Deandre is 26, African American, and gay. He worries about HIV, especially since several of his friends have tested positive over the years. "I try to be safe and use condoms most of the time, but sometimes they just get in the way."
Each year, about 50,000 U.S. adults and adolescents are diagnosed with HIV. The rates are highest among men who have sex with men (MSM) and they are climbing, especially among young African American MSM, like Deandre. Condom use has been the main focus of HIV prevention campaigns, but this message is not being heard, especially among those at highest risk. Studies in adolescents and young adults have shown that almost 25% of men and almost 40% of women had not used condoms during sex in the last month.
The NYS Plan to End AIDS aims not only to diagnose more people with HIV and improve their access to care and treatment, but also includes a goal to improve prevention of HIV using preexposure prophylaxis (PrEP). For this new prevention approach to be successful, there will need to be a major scale-up of resources by state and city health departments, as well as buy-in from legislators, other health sector partners, and communities at risk.
What Is PrEP?
PrEP is a daily pill that HIV-negative people can take that greatly reduces their risk of becoming infected. In 2012, the FDA approved Truvada for use as PrEP. Although it made headlines at the time, using anti-HIV meds to prevent HIV transmission was not a new idea. Over 20 years ago, the ACTG 076 study proved that giving AZT to mothers with HIV and their newborns dramatically reduced HIV transmission, by about 67%. HIV meds have also been used to reduce transmission after workplace exposures like needlesticks, and after sexual or injection-drug use exposure. This is known as post-exposure prophylaxis, or PEP. In these situations, the drugs must be given within 72 hours (preferably 36 hours) and taken for 28 days.
Studies of PrEP in people began with the iPrEx trial. Starting in 2007, it enrolled 2,500 HIV-negative gay men and transgender women from six countries who were at high risk for HIV. They took either a placebo pill or Truvada (a combination of two approved HIV meds, TDF and FTC). The study showed that the rate of HIV infection was reduced by 44% in people taking Truvada. But it is important to know that not all people who were given PrEP actually took the drugs. Based on tests of the level of medication in their blood, only 9% of people who became infected after being assigned to PrEP were actually taking it. Further analyses showed that people who took their pills consistently were more protected against HIV -- up to 92%. Later studies, including the Partners PrEP and TDF-2 studies, have confirmed these results, including in injection drug users. It is important to note that in all these studies, people were also offered condoms, comprehensive risk reduction counseling, and STI treatment.
But two studies, FEM-PrEP and VOICE, failed to show any reduction in HIV infections with PrEP. In both, rates of HIV infection were similar among those who received PrEP or placebo. Blood tests showed that people in these studies had very low adherence to PrEP, and this was thought to be responsible for the negative results.
The FDA and CDC Weigh In
The results from these studies provided the evidence that led the FDA to approve Truvada for prevention of HIV among those at high risk. According to recent CDC guidelines, this group includes sexually active adult MSM, heterosexuals who are at substantial risk for HIV, and injection drug users.
Before starting PrEP, a person must have a negative HIV test, no evidence of recent HIV infection, normal kidney function, and must be tested for hepatitis B. Once PrEP is started, people should be tested every three months for HIV, STIs, and kidney function. Truvada usually has few side effects, but nausea, vomiting, and headache can occur and generally resolve within four weeks. Some studies have also shown a small reduction in bone density among those on PrEP, but no increase in bone fractures. Truvada can be associated with changes in kidney function, so creatinine testing is done on a regular basis.
It's important to closely check for a new HIV infection before starting PrEP. If a newly infected person starts PrEP, it can result in their HIV developing resistance to Truvada. Although some people have been worried about people engaging in riskier sexual behavior while on PrEP, this doesn't seem to be the case. This was studied in iPrEx and a CDC safety study. Both showed that MSM did not engage in riskier behavior (condomless anal sex and higher numbers of sex partners) while on PrEP.
The main limitation of Truvada for PrEP is that it has to be taken every day, and adherence has been a significant issue in all the studies. A long-acting injectable integrase inhibitor is being studied as another PrEP option. GSK-1265744 has been shown to reduce the risk of SIV infection in monkeys. It is currently being tested in the ÉCLAIR study to examine its safety and acceptability (effectiveness is not being studied in this trial, but will be studied later if it is found to be safe). The benefit of this drug is that it may only have to be injected every 3 months, a much easier regimen for those who are unable to take a daily pill.
But many hurdles have to be overcome before widespread access to PrEP can be achieved. Even with the publicity following the iPrEx results, knowledge about PrEP remains low among communities at risk. A study conducted among gay men in Denver showed that only 20% were even aware of PrEP. Public health campaigns need to be created to provide targeted and accurate information about the risks and benefits of PrEP, as well as to counter stigmatization of those who decide to take it.
Unfortunately, the lack of knowledge about PrEP also extends to health care providers. Despite the CDC guidelines, many providers are still not knowledgeable about PrEP, and most have never prescribed it. Some are not comfortable asking patients about their sexual orientation, sexual behaviors, and injection drug use -- essential to establishing risk and eligibility. The NYS AIDS Institute recently published a PrEP provider directory that shows very few providers available to prescribe PrEP outside of New York City. Creating other venues for PrEP -- through DOH STI Clinics or community health centers -- may address gaps within and outside of NYC.
But it isn't just about a pill. Supportive and wrap-around services must be part of any comprehensive prevention plan. Clinical trials showed that adherence to PrEP is absolutely necessary, and that daily dosing is best. We need to develop and test PrEP education and adherence strategies that can be used by clinicians and staff with busy practices. Ideal adherence interventions should be short (around five minutes) cognitive-behavioral interventions or should use new technologies such as text messaging, phone apps, and other electronic reminders. Counseling about risk behaviors and substance use must be included under the umbrella of comprehensive prevention services.
I heard about PrEP from a friend who worked for a center doing PrEP research. He told me about their study, and I was sold on the idea. But most of my friends ask why I put myself on it. They feel that there's no need to take prep because they think their bisexual practices are very safe. For me, it was important to have extra support in case I had a slip-up, even though I still use condoms. I've been taking it for about ten months now and I feel it's the best thing I could have done for myself. So far there have been no side effects except for a little queasiness in the beginning. I'd recommend this pill to anyone who may be at high risk.
-- Joseph, 45, gay, African American
PrEP is expensive. Truvada costs about $1,200 a month retail (although most payers will pay less than that), and that doesn't include the cost of the lab tests and office visits that are needed every three months. Even with insurance, there are still copays for both medication and office visits. If a person has an insurance plan with a large deductible, this can result in high out-of-pocket costs. Truvada's maker, Gilead, has a patient assistance program for the uninsured, but to be eligible you have to meet specific income criteria. Although this program covers the cost of medication, condoms, and HIV testing, it doesn't cover things like STI and hepatitis B testing. Navigating the insurance requirements and preauthorization requests may create additional burdens for both doctor and patient. Funding for PrEP needs to cover not only treatment, but also the associated medical costs.
The plan to end AIDS needs to take into account that the communities most at risk for HIV often face multiple barriers to health care, including lack of insurance, other cost-related hurdles, fear, stigma, and discrimination. These result in missed opportunities for HIV prevention services. For example, transgender women have an extremely high risk (about 20% have HIV), yet they are less likely to obtain health care due to discrimination in medical settings -- including outright denial of care, verbal and physical harassment, and providers who are not knowledgeable about trans-specific health issues.
Many MSM attempting to obtain PEP or PrEP have encountered tremendous hurdles. This highlights the barriers that patients and providers experience when new medications come to market. Newly developed treatments are not immediately used by people in need. Introducing them and encouraging their adoption requires deliberate and coordinated efforts to raise patient and provider awareness, along with education to ensure that both have the information to make informed decisions. We need bold social marketing and educational programs to drive uptake and help the health care systems engage patients and providers.
Young MSM, especially young MSM of color, can encounter homophobia, stigma, and rejection from their families, which makes it difficult to be open about same-sex behaviors. About 10% of gay men do not disclose their sexual orientation to their medical providers. This is even more concerning for bisexual men. In a recent study in New York City, close to 40% of bisexual men did not disclose their sexual orientation to their medical providers, which means they may not get tested for HIV, nor get offered PrEP.
Access to PrEP also needs to be scaled up for women. Women now account for 25% of people with HIV in the U.S., and most acquired it from men. Despite this, heterosexual women may not be seen as being at risk unless they are known to be in a relationship with a partner who has HIV.
Finally, we need to improve the access of adolescents to PrEP. Adolescents and young adults are the group most at risk for new HIV infections, but they have largely been absent from the discussion about PrEP. Minors' access to PrEP without parental consent is unclear, creating an additional barrier. State laws will need to ensure the right of minors to access PrEP.
My lowest point on my journey to get pregnant with my HIV-positive husband was the day my doctor told me she would not prescribe Truvada for me, because it was "unethical" for her to do so. Nor would she keep me as a patient if I continued to engage in such "risky" behavior. I was being judged for my sexual choices, my maternal calling, for my own decisions about my own body. How different things would have been had I told that doctor I was just trying to stay negative. She probably would have prescribed it because it would have been "unethical" for her not to. I am not a human-sized uterus. I am a human-sized HUMAN.
-- Poppy, 39, white, heterosexual
Governor Cuomo has an ambitious plan to end AIDS. PrEP is an extremely important addition to HIV prevention services, but there needs to be a realistic understanding of the barriers to its use. Improving access to PrEP means that health care facilities and providers must create a welcoming environment for all patients, especially those who may feel unwelcome due to their gender identity or sexual orientation. Improved access also means that providers have to proactively address sexuality and sexual health with their patients, allowing them to make informed decisions about risk and prevention.
Rolling out PrEP on a large scale can happen only with a massive scale-up of resources, including educational campaigns for consumers, new access points for care, provider training, drug assistance programs for the under- and uninsured, wrap-around services to aid adherence, risk-reduction efforts, and programs that address mental health and substance use.
Anita Radix is director of research and education at Callen-Lorde Community Health Center. Sarit Golub is professor of psychology at CUNY and directs the Hunter HIV/AIDS Research Team.