDPH HIV/AIDS Inter-Agency Task Force met earlier this month in Chicago to discuss the specifics of the program, called PrEP for Illinois, following World AIDS Day (Dec. 1). Washington rolled out a similar program earlier this year.
The program is targeted to take off by mid-January, said Dr. Jeffrey Maras, administrator of Illinois’ AIDS Drug Assistance Program. It plans to offer fundamental HIV risk-reduction training sessions to providers throughout the state, provide an online referral resource for clients in need of PrEP prescriptions, and increase awareness of PrEP through marketing campaigns.
It also plans to cover co-pays for patients who have insurance. If a patient faces leftover fees following insurance coverage and Gilead’s Truvada for PrEP Medication Assistance Program, PrEP for Illinois will cover the remainder through general revenue dollars, Maras said at the meeting.
“There’s an opportunity here, it seems to me, for people who might be good candidates—whatever their reasons for risk—for PrEP,” said HIV/AIDS Section Chief Mildred Williamson, who led the meeting. PrEP for Illinois will provide financial assistance only to those who have health insurance, but the implementation of the Affordable Care Act could make this a “win-win” for Illinois, she said.
Without insurance, Truvada costs an average of $1,539.90 per month, according to the AIDS Foundation of Chicago (AFC). Some insurance plans cover the drug completely. Others leave patients shelling out as much as $769.96 each month for a prescription.
PrEP has proven to be up to 92 percent effective at preventing HIV, according to the CDC. But Jim Pickett, director of prevention advocacy and gay men’s health at AFC, says very few high-risk people take it.
“This is a new innovation, and the diffusion of new innovations takes time,” Pickett said. “What complicates the issue is that it’s about sex and sexuality, and we have, as a culture, a lot of morality and judging and shaming around sex.”
Prophylaxis: The nitty-gritty
PrEP is a combination of two HIV medications: tenofovir and emtricitabine, two drugs that can be used to treat hepatitis B. When someone who takes PrEP is exposed to sexual fluids or blood from an HIV-positive person, the drugs work together to block an enzyme called HIV reverse transcriptase, which replicates and infects the body if left untreated.
Full-fledged HIV is treated with a third medication, too—usually rilpivirine or efavirenz—which is why PrEP is not an option for people who already have the virus.
Like hormonal birth control, PrEP must be taken regularly in order to be fully protective. Missing doses can leave the bloodstream without enough medicine to fight a potential HIV encounter. Because of this, it “should only be prescribed to those who are able to adhere to the regimen and express willingness to do so,” said Marcella Abrams, IDPH HIV Prevention Program Manager. It should also be used in conjunction with other risk-reduction methods, like condoms, for the greatest possible level of protection.
Candidates for PrEP include men who have sex with men and engage in unprotected anal intercourse; individuals who are in a sexual relationship in which only one partner has HIV; injection drug users; transgender individuals who share equipment to inject hormones; and individuals who engage in transactional sex for drugs, money or housing.
Taking PrEP requires more than just an adhesion to a daily pill. In order for patients to refill their doses, they must adhere to regular doctor’s visits—including HIV tests—once every three months.
“Your sexual health is part of your life every day when you’re on Truvada,” Pickett said. “It isn’t just when you’re getting busy on a Saturday night … It’s saying, I want to protect myself. I don’t want to add more HIV into my community, so I want to do this for me and my community.”
Curtis Lewis, a 22-year-old college student living in Chicago, has been on PrEP for a year. As a young black male, he belongs to the demographic most at risk for contracting HIV. He said some members of the gay community would dub him a “PrEP whore”—a term used by gay men who believe PrEP users take the drug as an excuse to be promiscuous.
Few people in Lewis’ community talk seriously about PrEP, he said, and when they do it’s misinformed. “I think too many people who are ignorant to what PrEP is choose to have these type of negative ideals … and [the] lack of people taking PrEP is due to the fact that many people just don’t know too much about it.”
Gabe Bahena, a 22-year old PrEP user and supervisor at the Chicago O’Hare International Airport, echoed Lewis’ experience. “Some people I’ve heard say it’s an excuse to have more sex and get more STDs. I ignore it, usually, since I feel this is how people first reacted when birth control first came out.” Both Bahena and Lewis say they will sign up for PrEP for Illinois once it is in place.
The idea that gay men who take PrEP may have more unprotected sex than those who don’t is possible. But at this stage, there isn’t enough data to indicate that this could be the case. Participants in all major PrEP studies cited by the CDC were given condoms in addition to Truvada, and the studies showed reductions in their HIV risks.
Most gay men are not using condoms all the time. A 2013 analysis by Dawn Smith of the CDC found that only one in six gay men used condoms for 100 percent of their sexual encounters. Nonetheless, a few outspoken HIV/AIDS activists maintain that taking a daily pill instead of—or even in addition to—condoms is a step in the wrong direction.
Michael Weinstein, president of the California-based AIDS Healthcare Foundation, has called PrEP “a public health disaster in the making.” He speculated that people who contract HIV while taking PrEP could spread an untreatable strain of the disease. So far, however, research has not supported this. Most recently, a partnership of several institutions—including the University of California, San Francisco, the San Francisco Department of Public Health and the Veterans Affairs Medical Center in San Francisco—studied 2,451 men who have sex with men and transgender women, half of whom were given PrEP and the other half, placebos. Of the 131 in-study infections that occurred, none showed significant resistance mutations or reduced phenotypic susceptibility to PrEP.
Activist Larry Kramer made a similarly bold statement in May. “There’s something to me cowardly about taking Truvada instead of using a condom,” he told The New York Times. “You’re taking a drug that is poison to you, and it has lessened your energy to fight, to get involved, to do anything.”
Indeed, the HIV medications found in Truvada carry a side-effect warning of higher-than-normal levels of lactic acid in the blood, which can lead to fatigue. Liver problems and worsening of Hepatitis B, if Truvada is stopped, are the other possible side effects listed on Truvada’s website. Kramer himself has had firsthand experience with HIV drugs, having been HIV-positive since 1988.
Pickett calls Kramer a “hero” in many ways for the AIDS and HIV-positive community. But he, like Pickett, lived through the “horror show” of HIV in the ‘80s and ‘90s. Back then, “if you got sick, you died,” Pickett said. “It was horrifying. And people like Larry, people like me, lost their phone books … page after page crossed out. Gone.” Thin sheaths of latex became a matter of life or death.
A simple pill can seem dubious—lazy, even—to people for whom condoms were always the only available method of protection. “All of us have baggage around the epidemic. But there are a few people who are putting that in front of advances in science,” Pickett said. “I don’t know what is lazy or cowardly about recognizing what your risk is and taking a pill every day.”
“To me, there really isn’t a controversy or debate anymore,” he added. “There’s the AIDS Healthcare Foundation, and then there’s the rest of us … who all stand on the side of science.”
PrEPping for a healthier Illinois
Pushing for widespread access to a new drug of any kind is a challenge. “Since PrEP was recently approved by the FDA, some providers may not know about it or may not be knowledgeable or comfortable discussing PrEP with their clients or talking about sexual health,” Abrams said.
At the meeting, IDPH staff indicated that healthcare providers throughout the state will be made aware of the PrEP for Illinois program and educated about the drug, which many physicians have never encountered before. An upcoming “dear colleague” letter from IDPH to statewide providers will inform them of what’s to come.
“Hopefully we will have as strong as possible [of an] initiative for 2015,” Williamson said.
Looking over the details of the initiative, many members of the Inter-Agency Taskforce expressed optimism.
“The more choices people have, the more ability they will have to have protected sex, whatever that protection looks like. I’m excited about people having options,” Pickett said. “I feel like the glass is getting fuller [for HIV prevention]. And it’s not going down.”