A decade into the era of the HIV prevention pill, called PrEP, efforts to take advantage of its stated power to prevent new infections have stagnated in the United States.
This shortfall is a key reason the country lags far behind many others in combating HIV, a national epidemic long plagued by racial disparities and new infection rates with only a modest decline.
“We are reaching a scientific crisis in HIV prevention,” Lauron Nelson, an associate professor of nursing and public health at Yale University, told a conference on retroviruses and opportunistic infections in Seattle last month. Nelson bemoans the gap between PrEP’s impressive performance in key studies and its modest real-world impact.
The good news is that PrEP, which is short for pre-exposure prophylaxis and involves taking prescription antiretroviral drugs, either oral or injectable, before potential HIV exposure, has actually gained substantial popularity — but only among white gay and bisexual men. Among those who have over the long term saw a declining HIV rate.
Such a disparity persists despite the efforts of a nationwide public-health army and countless millions of dollars spent promoting PrEP use among black and Latino gay and bi men. Of all major intersectional demographics, these groups contract HIV at the highest rates, and transmissions among them have flatline or barely decreased in recent years.
And so, even in the midst of national calculations on racial disparities, PrEP has served to widen HIV-transmission racial disparities among men who have sex with men.
According to the Centers for Disease Control and Prevention, gay and bi men account for 70% of new cases of the virus. Whites in this demographic comprised 15% of the 34,800 HIV transmissions in 2019, while much smaller populations of their Black and Latino peers comprised 26% and 23% of new cases, respectively.
Additionally, more than a year after the approval of the long-acting injectable form of PrEP, ViiV Healthcare’s Apretude, few are receiving it. Insurers refuse to cover most of the expensive medicine. As a result, even after clinical trials showed injectable PrEP was dramatically better than oral PrEP at preventing HIV at the public health level, especially among black gay men, Aprateude will likely remain untested for the foreseeable future. .
Gilead Sciences’ two-drug combo pill Truvada was approved as a PrEP in 2012 and was followed in 2019 by the similar drug Descovy. According to several studies, when either drug is taken daily, it reduces the risk of HIV among gay and bi men and transgender women by at least 99%.
PrEP has helped drive down HIV rates in cities such as New York, San Francisco, and Seattle, where it has gained a critical mass of popularity. But nationally, PrEP has failed to move the needle much.
The CDC estimates that annual HIV transmissions declined by only 8% between 2015 and 2019. Cases are rising in some states where HIV prevention investment is lacking, such as Tennessee, where Republican Gov. Bill Lee recently added to the worsening factors of his state’s epidemic by blocking $8.3 million in annual CDC prevention funds.
approximately 814,000 gay and bi men The CDC estimates that there are good candidates for PrEP in the US. Between 2017 and 2022, the number of people using PrEP at any given time during each given year, who have always been gay and bi men, increased from 155,000 to 382,000. However, a CDC study presented in Seattle found that in September 2022, only 187,000 people were on PrEP within that 30-day period, suggesting that many people don’t take it long enough.
The growing popularity of PrEP could likely make a big dent in national HIV rates, according to HIV prevention experts, with its use more closely reflecting viral-transmission demographics. In the CDC’s estimate of 21,900 new HIV cases in 2019 (the most recent year for which the agency has estimated transmission), the three largest racial groups among gay and bi men were white, black, and white, with 23%, 41%, and 36%, respectively. Latino. But 69% percent of PrEP users last year were white, compared to a respective 9% and 18% black and Latino.
Apretude’s acceptance promises progress
Approved in December 2021, Apretude requires receiving an injection by a health care worker every two months. Compared to providing PrEP to trans women and men who have sex with men, giving them Aprateude was associated with a 66% lower overall HIV diagnosis rate in a major clinical trial.
The superior efficacy of Apretude was driven by the fact that participants adhered better to the injection schedule compared to the daily pill regimen.
An HIV prevention expert at the San Francisco Department of Public Health, Dr. Hyman Scott told the Seattle conference that among 844 black American participants in the trial, those who were randomized to receive the injected drug had a 72% lower HIV rate than those who were randomized. Who got Truvada.
Their analysis shows that if 10,000 similar black gay and bi men and trans women are followed for one year, about 50 will contract HIV if given Apretrude, while 200 will test positive if provided Truvada. .
Such dire findings about Truvada’s drawbacks are in keeping with previous studies finding relatively low rates of adherence to a daily PrEP regimen among black gay men. Such data suggest that even if HIV prevention advocates were successful in increasing oral PrEP access in this population, it may have only limited impact among them.
Referring to Apretude, Scott told NBC News, “Can we roll this out into communities is the real question.”
Cost is a major rub. As of 2021, Truvada is available from several generic manufacturers and now often costs from $25 to $35 per month, though up to $600 in some cases. ViiV lists Apretude for $1,878 per month, and some insurers are covering it.
A recently presented CDC PrEP-use study in Seattle found that only 1 in 200 PrEP prescriptions in September were for Apretude.
Dr. Anu Hazra, an LGBTQ-oriented physician, said, “There are patients who are now getting Aptitude, but it is people who have access to health care, who have health care literacy, who are calling their insurance companies. do and yell at the right people.” Focused on Howard Browne Health in Chicago.
Beginning in 2021, nearly all insurers are mandated under the Affordable Care Act to cover oral PrEP with no out-of-pocket costs for the drugs or quarterly clinic visits and lab tests needed to maintain a prescription Has gone. That’s because in 2019, an advisory body known as the US Preventive Services Task Force gave PrEP an “A” rating for being an eligible preventive tool.
In December, the task force issued a draft decision giving Apretude its “A” rating. If this rating is made official this year, insurers would be required to cover Apretude, and without any cost sharing – but not until January 2025.
In addition to the associated burden of coming back six times per year for injections, Apretude has one notable drawback: breakthrough HIV cases are markedly more likely among those taking injections versus oral PrEP.
Of the 25 people who contracted HIV in the 2,282-person Apretude arm of the injection-versus-oral PrEP trial among gay and bi men and trans women, six did so over time after injecting, according to a presentation in Seattle by Dr. Did. Susan Eshleman, professor of pathology at Johns Hopkins Medicine.
Eshleman’s team hasn’t yet calculated Apretude success infection rates per person, but when these researchers initially reported last year that the trial saw seven success infections (before revising that figure to six), Their calculations suggested that if 10,000 same-sex men and trans women were followed for a year, 15 would contract HIV despite periodically receiving Apretude injections.
At the same Seattle conference, Hazra reported the first breakthrough HIV case in an unprepared patient outside of clinical trials. By comparison, about four years passed after Truvada’s approval as a PrEP before a person honestly took that drug.
To date, there have been few other case-study reports of successful HIV in people taking oral PrEP. However, only one such clear case has been reported in major clinical trials involving Truvada or Descovy as prevention.
All of this suggests that for people who have a history of taking daily oral PrEP over time, switching to Apretude will actually increase their HIV risk; However, the absolute risk of infection will remain low.
optimism in the pipeline
HIV prevention experts report enthusiasm about the PrEP pipeline and expectations that in the coming decade, more convenient and longer-lasting forms will be approved.
“I’m wildly optimistic,” said Sharon Hillier, a leading HIV prevention researcher at the University of Pittsburgh. “We have to work through how to deliver these interventions and how to be less of a burden to health care systems.”
The Seattle conference held promising early-stage research findings about drug-infused suppositories that can be placed in the rectum or vagina for up to 48 hours after sex and could potentially prevent HIV. And researchers are developing implants that can be placed under the skin and emit preventive medicine for several months.
Gilead is also running a flagship PrEP trial of the drug lencapavir, which requires only one injection every six months. Dr. Jared Batten, who leads Gilead’s HIV strategy, said the company hopes to provide preliminary study results by 2025.
But if Apretude’s pacing is any guide, it could be 2030 before lencapavir is approved and widely covered by insurers.
In the meantime, PrEP advocates continue to express a dedication to working with the options currently on the table, albeit within a complex and fragmented health care system that proves alienating to many of those at risk for HIV. Is.