Since its approval by the U.S Food and Drug Administration in 2012, pre-exposure prophylaxis (PrEP) has been an increasingly crucial component of an HIV prevention strategy—one that, as of this year, eyes 2030 as a target date to eliminate HIV transmission.
But access to the drug, which is a highly effective preventive daily regimen prescribed to high-risk people who’ve yet to be exposed to the virus, is still relatively limited even seven years after it entered the market.
“There’s a gap in getting PrEP to the people who need it most,” says Helen Koenig, associate professor of clinical medicine and medical director of the MacGregor Infectious Diseases Practice at Penn.
Koenig, who is also the medical director of Philadelphia FIGHT’s PrEP program, which provides HIV prevention services to patients in the city for low or no cost regardless of insurance status, says one of the hurdles for getting high-risk individuals on PrEP is insurance. PrEP, advertised as Truvada under patent-holding Gilead, can cost from $2,000 for a 30-day supply to $0 under certain insurance policies and cost support programs. (Of note, the Trump administration recently filed a lawsuit against Gilead for patent infringement.) Those without insurance, however, are less likely to have access to the drug or even hear about it.
At Penn, Koenig says, about 400 people have been prescribed the drug—in the ballpark of 300 at Penn Family Medicine practices, she says, with the rest as patients in OBGYN, primary care, and the Division of Infectious Diseases. At Philadelphia FIGHT, she says, 2,000 people have been put on PrEP since 2012.
“If you talk to any one primary care provider at Penn, they’ll have a handful of patients on PrEP, and these are all people with health insurance, and more likely to be upper-middle-class, well-educated, and [mostly] white,” she says, citing black women and young gay men of color as particularly high-risk groups. “And we’re not at all reaching at Penn the population of people who inject drugs, which is a very high-risk group in Philadelphia for whom there is a great need for programs that can effectively reach and support them around HIV prevention.”
To address this, she says Penn is in the early stages of piloting a program in Infectious Diseases that will allow medical professionals to see uninsured PrEP patients and test its long-term financial feasibility. That program has yet to roll out officially.
“Another thing that is nice, on the Penn side of things, is that we have a ‘PrEP Navigator,’’” she adds. “We received a grant to have a person navigate anyone interested in PrEP to the right place in the health system, both within and outside of Penn’s walls.”
Individuals interested in PrEP might then be directed to a nurse navigator, who would gather information and lead them to the right care provider based on their needs and insurance, or even direct them to services like Philadelphia FIGHT or the Philadelphia Department of Public Health.
Ultimately, though, Koenig says, the current ideal is to get PrEP prescribed most frequently through a primary care provider.
“It’s where you would get your Gardasil, your flu shot, talk about nutrition and exercise. This is a well-tolerated and safe medication that should have a low barrier to be prescribed,” she says. “But that’s not always the case. We often have primary care [providers] not familiar with PrEP even though it’s now a Grade A [ U.S. Preventive Services Task Force] recommendation in the same prestigious boat as mammograms for women and hearing screenings for kids.”
Other barriers, Koenig says, exist around stigma: Adolescents, for example, may see the same family doctor as their parents and not be comfortable discussing their sexuality, sexual practices, or recreational drug use. Others may be on their family’s insurance plan and are wary of visits, blood tests, and prescriptions showing up on parents’ insurance statements.
And some, still, just don’t want to talk about sex with their doctor.
“So, sometimes they’ll come to Infectious Diseases, because we’re the specialists,” Koenig says. “They may not want their primary care to know about [their interest in PrEP]. And they just don’t want to have conversations with their primary care provider around sex.”
New to Penn, to be rolled out in the coming months in University practices, is the ability to test urine for PrEP adherence. That ability was the result of a Center for AIDS Research grant received in 2016. Urine tenofovir testing has since become part of the standard enhanced adherence support program at Philadelphia FIGHT. It’s another tool to boost PrEP’s effectiveness by doubling down on adherence as well as access.
“With PrEP, there’s no blood pressure to monitor, viral load, sugars, cholesterol levels, no blood work to monitor, so you have no way of knowing whether someone is taking enough PrEP to prevent HIV, or taking it some of the time, but not all the time,” she says. “The only way you find out, ultimately, that someone has not been taking it consistently is when they convert to HIV, which we see all the time. We can do better than this.”
Efforts to get access for injection drug users is especially frustrating, says David Metzger, research professor and director of the HIV Prevention Research Division at the Perelman School of Medicine. In Philadelphia, until 2016, there had been a 25-year trend of reduction in HIV transmission rates among injection drug users; the number of new infections dropped from a high of about 800 in 1993 to less than 30 in 2016.
“It was a remarkable accomplishment,” Metzger says. “But because of the opioid epidemic and use of fentanyl, which has a short half-life, many people are injecting more frequently, so the old ways people had been protecting themselves now just isn’t enough for many.”
Though injection drug users still only represent 15 percent of all new reported infections in Philadelphia, that’s an uptick of 115 percent since 2016, amounting to about 71 cases in 2018.
“There haven’t been enough efforts to find the best way to introduce PrEP to the drug-using community,” Metzger adds. “There’s real interest in finding the best way to do that, but right now, I don’t think we have any good models.”
Frankly, he says, there just aren’t many physicians working on making PrEP more accessible to high-risk injection drug users.
“Where we are now is trying to figure out what the best way to offer [PrEP] to injection drug users and make it available and sustainable,” he says. “But it’s something that needs to happen.”
The HIV/AIDS Prevention Research Division has applied for a prevention trial, to be a site that would test a new mobile strategy that will hopefully produce more data related to this issue.
As for PrEP stigma in the drug-using community, Metzger says it’s actually the reverse of what people might expect.
“I don’t think the stigma is within the drug-using community, but I think there are a lot of people who inappropriately feel that drug users won’t be interested, willing, or able to adhere to the medication,” he says.
Metzger, too, cites access to insurance as a major barrier to getting high-risk individuals on PrEP.
Meanwhile, Penn continues to be a site for ongoing research regarding new forms of and approaches for PrEP. The Penn Prevention Clinical Research Site is part of a global network of National Institutes of Health (NIH)-funded research sites that are testing new strategies for HIV prevention; one strategy being worked on is a new formulation of PrEP.
“Importantly,” explains Metzger, “most of them are long-acting versions of PrEP.”
One version being developed is an infusion administered once per month in a one-hour process that helps individuals develop a strong enough response through antibodies in the immune system that prevent infection. More data still needs to be gathered to establish the effectiveness of the infusion, but it’s currently in a phase 1 clinical trial monitoring the immune response among 18-to-49-year-olds and how long it lasts.
“Penn is also helping explore other versions of PrEP under consideration in the clinical trial pipeline,” adds José Bauermeister, Presidential Professor of Nursing and director of the Penn Program on Sexuality, Technology, and Action Research.
As a member of the NIH Microbicides Trials Network and the NIH Adolescent Medicine Trials Network for HIV/AIDS Interventions, Bauermeister is examining the acceptability of other formulations delivered as PrEP gels, fast-dissolving inserts, and enemas that may offer short-term protection against HIV and circumvent some of the challenges affecting access to long-acting prevention. Recently, Bauermeister received funds from the Philadelphia Foundation to involve sexual minority youths’ perspectives on the design and delivery of these next-generation HIV prevention products.
Key to this project, he emphasizes, is the integration of a team of Philadelphia-area youth co-investigators who will be hired and trained to participate equitably with the Penn research team on this initiative.
“Raising PrEP awareness among populations who would benefit most from PrEP will require an intersectoral effort,” Bauermeister adds, pointing to a partnership with the Philadelphia Department of Public Health’s AIDS Coordinating Office. He is leading a Penn Center for AIDS Research effort to identify needs of the HIV prevention specialists in the community and assess how to enhance PrEP discussions and referrals to Philadelphia youth.
“Testing is the cornerstone of PrEP access,” he says. “Our ending the HIV Epidemic Funds [awarded by the Centers for Disease Control] will inform implementation science strategies that can be tested in Philadelphia and scaled up across the country.”
Big picture, adds Koenig, PrEP still needs to be better understood as much as it needs to be more accessible. It is, she says, not just a drug for gay men or injection drug users.
“PrEP is for anyone who may be at risk for HIV; in fact, one in five new HIV diagnoses occurs in women,” Koenig says. “While groups at higher risk include young gay men of color, women of color, and people who inject drugs, the CDC and USPSTF recommend that we talk with everyone about PrEP to help all patients assess risk, and recommend it to people who meet eligibility criteria, which can be as simple as having had an STI in the last six months, or having unprotected sex with a person of unknown HIV status, in an area like Philadelphia with a high overall background prevalence of HIV.”
And, crucially, she says that expanding PrEP access will also be a matter of evaluating how doctors talk to new generations and understand how their approach to health care may differ.
“That’s why we’ve not been successful controlling the STI epidemic, and the same could be said for millennials at risk for HIV acquisition,” she says. “We have to think differently than approaches in the past.”