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Nearly 20 States Restrict H.I.V. Assistance Programs, Threatening Access to Treatment

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About 20 states are restricting access to assistance programs that help people pay for H.I.V. treatment, a shift that could leave tens of thousands of Americans without reliable access to lifesaving medications. Several additional states are considering similar changes, according to an analysis released Monday by the health research group KFF.

The tightening rules affect the Ryan White AIDS Drug Assistance Programs, known as ADAPs, which help cover the cost of H.I.V. medications, provide drugs at no charge to some patients, and pay insurance premiums for others. Roughly a quarter of the 1.2 million people living with H.I.V. in the United States rely on these programs.

H.I.V. medications can suppress the virus to undetectable levels, preventing transmission to others. Interruptions in treatment, however, may increase the number of new infections and lead to more cases of AIDS.

Some patients facing shortages may try to stretch their prescriptions by skipping doses or sharing pills, a practice that can allow the virus to replicate and develop resistance to medication. Drug-resistant strains can then spread to others.

The H.I.V. Medicine Association released a statement warning the cuts “will threaten the lives of people with HIV and will lead to spikes in new HIV diagnoses and a rise in health care costs as people with HIV develop serious infections requiring hospitalization.”

“H.I.V. treatment disruptions of this magnitude will result in a public health disaster. Florida must follow due process and work with health care professionals, people with H.I.V. and the state legislature to address any funding challenges.”

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The changes are being driven largely by financial pressure. ADAPs are funded through the federal Ryan White H.I.V. program, but the amount of federal support has remained largely unchanged for more than a decade, even as drug prices and insurance premiums have risen. Enrollment has also increased, with participation climbing about 30 percent from 2022 to 2024 after states began removing people from Medicaid rolls that had been expanded during the pandemic.

“Effectively, programs are being asked to do more with less federal funding,” said Lindsey Dawson, associate director of H.I.V. policy at KFF.

So far, 18 states have adopted at least one cost-cutting measure, including lowering income eligibility limits or reducing the number of covered medications. Five more states are weighing changes that could take effect as early as next month. Experts say additional states may follow, especially as new work requirements push some people off Medicaid and into ADAP programs.

“We’re expecting to see more states anticipating or contending with budget deficits, and we do anticipate a growing number of states having to implement cost-containment measures,” said Tim Horn, director of medication access at the National Alliance of State and Territorial AIDS Directors.

The alliance began tracking state policy changes last fall, when Pennsylvania reduced its income eligibility threshold from 500 percent of the federal poverty level to 350 percent.

Florida has enacted the most sweeping rollback so far. On Sunday, the state ended benefits for at least 16,000 residents living with H.I.V. and stopped covering Biktarvy, the most commonly prescribed H.I.V. medication. The move is part of a broader overhaul of the state’s ADAP program, the largest in the country, which serves more than 32,000 people.

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Earlier this year, Florida officials notified participants that the income limit for eligibility would drop from 400 percent of the federal poverty level to 130 percent — about $20,748 a year for an individual, down from $63,840.

The consequences, advocates say, could extend far beyond those directly affected.

“This is really an economic disaster, a public health disaster, a moral disaster,” said Esteban Wood, director of advocacy and legislative affairs at the AIDS Healthcare Foundation, which has filed for an injunction to stop the changes.

“We’re seeing patients across the state full of anxiety and fear rationing their lifesaving medication. These are people who have no other safety net. ADAP is the safety net.”

State health officials have said the changes are necessary to address a projected $120 million budget shortfall. However, the department has not released detailed figures and did not respond to requests for comment.

On Friday, the Centers for Medicare & Medicaid Services opened a special enrollment period for Floridians losing help with insurance premiums, allowing them to choose new plans through April 30.

Advocacy groups attempted to block the restrictions, arguing that the state had not followed proper procedures in changing the rules. On Tuesday, Florida filed an emergency regulation allowing the limits to take effect.

vaccine

Twice-a-Year HIV Prevention Drug Gets FDA Green Light

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The Food and Drug Administration has approved a new long-acting HIV prevention medication that has shown near-total effectiveness in clinical trials, offering a potential breakthrough in the decades-long effort to curb the spread of the virus. Gilead Sciences, the maker of the drug, announced the approval on Wednesday.

The injectable medication, branded as Yeztugo (generic name: lenacapavir), is administered just twice a year and is being hailed by public health experts as a significant advance in HIV prevention, particularly for individuals who struggle to adhere to daily oral PrEP regimens.

“This is the single best opportunity in 44 years of HIV prevention,” said Mitchell Warren, executive director of AVAC, an HIV advocacy nonprofit group.

Clinical trials of lenacapavir showed striking results. In a study involving gay and bisexual men and transgender individuals, participants who received the twice-yearly shot experienced an 89% lower rate of HIV infection than those who took Truvada, a daily oral PrEP pill, and a 96% lower rate than what would have been expected without any preventive medication. In a separate trial conducted among cisgender women in sub-Saharan Africa, no participants who received lenacapavir contracted HIV.

Yeztugo is the first drug in a new class of antiretrovirals designed to prevent HIV from infecting and replicating within the immune system’s target cells. It was previously approved in 2022 under the name Sunlenca for use alongside other medications to treat certain drug-resistant strains of HIV.

All PrEP medications operate on a similar principle. If a sufficient level of the drug is present in the body at the time of exposure, it can prevent the virus from establishing a permanent infection. What sets lenacapavir apart is its extended duration of protection, requiring just two injections per year, administered in a clinical setting.

Gilead’s CEO, Daniel O’Day, called the drug “a major milestone,” suggesting in a statement that it has the potential to “end the HIV epidemic once and for all.”

“Providers are excited about the approval of long-acting lenacapavir for HIV prevention since this once-every-six-month injection has been shown to have high efficacy in preventing HIV in both women and men in two large trials,” Dr. Monica Gandhi, a professor of medicine at the University of California, told Healthline.

“Data from our clinic in San Francisco, which serves low income people with or at risk of HIV, and others have shown that long-acting PrEP works well for people living with HIV who have high rates of concomitant challenges such as housing insecurity and substance use where it can be difficult to take a daily oral pill for PrEP.”

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However, despite the excitement surrounding the approval, public health experts warn that political and financial obstacles could limit the drug’s reach.

The cost of Yeztugo is expected to be a significant hurdle. At $14,109 per injection—or approximately $2,352 per month—the drug is significantly more expensive than generic oral PrEP options like Truvada, which can cost as little as $30 per month. Experts worry that insurers may either decline to cover the injectable or place it on a higher copay tier, making it financially inaccessible to many of the people who would benefit most from it.

A looming Supreme Court case that could strike down provisions of the Affordable Care Act requiring insurers to cover preventive services, including PrEP, adds another layer of uncertainty. Elizabeth Kaplan, director of health care access at Harvard Law School’s Health Law and Policy Clinic, said the potential policy shift “could further complicate access for the populations most at risk.”

Although a Gilead spokesperson stated that individuals could begin requesting the drug from healthcare providers within two days of FDA approval, it may take up to two months for patients to receive their first injection.

PrEP has been available in pill form for more than a decade. Truvada received FDA approval in 2012, followed by Descovy in 2019, both of which are manufactured by Gilead. While these drugs are highly effective when taken daily, reducing the risk of HIV transmission by more than 99%, their success has been uneven across demographic lines.

PrEP uptake has been highest among white gay and bisexual men, who make up the majority of PrEP users. But the HIV burden remains disproportionately high among Black and Latino gay and bisexual men, whose rates of PrEP usage remain comparatively low. Even when PrEP is prescribed, adherence rates are lower among these groups, limiting its effectiveness.

In 2021, ViiV Healthcare introduced an injectable PrEP option called Apretude, administered every two months. While Apretude demonstrated superior efficacy compared to Truvada in clinical trials, it has seen limited uptake. According to the manufacturer, only about 21,000 individuals are currently taking Apretude. Experts cite the frequency of required clinic visits, every two months, as a likely deterrent for many patients.

Yeztugo could overcome some of these barriers. Requiring only two clinic visits per year, the drug has the potential to simplify prevention for people who cannot or will not take a daily pill. However, maintaining adherence to a biannual injection schedule will still be a challenge. Two recent studies found that fewer than half of oral PrEP users continued the regimen for more than six months.

Dr. Susanne Doblecki-Lewis, chief of the Division of Infectious Diseases at the University of Miami Miller School of Medicine, who led several lenacapavir trials, said the new drug could help reduce racial disparities in HIV transmission, provided access is equitable.

“If there are barriers, like complicated prior authorizations or high copays that will prevent people from easily starting it, we could see disparities just get worse.”

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Another concern is the erosion of public health infrastructure needed to support the wide-scale deployment of new prevention methods. The Trump administration recently proposed a 35% cut to domestic HIV funding, including a plan to eliminate the CDC’s $794 million HIV prevention division. Although the administration says elements of the program will be absorbed into a restructured federal agency, many experts fear the impact of such cuts will be severe.

Much of the CDC’s HIV prevention budget is distributed through grants to local health departments and nonprofits that provide education, outreach, and services, such as PrEP navigation. If funding dries up, experts say, it will be significantly harder to raise awareness about lenacapavir or to get it into clinics and community health centers that serve uninsured or underinsured populations.

Despite these challenges, Gilead says it is working to make the drug accessible. The company has pledged to cover up to $7,200 in annual out-of-pocket costs for insured patients and will provide the drug at no cost to low-income individuals through its patient assistance program. Additional funding and logistical support may be available through a patchwork of federal and state programs that help cover the costs of clinic visits and lab work.

Some telehealth and clinic networks are already preparing to distribute the drug. Tristan Schukraft, CEO of the PrEP-focused telehealth service Mistr, said his company plans to begin offering lenacapavir immediately at its storefronts in seven major U.S. cities. The company is also partnering with a nationwide network of community-based clinics to provide the drug to uninsured patients. “We’re ready,” Schukraft said.

According to the Centers for Disease Control and Prevention, the national HIV transmission rate declined just 17% from 2012 to 2022, dropping from 38,300 to 31,800 cases annually. Most of the progress occurred in recent years, including a 12% drop between 2018 and 2022. That same period saw increased investment in HIV prevention under the federal Ending the HIV Epidemic initiative, launched by the Trump administration in 2019, which targeted nearly $3 billion in new spending to reduce infections in 48 high-burden counties.

Still, the reach of PrEP remains limited. In 2023, about 200,000 people were using some form of PrEP each month, a small fraction of the estimated 1.5 million gay and bisexual men who meet eligibility criteria. Whether lenacapavir can reach those who have been left behind by previous prevention methods remains to be seen.

Johanna Mercier, Gilead’s chief commercial officer, said in a recent interview that the company is “optimistic” about securing broad insurance coverage for lenacapavir and believes the new drug could play a transformative role in ending HIV transmission—if the systems to deliver it are adequately funded and supported.

For now, the focus will shift to implementation. With a medication that could radically change the trajectory of HIV prevention, the question becomes not whether it works, but whether the U.S. health system can deliver it to the people who need it most.

DNA Babies 3D

Chinese Biophysicist Given Jail Time For Genetically Modifying Babies

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There continues to be much debate over whether genetically modified embryos should be an acceptable practice in society and the viewpoints vary radically between countries, communities and cultures. Just last month, China handed down a prison sentence and fines to biophysicist He Jiankui and two of his colleagues after he was found guilty of illegal medical practices and jailed for three years. This followed his public announcement in December 2019 that he had, with the help of two embryologists, “created the world’s first gene-edited babies.” His claims attracted much negative attention and led to his prosecution at a Shenzhen court in December.

This case has led some scientists and ethicists to question the Chinese legal process for “lacking appropriate information about altered children.” It has been noted that China is lagging behind some other countries with regards to its views on genetic modification and there is much positive exploratory work taking place in the area of genetic modification which aims to tackle some of the most challenging genetically-related health issues affecting humans. But this work remains exploratory in nature as the future implications of altering genes in humans are unchartered territory and as such, are approached with caution, even by the most experienced of geneticists.

The courts revealed that Jiankui and his team, who also received lesser sentences, did not have the appropriate certifications to practice medicine and state news agency, Xinhua said, “in seeking fame and wealth, deliberately violated national regulations in scientific research and medical treatment. They’ve crossed the bottom line of ethics in scientific research and medical ethics.”

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Jiankui stated that his motivations behind his actions were driven by his interest in tackling HIV. The modified genes were designed to promote the resistance of HIV in the descendents of the babies and he sought out couples where only the father was infected with HIV, with the mother being clear. The couples were offered IVF in return for taking part.

He was extremely public about this work, speaking about his aspirations at the International Summit on Human Genome Editing in Hong Kong, China. He explained that he was committed to sparing future babies from becoming infected with HIV later in their lives. He had a vision that this could be used to reduce the prevalence of HIV and AIDS in much of Africa, where there is often intense discrimination of those inflicted with the disease.

That said, many remain skeptical and have accused him undertaking the work for his own fame than for the good of future humanity. It has also been highlighted that it was the way in which the accused had conducted the process which was worthy of the harsh sentence it attracted. It has been stated that the trio forged ethical review documents and knowingly misled the doctors responsible for implanting the gene-edited embryos into two women, resulting in the birth of twins for one of the mothers. It was these actions which the court deemed were “a direct and deliberate violation of national regulations on biomedical research and medical ethics.”

In addition, medical experts have also questioned the validity of Jiankui’s rationale, arguing that there are much more effective ways of preventing HIV infections and that his approach simply put babies at risk of the gene editing process, providing them with little benefit in return.

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They have also indicated that similar punishments would have been likely if he had carried out the same practices elsewhere, such as in the UK for example. Furthermore, it has been duly noted that stringent punishments do need to be in place in order to prevent the risks of rogue scientists taking matters into their own hands and making genetic modifications which could have long-standing consequences for the affected babies and even their future generations.

Indeed, questions have been raised over the future development of the children affected by Jiankui’s work is yet to be seen, and there is no doubt that the children born through this work, including a set of twins, are likely to be monitored in the coming years.

On this topic, Fyodor Urnov, a researcher at the University of California, Berkeley, told MIT Technology Review that although Jiankui had tried to recreate the CCR5 mutation already present in some human and leads to an immunity to HIV, he had in fact “created new mutations in the target gene, and apparently elsewhere in the genome, too, the consequences of which are unknown.”

What is clear is that the general consensus is that Jiankui acted prematurely and that work of this kind required far more research and preparation before it was ever practiced on human embryos. Further work needs to be conducted in the areas of standards, regulatory pathways and appropriate means of governance and these issues are being considered by the Academies Commission and by a WHO committee, who will return their findings later this year.

Vaccine

An HIV Vaccine Could Be Available As Soon As 2021

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HIV is a devastating illness that affects millions of people worldwide and in many cases leads to AIDS, which is often deadly. HIV attacks the immune system, making it more difficult for the body to fight other infections, and as the immune system deteriorates, infections that would ordinarily lead to temporary, minor illnesses can kill. Currently, no cure for HIV exists. In recent years, however, medicines have been developed to fight HIV infection and reduce the risk of infecting others, allowing people with the disease to live long and fulfilling lives. In the past, many devastating illnesses such as smallpox have been all but eradicated thanks to the development of vaccines, which work by stimulating the body’s immune system to create antibodies to kill viruses. Now, scientists have made tremendous progress in developing a vaccine for HIV, according to reports from Forbes and The Sun.

It should be noted, however, that this is not the first time that claims of the imminent development of an HIV vaccine have been reported. As early as 1984, government officials have predicted that a vaccine would be developed within a few years. This prediction turned out to be far from accurate, as many speculated that exposure to the experimental vaccine in question actually increased patients’ chances of being infected with HIV. Because HIV is a disease that works by attacking the immune system, attempts to develop a vaccine have failed as the virus effectively prevents the body from developing antibodies, which are necessary for fighting viral infections. This fact has made research on the development of an HIV vaccine both slow and dangerous, as researchers have had to grapple with the possibility that their experimental treatments were doing more harm than good.

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As such, an atmosphere of pessimism has clouded research on the development of an HIV vaccine for more than thirty years. But recent developments have provided hope that a safe, effective vaccine for HIV is possible, inspiring belief that the disease could be essentially eradicated like the many devastating viruses that have preceded it. Currently, there are three different late-stage human clinical trials underway for HIV vaccine candidates, and any one of these experimental treatments has the potential to one day be deployed on a massive scale, reducing incidences of infection by a substantial margin.

The first trial, called the HVTN 702 Trial, began in October 2016 and involves two intramuscular injections. These injections contain a genetically-modified variant of the canarypox vaccine which contains pieces of HIV that, while unable to cause infection on their own, could allow the immune system to develop antibodies to fight against the real virus. The trial, which is being conducted in South Africa, an area of the world strongly impacted by the AIDS epidemic, is scheduled to conclude in July 2021.

The second trial, called the HPX2008/ HVTN 705 or Imbokodo Study, uses a similar approach as the previous method, as treatment consists of two injections. However, the ingredients are different; this experimental vaccine includes a re-engineered form of the common cold with inert pieces of HIV attached. Like the previous trial, this trial is being conducted in southern Africa, and includes thousands of participants, all of whom are women. It’s expected to conclude in February of 2022.

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The third trial is the HPX3002/HVTN 706 or Mosaico Trial, and is being conducted in various countries around the world, including locations in North America, South America, and Europe. This trial just began in July of this year and is hoped to enroll 3,800 participants. The Mosaico Trial uses the same experimental vaccine as the Imbokodo Study, but aims to include a more diverse range of participants, including men between 18 and 60 years old as well as transgender people.

Perhaps the trial that shows the most promise is the HVTN 702 trial, as it is based on a vaccine that has shown moderate success in reducing HIV infection in the past. In 2009, a study featuring a similar vaccine reduced infections by roughly 30%, marking substantial progress but not a protection level high enough for general use. As the vaccine developed for the HVTN 702 trial seeks to address the shortcomings of the previous vaccine, many are hopeful that this updated version will offer a protection level great enough to warrant widespread deployment.

Developing a vaccine for HIV has proven to be enormously challenging, and while research on the illness has progressed significantly, the virus has proven to be extraordinarily resilient. As such, while optimism is warranted by the multiple ongoing trials, expectations that a vaccine will be available by 2021 should be tempered, despite the prevalence of such predictions throughout the news media. That being said, the development of an HIV vaccine would surely revolutionize the state of global health, and as such, these trials are surely worth paying attention to as they progress and eventually conclude.