A German man has probably been cured of HIV, a medical milestone achieved by only six other people in the more than 40 years since the AIDS epidemic began.
The German man, who prefers to remain anonymous, was treated for acute myeloid leukemia, or AML, with a stem cell transplant in October 2015. He stopped taking his antiretroviral drugs in September 2018 and remains in viral remission with no rebound. Multiple ultra-sensitive tests have detected no viable HIV in his body.
In a statement, the man said of his remission: “A healthy person has many wishes, a sick person only one.”
The case, which investigators said offered vital lessons for HIV cure research, is expected to be presented Wednesday by Dr. Christian Gaebler, a physician-scientist at the Charité-Universitätsmedizin Berlin, at the 25th International AIDS Conference in Munich.
“The longer we see these HIV remissions without any HIV therapy, the more confidence we can get that we’re probably seeing a case where we really have eradicated all competent HIV,” Gaebler said.
As with all previous cases of potential HIV cure, experts are eager to temper public excitement with a caveat: The treatment that apparently thwarted the virus in the seven patients will ever be available to only a select few. All contracted HIV and later developed blood cancer, which demanded stem cell transplants to treat the malignancy.
The transplants — in most cases from donors selected because their immune cells, the cells that HIV targets — boasted a rare, natural resistance to the virus and were instrumental in apparently eradicating all viable, or competent, copies of the virus from the body.
Stem cell transplants are highly toxic and can be fatal. So it would be unethical to provide them to people with HIV except to treat separate diseases, like blood cancer.
HIV is monumentally difficult to cure because some of the cells it infects are long-living immune cells that are in or enter a dormant state. Standard antiretroviral treatment for HIV works only on immune cells that, typical of infected cells, are actively making new viral copies. Consequently, HIV within resting cells stays under the radar. Collectively, such cells are known as the viral reservoir.
At any moment, a reservoir cell can start producing HIV. That is why if people with the virus stop taking their antiretrovirals, their viral loads typically rebound within weeks.
A stem cell transplant has the potential to cure HIV in part because it requires destroying a person’s cancer-afflicted immune system with chemotherapy and sometimes radiation and replacing it with a donor’s healthy immune system.
In five of the seven cases of definite or possible HIV cure, doctors found donors who had rare, natural defects in both copies of a gene that gives rise to a particular protein, called CCR5, on the surface of immune cells. Most HIV strains attach to thatprotein to infect cells. Without functional CCR5 proteins, immune cells are HIV-resistant.
The German man’s donor had just one copy of the CCR5 gene, meaning his immune cells most likely have about half the normal quantity ofthat protein. In addition, he had only one copy of the gene himself. Together, those two genetic factors may have upped his chances of a cure, Gaebler said.
While having two copies of the defective CCR5 gene is rare, occurring in about 1% of people with native northern European ancestry, having one copy occurs in about 16% of such people.
“So the study suggests that we can broaden the donor pool for these kinds of cases,” Dr. Sharon Lewin, director of the Peter Doherty Institute for Infection and Immunity in Melbourne, Australia, said in a media briefing last week.
Interestingly, a man treated in Geneva whose possible HIV cure was announced last year had a donor with two normal copies of the CCR5 gene. So his transplanted immune cells were not HIV-resistant.
Those two recent European cases raise critical questions about the factors that actually contribute to a successful HIV cure.
“The level of protection one might have predicted from transplant should not have been enough to prevent the virus from surviving and rebounding,” Dr. Steven Deeks, a leading HIV cure researcher at the University of California, San Francisco, who is not involved with the German man’s care, said of his case. “There are several testable theories, so I am optimistic we will learn something here that could shape the next generation of cure studies.”
Gaebler said having HIV-resistant immune cells in the mix surely greatly improves the chances of success in curing the virus with a stem cell transplant. And yet, he said, lacking that safety net, or having one with some holes in it, as with the German man, does not preclude success.
“We need to understand how the new immune system successfully grafted into his body and how it successfully eliminated HIV reservoirs over time,” he said. Suggesting that the transplanted immune cells may have attacked the viral reservoir, he said, “The donor’s innate immune system might have played an important role here.”
The 6 others cured or possibly cured of HIV
All were initially known by pseudonyms based on where they were treated.
Adam Castillejo, aka the “London patient.” Castillejo, 44, a Venezuelan man living in England, received a stem cell transplant for AML in 2016 and stopped HIV treatment in 2017. He is considered cured.
Paul Edmonds, aka the “City of Hope patient.” Edmonds, the oldest potential cure case at 63 when he received a stem-cell transplant for AML in 2019, received reduced-intensity chemotherapy because of his age. Off antiretrovirals since March 2021, he will be considered cured when he hits five years with no viral rebound. In an interview, he expressed excitement over the new case of a man probably cured, as well, and said, “My vision is clear: a world where HIV is no longer a sentence, but a footnote in history.”
The“New York patient.” The first woman and person of mixed-race ancestry possibly to be cured, she was diagnosed with leukemia in 2017 and received a stem cell transplant augmented with umbilical cord blood, which allowed for a lower genetic match with her donor, thus broadening the donor pool.
The “Geneva patient.” In his 50s, he was diagnosed with a rare blood cancer in 2018 and has been off of HIV treatment since November 2021. Researchers remain cautious about his cure status because his immune cells are not HIV resistant.
Franke, Edmonds and Castillejo, who have become friends, are expected to attend the HIV conference in Munich.
As concerns mount about a large outbreak of an especially virulent form of mpox in central Africa and an uptick in U.S. cases since early last year, the mpox vaccine appears to give long-term protection, the Centers for Disease Control and Prevention reported Thursday.
In a separate report, the CDC indicated that overall new mpox infections across the U.S. have remained at a steady, low level —– about 60 cases weekly, compared with 3,000 cases a week at the outbreak’s summer 2022 peak —– in recent months. However, cases so far this year are elevated nationally compared with the same period in 2023 and have seen a sharp increase in New York City.
People who have gotten two doses of the Jynneos mpox vaccine are protected against infection and don’t need a booster at this time, according to the CDC.
Public health experts are concerned that the launch of the summer travel season and the upcoming LGBTQ Pride festivals in cities across the country will drive greater sexual connectivity among gay and bi men and potentially hasten mpox transmission.
Christina Hutson, chief of the CDC’s Poxvirus and Rabies Branch, and other public health experts told NBC News that this is no time for complacency about mpox (formerly called monkeypox). The various factors that likely have kept the U.S. outbreak relatively in check since late 2022 — including vaccination, infection-driven immunity, and sexual behavioral change — may be tenuous.
The mpox outbreak is “poised to return under the right conditions,” said Dr. Jeffrey Klausner, an infectious disease expert at the University of Southern California. Infections rapidly tore around the globe beginning in May 2022 and made that summer a misery for many gay and bisexual men before collapsing worldwide.
Critically, the proportion of at-risk American gay and bi men who are fully vaccinated against mpox is considered inadequate to assure long-term protection for this vulnerable population.
“Vaccination is a critical way to help protect yourself and others,” Hutson said. “It’s important that people at risk for mpox exposure who have not previously recovered from mpox — including certain gay, bisexual, and other men who have sex with men — complete the two-dose Jynneos vaccination series.”
On May 16, the CDC published an ominous report about nearly 20,000 recent cases of what is known as clade 1 of mpox that have been documented in the Democratic Republic of Congo, or DRC, since January 2023.
Concerningly, this viral clade appears to be more transmissible and to cause higher rates of severe disease and death compared with clade 2 of mpox, which drove the recent global outbreak. Five percent of those diagnosed with clade 1 in the DRC have died, compared with just 0.2% of the 96,000 people in the global clade 2 outbreak.
To date, there have been no reports of clade 1 cases outside of the handful of African nations where mpox has been endemic for decades. In December, the CDC first alerted health care providers of the possibility that this more harmful viral clade could hit the United States.
“We’re facing a big, potentially dangerous situation,” Ira Longini, a biostatistician at the University of Florida, said of the potential for global spread of clade 1. “But we really don’t know.”
Dr. Boghuma Titanji, an assistant professor at the Emory University School of Medicine, suggested that the Jynneos vaccine will likely provide protection against clade 1. The Jynneos vaccine is approved in the U.S. for mpox regardless of clade.
“It’s reasonable to anticipate that there would be some immune cross-protection,” she said of immunity stemming both from the vaccine and previous infection with clade 2.
A clinical trial of the Jynneos vaccine is ongoing among health care workers in the DRC. It is not expected to be completed until the end of next year.
But the vaccine has not otherwise been rolled out in the DRC, a lost opportunity to help control the nation’s outbreak and prevent clade 1 from spreading globally, Titanji said.
Dr. Placide Mbala, the head of epidemiology and the global health department at the University of Kinshasa in the DRC, said the nation has seen “a lot of interest” from global public health leaders in providing such assistance.
“But we are still waiting for concrete action,” Mbala said.
In an interview earlier this year, CDC epidemiologist Dr. Jennifer McQuiston said mpox “needs to be thought about as an STD. The good news is it’s a preventable STD.”
Multiple studies of real-world uptake of the Jynneos vaccine have suggested that receiving both doses is associated with a 66% to 89% lower infection rate and one dose is 36% to 75% effective.
In one of the new CDC reports, agency investigators analyzed demographic data and clinical characteristics concerning 271 mpox cases from the U.S. outbreak’s outset in May 2022 to May 2024 among fully vaccinated people in 27 U.S. jurisdictions that provided sufficient related data.
According to a CDC official, the agency estimates that only 0.1% of the fully vaccinated population developed a breakthrough infection. Reported such cases amounted to 0.8% of all 32,819 mpox diagnoses nationally. Thirteen percent of mpox cases were in partially vaccinated people.
The CDC estimates that 2 million men in the U.S. are at significant risk of mpox because they engage in sex with multiple male partners or otherwise are HIV positive; people with HIV have had a high mpox diagnosis rate. Of the overall group of at-risk gay and bi men, only approximately 25% have been fully vaccinated and an additional 14% have received one Jynneos shot.
In keeping with previous studies, the CDC’s new report found that full vaccination was associated with less severe disease and a lower hospitalization rate.
All 56 mpox deaths were among unvaccinated people.
Recent research has raised concerns that the antibodies Jynneos prompts wane over time. But the CDC investigators found evidence that, at least so far, the vaccine’s actual protection against infection hasn’t waned, possibly due to what’s known as innate or cell-based immunity.
Shortly after the vaccine was first rolled out in midsummer 2022, U.S. health authorities began stretching the temporarily short supply by changing its administration from a traditional subcutaneous (under the skin) shot to an intradermal (within the skin) shot that allowed for a much lower dose.
The new CDC report found no evidence that this vaccine-application shiftcompromised vaccine effectiveness.
A separate new CDC analysis of recent U.S. mpox diagnoses found the virus is still overwhelmingly seen among gay and bi men. Just 0.4% of recent cases were in people younger than 18.
Between October and April, 1,802 probable and confirmed mpox cases were reported to the CDC by 42 jurisdictions — for an average weekly rate, which remained essentially steady, of 59 cases. By stark contrast, the nation saw 2,000 to 3,300 weekly cases at the outbreak’s peak between mid-July and late August 2022.
And yet, CDC records show that the nearly 750 mpox cases seen this year through mid-April is more than twice the figure reported during the comparable period in 2023. New York City has seen a nearly five-fold case-rate increase between these two periods, with 191 cases thus far in 2024.
As for concerns about how a U.S. outbreak of clade 1 might transpire, infectious disease experts said they could only speculate whether higher quality health care, for one, might yield a lower death rate than in the DRC. Global clade 2 deaths have largely occurred among peoplethose with compromised immune systems, mostly due to untreated HIV.
Other unknowns include how and among which groups clade 1 might tend to transmit in Western nations. The DRC outbreak has occurred both in men with multiple male sex partners and in female sex workers and their contacts. And two- thirds of the DRC’s clade 1 outbreak has been in people under age 16; only a bit over 1% of the global clade 2 outbreak was in minors.
Epidemiologists see evidence of sustained person-to-person transmission in one DRC province, where cases are primarily in adults.
While this transmission apparently has largely been through sex, compared with clade 2 of mpox clade 1 shows signs that it can nevertheless transmit more readily absent sexual contact. However, clade 1 still seems to require close personal contact, and nonsexual transmission appears largely limited to household settings. Also, the substantial transmission in children could be driven in part, the recent CDC report suggested, by multiple spillovers from wild animals encountered by young people in rural settings.
CDC officers believe that widespread transmission of clade 1 among children in the U.S. is much less likely, owing to a lack of an animal reservoir, less- crowded living quarters, and better cleaning and hygiene.
Emory’s Titanji reported worries that the gay and bi men she cares for quickly lost interest in mpox vaccination after the outbreak stopped being a primary concern for them. During the fall of 2022, the nation’s weekly distribution rate of Jynneos shots plummeted in tandem with the mpox case rate.
Since then, no substantial progress has been made in raising the proportion of at-risk gay and bi men who have received both Jynneos doses.
“If you’re not yet vaccinated and you meet criteria, go and get vaccinated,” Titanji said. “We can’t be complacent about the response now moving forward.”
The Food and Drug Administration’s first-ever approval of an at-home test for chlamydia and gonorrhea could help drive earlier detection and treatment of these sexually transmitted infections amid a ballooning epidemic in the U.S. But some sexual health advocates worry that the FDA’s proposal to begin stepping up regulation of over-the-counter self-testing of STIs could backfire.
The need for new tools to combat these infections is dire.
Diagnoses of gonorrhea, chlamydia and syphilis have soared in the past two decades. Public health experts argue that this is at least partially driven by woeful long-term flat funding of the Centers for Disease Control and Prevention’s budget to fight the spread of STIs during this period.
Some public health officials and advocates expect that greater FDA oversight will help legitimize home STI testing, making it easier to get insurance coverage and actually expanding its use.
Other home tests for these three bacterial STIs are already available over the counter. But the FDA, which has not previously sought to enforce regulation or require that their manufacturers apply for formal approval, cannot vouch for their accuracy.
A consortium of LGBTQ sexual health advocates has objected to a recent FDA policy proposal that, if enacted, would require the companies already offering at-home medical tests, including for STIs, obtain regulatory approval. A central worry is that the expense of meeting the FDA’s demands could drive some companies out of the STI self-testing market and otherwise drive up the cost of the tests.
There are also concerns that the newly approved test does not cover syphilis and is not well suited to address gay and bisexual men’s needs.
The test kit, called Simple 2, does not screen for syphilis, which typically requires at least a finger-prick blood sample. There were at least 177,000 syphilis cases in 2021, a 74% increase since 2017, according to the CDC. Most concerningly, CDC data shows that rates of syphilis in newborns, which can be fatal, rose more than tenfold in the past decade.
Dr. Boghuma Titanji, an infectious disease specialist at Emory University, said that the inconvenience of having to go into a clinic was a major barrier to getting at-risk people tested for STIs.
“Just remove that requirement, that will make the access better for a lot of patients,” she said.
Dr. Leandro Mena, director of the Division of STD Prevention at the Centers for Disease Control and Prevention, believes the new at-home test’s approval will indeed increase testing for gonorrhea and chlamydia.
Self-testing, he said, provides “a tremendous opportunity to empower people to control when, where and how they get tested, and how they learn about their test result, so they can get appropriate treatment for these STIs.”
Chlamydia and gonorrhea are the most common STIs in the U.S., diagnosed in 1.6 million and 710,000 people respectively in 2021, according to the CDC. They can often be asymptomatic and are easily cured with antibiotics. However, if left untreated, the infections can lead to infertility and can be especially harmful to women, leading, for example, to pelvic inflammatory disease. They spread disproportionately among adolescents and young adults, gay and bi men, and people of color.
Will FDA oversight help or hinder the STI fight?
On Nov. 15, the FDA granted marketing authorization for adults to use the over-the-counter Simple 2 Test for gonorrhea and chlamydia, from the home-testing company LetsGetChecked. The test kit, currently sold for $99 through the company’s website, can be activated online, where the consumer fills out a health questionnaire before shipping in samples to a laboratory.
If the results are positive, the company would then put the individual in contact with a physician.
Previously, HIV was the only other sexually transmitted infection to have an FDA-approved at-home test.
Other at-home STI tests are available through telemedicine companies and major pharmacy chains. However, these tests exist in a legal gray zone. Because they’re based on samples that are not taken in a lab, they don’t qualify for an exemption from requiring FDA approval that the agency grants to so-calledlaboratory-developed tests.
The FDA has generally not sought to exert control over home-based tests. However, on Sept. 29, the agency opened a two-month public comment period on a proposed new plan to require companies offering medical self-testing kits for any purpose to seek formal marketing authorization for their products. The FDA’s move followed reports of faulty self-tests that led to undertreatment or improper treatment for heart disease and cancer.
The goal, according to the FDA, is to “ensure the safety and effectiveness of these tests.”
In response, a group that includes sexual health advocates and owners of gay dating apps that provide free at-home HIV and STI testing, began circulating a petition that calls for the FDA to exempt such public health programs from the proposed new demands. Gaining approval for existing STI tests, the petition states, would involve a “time-consuming and expensive process.”
“Many public health leaders are concerned that new FDA regulations will create additional barriers to public health testing,” said Jen Hecht, director of the consortium Building Healthy Online Communities.
Dr. Matthew Golden, who leads the HIV and STI control program at Seattle’s public health department, said that the FDA is playing catch-up in an effort to enforce regulation of an industry that has grown fast since Covid.
“At some level, the horse has left the barn,” said Golden, noting that self-testing kits have been widely used for years. However, he said that for “some of those tests, how well they perform is not well known. So cleaning this up makes sense.”
A source familiar with FDA policies and practices told NBC News that if the agency decides to demand that self-testing companies obtain regulatory approval, it would not likely interrupt the availability of existing medical self-tests during the application process.
That said, it is likely that once a critical mass of self-testing companies obtained or otherwise sought approval, the agency would go after any laggards.
Gay men’s needs are left out — for now
The Simple 2 Test is effectively geared only toward STI exposures from vaginal intercourse.
The kit can process a urine sample and a swab of the vaginal area. Chlamydia and gonorrhea infections, however, can be localized in the throat, urogenital area or rectum. A urine sample can detect urogenital infections in men and women. For people who may have otherwise been exposed through oral or anal sex, oral and rectal swabs would also be needed.
David Harvey, executive director of the National Coalition of STD Directors, said that public health experts “expect and need” the FDA ultimately to approve at-home tests for syphilis and for oral and rectal gonorrhea and chlamydia infections, “so we’re also reaching others who are at high risk, including gay men.”
The CDC’s Mena said he hoped that the agency and the FDA will confer with LetsGetChecked or other testing companies about pushing for additional approvals.
The FDA’s authorization for the Simple 2 Test was based on data indicating that consumers could successfully use the home tests, understand the results and then take any necessary subsequent action.
It’s unclear whether the test will be available outside LetsGetChecked website or whether $99 kit will be covered by insurance. The company didn’t respond to requests for comment.
Tristan Schukraft, CEO of MISTR, a telehealth company that provides the PrEP HIV prevention pill, is supportive of greater FDA oversight of home tests, but expressed concern that tighter regulation could increase the cost of testing.
“Labs are going to be required to spend additional money and resources on studies, quality systems, reagents and software systems,” Schukraft said.
In addition, MISTR requires that PrEP recipients undergo testing every three months for chlamydia, gonorrhea and syphilis. At least 85% of MISTR customers on PrEP opt for at-home testing. The company advises people who test positive — about 13.5% of the kits detect at least one STI — to seek medical care and provides assistance in connecting people to care for those who need it.
Schukraft suggested that greater regulation could lead companies to pull such tests from the market.
If so, he said, “the FDA would be doing harm to public health.”
A new antibiotic has proven as effective as the last remaining recommended treatment for gonorrhea, helping to assuage mounting fears among public health experts about the emergence of drug-resistant strains of the sexually transmitted infection.
Gonorrhea is the second most common STI in the U.S. and has developed resistance to all antibiotics used to treat it, except for the recommended combined therapy of an injection of the antibiotic ceftriaxone with one dose of azithromycin pills. In recent years, ominous reports have suggested that this antibiotic arsenal might not maintain its robust effectiveness against the fast-evolving pathogen for much longer.
On Wednesday, results from a late-stage clinical trial of a new antibiotic called zoliflodacin showed the drug cured so-called uncomplicated gonorrhea infections as effectively as ceftriaxone and azithromycin. The drug was developed by the Global Antibiotic Research & Development Partnership, a Swiss nonprofit, and the U.S.-based Innoviva Specialty Therapeutics.
“Zoliflodacin gives us a new tool in the treatment of gonorrhea, and if used wisely, a barrier against the further spread of resistant infections,” said Dr. Jeffrey Klausner, an infectious disease expert at the Keck School of Medicine of USC, who was not involved in the trial.
The antibiotic, which would be the first new gonorrhea treatment approved in decades, could make it to market by 2025.
The World Health Organization estimates that globally there are more than 82 million new gonorrhea cases every year. In the U.S., in the wake of decades of cuts to state and local public health departments, STIs have soared to record heights. In 2021, there were 710,151 diagnosed cases of gonorrhea, a 28% increase since 2017, according to the Centers for Disease Control and Prevention.
Gonorrhea spreads through sexual contact and can separately infect the genitals, rectum and throat.
The STI is especially common among adolescents and young adults and occurs disproportionately among gay and bisexual men, the CDC reports. Left untreated, gonorrhea poses a risk of infertility and can prove especially damaging to women, leading to pelvic inflammatory disease and ectopic pregnancy. The infection can also raise the risk of HIV transmission.
In recent years, global health authorities have issued increasingly urgentwarnings that gonorrhea has been acquiring resistance to ceftriaxone and azithromycin, with cases of highly drug-resistant gonorrhea reported in multiple nations.
In January, the Massachusetts Department of Public Health reported the first two U.S. cases of gonorrhea that had resistance or reduced response to five classes of antibiotics. Ceftriaxone did cure those cases, but public health officials said they served as a harbinger for the emergence of strains that could evade the antibiotic.
Without a new antibiotic weapon, curing highly drug-resistant strains of gonorrhea could require intensive treatment with multiple antibiotics, according to Dr. Jeanne Marrazzo, director of the National Institute of Allergy and Infectious Diseases. This so-called kitchen-sink approach, she said, would strain medical resources and raise the risk of driving the emergence of further microbial drug resistance to those other antibiotics.
The ultimate fear is that eventually, gonorrhea could prove wholly untreatable, in at least some people.
According to an Innoviva representative, the company aims to file for approval of the antibiotic with the Food and Drug Administration “as quickly as practicably possible.” Innoviva expects an expedited review, meaning the FDA would take about six months to issue a decision.
Zoliflodacin belongs to a new class of antibiotics, and attacks gonorrhea in a novel way. In previous laboratory studies, zoliflodacin proved effective at neutralizing gonorrhea strains that were highly resistant to ceftriaxone and azithromycin and strains that had resistance to other antibiotics as well.
A downside of zoliflodacin is that a previous, phase two clinical trial published in 2018 found that it was not as efficacious at treating gonorrhea infections in the throat as in the genital or rectal areas. However, Marrazzo, who was a co-author on that study, said that this disparity is common among gonorrhea treatments.
“Gonorrhea in the throat is probably going to be a major Achilles heel in our battle to control gonorrhea going forward,” Marrazzo said.
But according to Dr. Margaret Koziel, chief medical officer of Innoviva, the new zoliflodacin trial showed “encouraging” results in the small number of participants with rectal or throat infections.
The company “will certainly engage the FDA about whether the label indication might be for urogenital disease or for all uncomplicated gonorrhea,” Koziel said.
According to Dr. Manica Balasegaram, executive director of Global Antibiotic Research & Development Partnership — Innoviva’s partner in the trial — zoliflodacin holds promise in retaining potency against gonorrhea for a longer period than previous treatments for the infection, because it was developed solely as a treatment for that STI. Ceftriaxone and azithromycin are each used to combat numerous other infections;and the more they are used, the more opportunity gonorrhea has to develop resistance to them.
“This new drug is also given orally instead of an intramuscular injection with ceftriaxone; this is an advantage,” said Dr. Jean-Michel Molina, who studies STI prevention at the University of Paris and was not involved in the clinical trial.
Molina is the head of one of the multiple clinical trials currently running of a meningitis B vaccine as prevention for gonorrhea. He said he expects to present final results of his trial at a scientific meeting in 2024.
The new zoliflodacin study enrolled 930 men, women and adolescents, including people with HIV, with uncomplicated gonorrhea at 16 trial sites in five nations, including Belgium, the Netherlands, South Africa, Thailand and the U.S. Participants were randomized to receive a single oral dose of zoliflodacin or a ceftriaxone injection plus oral azithromycin.
The WHO has called the emergence of drug-resistant pathogens one of the top 10 global public health threats facing humanity and has identified gonorrhea in particular as a priority pathogen.
The zoliflodacin trial is the first to address such a priority pathogen that was marshalled by a nonprofit organization. Established in 2016 by the WHO to help shepherd new antibiotics to market, efforts by the Global Antibiotic Research & Development Partnership’ represent a promising new front in the vital effort to spur research and development of new antibiotics. Offering only thin profit margins, antibiotics do not tend to attract investment by pharmaceutical companies.
“Treating gonorrhea, it’s not going to be your next Ozempic,” said Marrazzo.
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.
As an increasing proportion of Americans identify as LGBTQ, leaders in sexual and gender minority health care say that the nation’s medical schools are largely failing to adequately prepare the next generation of doctors to properly care for this population.
The need is critical, according to experts in medical education and LGBTQ care. Lesbian, gay, bisexual, transgender and queer people, as stigmatized minorities, often have difficulty accessing health care that properly addresses their health concerns, that is sensitive to their sexual and gender identities and that is not flat-out discriminatory, researchers have found.
“It’s terrible that there’s a whole population of people who aren’t getting the health care they need,” said Ann Zumwalt, an associate professor of anatomy and neurobiology at the Boston University Chobanian & Avedisian School of Medicine and a leader in the effort to improve medical school curricula pertaining to LGBTQ care.
In 2014, the Association of American Medical Colleges, or AAMC, released a call for the 158 U.S. and Canadian medical schools to provide comprehensive training in caring for LGBTQ people and those born with sex-development differences.
Since then, the need for such instruction has only ballooned, given the dramatic increase in LGBTQ identification among young people in particular.
“The current political and social climates are unfortunately leading to many, many health care-professional students and residents feeling uncertain and frightened to engage in LGBTQ+ education and training.”
DR. DUSTIN NOWASKIE, OUTCARE HEALTH
A constellation of medical schools has heeded the AAMC’s call — progress that inspires hope among queer-health advocates. But the schools’ adoption of comprehensive LGBTQ-focused curricula are the exceptions to the rule. The organization’s call, which was buttressed by a 300-page roadmap for reform but lacked the teeth of a mandate, has mostly gone unheeded nearly a decade later.
Progress at medical schools has been stymied by a myriad of factors, including the lack of LGBTQ-related content in medical licensing exams; inadequate or nonexistent knowledge and clinical experience among educators; administrators and the medical old guard’s resistance to change and concerns about competing educational priorities; and outside political pressures as conservatives seize upon transition-related care for minors and diversity policies as wedge issues and as they scrutinize higher education.
Dr. Alex S. Keuroghlian, director of education and training at the LGBTQ-focused Fenway Institute in Boston, and six other medical educators who asked to remain anonymous out of fear of the very reprisals they described told NBC News that recent state-level efforts to restrict diversity programs in education and transition-related health care for transgender minors have instilled fear in some medical schools that their LGBTQ-related medical training could draw increased scrutiny and punitive attacks from legislators.
Keuroghlian, who is also an associate professor of psychiatry at Harvard Medical School, said that the recent state gender-care bans would likely have a chilling effect “on our ability to teach in an evidence-based way that is grounded in human rights and autonomy.”
Where are the needs?
Researchers who have assessed the capacity of the nation’s health care workforce to serve the specific needs of LGBTQ Americans have found them woefully unprepared, especially to care for transgender people. And LGBTQ people remain in dire need of improved physical and mental health care, according to a trove of studies.
Despite the population skewing younger, 23% of LGBTQ people report being in poor health, compared with 14% of the non-LGBTQ population, according to the health-care analysis nonprofit KFF. And research finds that as many as 1 in 5 LGBTQ people have experienced discrimination during health care encounters, including refusals to prescribe medication and even verbal attacks.
Resulting alienation from the health care system, researchers say, is a key driver of the various health disparities that plague LGBTQ Americans. Such apparent consequences include elevated rates of heart disease, cancer, depression and anxiety, substance use disorders and risk of suicide. These disparate outcomes, according to researchers, are likely also fueled by the damage that being a member of a stigmatized minority can apparently inflict upon the mind and body. These are pervasive problems that the health care establishment would ideally mitigate, not exacerbate.
And yet a 2011 survey of 176 U.S. and Canadian medical schools found that their students received a median of just five hours of LGBT-related training. One in 3 schools devoted no such time during clinical rotations.
Dr. Dustin Nowaskie is the founder and president of OutCare Health, a nonprofit LGBTQ health-equity organization that is at the forefront of a growing movement to improve medical training on this front and has developed queer-medicine training programs for both medical students and physicians. Nowaskie, who uses gender neutral pronouns, argued in a 2020 paper that medical schools should, in fact, provide at least 35 hours of such training. This instruction, according to Nowaskie, should start with basic terminology and cultural sensitivity and expand to issues such as health conditions that occur at higher rates among LGBTQ people, including sexually transmitted infections and skin cancer.
“These skills should absolutely be required,” Nowaskie said, because of the expanding LGBTQ population and the inevitability that doctors will frequently treat such patients. Nowaskie said they consistently hear from medical students nationwide that LGBTQ-specific instruction is “often minimal,” and that it is “very outdated,” relying on language, terminology and an overall understanding of queer people that has otherwise been retired thanks to recent social progress.
A recent Gallup poll found that over the past decade, the proportion of Americans openly identifying as LGBTQ has doubled, to 7.2%, and that 1 in 5 young adults say they identify as something other than a cisgender heterosexual. The Williams Institute at UCLA Law recently estimated that 0.5% of older adults identify as transgender, compared with 1.4% of adolescents and 1.3% of young adults.
A team directed by Dr. Carl Streed, research lead for the Center for Transgender Medicine and Surgery at Boston Medical Center, is preparing to publish an update of the 2011 medical school survey. Streed was keen to highlight medical schools that have adopted comprehensive LGBTQ-related curricula — including, among many others, the University of Kentucky at Louisville, Stanford University and Boston University, where Streed is an assistant professor. But Streed tempered expectations that his team would identify much of an uptick in overall training.
“Who ends up being remotely comfortable and competent” in caring for sexual and gender minorities, Streed said, “is a matter of wherethey trained rather than whether they’ve been trained.”
Any progress over the past decade has transpired against a split-screen backdrop of sweeping advances for LGBTQ civil rights and, in response, a fierce backlash against transgender rights, in particular. At least 20 states have now passed various restrictions on transition-related care for minors — a legislative effort that even many physicians who express misgivings about the science backing such treatment say they oppose.
“The current political and social climates are unfortunately leading to many, many health care-professional students and residents feeling uncertain and frightened to engage in LGBTQ+ education and training,” Nowaskie said.
“At the same time,” Nowaskie said, “these climates are perpetuating health care stigma among biased, discriminatory providers.”
How medicine can fail LGBTQ people
Delia M. Sosa, a first-year medical student in Ohio, wants to focus on LGBTQ care. Sosa, who uses gender-neutral pronouns, said they are motivated, in part, by their own alienating encounter with the medical old guard.
After growing up in what they described as a conformist Christian community in New England, Sosa came into their trans and nonbinary identity in their early 20s. At 21, they sought to establish a relationship with a primary care physician in their hometown in hopes of eventually having a double mastectomy, or what’s known in trans medical care as top surgery. But after Sosa disclosed to the doctor their queer identity and the fact that they were dating a nonbinary person, they recalled, “she looked at me with a look of confusion” that was also “mixed with frustration.”
“Medicine is playing catch-up in a lot of ways. … I get some really seasoned, experienced physicians who come up to me and say, ‘I never had a chance to learn about this, yet I know this is something I need to learn.’”
DR. SARAH PICKLE
Sosa said they spent the bulk of the appointment providing the doctor a trans-identity 101 tutorial, including breaking down the difference between gender and sex, what it means to be nonbinary, what gender neutral pronouns are and how sexual orientation can be fluid with respect to the gender of partners. They found the experience so off-putting, they let three years pass before seeking surgery again, which they ultimately had last year.
Dr. Sarah Pickle, a family physician and medical educator in Ohio, is a leading proponent of medical schools cultivating a deft hand in up-and-coming physicians in how to care for LGBTQ people. Pickle insists that such training, which focuses, for example, on speaking with sensitivity and inclusivity regarding queer people’s differences, can be crucial in keeping LGBTQ people engaged in care.
“Medicine is playing catch-up in a lot of ways,” Pickle said. “I get some really seasoned, experienced physicians who come up to me and say, ‘I never had a chance to learn about this, yet I know this is something I need to learn.’”
Sosa discovered their own evidence of the potential perils of physicians’ lack of knowledge about treating LGBTQ patients when researching trans people’s experiences with cancer care. Some oncologists, Sosa found, were confounded over how to manage such treatment in a patient taking cross-sex hormones.
“I can’t tell you how many stories I heard of trans folks where they had delayed care because an oncologist didn’t know what to do with them,” Sosa said.
One expert in LGBTQ medicine, who preferred to remain anonymous because of attacks from the far right, described an often cavalier attitude among specialists toward trans patients’ hormone therapy. A cardiologist, they said, might advise a patient to simply go off hormones due to cardiovascular risk, rather than thoroughly reviewing the risks versus benefits of a therapy that is fundamental to many trans people’s sense of self and well-being.
This health care provider and medical educator expressed frustration that such doctors often remain ignorant to studies that provide insight into managing hormonal therapy in the context of certain health problems.
Who is leading the change?
Keuroghlian stands at the vanguard of the movement to train doctors in caring for trans and gay patients.
At Harvard, he and a team of colleagues led a three-year effort to design and implement a new curriculum that provides comprehensive training in such care.
The curriculum, which other schools are free to adopt, permits all professors, regardless of their own identity or experience, to weave LGBTQ themes and practices into their own instruction. So, for example, a course on endocrinology would include instruction on cross-sex hormonal treatment and an embryology course would teach about intersex variations.
Bringing a broad swath of medical educators up to speed is crucial, Keuroghlian said. A major roadblock to progress has been the fact that the professors, who are meant to pass on their own acquired knowledge, have typically never received their own training in sexual and gender minority care. So, in addition to the four-hour training he helped craft for Harvard faculty about how to teach this subject, Keuroghlian is among the educational pioneers, a group that includes Nowaskie, who are designing medical education seminars to train other health care providers nationwide.
Dr. Christopher Terndrup, an associate professor of medicine at Vanderbilt University Medical Center in Nashville, Tennessee, noted that most demand for LGBTQ health education “is actually pushed by the medical students themselves.”
But such eagerness from the new generation can hit old bureaucratic walls, according to Dr. Nelson Sanchez, an associate professor of clinical medicine at Weill Cornell Medicine and the chair of the annual LGBT Health Workforce Conference. Sanchez said administrators often resist calls for such curriculum by insisting that a zero-sum game governs all medical-school education hours.
Dr. Lily Rolfe, who recently graduated from Rush Medical College in Chicago and is matriculating to a residency in family medicine, with a focus on caring for LGBTQ patients, at Swedish Hospital in Seattle, conducted an informal survey of students at Chicago area medical schools about the quality of their education in caring for LGBTQ people.
“It’s always, ‘The gay guy has HIV,’” Rolfe quipped regarding the typical way the respondents characterized their limited education on this front.
“HIV is important,” Rolfe said. “We should learn about it. But that shouldn’t be the entirety of LGBT health.”
Otherwise, the Chicago students said that social determinants of health pertaining to sexual and gender minorities were commonly addressed. But the survey respondents, Rolfe said, “noticed a lack of discussion about trans people, including gender dysphoria; gender euphoria; medical, social, legal and surgical transitioning; and a lack of the discussion of the over pathologization of trans people.”
Harvard’s LGBTQ curriculum, meanwhile, goes beyond just infectious disease, including basic concepts and terminology about gender and sexuality; stigma’s impacts on health inequities; major health concerns that are more common in LGBTQ people, such as anal cancer in gay men or breast cancer in lesbians; effective doctor-patient communication methods; navigating power imbalances and implicit bias; addressing microaggressions; and how to generate learning opportunities if an LGBTQ patient responds negatively to a physician’s words or actions.
Other med schools that have also established substantial training efforts on such subjects include Louisiana State University, the University of Mississippi at Jackson, the University of Wisconsin at Madison, Vanderbilt University, the University of Pennsylvania and Cedars-Sinai in Los Angeles.
The current hostile political environment notwithstanding, Keuroghlian said he remains optimistic for how well prepared the next generation of doctors will be.
“People in medical school are increasingly passionate about doing this work, because there’s more understanding for the need for skilled, culturally responsive care,” Keuroghlian said of sexual and gender minority care.
“There’s also a sense of social justice and health equity that drives young people to do this work,” he said. “They see this as one of the major health rights issues of their generation, and that’s very engaging for them.”
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.”
A recent uptick in mpox diagnoses in Chicago, some of them in people vaccinated against the virus, has raised concerns about a possible increase in cases among gay and bisexual men during the summer.
On Monday, Howard Brown Health, an LGBTQ-focused clinic in Chicago, reported eight new cases of mpox, formerly known as monkeypox, since April 17. By comparison, only one case, also diagnosed at Howard Brown, was reported to the Chicago Public Health Department in the previous three months.
Public health experts expressed measured concern that, similar to other cases of infections that are transmitted through sexual contact, mpox cases could rise during the summer, especially as gay and bi men travel to Pride festivals and other major LGBTQ events.
“Without renewed vaccination and prevention efforts, we are at risk for a resurgence of mpox,” said Dr. Demetre Daskalakis, the deputy coordinator of the White House national mpox response. “Vaccine is a really important tool, even if it’s not perfect.”
Diagnosed cases have been “increasing slightly” in eight countries in the past three weeks, including France and several countries in east Asia, said Dr. Rosamund Lewis, the technical lead for mpox at the World Health Organization. About half of the recent French cases were in vaccinated people.
Otherwise, global case counts have continued to decline since the early-August peak. Since mid-April, Lewis said, only 21 of the 111 nations to report cases during the outbreak have reported any new diagnoses. However, many cases may go undetected, she said.
Chicago’s weekly mpox case rate is the highest since early November. According to Centers for Disease Control and Prevention data, which is updated biweekly, the U.S. has had a rolling seven-day average of no more than 17 diagnoses since mid-February.
The Howard Brown clinic is analyzing the new cases to determine whether any are part of a linked cluster of infections.
Mpox vaccination rates are insufficient
Seven of the eight newly diagnosed patients were in gay or bisexual men, said Dr. Leanna Gordon, the medical director of preventive medicine at Howard Brown. One person was unvaccinated, one had received one dose of the two-dose Jynneos vaccine, and six were fully vaccinated.
All eight cases were mild, none of them requiring treatment for pain. Even with a breakthrough infection, the vaccine is still likely to reduce the severity of an infection, Gordon said.
Gordon emphasized the importance that people at substantial risk of mpox get both doses of the Jynneos vaccine to protect themselves and their sexual partners.
“One of our major concerns is that our population at risk are under-vaccinated,” Gordon said. “We haven’t had as much interest in the vaccine as we would like.”
According to the CDC, more than 1.2 million doses of the Jynneos vaccine have been administered across the country to 725,000 people, 90% of them male. The agency estimates that only 1 in 4 of those most at risk, including gay and bi men and transgender people, have been fully vaccinated.
Two doses of the Jynneos vaccine reduced the risk of mpox disease by 69%, and that one dose was 37% effective, the CDC reported in December. Updated figures are expected next week.
Public health experts expressed concern that mpox could spread more widely across the country after Chicago hosts the International Mr. Leather festival, a popular destination for gay men, at the end of the month.
Daskalakis said the CDC is working with Howard Brown and other local partners to leverage the event to promote mpox prevention and awareness.
Dr. Jeffrey Klausner, an infectious disease physician at the University of Southern California, said, “We need to maintain vigilance and promote and provide free vaccination.”
Symptoms of mpox
Mpox, which has an incubation period of about three to 17 days, typically manifests as a rash and lesions. Other potential symptoms include:
Fever.
Chills.
Swollen lymph nodes.
Exhaustion.
Muscle aches.
Headache.
Sore throat.
In France, national health authorities recently reported that of the 19 diagnoses this year through April 3 in the Centre-Val de Loire region, 16 were made after March 1 and all but one were in men who have sex with men. Ten of the cases were in people who were fully vaccinated: six who had two doses of the Jynneos vaccine and four who had received the smallpox vaccine in childhood and a recent Jynneos dose.
Could mpox return this summer?
Last summer’s mpox outbreak declined following a combination of vaccination, immunity after infection and behavior change among gay and bi men.
Infectious disease experts believe existing immunity from previous infection and vaccination would be likely to prevent mpox from spreading at the same level as last year.
But questions remain about the duration of immunity and whether gay men, many of whom reported reducing their number of sexual partners or even practicing abstinence last summer, have returned to their baseline behavior patterns after mpox cases dramatically waned.
“Everybody’s efforts have contributed to controlling the outbreak, but it’s not gone,” Lewis said. She noted that there is evidence that mpox can spread both before symptoms begin and from people who never develop symptoms.
Dr. Marc C. Shamier, a resident in clinical microbiology at University Medical Center Rotterdam in the Netherlands, reported that in September, about 45% of gay and bi men visiting sexual health centers in Rotterdam and Amsterdam had detectable antibodies against orthopoxviruses, the family to which mpox belongs.
“However,” Shamier said in an email, “this level of immunity is not sufficient to fully stop viral circulation, so sporadic clusters of monkeypox are to be expected.”
Shamier continued: “Large-scale events such as annual Pride parties could increase the number of sexual contacts among the risk group, which may lead to a rise in viral circulation and infections.”
With testing, isolation of cases and higher levels of mpox immunity among risk groups, Shamier expects the number of cases to be relatively low compared to last year.
Daskalakis said the recent cases in Chicago amount to “a call to action as opposed to a call to panic.”
“We have the tools to take care of this,” he said. “We just have to get it done.”
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.”