On July 16, 2012, the Food and Drug Administration (FDA) approved Truvada for pre-exposure prophylaxis—better known as PrEP—to prevent HIV acquisition. But although uptake has improved over the past decade, PrEP still isn’t reaching everyone at risk for HIV.
Ten years ago the US FDA approved oral PrEP, a pill when taken daily, is highly effective in preventing HIV. This milestone promised to cut down new infections and help end the epidemic, but that promise is still unfulfilled. Urgent work remains to be done for universal access.????— AVAC (@HIVpxresearch) July 15, 2022
Truvada (TDF/FTC) contains two drugs, tenofovir disoproxil fumarate and emtricitabine, that are widely used for HIV treatment. The benefits of TDF/FTC for PrEP were first demonstrated in the iPrEx trial, which found that the daily pills reduced the risk of HIV acquisition by 42% overall for gay and bisexual men and transgender women, but this rose to 92% for participants who had blood drug levels indicating good adherence.
The Partners PrEP study, which enrolled mostly heterosexual serodiscordant couples in Kenya and Uganda, found that daily TDF/FTC reduced the likelihood of HIV acquisition by 75%. Another study of heterosexual men and women in Africa, TDF2, showed a 62% risk reduction. In contrast, the Fem-PrEP study did not show a significant protective effect for high-risk African women, but participants’ blood drug levels were low, indicating less than optimal adherence.
According to the Centers for Disease Control and Prevention (CDC), “PrEP reduces the risk of getting HIV from sex by about 99% when taken as prescribed.” The CDC adds that although there is less information about its effectiveness for people who inject drugs, PrEP reduces the risk HIV acquisition “by at least 74% when taken as prescribed.”
In 2014, researchers first reported results from the French Ipergay trial, showing that “on-demand” TDF/FTC taken before and after sex—known as PrEP 2-1-1—is also highly effective. In fact, the French PREVENIR study found that intermittent PrEP works as well as daily pills. PrEP 2-1-1 involves taking two doses of TDF/FTC between two and 24 hours before anticipated sex, one dose 24 hours after the initial double dose and a final dose 24 hours after that.
In 2019, the FDA gave the green light to a second PrEP option, Descovy (tenofovir alafenamide/emtricitabine, or TAF/FTC). However, due to a lack of data, the indication excludes people who are exposed to HIV via receptive vaginal or frontal sex.
Finally, late last year, the FDA approved the first long-acting injectable PrEP option, Apretude (extended release cabotegravir), which is administered by a health care provider every other month. Studies showed that the injections work even better than daily PrEP pills for gay and bi men, trans women and cisgender women.
Improving PrEP Access
The advent of PrEP is credited with helping reduce HIV incidence over the past decade. According to the CDC, an estimated 34,800 people acquired HIV in 2019, after remaining stable at around 50,000 for many years. (HIV diagnoses fell steeply in 2020, but that could in part be attributable to decreased testing due to the COVID-19 pandemic.)
PrEP uptake started out low but accelerated quickly, especially among white gay and bisexual men. But Black and Latino men who have sex with men, cisgender women and transgender people have not been as eager to embrace PrEP as a prevention strategy.
Initially, the high cost of Truvada and limited insurance coverage were barriers. But in 2019, the U.S. Preventive Services Task Force strongly recommended TDF/FTC PrEP for men and women at high risk of acquiring HIV, which meant that insurers were required to cover it. And in early 2021, cheaper generic versions of TDF/FTC came on the market in the United States. But Descovy and Apretude are still costly.
As POZ previously reported, 9 out of 10 gay and bisexual men at high risk for HIV were aware of PrEP, but only a third were using it in 2017. Black and Latino men who have sex with men were less likely to know about PrEP and less likely to use it than white and Asian men. In 2019, the CDC reported that 63% of eligible white people (not just gay and bi men) were receiving PrEP, but this fell to just 8% of Black people and 14% of Latinos.
PrEP adoption has been slow among women, but research points to ways to improve uptake. One recent study found that Black women said they would prefer PrEP injections over daily pills—but they don’t want to be rushed into a decision. And for trans women, recent data show that those with a gender-affirming provider are more likely to use PrEP.
But now there are new threats. A conservative lawyer in Texas, known for his work to restrict abortion access, recently filed a federal lawsuit to limit insurance coverage of PrEP. This is only one of several legal challenges against HIV services and health care access for LGBTQ people.
In order to increase PrEP access, Matthew Rose, a Black gay man who spoke in favor of PrEP approval in 2012, recommends community education and awareness campaigns, countering mistrust of the health care system, training more culturally competent providers, strengthening the health care infrastructure in the South (which accounts for a growing proportion of HIV cases), improving health care access in rural communities and better access for people who use drugs. Adapting service delivery to reach people of color could include primary care and family planning clinics, pharmacies, faith-based settings, youth centers, and hair salons and barbershops.
“[W]e must stop kidding ourselves and acting like our current ways of operating are working at a meaningful level,” he wrote in his POZ blog. “[I]t is still possible to right the ship and create a world that sees an end to the pandemic by delivering what people need to live their best lives.”
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