Now, there’s a new option that can prevent HIV without the need for daily pills: On December 20, 2021, the U.S. Food and Drug Administration approved Apretude (cabotegravir extended-release), a shot injected every two months to prevent HIV in at-risk adults and adolescents who weigh at least 77 pounds. The drug’s developer, ViiV Healthcare, said in a December 2021 statement that it would begin shipping the shot to U.S. distributors in early 2022.
New Delivery Method May Mean More Compliance, Depending on Availability, Other Factors
“This has the potential to be a game changer for certain populations that have challenges with taking a daily pill,” says Geoffrey Hart-Cooper, MD, founder and medical director of the Virtual PrEP Program for Adolescents and Young Adults at Stanford in San Mateo, California. The shot is approved for so-called pre-exposure prophylaxis (PrEP), treatment to prevent HIV among individuals at high risk for developing this sexually transmitted infection. These high-risk groups include men who have sex with men, injection drug users, teens, Black and Latino people, and transgender individuals, according to the Centers for Disease Control and Prevention (CDC).
Injection Every Other Month vs. Daily Pill
Two clinical trials the FDA reviewed before approving Apretude found the shots much more effective at preventing HIV than the pill, Truvada (emtricitabine–tenofovir disoproxil fumarate), which in 2012 became the first drug approved for PrEP in the United States. One trial of 4,566 cisgender men and transgender women who have sex with men found participants had a 69 percent lower risk of developing HIV with Apretude than with Truvada, according to the FDA. A separate trial of 3,224 cisgender women demonstrated a 90 percent lower risk of developing HIV with the shot than with daily Truvada pills. Side effects associated with Apretude in the trials included pain or other reactions at the injection site, headache, fever, back pain, and rash, according to the FDA.
Disparities in HIV Prevention
Currently, only about 1 in 4 Americans at high risk for developing HIV are prescribed PrEP, and there are stark disparities in who gets these pills and who does not, according to the CDC. For example, 66 percent of white people at risk for HIV get PrEP pills, compared with 9 percent of Black people and 16 percent of Hispanic individuals. And just 16 percent of teens and young adults 16 to 24 years old get PrEP, compared with 30 percent of adults 35 to 44 years old. Men at high risk for HIV are also almost 3 times more likely to get PrEP than women, the CDC reports. New long-acting shots may help improve these statistics, which are all based on a regimen of daily pills, according to the FDA. “PrEP requires high levels of adherence to be effective and certain high-risk individuals and groups, such as young men who have sex with men, are less likely to adhere to daily medication,” the FDA said in a statement announcing its approval of Apretude. Other factors such as depression, poverty, substance use disorders, and perceived stigma that motivates people to conceal meditation use can also get in the way of consistently taking daily pills for PrEP, according to the FDA. The hope with Apretude is that shots will get more people to start and stick with treatment, the FDA said.
Challenges Remain
“Injectable PrEP may be easier than daily pills in some ways but more challenging in others,” says Julia Marcus, PhD, MPH, an associate professor of population medicine at Harvard Medical School and the Harvard Pilgrim Health Care Institute in Boston. Pills may be a struggle for people who can’t consistently remember to take them, those who struggle to afford refills, and individuals who feel some stigma around their HIV risk and worry about others knowing they take PrEP, Marcus says. Some of these patients may find shots offer more privacy and are easier to stick with over the long term, Marcus says. Shots, however, aren’t without their own set of hurdles, Marcus notes. Getting to a medical appointment every other month for injections may be difficult for those who can’t afford to pay for these visits, take time off work, arrange childcare, or find transportation to a clinic. On top of this, price may be an issue. The sticker price for Apretude is $3,700 per dose, or $22,200 a year, similar to the list price for Truvada but 50 to 60 times more expensive than generic pills that can be used instead, Marcus says. While some uninsured people may qualify for free PrEP medications, according to the Department of Health and Human Services, and many private health insurance plans may be required to cover these drugs, per the Department of Labor (PDF), it’s not yet clear whether the shots will be as widely available or affordable as pills. “Apretude’s price is going to cause severe access challenges,” says Amy Killelea, a PrEP financing expert and owner of Killelea Consulting in Arlington, Virginia. While the exact out-of-pocket cost for patients isn’t yet clear, it’s likely that both government health programs for the poor and private insurers will have higher fees for the shots than for the older generic pills that can be used for PrEP instead, Killelea says. “For injectable PrEP to have any meaningful impact on the HIV epidemic, it needs to be free and easily accessible, particularly for people who are unable or unwilling to take a daily pill,” Marcus says.
