HIV & AIDS

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What’s new in HIV: Updates on long-acting injections for prevention & treatment

For many years, we’ve relied on daily oral medications to treat HIV and to prevent HIV. But long-acting injectable options for both PrEP and treatment are an exciting new strategy that may increase  acceptability, accessibility, and effectiveness. An injectable option is now available for both HIV treatmentand PrEP, and new research is showing how PrEP and treatment injections may transform our response to the epidemic. 

Long-acting injections for prevention 

Late in 2021, the FDA approved the first long-acting injectable option for PrEP. Named Apretude®, the medication is a long-acting version of the integrase inhibitor cabotegravir, and is delivered as an injection once every two months. Long-acting injectable cabotegravir has no limitations on which groups can use this method of HIV prevention, which is notable given some early PrEP studies which failed to show efficacy with cisgender women. 

“Those of you who followed the PrEP literature know that there’s been a lot of controversy about how well oral PrEP works for vaginal exposures in cisgender women,” said Raphael Landovitz, MD, MSc, professor of medicine at UCLA Center for Clinical AIDS Research & Education, during “State of the Science” presentation on injectable PrEP.  “A lot of people at the beginning said, ‘It doesn’t work for women, it can’t work for women,’ And it turns out that’s not true.” 

The problem, Landovitz explained, is that the medicine that’s used for oral PrEP (TDF/FTC, brand name Truvada), “doesn’t get into the tissues of the genital tract [for cisgender women] as well as it gets into rectal tissue. So you have to have much better adherence to daily oral products to get protection for vaginal exposures… You need to be pretty well perfect in your daily adherence to the oral PrEP to get the vaginal protection.”

Injectable options may be a game-changer–particularly for cisgender women and with other folks who may struggle with adherence. In the HPTN 084 study, researchers found an 89% reduction in HIV infections among cisgender women provided with injectable cabotegravir PrEP compared to those offered oral TDF/FTC. 

“In my mind, this is stunning. It’s mind blowing,” said Landovitz. 

PrEP cabotegravir injection
Photo: Prepared syringe of cabotegravir, courtesy of ViiV Healthcare

A recent PrEP study, presented at the 2023 CROI by Sybil Hosek, PhD, showed that injectable long-acting cabotegravir for PrEP could be a feasible option for younger sexually active adolescent cisgender women (12 – 17 years old). The young women in the study had “exceptional” adherence to injection visits, were very interested in long-acting HIV prevention medication, and most (92%) chose to continue taking injectable cabotegravir for PrEP over PrEP oral medication when given a choice.  

During a report-back on the study presentation for Getting To Zero San Francisco, Hyman Scott, MD, MPH, said that although injection site reactions (pain, swelling) were common in the study, no participants discontinued the study early because of these reactions and the frequency of reactions decreased over time. 

In terms of acceptability, “a lot of the young women talked about receiving injections to protect against HIV being easier than other methods,” said Scott. 

It is of note that researchers do not yet have much data on injectable PrEP with people who inject drugs, and transmasculine and non-binary people. “Those are huge gaps in our understanding of how to use this product,” said Landovitz. 

With Black men who have sex with men and Black trans women disproportionately affected by HIV in the U.S., a recent study by Hyman Scott, MD, MPH, and colleagues looked at the efficacy of injectable cabotegravir for PrEP among U.S.-based Black and African American participants enrolled in the HPTN 083 study. 

Cabotegravir PrEP worked even better to prevent HIV infections than oral PrEP. Over the course of the study, there were 15 infections among those taking oral PrEP, and only 4 infections among those receiving injectable PrEP. 

“This showed that this [injectable cabotegravir PrEP] is a highly effective intervention in that we see a really decreased incidence among those who are taking CAB-LA [long-acting cabotegravir PrEP],” said Scott. 

Unfortunately, cost and affordability may be one thing that prevents widespread uptake of long-acting cabotegravir PrEP. 

“All the insurance companies are playing hot potato by making people go through all sorts of hoops and bells and whistles to use it [long-acting injectable PrEP]. And I’m really concerned, particularly outside of the US as well, that it’s not going to be implementable,” said Landovitz.  

Long-acting injections for treatment 

For HIV treatment, Cabenuva (cabotegravir/rilpivirine) has been available as a once-monthly injection since early 2021, and new studies are evaluating the benefits that long-acting injectable treatments offer. 

In one study, presented at CROI by Moti Ramgopal, MD, people living with HIV who switched to an injectable treatment option shared reasons why they preferred injectable treatments over oral medications. 

“The individuals who were taking the oral medications talked about some psychological social cycle issues, challenges with daily oral therapy,” said Dr. Scott. At the end of the study, 90% of participants preferred the injectable treatment option over daily oral medication, and reported benefits including “I don’t have to worry as much about remembering to take HIV medication every day,” and “I do not have to think about my HIV status every day.”   

Another study presented at CROI by Monica Gandhi, MD, MPH, shared results from a real-world roll-out of injectable HIV treatment at the Ward 86 HIV Clinic in San Francisco. The clinic serves publicly insured people with high rates of mental illness (38%), substance use (39%), and unstable housing (34%), which may contribute to more difficulty in taking daily oral HIV medications. 

Although more than 40% of people beginning injectable HIV treatment had detectable viral loads at the start of the study, nearly all (98%) achieved viral suppression. The vast majority of participants (74%) received on-time HIV treatment injections, and 100% of those who started the study virally suppressed remained virally suppressed during the study.  

“This worked well within a patient population that included individuals who had not been virally suppressed,” said Scott. “I think this is going to be important as we move forward with the rollout of injectable treatment, as it shows that in a population that is more of a ‘safety net population,’ that you can have high success with this regimen.” 

A final study that Dr. Scott highlighted during the Getting To Zero report-back addressed the question of whether injectable cabotegravir/rilpivirine could be administered in the thigh versus the gluteal (butt) muscle. 

“If someone has gluteal implants, or gluteal injections in the gluteal region, then that’s a contraindication to administering medication in those sites,” he explained.  Franco Felizarta and colleagues presented data from the ATLAS-2M study, which compared medication levels and patient preferences of thigh versus gluteal injections at CROI. 

Levels of medication in the body were similar after thigh and gluteal injections, and about 30% of people preferred thigh injections over gluteal injections. Participants who preferred thigh injections said that the convenience and easy access to this site on the body was preferred. Thigh injection pain was frequently reported, however, after about 40% of all injections administered. 

“Injection site reactions are variable. I think that the location in the thigh would make sense anatomically, but it might give you more symptoms,” said Scott. 

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Tennessee shuns federal HIV funds

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While the country remains in shock after Tennessee’s recent ban on public drag performances, another, more insidious attack on the LGBTQ+ community has been underway in the state.

A coordinated effort by right-wing media and conservative lawmakers has decimated community-based programs addressing healthcare for LGBTQ+ people in Tennessee, including efforts to combat HIV.

In January, Tennessee Gov. Bill Lee (R) announced his administration was rejecting $8.8 million in federal funds provided by the Centers for Disease Control and Prevention (CDC) for HIV prevention and treatment.

Left unsaid was the fact that some of those dollars had made their way to programs run by groups associated with trans healthcare. After a months-long outrage campaign by right-wing media, Gov. Lee finally threw the baby out with the bathwater.

The pressure campaign started in September, when right-wing provocateurs Matt Walsh and Ben Shapiro set their sights on the transgender care program at Nashville’s Vanderbilt University Medical Center, which Walsh described as “barbaric.”

“They now castrate, sterilize, and mutilate minors as well as adults,” Walsh said at the time.

Walsh amplified the accusations with an appearance on Tucker Carlson’s Fox News show on September 21 publicizing his “investigation,” while the Daily Wire co-founder Shapiro promoted the charges on his YouTube channel and podcast, detailing “nonsense garbage that a boy can be a girl and a girl can be a boy.”

The very next day, Gov. Lee issued a statement calling for a “thorough investigation.”

The accusations ignited a social media firestorm and surfaced the existence of the Tennessee Transgender Task Force, a volunteer team at Vanderbilt focused on trans health and HIV prevention, funded in part by those CDC dollars.

Weeks later, in November, the trans program’s director Dr. Pamela Talley told staff that federal dollars funding the task force, as well as Tennessee Planned Parenthood, would cease at year’s end.

Then in mid-January, the Lee administration announced it would not just end funding for those recipients, which totaled $235,000, but also that it would reject entirely a pair of CDC grants directed at HIV prevention, treatment and monitoring in the state worth more than $8.8 million.

“People have been crying all week,” one Tennessee Health Department staffer told NBC News after the announcement on January 20.

Ashley Coffield, the CEO of Planned Parenthood of Tennessee and Northern Mississippi, said the decision “felt like they were punching me in the gut.”

“I couldn’t believe that the governor would take the nuclear option,” she said, adding that she saw the move as a “political vendetta against abortion rights groups and transgender people.”

On Wednesday, newly appointed Tennessee Health Commissioner Ralph Alvarado told a state Senate committee that money from the grants would be replaced with $9 million in state funds.

Alvarado called the federal grants “cumbersome.”

“I think this is going to allow a bit of innovation, a little bit of liberty,” Alvarado testified. “I think it’s going to help vulnerable populations: people who are in human trafficking populations, mothers, children, first responders.”

But those populations, also identified by the governor’s office,  are not the ones most affected by the HIV epidemic in Tennessee, experts say.

“Tennessee is preferring to fight a fictitious epidemic rather than their very real HIV epidemic,” Greg Millett, the director of public policy at amfAR, The Foundation for AIDS Research, told NBC News.

“First responders are just not at risk for HIV anywhere in the United States. Sexual trafficking is awful, but it’s not a major contributor for HIV cases in Tennessee or elsewhere.” 

He added: “All of this is willful ignorance on the part of the state government.”  

When State Sen. Jeff Yarbro (D-Nashville) asked Alvarado if future state funding would focus on the highest-risk groups, including men who have sex with men and intravenous drug users, the health commissioner was less than definitive.

“I imagine that the same populations they’ve been approaching will continue to receive benefits from this.”

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PrEP’s promise to change the course of HIV has succeeded — but only for white gay men

A decade into the era of the HIV prevention pill, called PrEP, efforts to leverage its heralded power to curb new infections have stagnated in the United States.

This shortfall is a key reason the nation lags far behind many others in combating HIV, with a national epidemic long plagued by racial inequities and only a modestly declining new infection rate. 

“We are reaching a scientific crisis in HIV prevention,” LaRon Nelson, an associate professor of nursing and public health at Yale University, said last month at the Conference on Retroviruses and Opportunistic Infections in Seattle. Nelson lamented the gulf between PrEP’s impressive performance in major studies and its moderate real-world impact.

On the bright side, PrEP, which is short for pre-exposure prophylaxis and involves taking either oral or injectable prescription antiretroviral medications in advance of potential HIV exposure, has indeed achieved substantial popularity — but only among white gay and bisexual men, who have long seen a dropping HIV rate.

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Such inequity persists despite the efforts of a nationwide public-health army and countless millions of dollars spent promoting and facilitating 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 flatlined or barely declined in recent years.

And so, even amid the national reckoning over racial inequity, PrEP has only 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 the much smaller populations of their Black and Latino peers comprised a respective 26% and 23% of new cases. 

Additionally, more than a year after the approval of a long-acting injectable form of PrEP, ViiV Healthcare’s Apretude, few are receiving it. Insurers have mostly refused to cover the expensive drug. Consequently, even after clinical trials found injectable PrEPwas dramatically superior to oral PrEP at preventing HIV on a public health level, especially among Black gay men, Apretude’s potential will likely remain untapped for the foreseeable future.

Troubling statistics

Gilead Sciences’ two-drug combo pill Truvada was approved as PrEP in 2012 and was followed in 2019 by a similar drug, Descovy. When either drug is taken daily, this lowers the risk of HIV by at least 99% among gay and bi men and transgender women, according to multiple studies. 

PrEP has helped drive down HIV rates in cities where it has achieved a critical mass of popularity, such as in New York, San Francisco andSeattle. But nationally, PrEP has failed to move the needle by much.

HIV prevention drug Descovy, at Pucci's Pharmacy in Sacramento, Calif., on Oct. 7, 2019.
HIV prevention drug Descovy, at Pucci’s Pharmacy in Sacramento, Calif., on Oct. 7, 2019.Rich Pedroncelli / AP file

The CDC estimates annual HIV transmissions declined by only 8%between 2015 and 2019. Cases are even rising in some states where HIV prevention investment is lacking, such as Tennessee, where Republican Gov. Bill Lee recently compounded the factors worsening his state’s epidemic by blocking $8.3 million in annual CDC prevention funding.

Approximately 814,000 gay and bi men in the U.S. are good PrEP candidates, the CDC estimates. Between 2017 and 2022, the number of people using PrEP, who have always overwhelmingly been gay and bi men, at any point during each given year increased from 155,000 to 382,000. However, a CDC study presented in Seattle found that in September 2022, just 187,000 people were on PrEP within that 30-day window, suggesting that many people do not take it for long.

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PrEP’s increasing popularity likely could have put a major dent in the national HIV rate had its use more closely reflected viral-transmission demographics, according to HIV prevention experts. Of the CDC’s estimate of 21,900 new HIV cases in 2019 (the most recent year for which the agency has produced a transmission estimate) in the three largest racial groups among gay and bi men, a respective 23%, 41% and 36% were in whites, Blacks and Latinos. But a lopsided 69% percent of PrEP users last year were white, while only a respective 9% and 18% were Black and Latino.

Apretude’s approval promised progress

Approved in December 2021, Apretude requires receiving an injection by a health care worker every two months. Compared with providing trans women and men who have sex with men Truvada as PrEP, giving them Apretude was associated with a 66% lower overall HIV diagnosis rate in a major clinical trial.

Apretude’s superior efficacy was driven by the fact that participants adhered better to the injection schedule than to the daily pill regimen.

Dr. Hyman Scott, an HIV prevention expert at the San Francisco Department of Public Health, reported at the Seattle conference that of the 844 Black American participants in the trial, those randomized to receive the injectable drug had a 72% lower HIV rate than those who got Truvada.

His analysis suggests that if 10,000 similar Black gay and bi men and trans women were followed for one year, approximately 50 would contract HIV if given Apretude, while 200 would test positive if provided Truvada.

Such sobering findings about Truvada’s shortcomings are in keeping with previous studies finding relatively low rates of adherence to the daily PrEP regimen among Black gay men. Such data suggests that even if HIV prevention advocates succeeded in vastly increasing oral PrEP access in this population, it might have only limited impact among them.

Referring to Apretude, Scott told NBC News, “Whether we can get this rolled out in communities is the real question.” 

Mayor London Breed, right, shakes hands with Dr. Hyman Scott at Zuckerberg San Francisco Hospital on Sept. 10, 2019.
Mayor London Breed, right, shakes hands with Dr. Hyman Scott at Zuckerberg San Francisco Hospital on Sept. 10, 2019.Gabrielle Lurie / The San Francisco Chronicle via Getty Images file

Cost is a major rub. Since 2021, Truvada has been available from multiple generic manufacturers and now often costs as little as $25 to $35 per month, although in some cases up to $600. ViiV lists Apretude at $1,878 per month, and few insurers are covering it. 

The recent CDC PrEP-use study presented in Seattle found that only about 1 in 200 PrEP prescriptions were for Apretude in September.

“There are patients who are getting Apretude now, but it’s people who have health care access, who have health care literacy, who call their insurance companies and yell at the right people,” said Dr. Anu Hazra, a physician at the LGBTQ-focused Howard Brown Health in Chicago.

Since 2021, almost all insurers have been obliged under the Affordable Care Act to cover oral PrEP with no out-of-pocket costs for the medications or the quarterly clinic visits and lab tests required to maintain a prescription. This is because in 2019, an advisory body known as the U.S. Preventive Services Task Force gave PrEP an “A” rating for being a worthy preventive tool.

In December, the task force issued a draft decision granting Apretude its own “A” rating. If this rating is made official this year, insurers will be required to cover Apretude, and with no cost sharing — but not until January 2025.

Apretude updates

In addition to the associated burden of having to come in six times per year for injections, Apretude does have a notable shortcoming: Breakthrough HIV cases are apparently much more likely among those taking injectable versus oral PrEP. 

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. 

Eshleman’s team has not yet calculated the per capita Apretude breakthrough infection rate, but when these researchers initially reported last year that the trial saw seven breakthrough infections (before revising this figure down to six), their calculations suggested that if 10,000 similar men and trans women were followed for one year, 15 would contract HIV despite receiving on-schedule Apretude injections.

Apretude.
Apretude.ViiV Healthcare

At the same Seattle conference, Hazra reported the first breakthrough HIV case in an Apretude patient outside of a clinical trial. By comparison, nearly four years passed after Truvada’s approval as PrEP before a breakthrough infection was first documented in someone faithfully taking that drug.

To date, there have been a handful of other case-study reports of breakthrough HIV in people taking oral PrEP. However, there has only ever been one clear such case in the major clinical trials including Truvada or Descovy as prevention.

All this suggests that for those with a history of taking daily oral PrEP on schedule, switching to Apretude would actually increase their HIV risk; although the absolute risk of infection would remain low.

Optimism in the pipeline

HIV prevention experts report excitement about the PrEP pipeline and expectations that in the coming decade, more convenient and longer-acting forms will be approved.

“I’m wildly optimistic,” said Sharon Hillier, a prominent HIV prevention researcher at the University of Pittsburgh. “We just have to work through how to deliver these interventions and how to be less burdensome for health care systems.”

The Seattle conference heard promising early stage research findings regarding medication-infused suppositories that could be placed into the rectum or vagina up to 48 hours following sex and likely prevent HIV. And researchers are developing implants that could be placed under the skin and emit preventive medication for many months.

Gilead is also running major PrEP trials of the drug lenacapavir, which requires an injection only every six months. Dr. Jared Baeten, who leads Gilead’s HIV strategy, said the company hopes to provide initial study results by 2025. 

But if Apretude’s pacing is any guide, it could be 2030 before lenacapavir is both approved and widely covered by insurers. 

In the meantime, PrEP advocates continue to express dedication to work with the options currently on the table, albeit within a complex and fractured health care system that proves alienating to many of those most at risk of HIV.

Benjamin Ryan

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Feds Seek Input on National PrEP Coverage

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The federal government is seeking public input concerning whether its Medicare department should cover HIV pre-exposure prophylaxis and PrEP medication nationwide, including a new injectable drug that has been developed.

Centers for Medicare and Medicaid Services (CMS) is considering whether it will cover HIV prevention pre-exposure prophylaxis drugs (PrEP) such as Apretude, a prescription injectable given every two months to individuals at risk of contracting HIV.

As part of the analysis, CMS seeks comments from the public, particularly those that include scientific evidence.

As of 2020, Medicare coverage for PrEP varies by state or county, but the average cost of the prevention is $2276 to $2430 per year, Endpoints News reports.

For a service to qualify for national coverage, it must be rated an A or B by the U.S. Prevention Services Task Force (USPSTF). The task force gave long-acting injectable PrEP an A rating last month. Oral PrEP received an A rating in 2019.

Under the Affordable Care Act, health insurance plans and private insurers that the ACA approves are required to cover preventive services that receive an A or B rating.

According to CMS, this analysis comes at the same time as the U.S. Preventive Services Task Force updated a recommendation for prescribing PrEP with effective antiretroviral therapy to HIV-infected individuals last month and gave the proposal an A.

ViiV Healthcare, a subsidiary of GSK, formally requested a national coverage determination last February after FDA approval in December 2021. Apretude is approved for use in adults and adolescents who weigh at least 77 pounds. Initiation injections for Apretude are given one month apart, followed by two monthly injections.

Representatives for the drug manufacturer asked government regulators to issue the passing certificate quickly.

“Given that the USPSTF’s current Grade A recommendation, by its terms, broadly applies to all PrEP therapies (even if it was based on clinical evidence supporting daily oral tenofovir disoproxil fumarate-emtricitabine), it is appropriate to apply the USPSTF’s current Grade A recommendation for PrEP to APRETUDE,” wrote Andrew Zolopa, head of ViiV North America Medical Affairs, in a letter to CMS. “Finally, provider-administered PrEP is appropriate for individuals enrolled under Medicare Part B. Data show that the Medicare program covers approximately 10% of individuals who could benefit from PrEP, including primarily younger individuals who are eligible for Medicare based on disability.”

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Repeal HIV Criminalization Laws to End the Epidemic & to Advance Racial Justice

On Black HIV/AIDS Awareness Day, we must remember the myriad ways the work to end the HIV epidemic overlaps with the work for LGBTQ justice and overlaps with the work to dismantle white supremacy. One of these overlaps is laws that criminalize HIV.

HIV criminalization is when a state criminalizes otherwise legal conduct or increases the penalties for illegal conduct based on a person’s HIV status. As of 2022, there are at least 35 states with HIV criminalization laws.

Each state’s laws vary. Some require the prosecution to prove the person intended to expose others to HIV, but in most states, simply not disclosing your HIV status is enough to convict. Apart from several state reforms over the last few years, no states require evidence of actual transmission or an intent to do harm.

Let’s look at the example of Robert Suttle, a Black man from Louisiana who was convicted under the state’s antiquated HIV criminalization laws.

Following a bad breakup, Suttle’s former partner reported him to the police, stating he was unaware of Suttle’s HIV status. Under Louisiana law, it is illegal to engage in sexual activity if you know your HIV status and do not disclose it. Suttle says he disclosed his status, but it was a case of he said, he said. At court, he took a plea deal to avoid trial and the possibility of the maximum sentence. As a result, he was charged with a felony and spent six months in prison.

After his release, Suttle was placed on the state’s sex offender registry, which places a mark on his driver’s license, and he was forced to publish a photo of himself in the newspaper.

Suttle’s story is a typical example of how HIV criminalization laws are used, and how they further criminalize marginalized and BIPOC communities.

States like Louisiana have laws that are outdated, based on obsolete science and misconceptions of HIV. Many of the HIV criminalization laws were drafted in the late 1980’s at the onset of the HIV epidemic and were driven by public fear when very little was known. In some states, spitting or biting — which has little possibility of transmission — are criminalized. In other states, safe sex practices (such as condom use) are irrelevant and cannot be used as defenses.

Most laws also do not take into account the fact that undetectable equals untransmittable. Once someone reaches a point in their treatment where the amount of the virus in their body is so low that it doesn’t show up on blood tests, they are said to have reached an undetectable viral load. A person with an undetectable viral load cannot pass the virus along to anyone.

Science has progressed by leaps and bounds, making treatment of STIs more manageable and HIV no longer a death sentence. The science has moved forward, it’s time for the law to follow suit.

What’s more, these laws are a barrier to preventing the spread of HIV. HIV criminal laws stigmatize HIV, discourage individuals from knowing their status and accessing medical treatment. That’s why almost all major public health organizations — including the American Medical Association, the Centers for Disease Control and Prevention, and the Presidential Advisory Council on HIV/AIDS — all urge a public health approach over criminalization.

New York is one state poised to update its archaic HIV laws, a law that was first written in 1909 to prevent the spread of “venereal diseases” among members of the military.

With the onslaught of World War II, combatting sexually transmitted infections (STIs) became a national priority as their treatment took soldiers out of commission for months. In 1943, the New York legislature increased the penalty to a felony. In 1946 the law was rewritten again making it applicable to the general public and a misdemeanor. It remains unchanged 76 years later.

The New York state law does not make sense in the age of modern medicine.

Pending before the New York state legislature is the REPEAL STI Discrimination Act. The act will repeal the state law that criminalizes STIs and provides for the expungement of past convictions. It also creates a defense so that having an STI does not mean potential criminal charges when engaging in consensual sex.

The New York legislature should pass the REPEAL STI Discrimination Act, and other states should quickly follow suit, because we are all only as safe as the members of our community most at risk and for HIV.

Public health advocates have long known that the best way to promote everyone’s health is an approach that treats people as individuals who need care rather than vectors for disease or criminals to be punished. Decreasing stigma and increasing access to testing, treatment and support are the best ways to combat disease.

On this Black HIV/AIDS Awareness Day, let us stand in solidarity and work to repeal all HIV criminalization laws.

Jose Abrigo is Lambda Legal’s HIV Project Director and Carl Baloney Jr. is AIDS United’s vice president and chief advocacy officer.

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How Tennessee axed millions in HIV funds amid scrutiny from far-right provocateurs

Tennessee’s recent decision to reject over $8 million in federal funds to combat HIV was motivated, at least in part, by right-wing provocateurs stoking anti-LGBTQ sentiment, according to four sources within the state Health Department.

The move by Republican Gov. Bill Lee will hamstring, if not cripple, efforts to combat one of the country’s most poorly controlled epidemics of the virus, HIV advocates said. 

The announcement followed a political crisis in Tennessee that began in September when conservative media personalities, including Matt Walsh and Ben Shapiro, launched attacks on Vanderbilt University Medical Center over its care of transgender minors, which they alleged was barbaric. 

Tennessee Gov. Bill Lee delivers his inaugural address in the Legislative Plaza Saturday, Jan.21, 2023, in Nashville, Tenn.
Gov. Bill Lee delivers his inaugural address in the Legislative Plaza in Nashville, Tenn., on Jan. 21, 2023.John Amis / AP file

In October, the pressure wound its way to the unit that combats HIV, sexually transmitted infections and viral hepatitis at the Tennessee Health Department.

On Oct. 24, the unit’s director, Dr. Pamela Talley, told employees that because of the social media firestorm over Vanderbilt, information about the Tennessee Transgender Task Force — a volunteer team the unit established in 2018 to focus on trans health and HIV prevention — and other trans resources had been scrubbedfrom the department’s website. That is according to two staffers present, who, like two of their colleagues, spoke anonymously because they were not authorized to speak to the media. 

Then, on Nov. 7, Talley told the unit that federal HIV funding from the Centers for Disease Control and Prevention for both the task force and Planned Parenthood in Tennessee would terminate at the end of the year, according to three staffers at the meeting, which took place in person and on a conference call. 

“There were at least three different levels of leadership on the call,” a staffer said. “It was discussed that there had been media attention around the Vanderbilt trans health clinic, which led those reporters to learn about the trans task force, and that they were funded by [the state Health Department] HIV prevention program and that all HIV prevention contracts were being reviewed.”

People walk outside Vanderbilt University Medical Center, Tuesday, July 16, 2013, in Nashville, Tenn. The hospital has announced it will offer early retirement as one way to reduce costs as the hospital seeks to close a $70 million revenue shortfall this fiscal year.
People walk outside Vanderbilt University Medical Center in Nashville, Tenn., on July 16, 2013.Mark Humphrey / AP file

In mid-January, the Lee administration announced it would pull the plug not just on federal HIV-prevention funds for Planned Parenthood and the task force, which total $235,000, but on all $8.3 million from a pair of CDC grants for HIV prevention, treatment and monitoring in the state. The move shocked HIV experts and advocates.

In addition, the Lee administration, which has said it will replace the federal funds with state dollars, has pledged a shift in funding priorities that would effectively steer HIV prevention efforts away from groups at substantial risk of contracting the virus, including gay men and people who inject drugs.

“All of this is willful ignorance on the part of the state government,” said Greg Millett, the director of public policy at amfAR, The Foundation for AIDS Research. “People at risk for HIV are going to suffer because of these decisions.”  

Right-wing media pile-on 

A leading voice in the right’s opposition to the treatment of gender dysphoria in minors, Matt Walsh, a columnist for the conservative media outlet Daily Wire,  published a series of widely read tweets on Sept. 20 targeting Vanderbilt University Medical Center’s treatment of minors at its Transgender Health Clinic. “They now castrate, sterilize, and mutilate minors as well as adults,” Walsh said.

The next day, Walsh appeared on Tucker Carlson’s Fox News show to publicize his investigation, and Ben Shapiro, a conservative commentator who co-founded Daily Wire, further amplified Walsh’s attacks on Vanderbilt on his YouTube channel and podcast, decrying the “nonsense garbage that a boy can be a girl and a girl can be a boy.”

Matt Walsh, author and filmmaker, speaks about firm traditional gender roles and definitions. Turning Point USA's "AmFest 2022" began its all-day"General Sessions" on Sunday, Dec. 18. 2022 in Phoenix, Arizona with speeches by over twenty of the most prominent figures in the extreme right wing of American conservatism. Their themes included standard culture-war fare of Christian nationalism, rigid gender definitions and roles, gun rights, and opposition to Covid science.
Matt Walsh speaks about firm traditional gender roles and definitions in Phoenix on Dec. 18. 2022.John Rudoff / Sipa USA via AP file

The same day, Lee issued a statement calling for a “thorough investigation.”

“We should not allow permanent, life-altering decisions that hurt children or policies that suppress religious liberties, all for the purpose of financial gain,” he said. “We have to protect Tennessee children.”

Despite such characterizations of gender-affirming care for minors as harmful, numerous major medical organizations — including the American Medical Association, the American Academy of Pediatricsand the American Psychological Association — support such care.

Walsh, Shapiro, Daily Wire and Fox News did not respond to requests for comment, and the Lee administration did not respond to questions about the impact right-wing media personalities had on the state’s rejection of federal HIV funds. 

Ray Holloman.
Ray Holloman.Emily April Allen

A Daily Wire article published on Oct. 20, which denounced the Tennessee Transgender Task Force as an “extreme” activist group, appears to have drawn the Lee administration’s attention. The task force, according to its chair, Ray Holloman, is staffed by trans-identified volunteers and focuses on providing HIV educational resources, sharing health insurance information and connecting people to supportive health providers — including those at Vanderbilt.

The article took a victory lap, saying that the Lee administration and the state Health Department denounced the task force “in response to a Daily Wire inquiry” and that information about the task force on the department’s website was “only removed after the Daily Wire asked about it.” 

Talley held her staff meeting four days after the article’s publication, announcing the trans-related web content had been scrubbed.

Around the same time, two Health Department supervisors told staffers in private conversations that critical media coverage provoked the Lee administration to scrutinize the source of the task force’s $10,000 in annual funding — a $6.2 million CDC HIV prevention and surveillance grant — two Health Department employees said.

Also under new scrutiny after the article was published, fouremployees said, was Tennessee’s Planned Parenthood program, which received $225,000 a year from the CDC grant, largely for condom distribution. 

In a Nov. 7 email that was among a collection of correspondence shared with NBC News by Ashley Coffield, the CEO of Planned Parenthood of Tennessee and Northern Mississippi, Talley informed Coffield that the Health Department’s separate arrangement to supply Planned Parenthood with about 500 HIV test kits a year would be canceled. Talley subsequently wrote to Coffield, “I want to thank you for your statewide efforts in HIV testing and reassure you that this discontinuation was not based on performance concerns.”

Ashley Coffield is the CEO of Planned Parenthood of Tennessee and Northern Mississippi.
Ashley Coffield is the CEO of Planned Parenthood of Tennessee and Northern Mississippi.Planned Parenthood

Three days later, Coffield said, she got a call from a director at the United Way of Greater Nashville, which distributes the CDC grant funds to dozens of community-based organizations in Tennessee, including Planned Parenthood. The director, Niki Easley, said Planned Parenthood would lose its $225,000 in CDC HIV prevention grant funds at year’s end. Coffield said Easley told her that politics were behind the funding cut. “I think you should fight back,” Coffield recalled Easley’s saying.

But there was a wrinkle in the state’s plan: Because of a 2013 legal injunction, the Lee administration could not legally block HIV-related federal funds specifically for Planned Parenthood. 

In the collection of emails and letters Planned Parenthood provided to NBC News, the nonprofit’s attorneys threatened to sue. In an emailed response, the Health Department’s attorney, Mary Katherine Bratton, denied having tried to disqualify the organization for the funds but said the department was “currently reviewing all” CDC grants. 

Several officials at the Health Department, including Talley, Bratton and communications staffers, did not respond to requests for comment. 

After it contacted Easley and several of her colleagues at the United Way of Greater Nashville, NBC News heard from a spokesperson, who said the group “is working closely with the Tennessee Department of Health to understand the changes being made to this grant funding,” adding that “the details of the changes and how our partner agencies will be affected are still developing” and that “all funding decisions are made by” the Health Department. 

‘The nuclear option’

Ultimately, instead of focusing on cutting funds for Planned Parenthood and the Tennessee Transgender Task Force, the Lee administration decided to pull the plug on the entire $8.3 million in CDC grants for HIV prevention, surveillance and treatment.

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On Jan. 17, Health Department officials held an 8 a.m. meeting with HIV prevention staffers and informed them of the decision to end all CDC HIV grant funding effective June 1, according to two employees who were present.

“People have been crying all week,” a staffer said in a Jan. 21 interview.

Coffield said “it felt like they were punching me in the gut” when she found out the state was abandoning the grants.

“I couldn’t believe that the governor would take the nuclear option,” she said, adding that she views the decision as the culmination of a “political vendetta against abortion rights groups and transgender people.”

Tennessee Department of Health in Nashville, Tenn.
Tennessee Department of Health in Nashville, Tenn.Google Maps

The rejected grants consist of the $6.2 million for HIV prevention and surveillance and $2.1 million for Shelby County, home to Memphis. The latter sum comes from a national plan focused, in part, on improving treatment and prevention of HIV in 50 local hot spots that account for about half of new HIV diagnoses nationally — a plan President Donald Trump endorsed in his 2020 State of the Union address.

Friends for Life, a nonprofit Memphis group that provides services to those living with and at risk for HIV, will lose about $500,000 a year, chief programs officer Mia Cotton said. The imminent lack of any federal grants will also render the organization’s health clinic ineligible for pharmaceutical rebates through a separate federal program that last year brought in $1.2 million to an overall operating budget of $8.5 million, Cotton said.

Molly Quinn, the executive director of OUTMemphis, Tennessee’s largest LGBTQ nonprofit group, said her organization would lose $120,000 a year, or 10% of its operating budget, compromising efforts to provide HIV testing, help clients access the HIV prevention pill, PrEP, and give financial assistance to people with the virus. 

‘A fictitious epidemic’

The Lee administration says it will replace the $8.3 million in CDC grants with state funds, giving it freedom to target such resources as it sees fit.

“We think we can do that better than the strings attached with the federal dollars that came our way, and that’s why we made that decision,” Lee said Jan. 20. 

Currently, the priority populations for the CDC grant for Shelby County, for example, include LGBTQ people, sex workers and those who inject drugs, are unhoused or are formerly incarcerated.

Lee’s press officer, Jade Byers, said in an email that the administration “is committed to maintaining the same level of funding, while more efficiently and effectively serving vulnerable populations, such as victims of human trafficking, mothers and children, and first responders.”

Those priorities, HIV prevention experts said, are in egregious conflict with the actual demographics of the people most at risk of the virus.

“Tennessee is preferring to fight a fictitious epidemic rather than their very real HIV epidemic,” said Millett, of amfAR. “First responders are just not at risk for HIV anywhere in the United States. Sexual trafficking is awful, but it’s not a major contributor for HIV cases in Tennessee or elsewhere.” 

Women comprised 9% of HIV diagnoses in Tennessee in 2019, down from 14% in 2016, and only 1 to 6 babies were born with HIV in the state annually from 2016 to 2020.

More than half of new diagnoses in Tennessee were in men who have sex with men in 2019, according to the state Health Department’s surveillance reports. And in 2016, the CDC released a report warning that 220 of the country’s counties, including 41 in Tennessee, were at high risk of HIV and hepatitis C outbreaks among people who inject drugs (that population accounted for 5% of new Tennessee HIV diagnoses in 2019).

New U.S. HIV cases, the CDC estimates, declined by 8% from 2015 to 2019, but that masks considerable progress in some states and either stagnancy or increases in most Southern states, where the bulk of transmissions occur. Even as HIV has steadily declined in, for example, New York and California, where liberal governments have invested heavily in evidence-based HIV treatment and prevention programs, the CDC estimates that Tennessee’s transmissions increased slightly from 2017 to 2019.

While Lee announced Jan. 20 that the state would forgo the federal HIV dollars, a CDC spokesperson said Thursday that the agency had received no word from Tennessee that it intends to block the $8.3 million in grants.

The political climate has become increasingly toxic for LGBTQ people in Tennessee, advocates in the state say.

Since he took office in 2019, Lee has signed several bills that target transgender youths, including one that bars trans students from joining sports teams that align with their gender identities. And so far this year, conservative Tennessee lawmakers have filed at least 11 bills targeting LGBTQ people, including one, which Lee said he supports, that would ban gender-affirming medical care for all minors. 

Nationally, lawmakers in at least 21 states have proposed bills to ban or restrict gender-affirming care for minors this year. Trump released a video Tuesday on Truth Social pledging to “stop” such care, which he described as “child sexual mutilation.” 

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PEPFAR marks 20th anniversary

The President’s Emergency Plan for AIDS Relief marks its 20th anniversary Saturday, marking the largest commitment by any nation to address a single disease in the world.

The initiative which was personally led and launched by former President George W. Bush in 2003,  its funding has totaled more than $110 billion to date, including funding for the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund), to which the U.S. government is the largest donor.

PEPFAR is credited with saving millions of lives and helping to change the trajectory of the global HIV epidemic. The White House today released a statement by President Joe Biden marking the 20th anniversary:

“20 years ago today, President George W. Bush declared that preventing and treating HIV/AIDS was a foreign policy priority of the United States. At a time when nearly 30 million people were HIV positive, but very few were receiving life-saving medicines, the President’s Emergency Plan for AIDS Relief (PEPFAR) transformed the global AIDS response and laid a marker for America’s commitment to countries that were impacted the hardest by the AIDS epidemic. Helping lead the bipartisan effort in Congress to authorize PEPFAR is among my proudest achievements from my time in the Senate. To this day, PEPFAR remains a powerful example of America’s unmatched ability to drive progress and make life better for people around the world.
 
Since 2003, PEPFAR has saved more than 25 million lives and dramatically improved health outcomes in more than 55 partner countries. AIDS-related deaths have declined by 68 percent since their peak in 2004, and new HIV infections are down 42 percent. PEPFAR investments have ensured that 5.5 million babies have been born HIV-free. And two decades of investment in partner nations’ health systems played a critical role in countries’ ability to respond to other health crises such as COVID-19, Mpox, and Ebola.    
 
Today, PEPFAR continues to support 20.1 million people around the world with HIV/AIDS treatment, and my administration is committed to continuing to lead the global HIV/AIDS response. We will build on our decades of progress to reach the Sustainable Development Goal of ending AIDS by 2030, work to eliminate the stigma and inequities that keep people from accessing care, and keep the voices of people living with HIV/AIDS at the center of our response. I look forward to working with Congress on PEPFAR’s reauthorization this year.”

PEPFAR is overseen by the U.S. Global AIDS Coordinator, who is appointed by the president, confirmed by the Senate, and reports directly to the secretary of state, as established through PEPFAR’s authorizing legislation.

PEPFAR’s original authorization established new structures and authorities, consolidating all U.S. bilateral and multilateral activities and funding for global HIV/AIDS. Several U.S. agencies, host country governments and other organizations are involved in implementation.

Dr. John Nkengasong, the current coordinator was sworn in on June 13, 2022, and holds the rank of ambassador leading the Office of the Global AIDS Coordinator at the State Department.

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Nobel Prize winning scientist Harold Varmus, who served as director of the National Institutes of Health from 1993-1999 and currently the Lewis Thomas University Professor of Medicine at Weill Cornell Medicine in New York, wrote in an article honoring World Aids Day 2013:

[…] “the PEPFAR story must begin with George W. Bush and his wife, Laura, and their interests in AIDS, Africa, and what Bush termed “compassionate conservatism.” According to his 2010 memoir, “Decision Points,” the two of them developed a serious interest in improving the fate of the people of Africa after reading Alex Haley’s “Roots” and visiting the Gambia in 1990. In 1998, while pondering a run for the U.S. presidency, he discussed Africa with Condoleezza Rice, his future secretary of state; she said that, if elected, working more closely with countries on that continent should be a significant part of his foreign policy. She also told him that HIV/AIDS was a central problem in Africa but that the United States was spending only $500 million per year on global AIDS, with the money spread across six federal agencies, without a clear strategy for curbing the epidemic.”

Key Facts (As provided by Kaiser Health and Family Foundation)

  • Although the U.S. has been involved in efforts to address the global AIDS crisis since the mid-1980s, the creation of PEPFAR in 2003 marked a significant increase in funding and attention to the epidemic.
  • PEPFAR is the largest commitment by any nation to address a single disease in the world; to date, its funding has totaled more than $110 billion, including funding for the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund), to which the U.S. government is the largest donor. PEPFAR is credited with saving millions of lives and helping to change the trajectory of the global HIV epidemic.
  • U.S. funding for PEPFAR grew from $2.2 billion in FY 2004 to $7.0 billion in FY 2022; FY 2022 funding includes $5.4 billion provided for bilateral HIV efforts and $1.6 billion for multilateral efforts ($50 million for UNAIDS and $1.56 billion for the Global Fund.)
  • As the COVID-19 pandemic continues to have profound effects across the world, PEPFAR has acted to respond to COVID-19 in countries that receive support in order to minimize HIV service disruptions and leverage the program’s capabilities to address COVID-19 more broadly.
  • Looking ahead, PEPFAR faces several issues and challenges, including how best to: address the short- and long-term impacts of COVID-19 on PEPFAR and the HIV response; accelerate progress toward epidemic control in the context of flat funding; support and strengthen community-led responses and the sustainability of HIV programs; define its role in global health security and broader health systems strengthening efforts; and continue to coordinate with other key players in the HIV ecosystem, including the Global Fund.

Key Activities and Results (As provided by Kaiser Health and Family Foundation)

PEPFAR activities focus on expanding access to HIV prevention, treatment and care interventions. These include provision of antiretroviral treatment, pre-exposure prophylaxis (PrEP), voluntary male circumcision, condoms and other commodities related to HIV services. In addition, PEPFAR has launched specific initiatives in key strategic areas. For example, in 2015, PEPFAR launched DREAMS, a public-private partnership that aims to reduce HIV infections in adolescent girls and young women.

The latest results reported by PEPFAR indicate that it has:

  • Supported testing services for 63.4 million people in FY 2021;
  • Prevented 2.8 million babies from being born with HIV, who would have otherwise been infected;
  • Provided care for more than 7.1 million orphans and vulnerable children;
  • Supported training for nearly 300,000 new health care workers; and
  • Supported antiretroviral treatment for 18.96 million people.
  • In the 15 countries implementing the DREAMS initiative, new diagnoses among adolescent girls and young women have declined with most DREAMS areas (96 percent) experiencing declines greater than 25 percent and nearly two-thirds with declines greater than 40 percent.

The achievements of the PEPFAR program have been remarkable, well-documented by outside evaluators, and hugely applauded throughout the advocacy community and the developing world. In general, milestones have been met, the program has been enlarged (for instance, to include some research on implementation of medical assistance), the roster of PEPFAR countries has grown and spending plans have not been exceeded.

/ / / /

AIDS/LifeCycle Announces New Santa Monica Beachside Finish Line

AIDS/LifeCycle, the seven-day, 545-mile bike ride fundraiser traversing the golden state from San Francisco to Los Angeles, has announced a new finish line location in Santa Monica. 

Co-producers the Los Angeles LGBT Center and San Francisco AIDS Foundation this week, the gFrom June 4-10, the route wheels out nearly 3,000 participants “from the Bay to the Beach” for the very first time in its almost 30-year history. 

“We are excited to welcome the AIDS/LifeCycle Ride to Santa Monica. The work of the San Francisco AIDS Foundation and the Los Angeles LGBT Center made possible by the Ride advances our commitments to equity and inclusion as we support and celebrate the LGBTQIA+ community during SaMo Pride this June,” said Santa Monica Mayor Gleam Davis. 

The 2023 ride will begin at the Cow Palace in the San Francisco Bay Area. Cyclists will camp in six California cities to experience the diverse landscapes. On June 10, riders will leave Ventura for LA and turn south on San Vicente Blvd, past Santa Monica Pier, to the finish line.

“Whether this is your first or your 20th AIDS/LifeCycle, this finish line will contribute to an unforgettable final day on the Ride,” said Tracy Evans, AIDS/LifeCycle’s Ride Director. “Riders and volunteer Roadies will have the Pacific Ocean as the perfect backdrop to celebrate their incredible accomplishment. What could be better than the Pacific Ocean as the final stop for an iconic California event?”  

The new location offers a fresh experience for cyclists and volunteer ‘Roadies’, while also being a beachside festival for friends, family, and spectators. Photo ops, sponsor activations and interactive stations will be part of the day-long celebration.

Proceeds from AIDS/LifeCycle benefit the HIV/AIDS-related services and research of the Los Angeles LGBT Center and San Francisco AIDS Foundation. Last year’s record $17.8M will serve these LGBTQ+ nonprofits, at a time when such assistance is most needed.

There are three ways to participate in AIDS/LifeCycle and support its mission: As cyclists who must fundraise a minimum of $3,500 for their “Ticket to Ride”; as roadies who are seven-day volunteers who may or may not fundraise; and @Home Heroes who set personal fundraising and fitness goals without traveling. Roadie teams cover areas of health services, route, and camp-based teams, while helping cyclists complete their 545-mile journey.

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Another major HIV vaccine trial fails

The only HIV vaccine in a late-stage trial has failed, researchers announced Wednesday, dealing a significant blow to the effort to control the global HIV epidemic and adding to a decadeslong roster of failed attempts.

Known as Mosaico, the trial was the product of a public-private partnership including the U.S. government and the pharmaceutical giant Janssen. It was run out of eight nations in Europe and the Americas, including the U.S., starting in 2019. Researchers enrolled nearly 3,900 men who have sex with men and transgender people, all deemed at substantial risk of HIV.

The leaders of the study decided to discontinue the mammoth research effort after an independent data and safety monitoring board reviewed the trial’s findings and saw no evidence the vaccine lowered participants’ rate of HIV acquisition.

“It’s obviously disappointing,” Dr. Anthony Fauci, who as the long-time head of the National Institute of Allergy and Infectious Diseases (NIAID) was an integral partner in the trial, said of the vaccine’s failure. However, he said, “there are a lot of other approaches” early in the HIV-vaccine research pipeline that he finds promising.

“I don’t think that people should give up on the field of the HIV vaccine,” Fauci said.

Fauci previously said he did not want to retire from the NIAID until an HIV vaccine had been proven at least 50% effective — good enough, in his view, for a global rollout. Instead, he retired from his post at the end of last month with this dream unfulfilled.

In addition to NIAID and Janssen, which is a division of Johnson & Johnson, the trial was run by the HIV Vaccine Trials Network, which is headquartered in the Fred Hutchinson Research Center in Seattle, and the U.S. Army Medical Research and Development Command. 

Mosaico’s lack of efficacy was not unexpected, experts said, because of the recent failure, announced in August 2021, of a separate clinical trial, called Imbokodo, which tested a similar vaccine among women in Africa. Between the two trials, NIAID spent $56 million, according to an agency spokesperson.

The vaccines tested in both trials used a common cold virus to deliver what are known as mosaic immunogens, which were intended to trigger a robust and protective immune response by including genetic material from a variety of HIV strains prevalent around the world, according to the National Institutes of Health. Mosaico included an additional element intended to broaden the immune response. 

Participants in Mosaico, who were between ages 18 and 60, received four injections over 12 months, either of the vaccine or a placebo. The monitoring board found no significant difference in the HIV acquisition rate between the two study groups.

Fauci said that a critical limitation of the Mosaico vaccine was that it elicited what are known as non-neutralizing — as opposed to neutralizing — antibodies against HIV.  

“It is becoming clear,” he said, “that vaccines that do not induce neutralizing antibodies are not effective against HIV.”

Up-and-coming HIV vaccine innovations, including efforts that rely upon the cutting-edge mRNA vaccine technology behind some of the coronavirus vaccines, may hold the key, Fauci said.

The critical problem that has bedeviled HIV vaccine research for decades, Fauci noted, is a crucial weakness that the virus already successfully exploits: The natural immune response to infection is not sufficient to thwart the virus. 

“So vaccines would actually have to do better than natural infection to be effective,” he said. “That would be a very high bar.” 

A decadeslong effort

In 1984, following the discovery of HIV as the cause of AIDS the previous year, President Ronald Reagan’s health secretary, Margaret Heckler, famously claimed a vaccine for the virus would be available within two years.

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In the decades since, there have been nine late-stage clinical trials of HIV vaccines, including Mosaico and Imbokodo, plus one, called PrEPVacc, that is still underway in Africa. However, the vaccine in PrEPVacc is not considered to be on a direct path to licensure if it demonstrates efficacy. Only one of these vaccines has shown any efficacy — and only at a modest level, not considered robust enough for regulatory approval — in a trial conducted in Thailand between 2003 and 2006, the findings of which were published in 2009.

In the years since, a phalanx of global researchers has studied the Thai trial in hopes of developing insights to inform further HIV-vaccine development. 

The yearslong effort to design the Imbokodo and Mosaico vaccines was in part grounded in an attempt to build on the modest success of the Thai trial. 

“We had hoped that we would see some signal of efficacy from this vaccine,” said Dr. Susan Buchbinder, an epidemiologist at the University of California, San Francisco, who co-led the Mosaico trial. She added that, promisingly, as in the Imbokodo trial, there were no evident concerns about the vaccine’s safety.

Buchbinder said it is too early to determine the reasons behind the Mosaico vaccine’s failure. Her team will be analyzing blood samples from participants over the coming months to investigate. They will also seek to determine if there were any subgroups of participants among whom the vaccine did show any efficacy. As with the Thai trial, the hope is to channel research findings into future HIV vaccine development.

Other HIV prevention tools

Jennifer Kates, director of global health and HIV policy at Kaiser Family Foundation, said the trial’s failure is a “stark reminder of just how elusive an HIV vaccine really is and why this kind of research continues to be important.”

“Fortunately, there are a number of highly effective HIV prevention interventions already,” Kates added. “The challenge is to scale them up to reach all at risk.” 

Pre-exposure prophylaxis, or PrEP, in which people at risk of HIV take antiretroviral medications in advance of potential exposure to the virus, is highly effective at preventing infection but remains vastly underutilized in the U.S. and around the world. 

Additionally, research published in the mid-2000s showed that voluntary medical male circumcision lowers the risk of female-to-male HIV acquisition by about 60%. This led to a major effort to promote circumcision in sub-Saharan Africa, home to two-thirds of the HIV cases in the world. 

In more recent years, an antiretroviral-infused vaginal ring has proven effective at lowering women’s HIV risk. Initial efforts are underway to introduce it in African nations.

And, of course, there is the old mainstay: condoms.

Globally, an estimated 38.4 million people were living with HIV in 2021, according to the Joint United Nations Programme on HIV/AIDS. Some 1.5 million people currently contract the virus annually, a figure that has more than halved since its peak in 1996.

It is at least theoretically possible, although extremely challenging, to bring HIV to heel without a vaccine. Fortunately, successfully treating HIV eliminates the risk of transmitting the virus through sex. So HIV transmission has declined in recent years in large part because of the dramatic scale-up of antiretroviral treatment of the virus, which by 2021 reached 28.7 million people.

Mosaico was particularly challenging to design ethically because of the advent of PrEP, which was first approved in the U.S. in 2012. To prove a vaccine works, researchers must recruit participants who remain at substantial risk of HIV over time. So Mosaico first offered PrEP to those seeking to enroll in the trial and only accepted as participants those who adamantly declined the preventive therapy notwithstanding their risk of HIV.

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Congress approves $100m boost to HIV/AIDS initiatives

The appropriations bill for the fiscal year 2023 released by Congress on Tuesday contains an additional $100 million for the U.S. Department of Health and Human Services’ Ending the HIV Epidemic in the United States initiative.

Among other programs, the funding will strengthen efforts to increase the adoption of preexposure prophylaxis (PrEP) to reduce the risk of new HIV infections.

In a press release, the HIV+Hepatitis Policy Institute celebrated the boost from Congress but noted that more must be done — including a national PrEP program.

“The increases will help expand HIV programs in the targeted jurisdictions most impacted by HIV,” said Carl Schmid, the group’s executive director. However, “given that Congress again has not fully funded the initiative and has not provided dedicated funding for a national PrEP program, ending HIV by 2030 will be in serious jeopardy.”

President Joe Biden has proposed a $9.8 billion 10-year national PrEP program, which is widely considered a crucial step in addressing the gaps in access to the HIV prevention drugs among, particularly, Black and Latino gay men and Black women.

HHS’s Ending the HIV Epidemic in the United States program, launched in 2019 under President Donald Trump, aims to bring the number of new HIV infections down 90 per cent by 2030 through investing in key strategies for prevention and treatment.

The initiative is coordinated with several other federal agencies: The Centers for Disease Control and Prevention, the Health Resources and Services Administration, the Indian Health Service, the National Institutes of Health, and the Office of the HHS Assistant Secretary for Health and Substance Abuse and Mental Health Services Administration.

The HIV+Hepatitis Policy Institute’s press release notes Tuesday’s appropriations bill will be the final spending package passed with House Speaker Nancy Pelosi (D-Calif.) serving as Democratic leader.

Pelosi, in her first speech as a congresswoman in 1987, said to her colleagues that “now we must take leadership of course in the crisis of AIDS.” 

“The speaker’s work on this issue continued through her time in leadership, including her passage of foreign aid packages, the Affordable Care Act, and funding for the HHS’s Ending the HIV Epidemic in the United States program,” said the HIV+Hepatitis Policy Institute press release.

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