Anti-abortion advocates in the U.S. are threatening to kill one of the most successful public health programs in history over unsubstantiated facts, unwavering opposition to a woman’s right to choose, and blatant anti-LGBTQ+ bias.
Conservative rganizations, including the Heritage Foundation and Susan B. Anthony Pro-Life America, are threatening U.S. lawmakers with the withdrawal of their support if they grant a routine reauthorization to the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), the hugely successful HIV prevention initiative in Africa.
The far-right Family Research Council describes the 20-year-old program as “a massive slush fund for abortion and LGBT advocacy.”
PEPFAR, initiated by President George W. Bush, is estimated to have saved over 25 million lives.
While the Biden administration maintains that the program — reauthorized every five years under Democratic and Republican presidents alike — does not fund abortions, those assertions aren’t enough for critics who are convinced that money from the initiative is flowing to abortion providers.
PEPFAR grantees are “promoting and helping to support abortions abroad,” Ryan Walker, the head of Heritage Action, told Christianity Today. “A five-year reauthorization to us is beyond the pale.”
The program’s $6 billion annual budget is dedicated to buying antiretroviral drugs and medical supplies, and paying for drug delivery and prevention programs, including funding for both condoms and abstinence education.
According to Doug Fountain, executive director of Christian Connections for International Health, assertions PEPFAR is funding anything other than HIV prevention are based on unsubstantiated “rumors” among people who are far removed from the funding’s beneficiaries.
“The way we look at it is, which is the more pro-life position: supporting a proven program that saves lives, or impeding it out of unsubstantiated fear?” Walker asked. “We actually can see a situation where HIV/AIDS will come under global control in the next decade or so. But we need to keep our eye on the ball and not stop progress based on rumors.”
Rep. Chris Smith (R-NJ), now in his 22nd term representing central New Jersey, is leading the charge against what was, until now, a routine and bipartisan five-year reauthorization.
The 70-year-old congressman has fallen in line with so-called pro-life organizations advocating for a one-year authorization, denying the program the long lead times required to properly implement it, and leaving PEPFAR’s fate to the whims of politics.
Smith now claims his previous support for the program was a response to an “emergency,” and a necessary if temporary “tourniquet” for a “horrific problem.”
PEPFAR was already subjected to prohibitions on abortion access through longstanding restrictions like the Helms and Siljander Amendments. However, in 2018, the administration of President Donald Trump included the program in the Mexico City Policy, at Smith’s insistence. The Mexico City Policy explicitly prohibits U.S.-funded organizations from using money from any source to perform or advocate for abortions overseas.
The Biden administration stripped that provision from the amendment reauthorizing PEPFAR. Smith has staked any new funding on reinstatement of the Mexico City Policy.
Smith also pointed to a lunch meeting with the head of PEPFAR, John Nkengasong, to explain his new-found opposition.
Smith claims Nkengasong told him he works at “10,000 feet” and didn’t know what local organizations were doing on the ground. “If you tell me face-to-face over lunch that you have no idea what they’re doing at the local level, I have a problem with that,” the congressman told Christianity Today.
PEPFAR gives “a pot of money that empowers the abortion lobby in each and every one of these countries,” Smith claimed, without evidence.
For his part, Nkengasong maintains “PEPFAR has never, will not ever, use that platform in supporting abortion.”
New HIV infections continue to ebb only modestly in the United States, while many other wealthy Western nations have posted steep reductions, thanks to more successful efforts overseas to promptly diagnose and treat the virus and promote the HIV prevention pill, PrEP.
In a new HIV surveillance report published Tuesday, the Centers for Disease Control and Prevention estimated that new HIV transmissions declined by 12% nationally between 2017 and 2021, from 36,500 to 32,100 cases.
By comparison, according to estimates by the Joint United Nations Programme on HIV/AIDS, between 2015 and 2021, the annual infection rate plunged by more than 70% in the Netherlands, 68% in Italy and 44% in Australia. United Kingdom health authoritiesrecorded about 2,700 diagnoses in England in 2021 — a drop of approximately one-third since 2017 and one-half since 2015.
Experts told NBC News that the U.S. remains so far behind in combating HIV because of the nation’s lack of a national health care system and sexual-health clinic network; fragmented and underfunded public health systems; and poorer synchronization between government, academia, health care and community-based organizations.
These experts also pointed to factors such as racism, inadequate adoption of evidence-based treatment for opioid use disorder, state laws criminalizing HIV exposure and medical mistrust in people of color.
“HIV in the United States is very much a disease of those who are most disenfranchised in society,” Dr. Boghuma Titanji, an infectious disease specialist at Emory University, said.
The power of the pills
The 2010s heralded the era of so-called biomedical HIV prevention. A series of landmark studies established two critical facts: one, that fully suppressing the virus with antiretroviral treatment eliminates sexual transmission risk in addition to extending life expectancy nearly to normal, and two, that when HIV-negative people take the antiretrovirals Truvada or Descovy daily as pre-exposure prophylaxis, or PrEP, they reduce their risk of contracting the virus by 99% or more.
Accordingly, the nations that have succeeded in far besting the U.S. in reducing new infections have gotten more people with HIV diagnosed and on treatment, and have done so sooner in the course of infection. These countries have also often seen a greater proportion of those at the highest risk of HIV, namely gay men, get on PrEP.
A medical assistant draws blood from a patient on National HIV Testing Day at a Planned Parenthood health center on June 27, 2017, in Miami.Joe Raedle / Getty Images file
An estimated 1.2 million Americans have HIV. According to the CDC, only 87% of them are diagnosed and just 58% are in treatment and have a fully suppressed viral load. This latter figure compares with robust national viral suppression rates, estimated by health authorities, of 82% in Australia, 83% in the Netherlands, 89% in the U.K and 74% in Italy. The rate is higher than 70% in at least 16 other European nations.
In the U.S., the virus has maintained its vastly disproportionate impact on gay and bisexual men, who, according to the new CDC report, comprise about 70% of new cases despite making up only about 2% of the adult population.
The CDC has estimated that about 814,000 gay and bisexual men are good PrEP candidates. Recent data suggested that the number of people, overwhelmingly from this population, who have ever used PrEP each year more than doubled between 2017 and 2022, to at least 318,400. However, a recent CDC study suggested that only about half that group took PrEP during any one month last year, suggesting that many people take it only temporarily.
HIV prevention drug Descovy, at Pucci’s Pharmacy in Sacramento, Calif., on Oct. 7, 2019.Rich Pedroncelli / AP file
The most recent four-year national decline was driven by an estimated one-third drop in cases among 13- to 24-year-olds, which Dr. Robyn Neblett Fanfair, acting director of the CDC’s Division of HIV Prevention, characterized as “very encouraging” on a Tuesday media call. The CDC attributes this success to progress in expanding testing, treatment and PrEP among gay and bisexual males, who comprised 80% of the cases in that age group.
But infection rates among these men’s older counterparts have remained statistically stable.
In England, vastly improved biomedical prevention among gay and bisexual men slashed their HIV diagnosis rate so drastically — by about three-quarters in a decade — that in 2022, fewer of them tested positive for the virus than heterosexuals. In the U.S., gay and bisexual men’s transmissions outnumber heterosexuals’ by more than three to one.
Dr. Chris Beyrer, director of the Duke University Global Health Institute, remarked that many of the nations that have seen such precipitous declines “don’t have to deal with the really sharp health disparities and lack of access” that have colored the U.S. HIV fight.
Persistent divides
HIV has for decades exposed racial and socioeconomic fault lines in the U.S., with the virus disproportionately affecting people of color and the poor.
Blacks and Latinos comprised a respective 40% and 29% of the most recent transmissions, despite these racial groups making up only 12% and 19% of the U.S. population. Approximately one in five new infections are among women, more than half of them among Black women.
The new CDC report reveals that such racial disparities have abated only slightly in recent years. Breaking down the transmission trajectory by race and sex showed that Black men were the only group to see a statistically significant reduction.
Estimated new infections among gay and bisexual men declined between 2017 and 2021 from 9,300 to 8,100 among Blacks and 7,800 to 7,200 among Latinos. However, these changes were not statistically significant, in contrast to the significant decline among whites, from 5,800 to 4,800 cases.
Politics and public health
Conservative politicians’ recent fervent use of anti-LGBTQ legislation and rhetoric to appeal to the Republican base threatens to further undermine efforts to combat HIV, public health experts warned.
“All of this plain hatred at the LGBTQ community is not good for ending the epidemic,” Kathie Hiers, CEO of AIDS Alabama, said.
Hiers also decried what she characterized as insufficient and poorly coordinated national support for housing among those living with and at risk for HIV. She pointed to the robust support New York provides HIV-positive homeless people as a pillar of that state’s success in fighting the virus.
About half of HIV transmissions occur in the South, which has an infection rate approximately 50% higher than in the West and Northeast, and double that of the Midwest. Southern states, dominated by Republicans, have tended to devote fewer resources to combatting the virus compared with liberal states, and cities elsewhere, such as San Francisco and New York, that have a history of beating back substantial HIV epidemics.
Mayor London Breed, right, shakes hands with HIV prevention expert Dr. Hyman Scott at Zuckerberg San Francisco Hospital on Sept. 10, 2019.Gabrielle Lurie / The San Francisco Chronicle via Getty Images file
Experts have long cited the refusal of most Southern legislatures to expand Medicaid under the Affordable Care Act as a major driver of regional disparities in HIV treatment and prevention.
“Medicaid expansion is a massive structural intervention to support the most vulnerable in our communities,” said Dr. Hyman Scott, an HIV prevention expert at the San Francisco Department of Public Health.
Silver linings
There is hope that the South may be turning a corner, given the CDC’s finding that it was the only region to see a statistically significant decline — of 12% — in estimated new HIV infections between 2017 and 2021.
Additionally, HIV’s decline appears to be accelerating, however marginally. The CDC previously reported the new infection rate was essentially stable during the mid-2010s and then inched 8% lowerbetween 2015 and 2019.
And while the most recent data are somewhat hazy due to a drop in HIV testing following Covid-19’s onset, an apparent sustained decline in transmissions in 2020 and 2021 represents a victory for the HIV treatment and prevention workforce. Infectious disease clinics, for example, often proved nimble in the face of the new pandemic’s disruptions by pivoting to telehealth and supplying patients with months of medications at a time.
The CDC isn’t satisfied.
“In prevention, patience is not a virtue,” Dr. Jonathan Mermin, director of the CDC’s National Center for HIV, Viral Hepatitis, STD, and TB Prevention, said during the Tuesday media call. “We can end HIV in America. We know the way, but does our nation have the will?”
Fighting for the future of HIV
The federal government is hoping that a surge in spending will be the linchpin that finally sends the HIV epidemic into a swift retreat.
In 2019, Donald Trump endorsed a plan to ratchet up federal outlays on HIV. Between the 2020 and 2023 fiscal years, this infusion of new annual funds, largely funneled to the 48 counties where about half of transmissions occur, has soared from $267 million to $573 million. Mermin called for Congress to approve President Biden’s budget request of $850 million for the 2024 fiscal year.
The expressed aim of the spending is to cause the 2017 HIV transmission rate to collapse 75% by 2025 and 90% by 2030. But as CDC surveillance quite evidently shows, the epidemic’s current trajectory is nowhere near on track to achieve such lofty goals.
Dr. Boghuma Titanji.Courtesy Dr. Boghuma Titanji
Emory’s Boghuma Titanji said that to succeed in beating HIV, the nation must address the myriad intractable social inequities that drive transmission, including poverty, racism, stigma, homophobia, homelessness and poor health care access.
Absent such progress, Titanji said, she anticipates that by the decade’s end, HIV in the U.S. will be “pretty much the same: a disease that will continue to disproportionately impact the most vulnerable communities.”
In a turnaround that has stunned and pleasantly surprised HIV advocates, Tennessee has gone from blocking $8.3 million in annual federal funds for HIV prevention, surveillance and treatment to including a new allotment of $9 million in the state budget approved Thursday to combat the virus.
This development came after the Centers for Disease Control and Prevention announced on Monday that it will circumvent the state government and continue providing about $4 million in HIV-prevention funds to Tennessee nonprofit groups, despite Gov. Bill Lee’s objections. The state has one of the nation’s most poorly controlled HIV epidemics.
Lee previously singled out the Tennessee Transgender Task Force and Planned Parenthood to be defunded from the CDC’s HIV-prevention grant to the state. The president of the task force, Ray Holloman, expressed hope that a cumulative $13 million budget will be “used to benefit the most vulnerable and at-risk populations.” But he shared HIV experts’ concerns that the new state funds, which will support county health departments and nonprofit groups, might not be spent wisely.
Jade Byers, a Lee spokesperson, said the $9 million in new state funding to combat HIV would recur and allow Tennessee to “provide better services and reach even more at-risk populations in the state, such as victims of human trafficking, mothers and children, and first responders.”
Toni Newman, a director of the HIV advocacy nonprofit organization NMAC, called the new state funds “a step forward.”
Toni Newman, a director at the HIV advocacy nonprofit NMAC.Courtesy of NMAC
“But the real impact of this move will be determined by how the money is distributed,” Newman said. “Without a clear understanding of where the money is going and who it will benefit, we risk worsening the HIV epidemic in our state.”
In recent years, the CDC has granted Tennessee $6.2 million annually for HIV prevention and surveillance, delivering the money to the state Health Department. The state has then sent about $4 million of those funds to the United Way of Greater Nashville, which has in turn distributed the cash to various community-based organizations fighting HIV throughout the state.
The remaining $2 million or so of the CDC grant has supported surveillance of HIV in Tennessee.
In January, the Lee administration announced that beginning in the new fiscal year, which starts June 1, it would block all $6.2 million of the CDC HIV funding, plus a separate $2.1 million annual federal grant for HIV prevention and treatment in Shelby County, home to Memphis.
Tennessee Gov. Bill Lee, shown at his State of the State address in Nashville on Feb. 6, previously rejected CDC funds for HIV initiatives. Mark Zaleski / AP
Outraged HIV advocates and experts said Lee’s move would spawn a public health crisis.
The CDC estimates that new HIV cases declined nationally by 8% from 2015 to 2019, a statistic that masks heady progress in some states and either stagnancy or increases in most of the South, where the bulk of transmissions occur. Even as liberal states such as New York and California have invested heavily in fighting the virus and seen substantial declines, the CDC estimates that Tennessee’s transmissions increased somewhat from 2017 to 2019.
A February NBC News investigation into the governor’s motivation for blocking the funds traced its origins, at least in part, to attacks on Vanderbilt University’s care for transgender children by far-right media stars, including the Daily Wire’s Matt Walsh. These attacks triggered a chain reaction that, fueled by Republican animus toward Planned Parenthood, gathered steam and ultimately politicized the Tennessee Health Department’s HIV prevention efforts.
Walsh and the Daily Wire did not respond to NBC News’ request for comment. Planned Parenthood declined to comment.
Along with a cadre of national and state HIV organizations, NMAC has spent the past three months lobbying the CDC to ensure funding continuity.
On Monday, the CDC announced plans for an end run around the Tennessee Health Department, pledging to deliver $4 million in HIV grant funds directly to the United Way during the next fiscal year.
In January, Rep. Steve Cohen, a Democrat representing Memphis,sent a letter to Health and Human Services Secretary Xavier Becerra asking the agency to circumvent the Tennessee Health Department and provide the $2.1 million federal grant directly to Shelby County.
The Memphis area has the nation’s third-highest HIV diagnosis rate, the CDC reports.
HIV testing at OUTMemphis, a center in Memphis, Tenn., on Jan. 25. The Washington Post via Getty Images
Representatives for Becerra and Cohen did not respond to inquiries about that grant’s status.
Earlier in the year, the Lee administration pledged to replace the blocked $8.3 million in federal funding with state money — a promise kept by the $56 billion state budget approved by the Legislature in Nashville on Thursday.
“Tennessee is pursuing a stronger HIV prevention and awareness program at the state level that will allow community partners to access more funding,” Byers said. In January, she said that spending state instead of federal dollars to fight HIV would permit Tennessee more “independence” in its use of funds.
Sarah Bishop, a United Way of Greater Nashville spokesperson, said the organization would continue funding all the current CDC grantees come June.
Dr. Richard Briggs, a surgeon and a Republican state senator representing Knoxville, celebrated Tennessee’s comparatively fulsome new HIV budget. Yet he still criticized Lee, also a Republican, for blocking the federal money.
“We should accept all the federal funds,” Briggs said.
Following Lee’s announcement in January, Friends for Life, an $8.5 million Memphis nonprofit that provides HIV prevention and treatment services, faced losing nearly $500,000 in CDC grant funding, according to Mia Cotton, its chief programs officer. Without a federal contract, the organization also would have become ineligible for $1.2 million in annual pharmaceutical rebates.
Now the nonprofit will receive a windfall of $891,000 from the state, plus continued CDC funding, which will maintain its rebate eligibility.
Cotton expressed relief and gratitude over this reversal of fortune.
“It is important to note, however, that unless we all work together,” Cotton said, alluding to the governor’s determination to detach the state’s spending from the CDC, “new transmissions of HIV will not be contained.”
A 10-year study has found that Australia could become one of the first countries to “virtually eliminate” HIV transmissions, with new infections decreasing dramatically.
The findings, published inLancet HIV, showed that HIV infections decreased by 66 per cent between 2010 and 2019 in New South Wales and Victoria, while there was a 27 per cent rise in people accessing effective HIV treatment.
Increased access to HIV treatment and PrEP (pre-exposure prophylaxis) – the medication that prevents a person from contracting HIV – was cited as a key reason for decreased transmissions.
The journal also endorsed the public health strategy “treatment as prevention” or TasP, explaining that HIV treatment “results in virally suppressing the HIV virus”, which reduces a person’s risk of transmitting HIV to another person to zero.
“We examined 10 years of clinical data from over 100,000 gay and bisexual men in New South Wales and Victoria,” Dr Denton Callander, who led the research at UNSW’s Kirby Institute, told the University of New South Wales.
“We found that over time, as viral suppression increased, HIV incidence decreased. Indeed, every percentage point increase in successfully treated HIV saw a fivefold decrease in new infections, thus establishing treatment as prevention as a powerful public health strategy.”
Dr Callander also underlined the importance of access to HIV testing, as well as the “widespread availability” of PrEP.
Professor Mark Stoové from the Burnet Institute, co-senior author on the paper, added that the success of Australian measures such as education on HIV and reduced patient treatment costs could see the country “virtually eliminate” new HIV transmissions.
“Australia is on track to become one of the first countries globally to virtually eliminate the transmission of HIV,” Professor Stoové said.
“The results of this research show that further investment in HIV treatment – especially alongside PrEP – is a crucial component of HIV elimination.”
HIV experts have explained how medical breakthroughs have transformed the treatment and prevention of the virus.
In fact, U=U means that if a HIV-positive person has been taking effective HIV treatment, and their viral load has been undetectable for six months or more, they cannot pass the virus on through sex.
In the UK, former health secretary Matt Hancock committed to ending new HIV transmissions by 2030, however, charities and activists have expressed doubt that the country will be able to meet its target.
Richard Angell, campaigns director at the Terrence Higgins Trust, told PinkNews that it’s now “possible but not probable” that the UK will reach the 2030 goal.
Some “huge successes” were praised in terms of UK HIV prevention, but experts explained that inequality and stigma, as well as a lack of resources, were still hurdles to overcome in order to meet Hancock’s aim.
The U.S. Justice Department (DOJ) is appealing a judge’s decision to nullify a section of the Affordable Care Act (ACA) that requires insurance companies to cover the HIV prevention drug regimen PrEP.
Last week, U.S. District Juge Reed O’Connor struck down a section of the ACA requiring coverage of certain preventive health care services, which, in addition to PrEP, includes some cancer screenings, contraception, immunizations, and more. O’Connor’s decision leaves over 150 million people vulnerable to the added costs of this care.
A coordinated effort by right-wing media and lawmakers has decimated community-based programs addressing healthcare for LGBTQ+ people in Tennessee
O’Connor’s decision came about in response to a lawsuit filed by two Christian business owners and six individuals who felt being required to cover PrEP promotes “homosexual behavior” and is a violation of religious freedom. The plaintiffs also argued that being required to cover other preventive services makes them “complicit in facilitating… drug use, and sexual activity outside of marriage between one man and one woman.”
In a statement on the appeal, out White House Press Secretary Karine Jean-Pierre said President Joe Biden “is glad to see the Department of Justice is appealing the judge’s decision” and that the case “is yet another attack on the Affordable Care Act, which has been the law of the land for 13 years and survived three challenges before the Supreme Court.”
“Preventive care saves lives, saves families money, and protects and improves our health,” she continued. “Because of the ACA, millions of Americans have access to free cancer and heart disease screenings. This decision threatens to jeopardize critical care. The administration will continue to fight to improve health care and make it more affordable for hard-working families, even in the face of attacks from special interests.”
Michael Weinstein, the founder and president of the Aids Healthcare Foundation, said O’Connor’s decision “will have dangerous consequences” for millions of Americans.
“While we expect this unconstitutional ruling ultimately will fail, the decision creates uncertainty and is a threat to public health,” Weinstein said.
This is not the first ruling O’Connor has made against PrEP and the ACA. In September 2022, he ruled that a provision of the act requiring employee health insurance plans to provide full coverage of HIV-prevention drugs (as well as other preventive health care services) is a violation of religious freedom. That ruling only applied to the companies of the plaintiffs in the case.
Long known as an anti-LGBTQ+ extremist, O’Connor also ruled in 2021 that businesses that say they’re religious can fire LGBTQ+ people, chipping away at the protections granted by the Supreme Court’s decision in Bostock v. Clayton Co.
He ruled the same year that a Catholic hospital doesn’t have to follow federal anti-discrimination laws when it comes to the provision of health care because of the chance that they’d be forced to provide care for a transgender person that affirms their gender, even if the procedure is not one the hospital objects to. His reasoning for the sweeping religious exemption for the Catholic hospital was that Biden and Barack Obama have a “pattern” of religious animus, so they can’t be trusted to enforce the law correctly.
On Wednesday, March 22, 2023, the Survivors of HIV Advocating for Research Engagement (SHARE) Board conducted a webinar highlighting the results of their survey “Aging with HIV: What do you need to thrive?” They sought to answer questions such as, “What are the key health-related questions/issues that research should address around HIV and aging?,” “What matters most to people aging with HIV?,” and “What health outcomes are of most relevance to people aging with HIV?”
Sadly, the SHARE survey and report revealed nothing new.
Their overall conclusions were that:
Community members living with HIV can be and need to be included in research projects;
Care concerns in long-term survivor groups may reflect the loss of friends and the potential of stigma from family members, necessitating need for paid care;
Planning for older adulthood is challenged further when it living into advanced age wasn’t anticipated; and,
Significant need exists for financial management, housing, medication burden support.
It is notable that SHARE meant for the survey not only to identify priority research issues that matter to long-term HIV survivors, but also to facilitate collaboration among long-term HIV survivors, policy makers, clinicians, and researchers.
They recruited a group of 267 long-term survivors (whom they defined as 50 years or older who had lived with HIV for ten years or more), ranging in age from 42 to 77, with an average length of diagnosis of 29 years. Survey respondents were heterosexual (36%), gay (29%), bisexual (19%), and lesbian (13%), with reported race/ethnicities of Black or African American (33%), Hispanic (28%), and white (52%) from both rural and urban areas around the country. Participants completed a survey and interviews by phone, Zoom, or face-to-face.
The survey revealed slightly different priorities among those who have lived with HIV for less than twenty years compared with those who have lived with HIV for more than twenty years, but overall, the six most frequently reported needs among long-term survivors were: (1) enhancing quality of life (by far the most prominent issue), (2) addressing mental health and cognitive decline, (3) maintaining physical health, (4) addressing loneliness and isolation, (5) issues of medication, including polypharmacy concerns, and (6) accessing appropriate healthcare.
Care planning and caregiving were also identified as critical issues, with more than 50 percent of respondents stating “I’m not sure who would provide care for me,” particularly among those who were diagnosed more than twenty years ago. More than 80% of respondents also reported having experienced stigma based on race/ethnicity, gender identity, sexual orientation, age, and HIV status.
Since January 2016, I have studied and reported on issues faced by us long-term HIV survivors, including several community-based surveys and studies such as this one. I have attended (via Zoom) several webinars reporting on the findings of those studies. While I make no unwarranted claim to expertise in the field of HIV, I can and do claim a great deal of lived experience with HIV as well as knowledge gained through my studying and reporting.
For many years, we long-term survivors have known and made public our concerns about being included in research projects that affect our lives and other issues identified in the SHARE survey. One need look no further than The San Francisco Principals 2020, which five of us long-term survivors wrote and distributed after the virtual AIDS2020 conference.
In the Principles, we identified the same issues (stigma, financial stress, mental healthcare needs, the lack of trained geriatricians, concerns about the effects of the virus and our medications on our bodies, the lack of political will to address those issues, etc.) and proposed solutions. We were not alone — several major AIDS-related groups have long insisted on the inclusion of us long-term survivors in any and all research and clinical trials that affect us. Nothing about us without us is more than just a catchy slogan — it is a priority that many of us have demanded since as early as 1983 when people living with AIDS promulgated the Denver Principles.
For me, this webinar raised several questions: What is being done to get the results of this survey, and others, into the hands of policy makers, clinicians, and researchers who can actually do something with them?
What concrete actions are being taken as a result of these many community surveys?
How many times must we ask the same questions, getting the same answers, before our answers to those questions are implemented in meaningful ways?
It seems to me, and to many of my fellow survivors, that our needs — for informed healthcare, for financial help to afford medications and living expenses, for mental healthcare, for community-based solutions, etc. — have been known for long enough. What we need is policies and actions that address those needs.
We already know what we need. When, if ever, will those needs be met?
U.S. District Judge Reed O’Connor ruled in Braidwood Management v. Becerra that the federal government cannot enforce many of the preventative care coverage requirements in the Affordable Care Act, notably including a requirement that employers provide insurance coverage for PrEP (Pre-exposure prophylaxis), a medication that prevents the transmission of HIV. The judge ruled that the ACA mandate violates employers’ rights under the Religious Freedom Restoration Act. Read the ruling in the case, the final judgment after he granted a motion for summary judgment in September.
Adam Polaski(he/him pronouns), Communications Director at the Campaign for Southern Equality, said today:
“This is yet another example of blatant judicial overreach that targets the LGBTQ community, which already experiences significant health disparities. PrEP is a medication that keeps people safe and prevents the transmission of HIV. This ruling is an attack on privacy and science and, if it’s allowed to stand, will drastically limit Americans’ ability to protect themselves from HIV.”
“Whether it’s access to abortion, gender-affirming care, birth control, or PrEP, we are seeing dangerous action from rogue activist judges forcing themselves into Americans’ private health care decisions. Particularly here in the South, rulings like this restrict access to essential health care for precisely those communities already experiencing the greatest disparities in access to care. We must push back – and we will – to ensure that people have access to life-saving medications like PrEP and the health care they need and deserve.”
PrEP is a daily pill used widely for HIV prevention by individuals who are HIV-negative but at high risk for exposure, including men who have sex with men, people who are in a sexual relationship with an HIV-positive partner, and people who have recently injected drugs. Daily PrEP use can reduce the risk of HIV infection from sex by more than 90%.
PrEP is an especially critical strategy for HIV prevention in the South, the epicenter of the modern HIV crisis in the United States. According to 2016- 2017 CDC data, one-half of all HIV diagnoses occur in the South, 47% of HIV related deaths happened in the South, and 46% of people living with HIV live in the South. In the Campaign for Southern Equality’s Report of the 2019 Southern LGBTQ Health Survey(direct link to HIV data), we found that respondents’ reported rates of living with HIV more than 15 times higher than the national rate, with 5% of respondents saying they are living with HIV and 10.4% saying that they don’t know their status. Recent research published this month in Open Forum Infectious Diseases found that if such a ruling were to stand in this case, more than 2,000 otherwise-preventable HIV infections could develop within a year.
Judge O’Connor has a long, infamous history, of ruling against the Affordable Care Act, and a history of rulings that specifically harm the LGBTQ community, including on denying federal benefits to same-sex couples and a decision on anti-LGBTQ workplace discrimination that blatantly violated the U.S. Supreme Court’s ruling in Bostock v. Clayton County.
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.
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.
“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.
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.”
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.
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 demographiccomprised 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.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 menin 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.
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.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 forceissued 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.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.
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.
