We have come a long way from the days when HIV was an almost certain death sentence. But our work is far from over. The COVID-19 pandemic led to an uptick in rates of sexually transmitted infections (STIs), including HIV, and low-income communities, LGBTQ+ communities, and communities of color continue to be impacted at alarming and disproportionately high rates.
These communities are also more likely to be served by Medicaid. Medicaid is the largest source of insurance coverage for people living with HIV in the United States, covering an estimated 40 percent of nonelderly adults with HIV, and Medicaid accounted for 45 percent of all federal HIV spending in 2022. During September, Sexual Health Awareness Month, it is worth examining the crucial ways Medicaid works to keep people healthy—and what threatens our progress today.
In recent weeks, we have seen a troubling trend develop. Five million Americans have been removed from Medicaid rolls, and many millions more are on the verge of losing coverage as a result of the Medicaid enrollment cuts. This represents the single greatest threat to our progress toward ending the HIV epidemic in years.
During the pandemic, Medicaid enrollment grew by an estimated 20 million people, contributing to the uninsured rate dropping to the lowest level on record in early 2022. But, after a three-year period during which states provided continuous enrollment in exchange for enhanced federal funding, some states resumed disenrolling people from Medicaid on April 1. A recent KFF survey found that 17 million people could lose Medicaid coverage as a result of this process, referred to as the Medicaid “unwinding.”
Many states are not doing enough to ensure that Medicaid-eligible residents don’t lose their coverage. While some have been removed from the rolls because they are newly ineligible, procedural issues account for 74 percent of people losing coverage. An unacceptably high number of Florida, Texas, and Virginia residents who are still eligible for Medicaid are losing coverage because of procedural reasons, such as failing to confirm proof of income or household size.
Our goal should be to ensure that no one who qualifies for Medicaid loses their coverage. The U.S. Centers for Medicare and Medicaid Services (CMS) gave states the option to use a 12-month grace period, along with other flexibilities, to prepare for the unwinding and make sure residents had what they needed to recertify. So why are some states so eager to remove their residents from Medicaid rolls?
New York, on the other hand, has made equity a cornerstone of recertification work and provides a template for what states can do to help their residents remain covered. The state maximizes the flexibilities offered by CMS and works directly with providers, health plans, and recipients to minimize procedural disenrollments and ensure that people retain health care coverage, either through Medicaid, the state’s health exchange, or private insurance. New York is among the nation’s top-performing states in terms of call center wait times, call drop rates, and average time it takes to make an eligibility determination, according to the Center on Budget and Policy Priorities. New York’s call center is also able to produce materials in 26 languages. In June 2023 alone, New York State certified renewals for more than 400,000 residents.
At Amida Care in New York, we know firsthand that gaps in care for people living with or placed at elevated risk of contracting HIV can be especially devastating. When people lose access to PrEP medication to prevent HIV, they are left vulnerable to contracting HIV, and when people living with HIV lose access to antiretroviral therapy, they risk becoming seriously ill and transmitting HIV to others. We support and guide our members through the recertification process with dedicated outreach efforts that include phone calls, mailings, text messages, and home visits to limit loss of coverage and interruptions in life-saving treatments.
We cannot begin to address health inequity or end the HIV epidemic without strengthening Medicaid. The recent moves by some states to strip their residents of Medicaid coverage will undermine the progress we’ve made.
Amsterdam, the capital city of the Netherlands seems well on its way to accomplishing its goal of zero HIV transmissions by 2026. Only nine cases of HIV were reported in Amsterdam last year, thanks to heavy investment in pre-exposure prophylactics (PrEP), a drug protocol that prevents HIV transmission, and other HIV-prevention efforts.
While scientists have announced that a half dozen people may have been cured of HIV worldwide, the process is painful and expensive. It generally requires a bone marrow transplant after a cancer diagnosis. Dutch health authorities have found a way to circumvent the curing process that prioritizes prevention rather than treatment.
The Dutch AIDS Fund’s report of only nine new cases proves that the city’s investment in PrEP and other prevention strategies, which started in 2019, has had an impact. 128 people in Amsterdam were infected in 2019. PrEP can be used by people who don’t have HIV to prevent the virus from gaining hold of their immune system. When taken by people with the virus, it lowers the viral load to undetectable levels and makes it transmissible.
Health authorities worldwide have particularly recommended the drug for gay men, sex workers, and other people who are at risk for transmission.
In addition to PrEP, health officials have collaborated with politicians and HIV-care workers to create and promote easily accessible services and programs for key at-risk populations, including men who have sex with men (MSM), people with a migration background, and people who inject drugs. Many clinics and hospitals in the city offer HIV testing and immediately provide anyone who tests positive with medication to lower viral loads to undetectable (and thus, untransmittable) levels.
According to Aidsfonds-Soa Aids Nederland, the number of new HIV infections in the city had decreased by 95% since 2010. Approximately 98% of city residents living with HIV have been diagnosed, 95% of those have received medication treatment, and 96% of those on treatment have suppressed the virus to untransmittable levels.
“After more than 40 years of working together to stop the spread of HIV, this is great news,” said Mark Vermeulen, the executive director of Aidsfonds-Soa Aids Nederland. “It really is possible to end HIV and AIDS. Amsterdam is proving to everyone that it can be done.”
The second of two Florida men identified as the “kingpins” in a massive scheme to supply counterfeit HIV medication to U.S. pharmacies, suppliers, and patients has pleaded guilty.
Armando Herrera pleaded guilty to one count of conspiracy to introduce adulterated and misbranded drugs into interstate commerce, the Department of Justice announced earlier this week.
The scheme was to find discarded HIV pill bottles, fill them with fake meds, and reseal them before selling them to unsuspecting victims.
According to the DOJ, Herrera and his co-conspirator, Lazaro Roberto Hernandez, set up companies in Florida, Texas, Washington, and California, which they used to primarily distribute adulterated HIV medication, along with other drugs, to wholesale pharmaceutical suppliers, which then sold the bogus drugs to pharmacies where they were distributed to patients. They also created false documentation to make it look like the drugs were acquired legitimately.
Hernandez pleaded guilty to his role in the scheme in April and was sentenced to 180 months in prison in July.
In 2021, biopharmaceutical company Gilead Sciences warned that knock-off versions of its Biktarvy and Descovy medications were circulated through pharmacies due to unauthorized distributors. Both medications are used to treat people living with HIV. Descovy is also used as pre-exposure prophylaxis (PrEP) to prevent HIV-negative people from contracting the virus.
The operation allegedly involved illegally acquiring pills manufactured by Gilead and repackaging them in used bottles purchased for cash, often from people who were homeless or suffering from drug addiction. The bottles were then resealed to appear unopened and then sold. Adulterated pills were found to contain potentially dangerous drugs, like the powerful antipsychotic Seroquel.
In June 2022, Hernandez was arrested and charged with distributing more than $230 million in adulterated HIV drugs. The following October, Gilead identified Herrera and Hernandez as the “kingpins” in the scheme.
“Gilead’s ongoing investigation revealed that these two kingpins directed the initial sale of the counterfeits through suppliers created solely to sell counterfeit medications,” the company said in a statement at the time.
According to the DOJ, Herrera is scheduled to be sentenced on December 21 and faces up to five years in prison.
A national health task force’s sterling new endorsement of a long-acting injectable medication for use as HIV prevention will require health insurers to begin covering the pricey drug by 2025. Such expanded access to the preventive therapy could lend a much-needed boost to the country’s relatively anemic efforts to thwart the HIV epidemic.
However, the hotly anticipated development in the four-decade fight against HIV is on a legal collision course. A conservative lawsuitadvancing through the courts could void the requirement that insurers cover the HIV-prevention drug, along with dozens of other coverage mandates stemming from the task force’s recommendations. That could have a sweeping impact on people’s ability to afford preventive interventions and screenings for a host of health conditions.
The U.S. Preventive Services Task Force, which is an independent, volunteer assembly of medical experts, issued a new recommendation Tuesday for using antiretroviral medications to prevent HIV, a protocol known as pre-exposure prophylaxis, or PrEP. After it commissioned a systematic review of the relevant scientific literature, the task force published the findings in JAMA. The paper states “with high certainty” that all three currently approved forms of PrEP provide a “substantial net benefit” to adults and adolescents at elevated risk of HIV.
The endorsement concerns two daily oral medications, Gilead Sciences’ Truvada and Descovy, and ViiV Healthcare’s long-acting injectable medication, Apretude. Research has shown that Apretude, which is provided every eight weeks by a health care worker, is superior to Truvada at preventing HIV across a population of at-risk people. But nearly two years after Apretude hit the market, its potential to combat HIV in the U.S. remains woefully unrealized; because of its high cost, insurers rarely cover it.
Dr. Kenneth Mayer, the medical research director at the Fenway Institute, an LGBTQ-focused clinic in Boston, characterized the task force’s Apretude recommendation as “gratifying.” However, he expressed frustration over the roadblocks prescribers such as him have faced when they seek to put patients on Apretude.
“Insurance hassles have definitely been part of the problem, including high copays and requirements that providers demonstrate that patients failed oral regimens,” said Mayer, who was the lead author of a 2020 paper that found Descovy was just as effective as Truvada at preventing HIV.
The task force granted Truvada, Descovy and Apretude “A” ratings for their use as HIV PrEP, as it previously had for Truvada alone in 2019. Under a provision of the Affordable Care Act, A or B ratingsprompt a legal mandate that the vast majority of insurers, including state Medicaid programs expanded under the ACA, cover the preventive intervention in question and at no out-of-pocket cost to patients. Medicare administrators are considering new coverage rules about PrEP under which the public insurance plan would fall in lockstep with the policies about HIV prevention medication.
Dr. Jonathan Mermin, director of the Centers for Disease Control and Prevention’s National Center for HIV, Viral Hepatitis, STD and TB Prevention, said the task force’s Apretude recommendation represented “a major step” toward expanding PrEP access.
“More ways to take PrEP means more people can benefit,” he said.
A legal showdown
By law, insurers now have until January 2025 to begin widely covering Apretude. But the requirement could be nullified by a lawsuit pending in the 5th U.S. Circuit Court of Appeals.
The suit is being waged by a group in Texas, many members of which are self-described Christian business owners, who oppose covering PrEP on religious grounds. In September, a U.S. district judge in Texas agreed that the plaintiffs’ religious freedom had been violated and ruled that the health task force had no constitutional authority to dictate insurance policy, because its members were not appointed by the president or confirmed by the Senate. The ruling has been stayed pending appeal.
Elizabeth Kaplan, an expert in health care law at Harvard Law School, said she “can’t venture a guess as to how the 5th Circuit will rule in this case,” but she noted that it “is one of the most conservative federal appellate courts in the country.” Ultimately, she said, she expects the case to land on the Supreme Court’s docket.
The case’s impact could stretch well beyond the HIV battleground. Ultimate victory for the plaintiffs could vacate the federal government’s authority to follow the task force’s recommendations and mandate free access to, for example, screening for colorectal and lung cancer, statin treatment and smoking cessation therapy.
The PrEP landscape
In July 2021, federal health authorities announced that insurers could not charge patients for Truvada as PrEP or for the quarterly clinic visits and lab tests required to maintain prescriptions. Should the task force lose its authority, insurers could return to imposing such fees. Truvada’s use as HIV prevention was, however, already widely covered by insurance before the task force ever weighed in. And Gilead has long covered up to $7,200 in annual out-of-pocket expenses for PrEP.
The PrEP landscape has evolved dramatically since the task force first lent its vote of confidence to Truvada four years ago. The Food and Drug Administration approved Descovy for use as PrEP in October 2019, followed by Apretude in December 2021. Truvada became available as a cheap generic in the spring of 2021 and is often available for as little as $30 per month. Consequently, insurers have largely refused to cover Apretude, which has a list price of $1,900 per month. Medicaid is already required to cover the injectable drug, although physicians may have to submit prior authorization requests to some state programs.
Descovy is considered gentler on the kidneys than Truvada. But many experts believe it offers no clinically significant benefit to most PrEP users. And so, given Descovy’s $2,160 monthly list price, insurers began restricting coverage for its use for HIV prevention after inexpensive generic Truvada came online. Kaplan said it remains unclear whether the health task force’s inclusion of Descovy in its new recommendation might compel insurers to cover it more liberally.
Jeremiah Johnson, the executive director of the public health advocacy nonprofit group PrEP4all, said the impact of the task force’s support for Apretude “will depend largely on how seriously the federal government takes enforcement of coverage with insurers.”
“And, of course,” Johnson added, “this will mean nothing” for the uninsured.
A nation in need of a game changer
Compared with other wealthy nations, many of which have experienced plummeting HIV transmission rates in recent years, the U.S. is a notable laggard. International health authorities estimatethat from 2015 to 2021, the annual new infection rate dropped by more than 70% in the Netherlands and 44% in Australia, whereas the CDC estimates that the U.S. rate declined by only 12% from 2017 to 2021, from 36,500 to 32,100 cases.
The CDC points to insufficient PrEP use among those most at risk of HIV as a major drag on the nation’s efforts to combat the virus.The agency estimates that gay and bisexual men account for 71% of new cases of the virus and that about 814,000 members of the demographic are good PrEP candidates. A recent CDC study found that only about 190,000 people — a group that other research suggests is overwhelmingly made up of gay and bisexual men — were taking PrEP last September. And crucially, PrEP has never become sufficiently popular among Black and Latino men who have sex with men, who contract HIV at much higher rates than their white counterparts.
If the results of a major clinical trial are any guide, Apretude could pack a substantial public health punch. In a double-blind, placebo-controlled study of gay and bisexual men and transgender women,published in 2021, the participants randomized to receive the injectable drug contracted HIV at a rate two-thirds lower than those who got Truvada as PrEP.
When they are taken as prescribed, Truvada and Descovy lower HIV risk by at least 99%. But many people do not take the pills daily, leaving them vulnerable to the virus. Apretude apparently bridged that gap in the clinical trial.
Dr. Hyman Scott, an HIV prevention expert at the San Francisco Department of Public Health, characterized the need to take a daily pill as the “Achilles’ heel of oral PrEP.” He expressed hope that widely accessible Apretude could mitigate the stark racial disparities in HIV transmissions.
However, Scott noted, “users will still need to adhere to the clinic visits.” That raises the question of whether the imperative that Apretude recipients attend medical appointments every two months, rather than every three months for Truvada or Descovy, will substantially alienate at-risk people.
There are, meanwhile, longer-acting forms of PrEP in the research pipeline, including implants and Gilead’s lenacapavir, which requires injecting only every six months. But even if the health task force keeps its authority in the wake of the legal challenge, insurers would most likely not wind up having to begin covering lenacapavir until 2030.
A European man has been in a state of remission from HIV infection for nearly two years after receiving a stem cell transplant to treat blood cancer. If enough time passes with no signs of viable virus, he could join the rarefied club of five people who are considered either definitely or possibly cured of HIV.
All six people had HIV when they received stem cell transplants to treat blood cancers such as leukemia or lymphoma. But unlike the five other cases, this new one involves a person whose donor did not have a rare genetic abnormality that generates resistance to HIV in the immune cells that the virus targets for infection.
The man’s case will be presented next week at the International AIDS Society Conference on HIV Science in Brisbane, Australia. This major biennial gathering of scientists will also hear noteworthy presentations regarding post-treatment control of HIV in infant boys, circumcision’s impact on HIV risk in gay men, and the relationship between HIV and mpox (formerly known as monkeypox).
It remains unethical for a person with HIV who does not already qualify for a stem cell transplant due to cancer to undergo such a treatment in hopes of curing the virus, given such treatment’s considerable toxicity. Scientists generally expect that any success in the effort to develop a widely scalable HIV cure therapy will likely take decades.
Nevertheless, Dr. Sharon Lewin, president of the IAS and director of the Peter Doherty Institute for Infection and Immunity in Melbourne, Australia, called the new viral remission case “great news.” Such case reports, she said, “help in many ways in the work toward a cure.”
The ‘Geneva Patient’
The man newly in remission from HIV has been dubbed the Geneva Patient, after the Swiss city where he has received his treatment. He is in his early 50s, was diagnosed with the virus in 1990 and began taking antiretroviral treatment in 2005. In 2018, he was diagnosed with a rare blood cancer known as an extramedullary myeloid tumor. He was treated with radiation, chemotherapy and a stem cell transplant.
His case has been overseen by a research team led by Asier Sáez-Cirión, head of the viral reservoirs and immune control unit at the Institut Pasteur in Paris.
HIV is vexingly difficult to cure. This is in large part because even when suppressed by antiretrovirals, the virus hides in nonreplicating immune cells, known collectively as the viral reservoir. Such standard HIV treatment only works on cells that are actively producing new viral copies. So the virus remains under the radar of antiretrovirals within these latently infected cells, each of which can take months or even years to return to a replicating state.
Since the first such case was announced in 2008, three people have definitely been cured and two additional people, pending more time passing without a viral rebound, have possibly been cured of HIV.
Prior to the Geneva Patient’s case, a handful of other people with HIV who developed cancer also received stem cell transplants from donors without the rare genetic mutation conferring natural resistance to the virus. But none from this group went more than 10 months after stopping antiretroviral treatment without a resurgent virus. Hopes that they had been cured were dashed.
The man in Switzerland has now spent 20 months with no viral rebound, having been taken off of antiretrovirals in November 2021. Sáez-Cirión and his colleagues have conducted a battery of ultrasensitive tests in search of HIV in his body and have only been able to detect trace amounts of defective virus. But they still cannot rule out that the man retains even a single cell infected with viable virus, one that could spring to action at any moment and repopulate the body with HIV.
“The possibility of viral rebound is indeed a concern,” Sáez-Cirión said. “The virus may persist in rare infected blood cells or anatomical sites that we have not analyzed.”
It remains unclear why the Geneva Patient’s case has been so successful, at least thus far, while others who received similar treatment were not so fortunate.
Dr. Steven Deeks, a leading HIV cure researcher at the University of California, San Francisco, who was not involved in the study of the Geneva Patient, said the details of the case “suggest that what we once assumed was impossible might in fact be possible.”
Speculating about the drivers of this man’s lengthy HIV remission, Deeks said, “Eliminating most if not all of the reservoir with chemotherapy was certainly the key intervention.” Deeks also noted the man’s repeated episodes of what is known as graft-versus-host disease, a powerful and potentially dangerous immune reaction that occurs as a consequence of a stem cell transplant. This might have also played a crucial role, Deeks said, “as the newly rebuilt immune system may have been attacking and clearing the old immune system, including any residual T cells harboring HIV.”
Sáez-Cirión said it is also possible that the immunosuppressive drugs that the Geneva Patient continues to receive to prevent graft-versus-host disease may be preventing any residual HIV from replicating.
Post-treatment control of HIV
Researchers in sub-Saharan Africa have identified a handful of boys born with HIV who did not experience viral rebound even after their antiretroviral treatment was interrupted for extended periods.
This finding comes from a study of 281 mothers in South Africa who had passed HIV to their newborns. The infants were all put on antiretrovirals immediately after birth. But the investigators eventually discovered that the caretakers of five boys had not provided them with HIV treatment for periods spanning three to 10 months, and yet each of these children maintained an undetectable or very low viral load.
Four of the boys were immediately put back on HIV treatment. However, one other has been kept off of treatment and has now passed 19 months without a viral rebound. Three of the others have been enrolled in a study in which their treatment will once again be interrupted, but under close monitoring.
Dr. Gabriela Cromhout, a research clinician and doctoral candidate at the University of KwaZulu-Natal and one of the lead authors of the study, said three of the boys can be classified as so-called post-treatment controllers of HIV, because they had sustained an undetectable viral load for more than six months while off antiretrovirals.
In advance of their conference presentation, Cromhout and her colleagues did not, however, conduct any ultrasensitive tests to search for the residual presence of HIV in the children’s bodies. Such tests are ongoing.
Dr. Deborah Persaud, a pediatric infectious disease specialist at the Johns Hopkins University School of Medicine and the head of a major ongoing study seeking to cure HIV in infants, said, “This is an enormous advance for the field of HIV remission and cure.” However, Persaud, who was not involved in the South African study, said to back their findings, the study’s investigators would need to present data at the conference confirming that the five boys were infected and that they were indeed off antiretrovirals for the extended periods — data that Cromhout confirmed her team has on hand.
Circumcision and HIV risk
In the mid-2000s, a trio of randomized controlled trials in sub-Saharan Africa determined that circumcising men reduced the risk of female-to-male sexual transmission of HIV by about 50% to 60%.
Now, a research team in China is the first to have completed such a study of gay and bisexual men. They enrolled about 250 uncircumcised men who have sex with men who reported primarily being the insertive partner in intercourse (known as being the “top”). Half were randomly selected to be circumcised. After one year, five study participants contracted HIV, all of them in the control group. The study registered no significant differences in sexual behaviors between the two study groups that might have affected the men’s relative risk of HIV.
The difference in the HIV acquisition rate between the two study groups, the investigators calculated, was statistically significant.
On a media call Wednesday, Dr. Huachun Zou, a professor of epidemiology at the Sun Yat-sen University School of Public Health in Shenzhen, China, said larger studies may be necessary to fully establish whether circumcision reduces the risk of HIV among gay and bisexual men. But he said it is “very unlikely” that researchers will, indeed, launch such research because of the global popularity of the HIV prevention pill, known as PrEP, as a means of reducing risk of the virus among gay and bi men. He said PrEP is not, however, widely used in China, a nation that also has a low circumcision rate.
HIV and mpox hospitalization
This study looked at surveillance data from the World Health Organization regarding 82,290 mpox cases from 2022. There was information about the HIV status for 39% of these people, among whom 52% — 16,633 people, or 20% of the total — had that virus.
The study found that overall, having HIV was not associated with a greater likelihood of being hospitalized with mpox. However, being immunocompromised, including from HIV or from another factor, was tied to about two to four times the hospitalization risk, compared with being HIV-negative and having a healthy immune system.
Fifty-eight of the people with HIV died, as did four of the 15,371 people without HIV.
Lambda Legal, with partners McDermott Will & Emery and Merchant Gould P.C., filed a federal lawsuit against Metropolitan Government of Nashville and Davidson County late last week challenging the Metropolitan Nashville Police Department’s (MNPD) discriminatory policies and practices that reject all job applicants living with HIV.
The lawsuit was filed in the U.S. District Court for the Middle District of Tennessee on behalf of an anonymous plaintiff, John Doe, a 45-year-old Black man and decorated civil servant living with HIV who has worked as a Tennessee State Trooper and with the Memphis Police Department for several years. The plaintiff was previously offered a position in the MNPD, but his 2020 offer was later rescinded solely because of his HIV status.
“This lawsuit responds to a clear case of HIV and employment discrimination where the MNPD denied employment to a well-qualified applicant due only to his HIV status. This applicant was taking advantage of today’s medical advancements and treatments; there is absolutely no reason why his HIV status is at all relevant to his ability to perform the duties of a job in law enforcement, the military, or any other job. In this case, the discrimination is even more egregious since the plaintiff had been serving as a police officer in Tennessee for years with no issue. To the contrary, he has been recognized for his work.” said Greg Nevins, Senior Counsel and the Director of Lambda Legal’s Employment Fairness Project.
“There are many concerning aspects of this discriminatory policy but a particular one is the racial aspect. Nashville is a city where almost 60% of people living with HIV are Black, and black men, who face disproportionate access to preventative health care, are 3.1 times more likely to live with HIV than White males. Given this data, the MNPD’s discriminatory policy clearly has a disproportionate impact on Black people and people of color. Discriminating on the basis of HIV status brings up other potential intersectional issues of race, gender, sexual orientation and, of course, stigma,” said Jose Abrigo, HIV Project Director at Lambda Legal.
“McDermott Will & Emery is proud to serve as co-counsel with Lambda Legal and Merchant Gould on this important employment discrimination case,” said Lisa A. Linsky,McDermott Litigation partner, co-lead on the case and founder of McDermott’s LGBTQ+ Diversity, Equity and Inclusion committee. Our law firm has a rich history of pro bono work supporting marginalized communities and fighting unjust laws, and we are committed to ensuring justice for all Americans.”
The Police Department’s policy rejected the plaintiff’s application during the Civil Service Medical Officer’s exam process claiming that an applicant “must meet or exceed the medical standards set forth in the United States Army Induction Standards.” MNPD uses the Pentagon’s medical exam policies for hiring purposes. Lambda Legal is fighting this same hiring policy from the Pentagon in federal court in the lawsuit Wilkins v. Austin, related to the U.S. Armed Forces’ policy barring people living with HIV from enlisting.
However, since 2022, the Pentagon is no longer either discharging military members due to HIV or considering HIV status for deployment or commissions, following a landmark ruling in April 2022 that was not appealed. A Virginia federal judge ruled that, as to servicemembers living with HIV who are asymptomatic and virally suppressed, the military could not discharge them, refuse to commission them, or categorically bar their worldwide deployment based on their HIV status. This victory came in lawsuits Harrison v. Austin and Roe and Voe v. Austin – litigation Lambda Legal brought with its partners Modern Military Association, Winston & Strawn LLP, Peter Perkowski, Esq., and Scott Schoettes.
The lawsuit filed last week, John Doe v. Metropolitan Government of Nashville and Davidson County, Metropolitan Nashville Police Department argues that MNPD’s policies are unlawful and constitute a violation of federal law including, but not limited to, the Americans with Disabilities Act of 1990.
This lawsuit is the latest in Lambda Legal’s long history of fighting HIV discrimination nationwide, starting in 1983 with People v. West 12 Tenants Corp., helping to establish the illegality of discriminating against people living with HIV.
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.
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.
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.
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.
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.”
“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.
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.
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.