In a potentially major development for ending the HIV epidemic, the FDA has just approved the first long-lasting, injectable form of HIV prevention medication.
Apretude, from ViiV Healthcare, is administered as a single shot once every 60 days. Because that makes adherence much easier than taking a daily pill, the injectable proved far more effective in clinical trials at preventing HIV infection than Truvada or Descovy, the two PrEP (pre-exposure prophylaxis) medications currently available in the United States.
“Ending the epidemic requires getting people on PrEP–so Apretude is great news,” said Mark Milano, the lead trainer for ACRIA Centers at GMHC. “Now we have a hell of a lot of work to do to get it into people’s butts.”
The longtime HIV educator and activist cautioned that many barriers for oral PrEP—such as the high cost and HIV medication hesitancy—also apply to injectable PrEP.
“There is significant work still to be done to educate people and overcome the barriers,” he said.
“African Americans are sharply outpacing whites in new infections—but whites outpace people of color in PrEP prescriptions. It’s exactly the reverse of what’s needed,” Milano added.
African Americans accounted for 42% of the 34,800 new HIV diagnoses reported by the CDC in 2019, even though they make up only 13% of the U.S. population. “It is essential that we reduce the rates of infection for men having sex with men of color,” Milano said, adding that PrEP usage in communities of color “has not been nearly as high as it needs to be.”
Nationally, only 25% of the 1.2 million people at risk for HIV are prescribed PrEP, according to the CDC’s 2020 estimate.
New York State’s Ending the AIDS Epidemic initiative, begun in 2014, has fallen short of the “very clear targets it set to get people on PrEP,” Milano added. The initiative aimed to have 65,000 people on PrEP by 2020, but it fell far short, at just over 39,000 PrEP users.
Among men who have sex with men (MSM), it’s youth having casual sex and older men having infrequent, unplanned sex who are less likely to be on daily PrEP, Milano said.
In a hopeful sign, Apretude, administered as a single shot in the buttock, significantly outperformed Truvada daily pills in clinical trials. According to the FDA, Apretude injections were 69% more effective than Truvada at preventing HIV infection in a trial for men and transgender women who have sex with men—and 90% more effective in another trial for cisgender women.
Truvada and Descovy are both extremely effective (close to 99% in some studies), Milano added, but only when taken daily as prescribed. “That’s difficult for a lot of people—especially if they have sex infrequently,” he said.
Apretude could help to sharply reduce HIV infection, he said, because “you go to a clinic six times a year for a doctor to give you the shot, and you’re good for two months. That’s the big game-changer. It takes away that nagging doubt about whether you’ll test positive. If you’re getting your shot, you won’t.”
The FDA approved Apretude for PrEP in late December, and it has been tested and approved for MSM, transgender and cisgender women.
Milano noted that ViiV made sure to test Apretude on the most at-risk populations, not just white men. Half the participants in one clinical trial were Black MSM, and cisgender women received their own trial.
Both nationally and in New York, the highest rates of new HIV infections are for African-American MSM, followed by Latino MSM, white MSM, and African-American women.
Some healthy, HIV-negative people worry PrEP could be harmful, even though modern HIV medications are safe and have minimal side effects, Milano said. “They still have the reputation for toxicity.”
“We have to get the word out that oral PrEP is available to most people for free,” he added. “People hear how expensive it is and think they can’t afford it, so they don’t even try.”
At $3,700 per dose, or $22,200 per year, Apretude isn’t cheap. ViiV has priced it similarly to Truvada ($22,100 annually) and Descovy ($23,160 annually), both from Gilead Sciences. (Generic versions of Truvada came to market last year that cost $40 or less for a month’s prescription.)
In New York, Medicaid covers PrEP prescriptions, provider fees and HIV tests. (A negative HIV test is required to start PrEP, with regular follow-up tests every three months.) Any New York State resident with an annual income of less than about $65,000 can obtain free oral PrEP, regardless of immigration status, Milano said. “We don’t know yet if Apretude will have a similar free distribution program,” he added.
For people who are on Medicaid or uninsured, Milano emphasized that a knowledgeable PrEP navigator is essential to access free PrEP. People who get tested for HIV through GMHC can connect with a PrEP navigator who can get them on PrEP in just a few days, Milano said. “If you try and do it yourself, it is very difficult, requiring many phone calls and paperwork.”
Milano added that some people fear that a PrEP funding program won’t keep their information confidential, or that the authorities could learn of their immigration status. “They won’t,” he said.
Most private insurers are required to cover PrEP prescriptions—and, starting last September, provider fees and regular HIV tests as well, under new Affordable Care Act rules. Medicare coverage depends on the plan.
But co-pays for Truvada and Descovy are “enormous,” Milano said, ranging from $600 to as much as $2,000 per month. Gilead offers a co-pay assistance program for up to $600 a month for people making under $65,000 annually.
“Lack of health care access is why we have some of the worst health outcomes in the world here in the United States,” Milano said. “This applies to PrEP.”