Doctors from Harvard Medical School today challenged the removal of their articles from the Patient Safety Network (PSNet), a government-run website for doctors and medical researchers to share information about medical errors, misdiagnoses, and patient outcomes. The papers were removed as part of a takedown of information that the government contends promotes “gender ideology,” including any articles containing certain prohibited terms, including “LGBTQ” and “trans[gender].”
“Here in Massachusetts, we deeply understand that academic research and knowledge-sharing is essential to our economy and for the health care of all people,” said Rachel Davidson, staff attorney at the ACLU of Massachusetts. “Our clients were given an impossible choice between removing their article from PSNet entirely or censoring parts of it. This is an intentional erasure of knowledge, an attack on the integrity of scientific research, and an affront to the public’s need for accurate, adequate health information.”
The suit argues that the government violated the First Amendment by imposing a viewpoint-based and unreasonable restriction on the doctors’ participation in a forum the government has opened to private speakers. It also argues that the government violated the Administrative Procedure Act, including by removing articles without a reasoned basis. OPM, AHRQ, and HHS are named in the suit.
The Centers for Disease Control and Prevention on Friday is scrubbing a swath of HIV-related content from the agency’s website as a part of President Donald Trump’s broader effort to wipe out diversity, equity and inclusion initiatives across the federal government.
The CDC’s main HIV page was down temporarily but has been restored. The CDC began removing all content related to gender identity on Friday, according to one government staffer. HIV-related pages were apparently caught up in that action.
CDC employees were told in a Jan 29. email from Charles Ezell, the acting director of the U.S. office of personnel management, titled “Defending Women,” that they’re not to make references or promote “gender ideology” — a term often used by conservative groups to describe what they consider “woke” views on sex and gender — and that they are to recognize only two sexes, male and female, according to a memo obtained by NBC News.
President Donald Trump speaks before signing the Laken Riley Act in the East Room of the White House in Washington, DC, January 29, 2025. Perdo Ugarte / AFP / Getty Images
Employees initially struggled with how to implement the new policy, with a deadline of Friday afternoon, the staffer said. Ultimately, agency staffers began pulling down numerous HIV-related webpages — regardless of whether it included gender — rushing to meet the deadline. It was unclear when the pages might be restored.
“The process is underway,” said the government agency staffer, who requested anonymity for fear of repercussions. “There’s just so much gender content in HIV that we have to take everything down in order to meet the deadline.”
The White House did not immediately respond to requests for comment. Communications representatives within the CDC’s HIV and STD prevention departments did not return requests for comment; last week, the Trump administration ordered all employees of HHS, which includes the CDC, to stop communicating with external parties.
Trump’s sweeping executive order to wipe out DEI programs across the federal government threatens to upend the CDC’s efforts to combat HIV among Black, Latino and transgender people — groups disproportionately affected by the virus — according to public health experts.
The executive order, signed by Trump last week, proclaims that the U.S. government will recognize only two sexes — male and female — and end what it characterizes as “radical and wasteful” DEI spending. It also requires that the government use the term “sex” instead of “gender.”
These sweeping directives from the Trump administration, health experts say, threaten to dismantle the CDC’s HIV prevention division, as addressing disparities based on race, sex or gender identity is fundamental to HIV prevention work. The virus has long disproportionately impacted various minority groups, including Blacks and Latinos, gay and bisexual men and transgender people.
Separately, a website that provides technical assistance and training resources to agencies and clinics that receive funding from the Ryan White HIV/AIDS Program, which is run by HHS and provides safety-net funding for the care and treatment of low-income people with HIV, has also been pulled down this week, replaced by a note that says it is “under maintenance.”
An archived version of the site indicates it was active as recently as Jan. 24 and rendered inactive by Jan. 29.
“How can we work on preventing HIV among the populations who are most at risk for it if we can’t talk about it?” said the government worker. “This essentially shuts our entire agency down. We are scrambling to figure out what to do.”
Since Trump’s inauguration, an NBC News analysis found, the administration has scrubbed dozens of webpages that mention diversity, equity, inclusion, gender or sexuality from the sites of federal health agencies like the National Institutes of Health, Food and Drug Administration, CDC and Department of Human and Health Services.
Reproductiverights.gov, the HHS website that provided information about access to reproductive care, including abortion, in the U.S. is among the sites that are now offline. The FDA’s Office of Minority Health and Health Equity website has also been purged, and the NIH’s Office of Equity, Diversity and Inclusion website now redirects to a page on equal employment opportunity.
The formation of the CDC’s HIV prevention division dates back to the early 1980s, as the agency responded to the emerging AIDS epidemic.
The agency is responsible for tracking HIV infections across the U.S., conducting research — in some cases with outside groups — that inform HIV transmission efforts, and also launching initiatives to promote testing and prevention, such as the use of the HIV prevention pill, known as PrEP.
Prioritizing local control of HIV prevention efforts, the CDC provides millions of dollars of grants to state and local health departments and nonprofits to conduct much of the on-the-ground efforts to surveil and combat the virus.
The bulk of federal spending on HIV research, including on experimental vaccines, treatments and cure therapies, comes from the NIH. It remains unclear whether such funding is at risk as the Trump administration exerts its influence across the nation’s health agencies.
But Trump’s pick to lead HHS, Robert F. Kennedy Jr., has said he wants to impose an eight-year “break” on infectious disease research to prioritize studying chronic health conditions, such as obesity and diabetes.
While HIV is an infectious disease, it is also considered a chronic health condition, thanks to effective antiretroviral treatment that has extended the life expectancy of people on such medication to near normal. People with the virus are at higher risk of various other chronic health conditions associated with aging, including cardiovascular disease and diabetes. The NIH has devoted considerable resources to seeking means to mitigate these intersecting health risks.
The annual HIV transmission rate peaked in the mid-1980s at an estimated 135,000 cases per year and plateaued at about 50,000 cases during the 1990s and 2000s, according to the CDC. In recent years, as PrEP has become more popular, HIV has declined modestly, including a 12% drop between 2018 and 2022, to an estimated 31,800 new cases. But such progress pales in comparison to the steep recent declines seen in many other wealthy Western nations.
In 2022, the most recent year for which granular data are available, Blacks and Latinos accounted for 37% and 33% of new HIV cases, despite being just 12% and 18% of the U.S. population.
About two-thirds of new cases occur among gay and bisexual men, who are just 2% of the adult population. While research indicates that transgender women in particular have a high HIV rate, the CDC’s routine HIV surveillance reports do not break down the data according to gender identity.
HIV advocates expressed concern that the Trump administration’s anti-DEI efforts would hamstring the CDC’s efforts to combat HIV and jeopardize hard-fought gains.
“An HIV prevention policy that does not tailor outreach, programs, and services to the communities most in need could increase stigma, make outreach and engagements more challenging, and affect trust,” Lindsey Dawson, an associate director at KFF, a nonprofit group focused on health policy, wrote in an email.
Politics have collided with HIV prevention and advocacy since the dawning of the epidemic.
During the 1980s, activists excoriated President Ronald Reagan for his administration’s slow response to the burgeoning AIDS crisis that was decimating the gay community.
In 1987, Congress passed the Helms Amendment, derisively known as the “No Promo Homo” bill, which prohibited the CDC from creating HIV educational materials or developing programs that would “promote or encourage, and condone homosexual activities.”
Carl Schmid, executive director of the HIV+Hepatitis Policy Institute, said that during George W. Bush’s presidency, researchers and organizations writing applications for federal grant funding for HIV-related matters had to avoid making any reference to gay people or condoms.
The iron-fisted impact of Trump’s anti-DEI order, however, appears to be a league unto itself, HIV prevention experts said.
“Many programs that support disadvantaged groups in the United States are in the crosshairs of the administration,” said Dr. Jeffrey Klausner, an infectious disease expert at the University of Southern California and a veteran of the fight against HIV. “I am very worried about HIV prevention in the United States. We have had tremendous success in the United States brought about by career, highly dedicated NIH and CDC scientists who then transferred their discoveries to the private sector for sales and implementation.”
The government employee called Trump’s order “demoralizing.”
The U.S. Department of Health and Human Services has eased the regulations on kidney and liver donations between HIV-positive donors and HIV-positive recipients, something that HHS says will increase access to these organs.
A rule on interpretation of the HIV Organ Policy Equity Act removes requirements for clinical research and institutional review board approval for such donations, “based on research demonstrating the safety and effectiveness of kidney and liver transplants between donors and recipients with HIV,” says an HHS press release. The rule became final Wednesday.
“We continue to do everything in our power to increase access to life-saving organs while addressing health inequities faced by people with HIV,” HHS Secretary Xavier Becerra said in the release. “This rule removes unnecessary barriers to kidney and liver transplants, expanding the organ donor pool and improving outcomes for transplant recipients with HIV. This evidence-based policy update demonstrates our commitment to ensuring all Americans have access to the care they need.”
“Research shows that kidney and liver transplants between donors and recipients with HIV can be performed safely and effectively,” added Adm. Rachel Levine, assistant secretary for health. “This policy change reflects our commitment to following the evidence and updating our approaches as we learn more. By removing research requirements where they are no longer needed, we can help more people with HIV access life-saving transplants.”
The HOPE Act, passed in 2013, allows for organ donation by people with HIV only to those who are already living with the virus. Under the act, “donors with HIV must not have evidence of opportunistic infections and recipients must have a stable CD4+ T-cell count and established HIV suppression and control on effective antiretroviral therapy,” the new rule explains.
Research has demonstrated “that the safety and outcomes of kidney and liver HOPE Act transplants are well established, with over 517 HOPE Act kidney and liver transplants conducted to date,” the new rule notes. The requirements for these transplants that were revoked by the new rule created an unnecessary barrier, according to HHS.
HHS published the proposed rule in the Federal Register in September and received 56 public comments on it before it became final.
Also Wednesday, the National Institutes of Health, part of HHS, published a notice seeking public comment on a proposed revision to its research criteria for HOPE Act transplants of other organs, such as heart, lung, and pancreas. “This effort aims to streamline the HOPE Act research requirements and continue to build an evidence base of outcomes data on HOPE Act transplants of organs other than livers and kidneys,” the press release says. Comments are due by December 12.
On World AIDS Day, we unite to remember those we’ve lost, support those living with HIV, and renew our commitment to ending the epidemic. Raising awareness is vital to breaking stigma, promoting testing, and advancing treatment. Together, we can make a difference.
Join us in spreading the word, educating others, and standing up for a future free from HIV/AIDS. Together we can make a difference.
For over 40 years, Face to Face has been at the forefront of compassionate care and innovative responses to emerging health crisis here in Sonoma County. Our journey began in 1983 as a grassroots organization responding to the devastating impact of the AIDS epidemic. Since then, we have expanded our services to meet the evolving needs of our community, from HIV prevention and support to addressing the opioid overdose epidemic, housing insecurity, and the rising mental health crisis.
At Face to Face, we lead with love.Every day, we open our doors and our van to provide services without judgement, meeting people where they are. Our community-focused approach ensures that no one faces their health challenges alone.
Join the Fight Against AIDS December 1st is World AIDS Day—a day to unite in the fight against HIV, show support for those living with the virus, and remember those who have lost their lives. This year, let’s raise awareness, promote testing, and break the stigma surrounding HIV/AIDS. Together, we can work toward a future without AIDS.Aids Prevention
Preventing HIV starts with knowledge. Practice safe sex, get tested regularly, and know your status. Early detection and treatment are key to stopping the spread of HIV and protecting your health. All our services are offered free.
Half of people with HIV in the United States are living in places that are vulnerable to extreme weather and climate disasters, according to a new analysis from the left-leaning Center for American Progress (CAP).
The report from CAP released Wednesday finds that the areas of the country where HIV is being diagnosed at disproportionately high rates are also places most at risk of disasters. The analysis used data from the Ending the HIV Epidemic in the U.S. (EHE) program, a federal program that aims to reduce the rate of new HIV infections, and the Federal Emergency Management Agency (FEMA) national risk index. FEMA’s tool takes into account the frequency of disasters, but also the vulnerability of the population, accounting for certain at-risk demographics like low-income and socially disadvantaged people.
Fifty locations, including 48 counties, Washington, D.C., and San Juan, Puerto Rico, have been designated by EHE as high-priority areas to combat HIV because they are where more than 50 percent of new HIV cases occur. On average, those places had a national risk index score of 96.8 out of 100.
“It is not surprising that those most at-risk live in areas particularly vulnerable to extreme weather and climate events. That is true for many other climate-sensitive health outcomes,” said Kristie Ebi, professor of global health at the University of Washington, who reviewed the analysis. “The poor and marginalized are generally at higher risk and often live in less desirable locations that are less desirable because of vulnerability to extreme weather and climate events.”
Haley Norris, policy analyst with CAP and author of the report, said what stood out to them was the variability in threats faced by the different parts of the country. On the West Coast, wildfires cause issues for people with HIV because many develop lung conditions that are exacerbated by wildfire smoke. In the South and Northeast, flooding and hurricanes pose unique health issues for people with HIV by making it more difficult to access medical care. All three of these types of climate disasters are becoming more destructive due to climate change.
“We’re seeing extreme weather and climate events that are quite far outside of historic experience,” Ebi said, pointing to flooding in Asheville, North Carolina, as one recent example.
For those with HIV, those extreme events are making it harder to stay on track with their medications, which stop the disease from progressing to AIDS and prevent transmission to others.
Vatsana Chanthala is director of the New Orleans Health Department’s Ryan White HIV/AIDS Program, a federal initiative that provides funding for clinics and treatments that support low-income people. New Orleans is located in one of the priority jurisdictions to combat new HIV infections.
After Hurricane Ida in 2021, her team surveyed patients in the program to gain a better understanding of how the disaster may have disrupted their care or access to medications. HIV treatment involves taking antiretrovirals daily or bimonthly injections to suppress the virus and keep it at a level that prevents it from spreading. After Ida, pharmacies closed due to damage; electricity was also out for nearly two weeks in parts of the city, making it difficult to contact pharmacies to refill lost prescriptions or others that had run out, Chanthala said. The high cost of the drugs means some pharmacies were hesitant to fill prescriptions, worried that people wouldn’t come to pick them up.
The cost of the drugs was also an issue for those who evacuated: Many did not know that they could use their insurance to cover medication out of state, so they did not attempt to purchase the medication due to out-of-pocket costs, Chanthala found. Of the 194 patients surveyed, 30 percent of those who evacuated said they had trouble accessing care, and of those who stayed in New Orleans, 32 percent also had trouble accessing care.
Another barrier to taking medications is the stigma surrounding HIV. In times of disaster, many people evacuate to the homes of family and friends, and some people in the survey said their family was unaware they had HIV.
“There’s still a lot of fear with HIV and so many clients don’t disclose their status,” Chanthala said. “And so they find ways to hide their medications, and if they’re around people, they’re less likely to take those medications out.”
Norris, the author of the CAP report, said one study on HIV care and wildfires in California also found that people expressed fear of disclosing they had the disease.
“These are people who are going through extremely stressful, life-destroying situations and they have to do the emotional calculation of, ‘will disclosing this make me less safe?’” they said. “That is the hardest part of the puzzle for us to figure out. It is not just about access, it is the reality that HIV stigma is still very alive and well and still very powerful.”
The risk associated with not taking medications is high for people with HIV. If someone stops taking their antiretrovirals, also known as ART, or if they run out of medication, their viral load will go up over time, said Dr. Paula Seal, who works at the HIV Outpatient Clinic at the University Medical Center New Orleans. The length of time it would take for that to happen depends on the individual patient and when they were diagnosed with HIV.
But Seal said they stress the importance of patients staying on their medication.
“When you have trouble is when patients are running out of medications because if they don’t have enough medicine, then they start skipping doses to make it last longer, that’s when we run into problems, and then the virus can become resistant to those medications,” Seal said.
To offset those risks, Seal and other providers follow a hurricane preparedness protocol, talking with patients every year before hurricane season hits and urging them to refill their prescriptions. In many instances, people can get up to 90 days covered by insurance, which could last through a hurricane season. Seal also provides numbers to pharmacies they can contact if something happens to their medication.
This October, the Biden administration updated its guidelines for providers who are treating people with HIV who have been displaced, Norris said. The new guidelines walk providers, who might not have expertise in treating HIV, through how to assess and prescribe medication for new patients who otherwise may have disruption in their care. “Providing ART is very complex, it’s really really good that they were able to get that out when they did,” they said.
One way that the Ryan White Program could become more nimble is by having its services follow the enrolled patients, Chanthala said. Currently, patients at the Ryan White clinics have access to wrap-around services, like transportation and help with housing, but they lose that support if they evacuate.
“Medications are important, and adherence is important. But if a person needs food, needs a place to stay, that’s going to be first on their minds,” she said.
Currently, these supports are not provided through money directly, but Chanthala thinks that in disaster situations having that flexibility to provide funds for people with high medical needs could also help: “If they can’t afford gas to get out of the area, they aren’t going to evacuate.”
Every election changes the political landscape. These changes will impact the ways we advocate and live our lives, but they do not alter the goals we seek to achieve. Regardless of the outcome of any election, it is our mission to end the HIV epidemic in the United States. But particularly after this election, during these uncertain times, we must remain vigilant and proactive to protect essential funding and ensure that health services remain accessible to those who need them most.
“Now, more than ever, we must act with urgency to ensure that President-Elect Donald Trump and Vice-President Elect JD Vance understand that critical services and resources that people living with HIV depend on are not to be compromised,” said Jesse Milan Jr. JD, President and CEO of AIDS United.
AIDS United stands on its history with its 60 – members of the Public Policy Council of turning challenges into opportunities, driving the conversation forward to protect healthcare access for not just for people living with and vulnerable to HIV but all Americans with pre-existing conditions.
In the wake of President-elect Trump’s first victory in 2016, more than 600 HIV advocates came together in that following year’s AIDSWatch to fight for one another in the largest and most impactful HIV advocacy event in our history. We worked with policymakers to turn a moment of uncertainty into a call for justice and an opportunity for progress, protecting the Affordable Care Act and helping usher in the Ending the HIV Epidemic Initiative that has significantly lowered HIV transmission rates and provided care to tens of thousands of people living with HIV. We must once again unite in solidarity to protect our communities and forge a new path forward.
To speak to someone from AIDS United’s team or leadership, please contact AIDS United’s Communications Department at communications@aidsunited.org.
About AIDS United – AIDS United’s mission is to end the HIV epidemic in the U.S. through strategic grant-making, capacity-building, and policy/advocacy. AIDS United works to ensure access to life-saving HIV care and prevention services and to advance sound HIV-related policy for populations and communities most impacted by the U.S. epidemic. As of January 2021, our strategic grant-making initiatives have directly funded more than $118 million to local communities, and we have leveraged more than $184 million in additional investments for programs that include, but are not limited to, syringe access, access to care, capacity-building, HIV prevention, and advocacy. Learn more at www.aidsunited.org.
A new study conducted by the California HIV/AIDS Policy Research Centers (CHPRC) explores the potential of artificial intelligence (AI) chatbots to aid in HIV prevention efforts. The research led by Marisa Fujimoto at UC Berkeley and the Northern California HIV/AIDS Policy Research Center is titled “Evaluating AI Chatbots for HIV Prevention: An Assessment of Response Quality and User Tailoring” and examines the ability of AI-driven chatbots to deliver accurate, engaging, and personalized health information to people from groups affected by HIV and community-based organizations. More information is available at www.chprc.org.
As healthcare increasingly turns to digital solutions, this study provides critical insights into how AI can be leveraged to address HIV prevention in communities that may face barriers to traditional healthcare access. The research assesses not only the technical performance of these chatbots but also how well they cater to individual needs, offering an evaluation of both response quality and user-tailoring in a public health context.
Key Findings Include:
High Response Accuracy, but Variable Clarity: AI chatbots can provide HIV prevention information and guidance that is accurate and neutral in tone across a wide range of HIV prevention topics, including pre-exposure prophylaxis (PrEP). However, some responses had a disjointed flow, lacked clear conclusions, and/or did not follow current best practices for use of non-stigmatizing HIV language.
Personalized Engagement: Chatbots successfully simplified their responses when asked, but they largely did not tailor their responses to the needs of specific populations, such as transgender users or users in specific locations.
Opportunities for Integration with Existing Public Health Services: When responses are reviewed and tailored by health professionals, AI chatbots may be a valuable tool for community-based organizations to enhance the efficiency and quality of service provision and to support the development of educational materials.
“New and innovative ways to enhance HIV care and prevention efforts are needed, especially to reach younger, tech-savvy groups who may turn to digital solutions for health information,” said Marisa Fujimoto, the study’s lead author. “Based on our results, we are cautiously optimistic about the use of AI chatbots for HIV prevention by individuals from communities affected by HIV, community organizations, and health providers. Chatbots are capable of providing reasonably accurate information with few access barriers and could be used best in conjunction with advice from health professionals to optimize information and provide referrals to services.
Nevertheless, our research also raises important questions about how to ensure that AI chatbots provide inclusive guidance that addresses the needs of communities disproportionately affected by HIV, like those seeking gender-affirming care.”
The research, funded by the California HIV/AIDS Research Program through the University of California Office of the President, was led by Marisa Fujimoto, Lauren Hunter, and Sandra McCoy from the University of California, Berkeley School of Public Health, alongside Simon Outram and Laura Packel from the University of California, San Francisco.
About California HIV Policy Research Centers Three collaborative California HIV/AIDS Policy Research Centers, funded by the California HIV/AIDS Research Program, support research and policy analysis that addresses critical issues related to HIV/AIDS care and prevention in California. The work of the research centers focuses on a “rapid response,” which involves short-term research projects designed to quickly address questions that emerge in a dynamic health policy environment.
California Center for HIV Syndemic Policy Research The California Center for HIV Syndemic Policy Research (CalCenSyn) is led by Dr. Laramie Smith (UCSD) and Dr. Orlando Harris (UCSF). CalCenSyn seeks to expose the root causes of HIV and syndemic conditions through community-focused capacity building. such as tobacco, substance use, and socio-structural barriers to treatment through its community-academic collaborative.
Southern California HIV/AIDS Policy Research Center The Southern California HIV/AIDS Policy Research Center, led by Dr. Ian Holloway (UCLA) and Dr. Jamila Stockman (UCSD), celebrated a successful year of collaboration. Their collective work includes academic manuscripts, policy briefs, infographics, conference presentations, consultations with the California Board of Pharmacy, and has garnered additional state and federal funding. In 2024, the Center is examining the implementation of the California Healthy Youth Act, California’s comprehensive sex education law; the intersection of HIV and intimate partner violence; and strategies to implement integrated HIV prevention and treatment services, especially for women experiencing violence.
Northern California HIV/AIDS Policy Research Center The Northern California HIV/AIDS Policy Research Center is led by Dr. Emily Arnold (UCSF), Dr. Sandra McCoy (UCB), and Laura Thomas (San Francisco AIDS Foundation). In 2024, the Northern California HIV/AIDS Policy Research Center is planning to examine the impact of staffing shortages on the HIV healthcare system and is looking forward to working collaboratively with the other PRC on rapid response research addressing syndemic factors that contribute to HIV in California.
The hotly anticipated results are in from a landmark pair of major clinical trials of a long-acting, injectable HIV-prevention drug that only requires dosing every six months.
They are sensational.
Thrilled over the news Thursday that lenacapavir was 89% more effective at preventing HIV than daily oral preventive medication among gay, bisexual and transgender people, plus previous news that the injectable drug was 100% effective in cisgender women, HIV advocates are looking to the future. They hope that if rolled out broadly and equitably, lenacapavir could be the game changer the nation badly needs.
“These kinds of results are unprecedented,” said Dr. Jared Baeten, senior vice president of virology clinical development at Gilead Sciences, which manufactures lenacapavir. “I have moments like this where I truly am speechless. What this can mean for the trajectory of the HIV epidemic is everything that all the world has imagined for years. We can actually turn off new infections.”
And yet, as battle-worn public health advocates stand on the front lines of an over four-decade effort to finally bring the U.S. HIV epidemic to heel, they find a cold, hard fact staring back at them: Lenacapavir is extraordinarily expensive.
Calling lenacapavir’s clinical trial results “nothing short of amazing,” Jen Kates, director of global health and HIV policy at the nonpartisan health nonprofit KFF, said the news “raises the stakes on the importance of getting this new tool to all those who need it, in the United States and around the world. The track record thus far has unfortunately not been a good one.”
Gilead also manufactures Truvada and Descovy, the two daily oral tablets approved for use as pre-exposure prophylaxis, or PrEP. The pharma giant has already secured approval for the injectable drug in treating highly drug-resistant HIV.
Lenacapavir’s current list price for use as HIV treatment is $3,450 per month. Gilead has not yet indicated whether it will set a different price for the drug’s use as PrEP. A company spokesperson told NBC News on Thursday, however, that the reference point for the price of lenacapavir as PrEP will not be its current use as treatment. It remains unclear whether that statement signals a willingness on the part of the pharmaceutical giant to bring the injectable drug’s price down closer to Earth for its use as HIV prevention.
Given that Truvada has been available as a generic since 2020 and now costs as little as $20 per month (Descovy remains on patent and has a $2,200 sticker price), it remains unclear whether, absent some perhaps novel form of government intervention, insurers will indeed make lenacapavir available widely enough to have what epidemiologists predict could be a sweeping public health impact.
Gilead plans to submit lenacapavir for approval for use as PrEP to the Food and Drug Administration by the end of the year. So this powerful new HIV-prevention tool could hit the U.S. market by mid-to-late 2025.
An HIV-prevention upgrade is badly needed. Since Truvada was approved as the first form of PrEP 12 years ago, the drug has failed to achieve anything in the U.S. approaching its awesome impact on HIV rates among gay and bisexual men in wealthy Western nations such as Australia and the United Kingdom. Those countries boast the type of streamlined sexual-health-care systems that the fragmented U.S. health care system lacks.
“The entire story of PrEP is a missed opportunity,” said Amy Killelea, a health consultant in Arlington, Virginia, and a prominent HIV advocate.
Unprecedented clinical trial results
The advanced clinical trial of lenacapavir in gay men was launched in 2021 at 88 sites across the U.S. and Latin America, and in South Africa and Thailand. It enrolled more than 3,250 cisgender men and transgender and nonbinary people who have sex with male partners.
The participants were randomized to receive either lenacapavir or Truvada on a placebo-controlled, double-blind basis, meaning neither the participants nor the researchers knew who was getting which drug. They were instructed to return every six months for an injection and to take the one dose of the provided pills daily.
A planned interim independent analysis of the trial results indicated that two out of 2,180 participants who received lenacapavir contracted HIV during the trial, as did nine out of 1,087 people who got Truvada. For the lenacapavir group, this represented an 89% lower HIV rate than those in the Truvada group and what Gilead estimated was a 96% lower infection rate than would be expected absent either drug.
Given the clear statistical superiority of lenacapavir over Truvada, the trial’s blinded phase will now be ended several months early. The participants will be informed of which drug they received and provided the option of receiving either going forward.
Lenacapavir proved safe and well-tolerated, with no major safety concerns, according to Gilead. One catch is that the subcutaneous, or under the skin, injection of the drug in the abdominal area leaves a small deposit that can be visible among those with low body fat. It is possible that in real-world use, some will find this off-putting or stigmatizing.
When taken as prescribed, Truvada is over 99% effective at preventing HIV; Descovy is comparably effective. But poor adherence to the daily oral PrEP regimen compromises oral PrEP’s efficacy. And gay and bisexual Black men in particular — the group with the highest HIV rate — have often posted particularly low adherence rates in oral PrEP studies.
The Centers for Disease Control and Prevention estimated in May that between 2018 and 2022, annual U.S. HIV transmissions declined by a modest 12%, from 36,200 to 31,800 cases. Approximately 7 in 10 new HIV cases are in gay and bisexual men, with Black people and Latinos in this group acquiring the virus at much higher rates than their white counterparts. Transgender women, in particular those of color, are also at substantial risk of the virus.
A problem that has bedeviled the CDC and HIV advocates for over a decade is that, in particular given the disproportionately high rates of the virus in their respective demographic groups, Black and Latino gay and bisexual men have never adopted PrEP use at the critical mass needed to truly bring the U.S. epidemic to heel among them. Meanwhile, PrEP has accelerated a long-standing decline in HIV among their white counterparts, exacerbating the gap between the groups.
HIV advocates worry that lenacapavir could only widen such racial disparities further.
“Oral PrEP has been around since 2012. Look at our failure,” said Jirair Ratevosian, an associate research scientist at the Yale School of Nursing.“How do we learn from the past so we don’t squander the opportunity?”
Excitement about lenacapavir’s potential
Dr. Hansel Tookes, a professor in the infectious diseases division at the University of Miami Miller School of Medicine, was the most bullish HIV expert to speak with NBC News about lenacapavir’s prospects.
“I am borderline delusional,” Tookes said of his excitement about how lenacapavir could benefit, in particular, the Southern gay men of color he’s charged with helping protect from HIV.
The South, where the effort to treat and prevent HIV remains hampered by the refusal by seven of 11 states to expand Medicaid under the Affordable Care Act, accounts for half of all new HIV cases, according to the CDC.
“Right now, the challenge is having people take a pill every day to prevent something that they don’t have,” said Tookes of the difficulty of engaging young people in particular in such a banal, forward-thinking routine. “Having to get an injection twice a year is an easier sell.”
Dr. Boghuma Titanji, an infectious disease specialist at Emory University, said she frequently sees new HIV diagnoses in Atlanta, where her university is based, especially among young Black and Latino men who have sex with men.
“These groups often lack access to and information about existing PrEP options,” she said. “While lenacapavir is a valuable addition to our toolkit, for it to reach its full potential, it must be made accessible to those who stand to benefit the most from its effectiveness.”
After Gilead released its initial findings in June from an advanced clinical trial of lenacapavir in cisgender women and adolescent girls in sub-Saharan Africa, HIV advocates immediately put pressure on Gilead to provide the drug at a scalable cost to lower-income nations. This chorus is sure to get louder now that lenacapavir is officially highly effective at protecting gay and bisexual men and trans people as well. Still to come are results from ongoing clinical trials of the drug in people who inject drugs and cisgender women in the U.S.
On Thursday, Gilead stated in a release that the company is committed to delivering “lenacapavir swiftly, sustainably and in sufficient volumes, if approved, to high-incidence, resource-limited countries, which are primarily low- and lower-middle-income countries.” The company is in “active discussions with the HIV community” about these plans.
“It’s not progress if lenacapavir’s cost and other structural challenges impede access, domestically or globally,” said Tim Horn, director of medication access at the public health nonprofit NASTAD. “The results of the drug’s clinical trials, he said, “must be to the benefit of all people at risk for HIV, including those with cost-related hurdles to state-of-the-art prevention and care.”
CORRECTION (Sept. 12, 2024, 3:15 p.m. ET): A previous version of this article misstated the monthly sticker price of ViiV Healthcare’s injectable drug Apretude. It’s $1,965 monthly, not $3,930. The price per injection, which is administered every two months, is $3,930.
The AIDS United board of trustees is proud to announce the appointment of Dr. Jirair Ratevosian to the Board, effective August 21, 2024. Dr. Ratevosian will serve on the Fundraising Committee and chair the upcoming fall fundraiser with Emmy-nominated actor and Advisory Council member John Roberts.
“I am deeply honored to join the AIDS United board of trustees at such a critical time in our fight to end the HIV epidemic, Dr. Jirair Ratevosian stated. AIDS United has been a beacon of hope and action, advocating tirelessly for those most impacted by HIV. I look forward to working alongside this dedicated team to drive forward our shared mission of equity, justice, and impact for all communities.”
“We are thrilled to welcome Dr. Jirair Ratevosian to the AIDS United board of trustees,” said Dr. Eugene McCray, Chair of the board of trustees. “His professional expertise and personal integrity strengthen our commitment to ending the HIV epidemic in the United States.”
Dr. Ratevosian (he/him) is an Associate Research Scientist at Yale University and holds appointments at the Duke Global Health Institute and the Center for Strategic and International Studies. With over two decades of experience spanning public service, nonprofit work, the private sector, and diplomacy, Dr. Ratevosian has an exemplary record of advancing global health and human rights initiatives. He has built partnerships with governments and international organizations, developed bipartisan political coalitions, and spearheaded advocacy efforts that have raised billions of dollars for the global HIV/AIDS response.
His efforts have also modernized laws and policies to align with public health evidence and promoted global peace and justice for genocide survivors. From 2021 to 2023, he served as Acting Chief of Staff and Health Equity Advisor to Ambassador John Nkengasong at the U.S. State Department. Previously, Dr. Ratevosian was the Corporate Social Responsibility Director for Gilead Sciences, Legislative Director to U.S. Congresswoman Barbara Lee (2010-2014), and Deputy Director at amfAR.
In 2023, Dr. Ratevosian launched a historic bid for Congress, driven by his vision of a more equitable, inclusive, and healthy society. He holds a doctoral degree from the Johns Hopkins Bloomberg School of Public Health, an M.P.H. from Boston University, and a B.S. from UCLA. His contributions have been featured in publications such as the Bulletin of the World Health Organization, The Lancet, The New York Times, The Body, and The Washington Post.
Following Dr. Ratevosian’s appointment, the board of trustees will comprise twelve trustees. “Jirair is an exceptional leader in the HIV/AIDS movement, and we’re proud and excited to welcome him to the AIDS United family,” added Jesse Milan Jr., President and CEO of AIDS United.
For interview requests with spokespersons from the AIDS United board of trustees or Executive Team, please contact Senior Communications Manager D. D’Ontace Keyes at communications@aidsunited.org.
About AIDS United: AIDS United’s mission is to end the HIV epidemic in the U.S. through strategic grant-making, capacity building, technical assistance, and policy and advocacy. AIDS United works to ensure access to life-saving HIV care and prevention services and to advance sound HIV-related policy for the populations and communities most impacted by the U.S. epidemic.
The Tennessee government has agreed to scrub sex workers who were unjustly convicted of being sex offenders due to an HIV diagnosis from the sex offender registry following a settlement this past Monday.
The lawsuit, OUTMemphis vs. Lee, concerns a Tennessee criminal statute regarding Aggravated Prostitution, which says that if any sex worker knows they are HIV-positive and has sex, they can be put on the state’s sex offender registry, regardless of whether the other party knew or if there’s proof of intent to transmit the infection. An additional lawsuit was filed by the U.S. Department of Justice earlier this year on the same issue.
“The Aggravated Prostitution statute does not provide for any inquiry into the underlying facts and circumstances in an individual case,” says the ACLU in their initial complaint in the OUTMemphis case. “For instance, the statute does not allow for consideration of the alleged sexual activity at issue; the degree of the risk of HIV transmission involved (if any); whether preventative measures such as a condom, PrEP, or PEP were used; the client’s HIV status; whether the accused individual has a suppressed viral load; nor whether their HIV status has been disclosed.”
The complaint continues, “A person with HIV can be convicted of Aggravated Prostitution for offering or agreeing to engage in sexual activity in exchange for compensation without actually engaging in that activity, or for engaging in, offering, or agreeing to sexual activity that carries no risk of HIV transmission”
At least 83 people are believed to have been affected by this, and most of them are Black and/or transgender women in the Memphis area, where police enforced this statute more and targeted marginalized individuals.
The settlement details how aggravated prostitution has been removed from the list of offenses that can put a person on the sex offender registry, and that notice of this must be given on the Tennessee sex offender website alongside letters sent to those affected by this law. The specific claims made by the plaintiffs regarding the illegality of the law are not going to be debated. Instead, the law will be overturned with the state paying legal fees for the plaintiffs.
“The General Assembly has also permitted anyone who is registered solely because of a conviction for one of these offenses to request termination of registration requirements with the Tennessee Bureau of Investigation,” says the letter.
“Each of us, regardless of our race, our genders, or our HIV status, deserves to be treated with dignity and respect and welcomed as full members of our communities,” said Milo Inglehart, staff attorney at Transgender Law Center, in a press release for the initial lawsuit. “With today’s filing, we join the ACLU, ACLU-TN, OUTMemphis, and our individual plaintiffs to challenge the counterproductive and discriminatory Aggravated Prostitution statute that unlawfully singles out people living with HIV, disproportionately impacts Black transgender and cisgender women, and places lifelong, punitive restrictions on those who are criminalized for trying to survive.”
The ACLU of Tennessee said in a statement, “We are pleased to share that today we entered into a partial settlement with the state of Tennessee on behalf of OUTMemphis and our individual plaintiffs. Through this settlement, the Tennessee Bureau of Investigations has agreed to promptly, fairly, and efficiently facilitate the process of removing people from the sex offender registry who were on it due to convictions for aggravated prostitution.”
“Tennessee’s discriminatory aggravated prostitution statute irrationally targets people living with HIV who engage in sex work, regardless of whether they take steps to ensure against HIV transmission. This settlement is one step towards remedying those harms by addressing the sex offender registration. However, as aggravated prostitution remains a felony, our legal team will continue to fight to overturn this statute and ensure that no one in Tennessee is criminalized based on their health status.”
LGBTQ Nation reached out to OUTMemphis and the Tennessee attorney general’s office for comment. Neither responded before this article was published. This article will be updated if they respond.
