HIV Prevention Has An Equity Problem. Here’s What Needs to Change

Now, 3½ years later, she says the gap is “worse than it was before.”

Indeed, the data bears this out. In 2018, Black Americans made up 44% of those who could benefit most from PrEP, and Latinos made up a quarter. But when she looked at data from commercial pharmacies, they showed that just 1% of Black people and 3% of Latinos who could benefit actually had prescriptions for the pills. Meanwhile, 16% of white Americans had a prescription. They accounted for just a quarter of people with indications for PrEP.

In 2020, PrEP use by Black Americans increased by more than eight times, to almost 40,000 people. But eight times 1% is still just 8%.

The same goes for women. The CDC estimates that a quarter of a million American women could benefit from new ways to prevent HIV. But in 2020, fewer than 1 in 10 women were taking PrEP.

A Shot in the Arm (or Butt) Against HIV

This is the gap Apretude could help fill. Clinic staff inject the drug into the buttocks muscles every month for the first 2 months, and then every 2 months after that. People taking it can choose to start with the oral pill version of the medicine, known as Vocabria, to see how it agrees with them, or they can start directly with the shots, according to an FDA news release.

The daily pills and the shots can stop HIV very well. The pills are up to 99% effective when used as directed. In one large trial, the shots reduced HIV acquisition by 69% over the pills. And in another, the decrease was 90%. But the shots were so effective that one of the trials stopped early; people who had a hard time sticking to the pills found it easier to come to the clinic every month.

What’s more, the FDA approval comes for adolescents and adults, a decision the FDA also made when it first approved the pills Truvada for PrEP in 2012 and Truvada’s molecular cousin Descovy in 2019. But unlike Descovy, which was only approved for gay and bisexual men and transgender women, the FDA approved this new shot for everyone -- people of all genders at risk for HIV through sex.

This is something that Kimberly Smith, MD, senior vice president and head of research and development at ViiV Healthcare, says “thrills” her about the approval.

“This is an indication that covers everybody,” she says. “And we want to make sure we can roll this out to the whole population.”

To do that, ViiV, the health care industry, and public health departments will have to learn from the mistakes of past PrEP rollouts, and will need to address the stubborn ways in which health care continues to fail to offer prevention services to Black and Latino people in the broader world, let alone in HIV prevention.

But ViiV did both those studies from the start, drawing praise from people in the communities most impacted, says Sean Bland, JD, a senior associate in the Infectious Diseases Initiative at Georgetown University’s O’Neill Institute for National and Global Health Law.

“It really does matter in research, when folks are brought in from the very beginning -- that we actually have data on those communities and that the communities are involved,” he says. “It just really fosters trust in the research.”

In addition, ViiV plans to launch two after-market studies next year, says Maggie Czarnogorski, MD, the company’s head of innovation and implementation science. One will focus on discovering best practices for rolling out Apretude among gay and other men who have sex with men, including transgender men, with the potential of using telehealth to expand access.

That study will take place mostly in the 50 metropolitan areas and seven rural states in which more than half of all new HIV transmissions occur. The other, the Ebony study, will enroll specifically Black cisgender women and transgender women, mostly in the Southeast.

Both studies are meant to bring the innovation not only to the clinics that already prescribe lots of the oral pills, but also to those that do very little PrEP prescribing now. The study in women, in particular, will require more discussion among primary care and OB/GYN providers who have been slow to integrate PrEP into their regular well-woman health screenings, says Czarnogorski.

“We know that [the solutions] are not going to be quite the same for each of these subpopulations,” she says. “Where they receive care may be different. How to integrate it into routine care may be different. But we really want to understand these different contexts and be able to support patients and providers.”

Half of Westbrook’s clients are uninsured, and 28.9% live under the federal poverty level -- more than double the national average. And aside from Planned Parenthoods in Brownsville and Harlingen, Westbrook Clinic is one of the only PrEP providers in the area. Cameron County, where Westbrook has clinics, is in the third-highest tier of HIV transmission rates per capita, according to data on AIDSVu.org.

And while they offer PrEP, they aren’t actually a primary care clinic for the general public. They get their funding through the Ryan White CARE Act, which provides services for people who have HIV -- but no funding for those without it, even people trying to keep from getting it.

“We do offer PrEP, but of course there’s no real funding for us to do it,” says Martinez, who grew up and trained as a family doctor in the area and is now Westbrook’s medical director. “We do it at low cost and utilize whatever donations, grants, programs, etc. that we can leverage.”

Recently the clinic received CDC funding to continue to offer PrEP. But with a price tag of $3,700 per shot, Martinez says she hopes she won’t have a repeat of a few of the cases she’s had in recent years since the clinic started offering oral PrEP: People had to go off PrEP because their insurance changed, or pre-authorizations deterred them.

Then they came back to the clinic as clients living with HIV. She’ll be relying heavily on ViiV’s patient assistance program and savings from a federal drug discount program to keep offering PrEP, she says. It will help if some clients have their own private insurance, too.

One of them is that current reimbursement policy only applies to pills right now. Bureaucratic changes, like the approval of oral PrEP by the U.S. Preventive Services Task Force, mean that all the PrEP care services should be reimbursed with no cost-sharing to people taking the pills.

But the shots aren’t in that task force recommendation, so it’s possible, in the short term, financial challenges could limit who can access it -- kind of the way they did when Chancley watched privately insured, mostly white people access the pills early on, while clinics and health systems waited to get the grants to allow them to offer the pills to everyone.

And then there’s the complicated behind-the-scenes work that clinics will have to do to make it feasible for someone in the clinic to do the shots, and to bill for them. These are the things that show up in explanations of benefits that can be baffling, especially as someone tries to figure out what applies to their deductible and what doesn’t: Things like billing the shots as a pharmacy benefit or a medical benefit. Or of working out where insurance companies will put the shots on their formulary, the list of medications they will cover without prior authorization, those that require prior authorization, and those they will not cover.

And then there’s the time people will need to take off work to come in for the shot every other month -- a task that’s more feasible for some people than others.

Still, Westbrook will offer Apretude, Martinez tells WebMD. In fact, weeks before the FDA approval, she got an email from the company, asking if they would be interested in becoming a trial site for the upcoming study of Apretude in gay and bisexual cisgender men and transgender men.

But for shots to roll out equally, more than a few small clinics like Westbrook will need to scale up. For one thing, there are all the challenges Bland and his team lay out in their reports. For the other, the rollout of Apretude’s cousin, a long-acting treatment for those already living with HIV, Cabenuva, has been slow, says Bland.

Many people have had to wait months to start on those shots as ViiV and clinics figure out how to work them in, he says. Martinez’s clinic, which now offers Cabenuva, says they didn’t start the shots until the summer.

For another, in the short term, ViiV is planning a limited distribution of the preventive shots, ViiV spokesperson Melinda Stubbee says. At first, ViiV CEO Deborah Waterhouse said they would scale up the shots at large medical clinics around the country, followed by locations in the Southeast, where Stubbee says “the focus would absolutely be on reaching those disproportionately impacted.”

But it’s unclear which medical clinics those will be or how well those particular clinics have done enrolling Black, Latino, transgender, and cisgender women on PrEP. Many health systems that have done a great job prescribing PrEP in general still struggle to do so equitably.

Kaiser Permanente Northern California has prescribed PrEP to 13,906 people since 2012. But Black participants are 26% less likely to receive a PrEP prescription and less likely to continue to take it than their white counterparts, according to data published in the Journal of the American Medical Association Network Open this year. Likewise, prescriptions for Latinos are 12% lower than for white patients. And women had PrEP prescribing rates that were 44% lower than men.

A study this year showed that Southern public health staff were 75% less likely to refer Black partners of people living with HIV for PrEP appointments than were public health staff doing the same work in the Northeast. And studies of provider biases and prescribing behavior have found that providers are less likely to prescribe PrEP to Black women, people who inject drugs, and gay and bisexual Black men who asked for it.

New CDC guidelines say providers should prescribe it if someone asks for it, even if they don’t fully understand the person’s risks for HIV.

And Bland says he has already heard that some doctors have dissuaded their Black patients living with HIV from switching to the injectable drug.

“It’s not just, ‘Do we really want to deal with administrative burden of this?’” he says. “All the stigma that providers hold for people of color, young folks, populations that they don’t think necessarily are going to be responsible with using this or that -- that they won’t come back for their injections every 2 months.

“All of those kinds of biases could lead to them saying, ‘Hey this isn’t really right for you. We’re not even going to go through the process, even telling you about it and supporting you actually to get on to the medication.’ We’ve seen a little bit of that already with long-acting injectable treatments.”