Ten years after the introduction of PrEP, the HIV prevention pill, American efforts to stop new infections have stagnated.
This is why the country lags behind other countries in HIV combating, with a national HIV epidemic that has been plagued by racial inequalities and a declining rate of new infections.
LaRon Nelson, an associate professor at Yale University of nursing and public, stated last month that “We are approaching a scientific crisis HIV prevention.” Nelson lamented the gap between PrEP’s impressive performance in major research and its modest real-world impact.
PrEP is short for preexposure prophylaxis. It involves taking prescription antiretroviral medication either orally in order to prevent potential HIV exposure. However, PrEP has only gained popularity among white gay and bisexual males who have seen an increase in HIV rates over the years.
This inequity persists despite efforts by a national public-health army, and the countless millions of dollars spent on promoting and facilitating PrEP use among Black and Latino homosexual and bi men. These groups are the most likely to contract HIV, and transmissions have slowed or even stopped in recent years.
PrEP, despite the national debate over racial injustice, has only contributed to increasing HIV-transmission disparities among men who have had sex with men.
The Centers for Disease Control and Prevention estimates that gay and bi men are responsible for 70% new cases of the virus. This demographic included 15% of 34,800 HIV transmissions in 2019. However, the smaller numbers of HIV-positive Black and Latino people made up 26% and 23% respectively.
A year after the approval for a long-acting injectable PrEP form, ViiV Healthcare’s Apretude, very few people are still receiving it. The expensive drug has been refused coverage by most insurance companies. Even though clinical trials showed that injectable PrEP was significantly more effective than oral PrEP in preventing HIV at a public level, especially among Black gay men and women, Apretude’s potential remains untapped.
In 2012, Truvada, a two-drug combination pill from Gilead Sciences was approved as PrEP. Descovy was then followed in 2019. Multiple studies have shown that this reduces the HIV risk for gay men, bi men, and transgender women by at least 91% when either drug is taken every day.
PrEP has been able to lower HIV rates in cities where it is popular, such as New York and San Francisco. PrEP has not been able to significantly improve HIV rates nationally.
According to the CDC, annual HIV transmissions have declined by just 8% between 2015-2019. In some states, like Tennessee, where Republican Governor. Bill Lee recently added to the problem by blocking $8.3 Million in annual CDC prevention funding.
The CDC estimates that approximately 814,000 homosexual and bi men in the U.S. are PrEP candidates. The number of PrEP users, who are overwhelmingly gay and bi men at any given time during the year, increased from 155,000 up to 382,000 between 2017 and 2022. A CDC study in Seattle showed that PrEP was used by only 187,000 people in the 30-day period ending September 2022. This suggests that people don’t take it long enough.
PrEP’s popularity could have made a significant impact on the national HIV rate if it was more closely aligned with viral-transmission demographics. HIV prevention experts believe this would have been possible. The CDC estimates that there were 21,900 new HIV cases last year. This is the most recent year the agency has provided a transmission estimate. Whites, Blacks, and Latinos made up 23%, 41%, and 36% respectively of the respective 21,000. However, 69% of PrEP users in last year were white while only 9% and 18% respectively were Black and Latino.
Apretude’s approval promised progress
Apretude was approved in December 2021. It requires that an injection be administered by a healthcare worker every two months. Apretude is 66% less likely to be diagnosed with HIV than Truvada for transgender men and women who have had sex with men.
Apretude’s superior efficacy is due to the fact that participants stayed on the injection schedule more than the daily pill regimen.
At the Seattle conference, Dr. Hyman Scott, an HIV prevention expert from the San Francisco Department of Public Health reported that the HIV rate for the 844 Black American participants was 72% lower than the Truvada-treated group.
According to his analysis, approximately 50 HIV-positive Black bi and gay men and women would be infected if they were given Apretude. Truvada would make 200 HIV-positive.
These sobering facts about Truvada’s failings are consistent with previous studies revealing low rates for Black gay men to adhere to the daily PrEP regimen. These data suggest that even though HIV prevention advocates have succeeded in greatly increasing oral PrEP access within this population, the impact might be limited among them.
Scott spoke out about Apretude and said to NBC News: “Whether we can roll this out in communities, is the real question.”
Cost is a big problem. Truvada has been made available by multiple generic manufacturers since 2021. can be purchased for as low as $25 to $35 per monthly, but in some cases, up to $600. ViiV lists Apretude as $1,878 per monthly, but few insurance companies cover it.
According to a recent CDC PrEP-use Study presented in Seattle, only 1 in 200 PrEP prescriptions was for Apretude in September.
“There are some patients who are getting Apretude right now, but it is people who have access to health care, who have literacy in health care, and who call their insurance companies to yell at them,” Dr. Anu Hazra of the LGBTQ-focused Howard Brown Health in Chicago said.
Nearly all insurers have been required by the Affordable Care Act to provide oral PrEP coverage. There are no out-of pocket costs for medications, or quarterly visits to the clinics and lab tests that are necessary to keep a prescription. PrEP was given an “A” rating by the U.S. Preventive Services Task Force in 2019.
The task force issued a draft of its December decision, granting Apretude an “A” rating. Insurers will have to cover Apretude if this rating is officially made this year. However, this coverage will not be effective until January 2025.
Apretude has a significant weakness: Breakthrough HIV cases seem to be more common among people who take injectable PrEP than those who have to visit the clinic six times a year.
Of the 25 people who contracted HIV in the 2,282-person Apretude arm of the injectable-versus-oral PrEP trial among gay and bi men and trans women, six did so after getting their injections on schedule, according to a presentation in Seattle by Dr. Susan Eshleman, a professor of pathology at Johns Hopkins Medicine.
Although Eshleman’s group hasn’t yet calculated the per-capita Apretude breakthrough infected rate, originally reported last January that seven of the trials saw breakthrough infections. However, these researchers then revised this number down to six. Their calculations indicated that 15 HIV-infected people would be born if they were followed for one full year by 10,000 men and women, despite being given on-schedule Apretude shots.
Hazra also reported on the Seattle conference the first case of HIV in Apretude patients outside of clinical trials. Comparatively, it took nearly four years after Truvada was approved as PrEP before a breakthrough infected person was .
There have been few cases that show breakthrough HIV among oral PrEP users. There has been only one such case in major clinical trials, including Truvada and Descovy.
This suggests that switching to Apretude could increase HIV risk for people who have been taking oral PrEP daily on a regular basis. However, the absolute risk of getting infected would not change.
Optimism in The Pipeline
HIV prevention experts are excited about the PrEP pipeline. They also expect that more convenient forms and more effective forms will be approved in the next decade.
Sharon Hillier, a well-known HIV prevention researcher at University of Pittsburgh, said that she is “wildly optimistic”. “We need to figure out how to deliver these interventions, and how to make it less burdensome for the health care system.”
At the Seattle conference, promising research results were presented about medication-infused suppositories. These could be used to prevent HIV and can be administered into the rectum or vagina for up to 48 hours after sex. Researchers are also developing implants that can be placed under the skin to emit preventative medication for many months.
Gilead also runs major PrEP trials for the drug lenacapavir. This drug requires injections only once every six months. Gilead’s HIV strategy leader, Dr. Jared Baeten said that the company hopes to have initial results by 2025.
Apretude’s pace suggests that it could take until 2030 before lenacapavir becomes widely covered by insurances.
PrEP advocates are continuing to show dedication to working with the options currently available, even within a complex, fractured health system that alienates many of the most vulnerable to HIV.