Each year, 1.7 million people globally are newly infected with HIV — more than 38,000 in the United States alone. This year, President Trump announced a 10-year initiative aimed at reducing new HIV infections in the US, and ultimately ending an epidemic that has plagued this country, and the world, since HIV first emerged in the early 1980s. A key part of that plan is pre-exposure prophylaxis or PrEP, a daily medication to help prevent HIV that is recommended for people at high risk. Recently, the FDA approved a new formulation of PrEP for many — but not all — of those at risk.
What is PrEP and who should consider it?
PrEP is a daily pill taken to lower a person’s risk for getting HIV. It works best as part of a program of preventive services that includes regular HIV testing.
Global research during the past decade shows that a combination of two antiretroviral medicines is more than 90% effective at preventing HIV. These medicines, emtricitabine and tenofovir disoproxil fumarate, are known by the brand name Truvada. Along with other medicines, they are also used to treat HIV.
The Centers for Disease Control and Prevention (CDC) and many expert guidelines recommend PrEP for those at high risk for HIV, including
- men who have sex with men
- heterosexual men and women who have high-risk exposure (such as having a partner with known HIV infection, exchanging sex for drugs or money, or having sex with a person at high risk for HIV)
- people who inject drugs
- transgender women.
Currently, 50% of new HIV cases in the US occur among Black and Latino gay and bisexual men. Slightly more than 15% occur among heterosexual women, roughly three-quarters of whom are women of color.
The CDC estimates that 1.1 million people in the US would benefit from PrEP, including 175,000 women and 780,000 people of color. Yet prescriptions for PrEP are sluggish, particularly in populations at increased risk. Since 2012, only 135,000 PrEP prescriptions have been filled in the US. Almost all were for men — largely, white men in the Northeast and on the West Coast who have sex with men.
The new formulation of PrEP
In August, an FDA advisory panel voted 16 to 2 to recommend a new formulation of PrEP for men who have sex with men and transgender women, while voting 8 to 10 against approval in cisgender women. The panel was presented with data from a single study sponsored by Gilead, the manufacturer of the drug, which is a combination of emtricitabine and tenofovir alafenamide (brand name Descovy). This new formulation is less likely to affect the kidneys and bones, yet is just as effective as Truvada in preventing HIV.
The DISCOVER trial enrolled 5,387 participants across 92 study sites. Nearly all were cisgender men. Less than 10% of the study participants were Black. Only 74 transgender women were enrolled, and the study explicitly excluded cisgender women.
The FDA panel members acknowledged these limitations. Dr. Lindsey Baden, an infectious disease physician at Brigham and Women’s Hospital and the Dana-Farber Cancer Institute, noted “we’ve failed women,” and Dr. Roblena Walker, a consumer representative on the panel, voted against approval, citing the poor representation of Black men in the study, calling this “a lost opportunity to provide substantial data reflective of the community that is impacted by HIV.”
How else might the 10-year initiative help?
Four key strategies are emphasized in the 10-year initiative and backed by the global research community:
- Increase access to HIV testing, and ensure that all people living with HIV know their diagnosis.
- Expand access to effective treatment to get people on medication and virally suppressed, which helps prevent HIV transmission.
- Respond quickly to sites of potential HIV outbreaks and populations at increased risk.
- Prevent those at risk for HIV from becoming infected.
The bottom line
The fact is that PrEP works. Studies in men, women, and people who inject drugs have repeatedly demonstrated substantial decreases in HIV incidence after PrEP programs are rolled out. So if you’re concerned about your risk for HIV, talk to your doctor about taking PrEP or find a provider near you. If you’ve tried PrEP, but had trouble taking it regularly, discuss those issues with your provider, too.
Given the low numbers of PrEP prescriptions, we should encourage anyone who might benefit from PrEP to consider taking it. Globally, estimates suggest less than 350,000 people are on the medication, far short of the World Health Organization goal of three million PrEP users by 2020. We can lobby for additional investment in PrEP programs, innovative implementation projects, and clinical trials for new drug development. And we can insist that those investments reflect the nearly 800,000 new global infections in women and the racial disparities in HIV diagnoses that persist in the US.
We can, and we must, push for broader access to PrEP and clinical trials that enroll all of those at risk for HIV. We cannot settle for the status quo that has seen continued spread of the virus. As individuals and as a community, we can, and we must, act now to truly end this epidemic.