Zach Manley, 25, a software implementation consultant in Atlanta, has been happily taking PrEP pills since the fall of 2019 to prevent him from getting HIV during sex. A friend of his who works as a PrEP access advocate first encouraged him to take PrEP.
“He’d been telling me about the importance of sexual health since 2016,” Manley explains, “so finally, with PrEP, I was like, ‘You know what? Let’s go and see what happens. “
And, according to him, it feels good. “I haven’t had any adverse side effects, and I no longer have that anxiety of wondering if I’m going to be HIV-positive every time I take an HIV test. It relieved a lot of stress.
Until recently, PrEP only existed in pill form: there’s Truvada (the brand name for a combination of two anti-HIV drugs), the generic equivalents of Truvada and Descovy (essentially a newer version of Truvada using a more advanced form of tenofovir). But on December 20, the United States Food and Drug Administration (FDA) approved the first injectable version of PrEP: Apretude (aka cabotegravir), which requires an injection in the buttocks at your health care provider’s office every two months.
After about a day of moderate butt pain (this is the most common side effect), with Apretude you are protected against HIV for at least 60 days and you don’t have to worry about taking (or miss) doses of your Truvada or Descovy. pills. At first, you have the option of taking an oral version of Apretude for 30 days first – to clear it quickly from your system if you have side effects – or start the injections immediately.
Manley is thrilled to make the switch. “It seems super convenient,” he says. “If my health plan covers it, I’ll be on it in a heartbeat.”
Manley is not alone in his enthusiasm. TheBody has spoken to a handful of HIV-negative gay or bisexual men who rave about Apretude. One is Mark, 27, a data management officer in Atlanta who has been taking oral PrEP since 2018. He calls his experience “pretty good,” but he plans to talk about Apretude with his doctor next month. “I want that protection without worrying about taking the pill every day,” he says.
Then there’s David, 37, a community organizer from New York who has been on Apretude for the past few months as part of an ongoing clinical trial for the drug. He says he wants to continue because he’s been inconsistent about his oral PrEP since he started it in 2015, and like with some other medications, I’d sometimes stop taking them for months.
When David learned that a clinical trial (called HPTN 083) for a long-acting injectable form of PrEP was starting near him, he signed up. At some point he was informed that the group taking Apretude in the trial had so many fewer new cases of HIV compared to the group taking oral PrEP that the study was terminated early and everyone transferred to Apretude.
David is still getting the drug through the study organizers and isn’t sure when it will stop, but when it does he says he will talk to his provider about getting Apretude through the through his insurance, though he admits he’s “a bit pessimistic” that New York State Medicaid, his current plan, will cover him.
Granted, access issues aside, Apretude won’t be for everyone. Damon Jacobs, a longtime PrEP advocate, isn’t interested in giving up the oral PrEP he’s been taking for years. “I don’t want to be beholden to a physical office where I have to go every eight weeks to get vaccinated,” he says. He adds that he maintains his current oral PrEP labs primarily through telemedicine and online services, minimizing the need for in-person visits.
However, “Having said that, I think Apretude will be a great option for many people, especially those who are unstablely housed, institutionalized, or who for some reason can’t take a pill on a regular basis,” adds Jacobs.
James Krellenstein, co-founder and chief executive of PrEP access advocacy group PrEP4All, shares this combination of personal aversion coupled with professional optimism. “I’ve been on [oral] PrEP since 2013 and I don’t plan on changing it,” he says. “It’s quite annoying having to go to the doctor every three months [for PrEP-related labs]so why do it every two months to get a painful sting?
Michael Chancley, director of communications for PrEP4All — and the friend who first told Zach Manley about PrEP in 2016 — welcomes the change. “Throughout studying Apretude, I wasn’t interested,” he says, “but since I’ve talked to more people, I’m looking forward to it.”
Chancley says he hopes his health plan covers injectable PrEP, but he predicts many plans won’t include it on their formulary (or list of covered drugs) for at least a year — as is common for expensive new drugs – and may only cover it if a provider specifically requests it (usually called ‘prior authorization’).
How accessible will Apretude be?
So does Aprétudes portend the latest revolution in HIV prevention since oral PrEP itself was approved by the FDA a decade ago? That remains to be seen, especially given the racial disparity of PrEP use in general.
Research shows that adoption of PrEP in the United States among white gay and bisexual men has far exceeded adoption among black and Latino gay and bisexual men. And annual HIV rates over the past decade reflect this disparity; they dipped from around 7,500 to 5,000 among white gay and bi men, but remained stable (at around 9,000) among black gay and bi men, and even increased slightly (to almost 8,000) among Latinx gay and bi men. Proponents say this disconnect illustrates a failure of the federal government to maximize the preventive power of PrEP.
“The CDC [Centers for Disease Control and Prevention] completely dropped the ball on scaling up PrEP,” says Krellenstein. “It took them two years after PrEP was approved to even get out of the clinical guidelines, and they did nothing to raise awareness about it even though more than 30,000 new people a year were getting HIV.”
Recently, the CDC’s HIV Prevention Unit, under the leadership of Demetre Daskalakis, MD, MPH, introduced new measures to make PrEP more accessible. In December, Daskalakis spoke to TheBody about the CDC issuing more aggressive prescribing guidelines for PrEP and said some (but not all) health centers across the country may now use CDC funds for services related to PrEP such as doctor visits, labs and outreach.
But Krellenstein says the CDC needs to step up its efforts when it comes to Greed. “What steps [are they] take to ensure that anyone who needs Apretude can access it? ” he asks. “What conversations has CDC engaged ViiV in [the drug’s developer] to ensure it is accessible and affordable? They should actively work with insurance companies and clinicians, and conduct demonstration projects targeting the most vulnerable communities to discover best practices.
In the United States, Aprétudes has an average wholesale price of about $22,000 per year, compared to about $400 per year for generic oral PrEP. This suggests that most health plans will default to covering pills unless providers can offer a good reason for injections.
In an email to TheBody via a CDC representative, Daskalakis said, “The CDC is working with partners to expand efforts to ensure that anyone who could benefit from PrEP can get it and to increase the use of this highly effective prevention strategy in overrepresented populations. in the HIV epidemic.
The CDC representative added that they have been in contact with ViiV about Apretude’s demonstration projects in high-HIV communities, and have asked the US Preventive Services Task Force to review Apretude for a recommendation that providers should offer it as PrEP to those at high risk of contracting HIV, as they did in 2019 for oral PrEP. The CDC also funded a survey to understand what most influences people’s choice to use a particular PrEP method, including Apretude, the representative said.
Additionally, a representative from ViiV told TheBody that they plan to work with clinics to help address issues around access and affordability. “If you are commercially insured, our Apretude savings program will offer a co-pay card to help offset the individual’s out-of-pocket. The co-pay card limit is $7,500 per calendar year, plus $350 for injection administration fees,” the rep said. If you are uninsured and meet ViiV’s eligibility criteria, the rep said Apretude will be given free through its patient assistance program. (For more information, you can visit ViiVConnect or call 844-588-3288 toll-free.)
LGBTQ health centers brace for bitterness
In interviews earlier this year, a handful of LGBTQ-focused health centers nationwide told TheBody that it’s too early to tell if or how many plans Apretude will cover, or even how many patients would like it. A Fenway Health representative in Boston said the center is still in a “pilot phase” with Apretude and has less than 10 patients enrolled.
“We don’t even have it in stock yet,” said Dexter Etter, who directs prevention services at the Damien Center in Indianapolis. He said his center plans to ask patients about their interest in the product and if interest is high, the center may set up a weekly overnight clinic to administer it.
As for coverage of the plan, Etter said he expects some pushback. “Our pharmacy manager anticipates that insurance companies, rather than approving injections willy-nilly, will want to see that patients have tried oral PrEP first and are not tolerating it for whatever reason,” said he declared.
In Baltimore, Amit Dhir, MSN, an HIV care specialist at Chase Brexton Health Center, said patients had been asking about injectable PrEP for some time, but he suspected getting ‘coverage’ isn’t going to be easy because…insurance companies don’t like to spend extra money. … I’m sure it will take a long pre-clearance process to get it approved.
This all comes down to the $22,000 question: Will Apretude play a significant role in closing the racial gap in terms of people taking PrEP and, therefore, who still gets HIV in the United States?
“I feel like the cliched answer is that it gives us more options,” Chancley says. “When I was working in a health care center, someone told me every day that taking a daily pill was a lot for them.” Injectable PrEP could be an excellent option for, among others, young people living at home with their parents “who do not want their medication to be seen”.