“We want her to stay in her house,” Jemmott said. “That’s what’s probably keeping her alive, because she’s in her element, not in a strange place.”Ìý

The private insurance market has proved wildly inadequate in providing financial security for most of the millions of older Americans who might need home health aides, assisted living, or other types of assistance with daily living.Ìý

For decades, the industry severely underestimated how many policyholders would use their coverage, how long they would live, and how much their care would cost.Ìý

And as Jemmott belatedly discovered, the older generation of plans — those from the 1980s — often covered only nursing homes.Ìý

Only 3% to 4% of Americans 50 and older pay for a long-term care policy, according to LIMRA, an insurance marketing and research association. That stands in stark contrast to federal estimates that will need critical services before they die.Ìý

Repeated government efforts to create a functioning market for long-term care insurance — or to provide public alternatives — have never taken hold. Today, most insurers have stopped selling stand-alone long-term care policies: The ones that still exist are too expensive for most people. And they have become less affordable each year, with insurers raising premiums higher and higher. Many policyholders face painful choices to pay more, pare benefits, or drop coverage altogether.Ìý

“It’s a giant bait-and-switch,” said Laura Lunceford, 69, of Sandy, Utah, whose annual premium with her husband leaped to more than $5,700 in 2019 from less than $3,800. Her stomach knots up a couple of months before the next premium is due, as she fears another spike. “They had a business model that just wasn’t sustainable from the get-go,” she said. “Why they didn’t know that is beyond me, but now we’re getting punished for their lack of foresight.”

The glaring gaps in access to coverage persist despite steady increases in overall payouts. Last year, insurers paid more than $13 billion to cover 345,000 long-term care claims, according to . Many policyholders and their relatives reported that their plans helped them avert financial catastrophes when they faced long-term care costs that would have otherwise eviscerated their savings.Ìý

But others have been startled to learn that policies they paid into over decades will not fully cover the escalating present-day costs of home health aides, assisted living facilities, or nursing homes. And in other cases, people entitled to benefits confront lengthy response times to coverage requests or outright denials, according to records kept by the , the organization of state regulators.Ìý

Jesse Slome, executive director of the , an industry trade group, said long-term care was the most challenging type of insurance to manage. “You need multiple crystal balls,” Slome said. “And you have to look 20 years into the future and be right.”

The Pandemic Paused a Long-Term DeclineÌý

The industry’s wobbly finances haven’t steadied despite a brief profitable surge during the coronavirus pandemic. Earnings rose because thousands of people who were drawing benefits, many in nursing homes or assisted living facilities, died from covid-19, and other policyholders died before using their insurance. Others stopped tapping their benefits because they fled facilities and went to live with their families, who provided unpaid care.Ìý

Overall, earnings went from $2.3 billion in losses in 2019 to two years of profits totaling $1.1 billion, before receding into the red in 2022 by losing $304 million, according to Fitch Ratings.Ìý

Still, none of that was enough to reverse the industry’s long-term decline. Doug Baker, a director in Fitch’s U.S. life insurance group, said long-term care insurance “is one of the riskiest in our universe” because of the lingering financial burden from underestimating the number of people who would tap their policies.Ìý

More insurers now offer hybrid plans that combine life insurance with long-term care. Those policies are less generous than the ones offered a decade ago — and using the long-term care benefit drains some or all of the money policyholders hoped to leave to their heirs.Ìý

“I don’t think people will offer unlimited again,” said Tom McInerney, the chief executive of Genworth Financial, which suspended selling plans through brokers in 2019. “One way or another, taxpayers are going to have to pay more for long-term care needs of the baby boomers.”Ìý

Many experts believe it’s untenable to expect that a private insurance market can protect most people from the growing burden of long-term care costs.Ìý

“The whole situation is poorly suited to that kind of insurance offering,” said Robert Saldin, a political science professor at the University of Montana who studies the industry.Ìý

Falling Profits and Skyrocketing Premiums

Starting in the 1970s, long-term care insurance was touted as a way to keep older people from eroding their retirement savings or resorting to Medicaid, the state-federal program for the poor and disabled. Early plans were limited to nursing home care but later expanded to cover in-home care and assisted living centers.ÌýSales of the policies 1990 to 2002.

As demand grew, however, there were signs the industry had vastly miscalculated the cost of its products. Insurers set early policy prices competitively low, based on actuarial models that turned out to be markedly inaccurate. Forecasters’ estimates of policyholders’ longevity were wrong. U.S. life expectancy increased to nearly 77 years in 2000 from about 68 years in 1950, . And as people lived longer, their need for care increased.Ìý

Industry officials also failed to account for the behavior of savvy consumers determined to keep their long-term care coverage. Insurers counted on policy lapse rates — people giving up their policies or defaulting on payments — of about 4% annually. The actual lapse rate was closer to 1%.Ìý

As the miscalculations sent profits plummeting, insurers raised premiums or exited the market. By 2020, sales of traditional policies had dropped to 49,000 and the number of carriers offering plans had fallen to fewer than a dozen from more than 100.Ìý

Premiums for some consumers doubled in just a year or two. Three class-action lawsuits accused Genworth of failing to disclose to policyholders that it had planned multiyear rate increases, leaving them without information they needed to decide whether to keep their policies. Genworth settled the lawsuits with offers to allow customers to adjust their policies, and in some cases it paid cash damage to those who accepted reduced benefits. The company did not admit wrongdoing.

The increases continue. AM Best, a rating agency, said in a report last November that Genworth “will continue to need annual rate increases for at least several more years to reach economic break-even.”Ìý

Prices for new policies have jumped, too. A decade ago, a couple aged 55 could expect to pay about for a policy that included $162,000 in total benefits and 3% annual inflation protection, according to the American Association for Long-Term Care Insurance. Today, a policy that is virtually the same , 35% more, even as rising health costs and inflation have eroded the value of the benefits.Ìý

And that’s only for the people who can qualify. To limit their losses, insurers have narrowed the eligible pool of clients. In 2021, of applicants ages 60 to 64 were denied long-term care insurance. For applicants 70 to 74, the rejection rate was 47%. Even among people in their 50s, more than 1 in 5 were turned down. , a history of stroke or diabetes, or psychiatric illness may all be grounds for disqualification.Ìý

At the same time, claims more closely. “They tightened their belts,” said Alan Kassan, a senior partner with the California law firm Kantor & Kantor, which represents clients challenging denials. “Then they tightened their claim administration and started denying claims more and more.”Ìý

In 2022, the proportion of traditional long-term care claim denials varied, from 4.5% in Rhode Island to 9.6% in Alaska, according to the .Ìý

Despite efforts to limit liability, financial problems forced several high-profile insurance providers to drastically revise policy terms and premiums or go into insolvency, affecting the investments of thousands of clients.Ìý

They included Alice Kempski, a retired nurse who, after her husband died, bought a policy from the insurance company in 2004 on the advice of a financial adviser, paying premiums of $180 a month for 16 years. By 2017, she was hobbled by osteoporosis and was struggling to manage her multiple medications, according to her daughter, Ann Kempski. She sold the family home in Wilmington, Delaware, in 2017 and, now needing help bathing, moved to an assisted living center there. But when the family tried to file a claim, they discovered that and the policy had been taken over by the Pennsylvania state insurance guaranty fund.Ìý

The fund had frozen Kempski’s benefits and increased her premiums to about $280 a month, her daughter said. Her doctor told Penn that she had “mild dementia” and osteoporosis and should be in an assisted living facility. But the insurer said that there was not enough evidence that she needed help with two daily living activities or had severe cognitive impairment, conditions that would trigger coverage, according to correspondence between Kempski and the company.Ìý

Kempski was paying roughly $5,400 a month out-of-pocket to the assisted living center. She moved in with her daughter when the pandemic hit, but she continued to pay full rent to the facility to save her spot until she returned in 2021. In March of that year, when her daughter was preparing to refile a claim for long-term care insurance and her premiums had reached $320 a month, Kempski had a massive stroke. She died the next month. The insurer never paid for any of her care.Ìý

Coverage in a Facility but Not at Home

The policy held by Angela Jemmott’s mother, Jewell Thomas, went unused for a different reason: Like many older policies, it covered only skilled nursing care in a facility. Her children had purchased the policy after Thomas’ husband died at 56.Ìý

But decades later, once Thomas developed dementia in her 80s, her children realized how desperately their mother wanted to stay home. Jemmott said they tried to add a rider to the policy to cover home care but were told that their mother’s age (older than 75) barred add-ons. Now the siblings jointly pay about $4,000 a month for two home health aides, while still paying the insurance premium of more than $2,500 a year. “We feel like if we stop paying it, another unforeseen need will arise and cause us to wish we kept it,” Jemmott said.Ìý

Not all policyholders are displeased.Ìý

Bert Minushkin, of Royal Palm Beach, Florida, paid monthly premiums for 27 years, beginning in 1993 when the policy was offered as a benefit by Westinghouse Electric Corp., where he worked as a nuclear engineer. Over time, he paid about $120,000 toward the policy, said his daughter Lisa Heffley, 61, of Louisville, Kentucky.Ìý

Diagnosed with dementia, Minushkin began declining swiftly in 2019. His wife spent $220,000 on assisted living facilities and private aides for him over three years, with about $90,000 of the cost offset by his policy, Heffley said. He died in February 2022 at age 91.Ìý

“He didn’t break even, but thank God he had it,” she said.Ìý

Turning to Crowdfunding

Many experts say what’s needed is a government-subsidized or public program that requires people to carry long-term care insurance, as the Netherlands and Singapore have. But federal efforts to create such a system, including , which was repealed in 2013, and , introduced in 2021, have failed to gain traction in Congress. At the state level, Washington this summer started a that will provide long-term care benefits for residents who pay into a fund, but the maximum benefit of $36,500 will not cover a year in most assisted living facilities.

Lack of a safety net leaves some people unprotected, like Jeffrey Tanck, a real estate broker in Washington, D.C. In 2021, his mother, Sue Tanck, at 75, suffered a serious fall, leaving her with broken arms and a traumatic brain injury. She had been the primary caretaker for his father, Roger, then 77, who had rapidly worsening dementia.Ìý

Without warning, Jeffrey Tanck had to assume charge of his father’s care, moving him into an assisted living center in Ocala, Florida, that now charges $4,600 a month, and had to get his mother into a skilled nursing facility paid for by Medicaid. With no money to cover his father’s costs until he sold their house, Tanck resorted to a plea on the crowdfunding site GoFundMe.Ìý

Wanting to shield himself from a similar financial crisis somewhere down the road, Tanck, who is 51, applied for long-term care insurance, only to be denied. The reason? He takes antidepressants, which help him cope with the anxiety and stress of caring for his parents.Ìý

“What are people supposed to do?” Tanck asked. “I’m going to need something.”Ìý

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Use of the newly ineffective treatments produced by Regeneron Pharmaceuticals and Eli Lilly and Co. is highest in a dozen states. They include several Southern states with some of the nation’s lowest vaccination rates, but also California, which ranks in the nation’s top 20 for fully vaccinated residents, a KHN analysis of federal data shows. Many hospitals and clinics are still infusing the costly treatments — often charging hundreds of dollars a session — that public health officials now say are almost certainly useless.

That’s because of the near-total dominance of omicron, which accounted for in the U.S. during the week that ended Jan. 15, according to the Centers for Disease Control and Prevention.

That point was underscored this week by updated from the National Institutes of Health that now recommend sotrovimab as the primary monoclonal treatment for the disease.

Unless providers are certain they are still treating patients infected with the delta variant, they shouldn’t use the others, said Dr. Mark McClellan, director of the Duke-Margolis Center for Health Policy, who is also a former commissioner of the FDA and former administrator of CMS. And the delta variant is , accounting for 3% of cases in Louisiana, 7% in California, and 10% in Ohio, as examples.

“There’s not a medical justification based on the evidence on the Regeneron and Lilly products,” McClellan said.

Determining which patients are infected with the delta vs. omicron variant is complicated, said Dr. Christian Ramers, chief of population health and an infectious disease specialist at Family Health Centers of San Diego.

His clinic is one of the few sites in the nation using laboratory screening of positive PCR covid tests that can tell whether patients are infected with delta vs. omicron — and then treating them accordingly. “Otherwise, you’re giving this false sense of security to a patient that they’re getting treatment,” Ramers said. “I don’t think it is ethical, and it goes against the principle of doing no harm.”

Overall, U.S. hospitals used about 72,000 doses of the Regeneron and Lilly monoclonal antibody therapies from Jan. 5 through Jan. 18, according to the from the Department of Health and Human Services. Data regarding hospital-level use of sotrovimab, which became available more recently than the other products, is not yet available on the HHS site.

By comparison, hospitals used about 153,000 courses of the Regeneron and Lilly treatments from Dec. 22 through Jan. 4. They used about 169,000 courses from Aug. 26 through Sept. 8, near the height of the delta surge.

On Jan. 19, hospitals still had about 295,000 doses of the Regeneron and Lilly treatments on hand.

Nationwide, the federal government is distributing of sotrovimab per week, though it remains in short supply. The Biden administration has agreed to buy about 1 million doses, including about 600,000 promised by March,

Respectively, Michigan, Florida, Indiana, Missouri, Louisiana, California, Oklahoma, Kansas, Georgia, Ohio, New York, and Mississippi used the most courses of the Regeneron and Lilly treatments from Jan. 5 through Jan. 18, KHN’s analysis showed.

In Florida, which used more than 5,200 courses of the outdated treatments during that two-week period, Republican Gov. Ron DeSantis has said he is not convinced that the Regeneron and Lilly products don’t work against omicron. In Florida, omicron accounted for as of Jan. 20; delta accounted for 3%.

“We have had practitioners give both of those to people with omicron who said the symptoms got resolved,” he said in a Jan. 5 speech provided by his spokesperson, Christina Pushaw.

Federal health officials managing allocation of the monoclonal antibody therapies paused shipments of the Regeneron and Lilly treatments on Dec. 23, after laboratory tests showed they were less effective against the surging omicron variant than the delta variant. But the Biden administration , after complaints from DeSantis and some doctors that those therapies could still help people in places where the delta variant persisted.

Regeneron itself has said its antibody treatments are ineffective against the omicron variant. It contains more than 30 mutations in the virus’s spike protein, which makes the variant better at dodging the monoclonal antibody treatments.

“It’s really not justified at this point unless there’s some other underlying secondary gain, political pressure, or perhaps the providers are truly not in touch with the reality of the variant proportions,” Ramers said.

Earlier this month, HHS officials indicated that shipments of the three monoclonal antibody treatments would continue through Jan. 31, despite the growing proportion of omicron cases. A department spokesperson on background said the agency would continue to assess “any impacts to covid-19’s therapeutic allocations.”

Monoclonal antibody treatments are lab-based molecules that mimic the body’s immune response to infection. They are most often given through IV infusion, though some can be delivered with an injection. The federal government has agreed to purchase millions of doses of the Regeneron and Lilly products at a cost of about $2,100 per dose. The medicines are free to consumers, though hospitals and clinics do charge fees for administering the drugs and monitoring patients during the process.

Other treatments expected to be effective against omicron in high-risk, non-hospitalized patients include AstraZeneca’s Evusheld, a long-acting injectable monoclonal antibody for immunocompromised people, and a three-day infusion of Gilead Sciences’ remdesivir, which is approved by the FDA. New oral antiviral pills also are expected to be effective, although they, too, remain in short supply.

Providers in several states that have continued to use the Regeneron and Lilly products have offered varied reasons. Some said they believed delta infections continued to circulate locally; others said they felt desperate to try something.

Officials in Michigan, which used more than 5,800 doses of the Regeneron and Lilly products during the most recent two weeks, and California, which used more than 3,400, have allowed health care providers to use their clinical judgment about which treatment to prescribe.

But in Mississippi, where omicron is rampant and fewer than half of residents have been fully vaccinated, state health officer Dr. Thomas Dobbs called for an end to the use of the treatments.

“We will be recommending that clinicians and physicians do not use these products right now based on the distribution of omicron vs. delta,” he said during a recent

At Ramers’ clinic in San Diego, care providers have been dispensing scarce doses of the monoclonal antibody treatments only when they’re confident they’ll help. That has meant sending batches of positive PCR tests to a laboratory in nearby Irvine, where they are screened to see whether one of three target genes is not detected, a known marker for an omicron infection.

Patients infected with the delta variant were able to be treated with REGEN-COV, the Regeneron product, preserving sotrovimab for the growing number of omicron cases, said Pauline Lucatero, the clinic’s director of nursing.

“Looking into my patients’ eyes and seeing fear, just fear, all I could tell them is we believe this treatment works and we’re going to do everything we can to save as many people as we can,” she said.

Phillip Reese, an assistant professor of journalism at California State University-Sacramento, contributed to this report.

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Now under federal review, both pills are being hailed by infectious-disease doctors not prone to superlatives.

“This is truly a game changer,” said Dr. Daniel Griffin, an expert on infectious diseases and immunology at Columbia University. “This is up there with vaccines. It’s not a substitute for vaccines; we still want to get people vaccinated. But, boy, this is just another great tool to have.”

The new regimens, which require 30 or 40 pills to be taken over five days, have been shown to dramatically reduce hospitalizations and prevent deaths in adults with mild to moderate covid who are at risk for severe disease because of age or underlying conditions. But experts say the success of the treatments would hinge on one uncertain factor: whether high-risk patients infected with covid will be able to get tested — and then treated — fast enough to make a difference.

“Early, accessible testing and access to the results in a time frame that allows us to make a decision is really going to be key to these medications,” said Dr. Erica Johnson, who chairs the Infectious Disease Board of the American Board of Internal Medicine. “It puts the onus on our public health strategy to make these available.”

In clinical trials, molnupiravir, the antiviral drug developed by Merck & Co. and Ridgeback Biotherapeutics, was given to non-hospitalized, unvaccinated, high-risk adult patients within five days of their first covid symptoms. Pfizer’s product, Paxlovid, was tested in similar patients as early as three days — just 72 hours — after symptoms emerged.

Results from the Merck trial, month, showed the drug reduced the risk of hospitalizations by about 50% and prevented deaths entirely. It will be considered by an advisory panel to the federal Food and Drug Administration on Nov. 30. Pfizer officials, , said Paxlovid cut the risk of hospitalizations and deaths by 89%. Both drugs work by hampering the way the covid virus reproduces, though they do so at different points in the process.

But those promising results assume the drugs can be administered in the narrow window of time used in the trials, a proven challenge when getting antiviral treatments to actual patients. Similar drugs can prevent dire outcomes from influenza if given early, but that only about 40% of high-risk patients during five recent flu seasons sought medical care within three days of falling ill.

“That’s just not human nature,” said Kelly Wroblewski, director of infectious disease programs for the Association of Public Health Laboratories. “If you have a sniffle, you wait to see if it gets worse.”

Even when patients do seek early care, access to covid testing has been wildly variable since the start of the pandemic. U.S. testing capacity continues to be plagued by a host of problems, including supply-chain bottlenecks, staffing shortages, intermittent spikes in demand and results that can take hours — or far longer.

PCR, or polymerase chain reaction tests, the gold standard to detect SARS-CoV-2, can require scheduled appointments at medical offices or urgent care centers, and patients often wait days to learn the results. Rapid antigen tests are faster but less accurate, and some medical providers are hesitant to rely on them. Over-the-counter tests that can be used at home provide results quickly but are hard to find in stores and remain expensive. And it’s not yet clear how those results would be confirmed and whether they would be accepted as a reason for treatment.

“Get ready,” Griffin said. “You don’t want to call someone four days later to say, ‘Ooh, you’re now outside the window,’ and the efficacy of this oral medication has been lost because of problems on our end with getting those results.”

The situation is expected to improve after a Biden administration push to invest $3 billion in rapid testing, to ramp up manufacturing capacity for rapid tests. But it could be months before the change is apparent.

“Supplies will be getting better, but it’s going to be slow,” said Mara Aspinall, co-founder of Arizona State University’s biomedical diagnostics program, who writes monitoring national testing capacity.

If getting tests will be tough, acquiring doses of the antiviral drugs is expected to be tougher, at least at first. The federal government has agreed to purchase about 3.1 million courses of molnupiravir for $2.2 billion, which works out to about $700 per course of treatment. The Biden administration is planning to announce a deal to pay $5 billion for 10 million courses of the Pfizer drug, paying about $500 per treatment course,

Doses of the drugs distributed by the federal government would go to states and patients at no cost. But only a fraction of the planned inventory will be available to start, said Dr. Lisa Piercey, Tennessee’s health commissioner, who has been part of a small group of state health officials working on the distribution plans.

Under one scenario, in which 100,000 courses of the Merck drug are available as early as Dec. 6, Piercey said Tennessee would receive just 2,000 patient courses even as the state is reporting more than 1,200 new cases a week on average. Deciding which sick patients receive those scarce supplies will be “an educated stab in the dark,” Piercey said.

U.S. Department of Health and Human Services officials have said the antiviral treatments will be distributed through the same state-based system adopted for monoclonal antibody treatments. The lab-made molecules, delivered via IV infusion or injection, mimic human antibodies that fight the covid virus and reduce the risk of severe disease and death. Federal officials took over distribution in September, after a covid surge in Southern states with low vaccination rates led to a run on national supplies. They’re now allotted to states based on the number of recent covid cases and hospitalizations and past use.

The antivirals will be cheaper than the monoclonal antibody treatments, which cost the government about $1,250 per dose and can carry infusion fees that leave patients with hundreds of dollars in copays. The pills are much easier to use, and pharmacies likely will be allowed to order and dispense them for home use.

Still, the antiviral pills won’t replace the antibody treatments, said Dr. Brandon Webb, an infectious-disease specialist at Intermountain Healthcare in Salt Lake City.

Questions remain about the long-term safety of the drugs in some populations. Merck’s molnupiravir works by causing mutations that prevent the virus from reproducing. The Pfizer treatment, which includes Paxlovid and a low dose of ritonavir, an HIV antiretroviral, may cause interactions with other drugs or even over-the-counter supplements, Webb said.

Consequently, the antivirals likely won’t be used in children, people with kidney or liver disease, or pregnant people. They’ll need to be administered to patients capable of taking multiple pills at once, a couple of times a day, and those patients should be monitored to make sure they complete the therapy.

“We’ll be on an interesting tightrope in which we’ll be trying to identify eligible patients early on to treat them with antivirals,” Webb said. “We’re just going to need to be nimble and ready to pivot.”

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The 60-year-old man, who had been fully vaccinated, was diagnosed with a breakthrough infection in late September. Almost immediately, he required supplemental oxygen, and lung exams showed ominous signs of worsening disease. Yates, who is medical director of Jacksonville Health and Rehabilitation, a skilled nursing facility 75 miles northeast of Birmingham, knew his patient needed more powerful interventions — and fast.

At the first sign of the man’s symptoms, Yates had placed an order with the Alabama Department of Public Health for monoclonal antibodies, the lab-made proteins that mimic the body’s ability to fight the virus. But six days passed before the vials arrived, nearly missing the window in which the therapy works best to prevent hospitalization and death.

“We’ve been pushing the limits because of the time frame you have to go through,” Yates said. “Fortunately, once we got it, he responded.”

Across the country, medical directors of skilled nursing and long-term care sites say they’ve been scrambling to obtain doses of the potent antibody therapies following a change in federal policy that critics say limits supplies for the vulnerable population of frail and elder residents who remain at highest risk of covid infection even after vaccination.

“There are people dying in nursing homes right now, and we don’t know whether or not they could have been saved, but they didn’t have access to the product,” said Chad Worz, CEO of the American Society of Consultant Pharmacists, which represents 1,500 pharmacies that serve long-term care sites.

Before mid-September, doctors and other providers could order the antibody treatments directly through drug wholesaler AmerisourceBergen and receive the doses within 24 to 48 hours. While early versions of the authorized treatments required hourlong infusions administered at specialty centers or by trained staff members, a more recent approach allows doses to be administered via injections, which have been rapidly adopted by drive-thru clinics and nursing homes.

Prompt access to the antibody therapies is essential because they work by rapidly reducing the amount of the virus in a person’s system, lowering the chances of serious disease. The therapies are authorized for infected people who’ve had symptoms for no more than 10 days, but many doctors say they’ve had best results treating patients by Day 5 and no later than Day 7.

After a slow rollout earlier in the year, use of monoclonal antibody treatments exploded this summer as the delta variant surged, particularly in Southern states with low covid vaccination rates whose leaders were looking for alternative — albeit costlier — remedies.

By early September, orders from seven states — Alabama, Florida, Georgia, Louisiana, Mississippi, Tennessee and Texas — accounted for 70% of total shipments of monoclonals.

Those Southern states, plus three others — Arkansas, Kentucky and North Carolina — ordered new courses of treatment even faster than they used their supplies. From July 28 to Sept. 8, they collectively increased their antibody stockpiles by 134%, according to a KHN analysis of federal data.

Concerned the pattern was both uncontrolled and unsustainable given limited national supplies, officials with the Department of Health and Human Services stepped in to equalize distribution. HHS barred individual sites from placing direct orders for the monoclonals. Instead, they took over distribution, basing allocation on case rates and hospitalizations and centralizing the process through state health departments.

“It was absolutely necessary to make this change to ensure a consistent product for all areas of the country,” Dr. Meredith Chuk, who is leading the allocation, distribution and administration team at HHS, said during a conference call.

But states have been sending most doses of the monoclonal antibody treatments, known as mAbs, to hospitals and acute care centers, sidestepping the pharmacies that serve long-term care sites and depleting supplies for the most vulnerable patients, said Christopher Laxton, executive director of AMDA, the Society for Post-Acute and Long-Term Care Medicine.

While vaccination might provide 90% protection or higher against serious covid in younger, healthier people, that’s not the case for the elders who typically live in nursing homes.

“You have to think of the spectrum of immunity,” Laxton said. “For our residents, it’s closer to 60%. You know that 4 out of 10 are going to have breakthrough infections.”

The mAb treatments have for use in high-risk patients exposed to the virus, and experts in elder care say that is key to best practices in preventing outbreaks in senior facilities. That could include, for example, treating the elderly roommate of an infected nursing home patient. But because of newly limited supplies, many long-term care sites have started to restrict use to only those who are infected.

Still, some states have worked to ensure access to mAbs in long-term care sites. Minnesota health officials that prioritizes residents of skilled nursing facilities for the antibody therapies through a weighted lottery. In Michigan, state Medical Director Dr. William Fales directed emergency medical technicians and paramedics to the Ascension Borgess Hospital system in Kalamazoo to help administer doses during recent outbreaks at two centers.

“The monoclonal antibodies made a huge difference,” said Renee Birchmeier, a nurse practitioner who cares for patients in nine of the system’s sites. “Even the patients in the assisted living with COPD, they’re doing OK,” she said, referring to chronic obstructive pulmonary disease. “They’re not advancing, but they’re doing OK. And they’re alive.”

Long-term care sites have accounted for a fraction of the orders for the monoclonal treatments, first authorized in November 2020. About 3.2 million doses have been distributed to date, with about 52% already used, according to HHS. Only about 13,500 doses have gone to nursing homes this year, according to . That doesn’t include other long-term care sites such as assisted living centers.

The use is low in part because the treatments were originally delivered only through IV infusions. But in June, the Regeneron monoclonal antibody treatment was authorized for use via subcutaneous injections — four separate shots, given in the same sitting — and demand surged.

Use in nursing homes rose to more than 3,200 doses in August and nearly 6,700 in September, federal data shows. But weekly usage dropped sharply from mid-September through early October after the HHS policy change.

Nursing homes and other long-term care sites were seemingly left behind in the new allocation system, said Cristina Crawford, a spokesperson for the American Health Care Association, a nonprofit trade group representing long-term care operators. “We need federal and state public health officials to readjust their priorities and focus on our seniors,” she said.

In an to White House policy adviser Amy Chang, advocates for long-term care pharmacists and providers called for a coordinated federal approach to ensure access to the treatments. Such a plan might reserve use of a certain type or formulation of the product for direct order and use in long-term care settings, said Worz, of the pharmacy group.

So far, neither the HHS nor the White House has responded to the letter, Worz said. Cicely Waters, a spokesperson for HHS, said the agency continues to work with state health departments and other organizations “to help get covid-19 monoclonal antibody products to the areas that need it most.” But she didn’t address whether HHS is considering a specific solution for long-term care sites.

Demand for monoclonal antibody treatments has eased as cases of covid have declined across the U.S. For the week ending Oct. 27, an average of nearly 72,000 daily cases were reported, a decline of about 20% from two weeks prior. Still, there were 2,669 confirmed cases among nursing home residents the week ending Oct. 24, and 392 deaths, according to the .

At least some of those deaths might have been prevented with timely monoclonal antibody therapy, Worz said.

Resolving the access issue will be key to managing outbreaks as the nation wades into another holiday season, said Dr. Rayvelle Stallings, corporate medical officer at PruittHealth, which serves 24,000 patients in 180 locations in the Southeast.

PruittHealth pharmacies have a dozen to two dozen doses of monoclonal antibody treatments in stock, just enough to handle expected breakthrough cases, she said.

“But it’s definitely not enough if we were to have a significant outbreak this winter,” she said. “We would need 40 to 50 doses. If we saw the same or similar surge as we saw in August and September? We would not have enough.”

Phillip Reese, an assistant professor of journalism at California State University-Sacramento, contributed to this report.

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En todo el país, un número creciente de programas de trasplantes ha optado por excluir a los pacientes que se niegan a recibir las ampliamente disponibles vacunas contra covid, o darles una prioridad menor en las abarrotadas listas de espera de órganos. Sin embargo, otros dicen que por ahora no implementarán estas restricciones.

En el centro del debate: si los pacientes de trasplantes que rechazan las vacunas no solo se ponen ellos mismos en mayor riesgo de sufrir una enfermedad grave y la muerte por una infección por covid, sino también desperdician órganos escasos que podrían beneficiar a otros.

El argumento semeja a las demandas de que los fumadores dejen de fumar seis meses antes de recibir un trasplante de pulmón o que los adictos se abstengan de consumir alcohol y drogas antes de recibir nuevos hígados.

“Es un debate en curso”, dijo el doctor Deepali Kumar, experto en enfermedades infecciosas y trasplantes de la Universidad de Toronto y presidente electo de la Sociedad Estadounidense de Trasplantes. “Es realmente una decisión individual del programa. En muchos programas, está cambiando”.

Leilani Lutali, de 56 años, una paciente con enfermedad renal en etapa avanzada de Colorado Springs, Colorado, se enteró en una carta del 28 de septiembre de UCHealth en Denver que si no comenzaba con la serie de vacunas contra covid en 30 días, perdería su lugar en la lista de espera de trasplantes. Tanto ella como su donante vivo, Jaimee Fougner, de 45 años, de Peyton, Colorado, se negaron a vacunarse, citando objeciones religiosas e incertidumbre sobre la seguridad y eficacia de las vacunas.

“Tengo demasiadas preguntas sin respuesta en este momento. Siento que me están obligando a no poder esperar y ver, y a vacunarme si quiero este trasplante que salvará mi vida”, dijo Lutali.

Agregó que ofreció a hacerse la prueba de covid antes de la cirugía o firmar una exención que absolviera al hospital del riesgo legal por su negativa a la vacuna. “¿En qué momento ya no eres partícipe de las decisiones sobre tu propia atención?”, se preguntó Lutali.

Lutali ahora espera buscar un trasplante en Texas, donde varios hospitales, incluidos Houston Methodist y Baylor University Medical Center, en Dallas, dijeron que no requieren vacunas contra covid para aprobar a candidatos activos en la lista de espera nacional.

La diferencia entre las normas en Denver y Dallas, y en otros lugares, remarca una tensa división nacional. A fines de abril, menos del 7% de los programas de trasplantes en todo el país informaron que iban a cambiar el estatus de pacientes que no estaban vacunados contra covid, según de la doctora Krista Lentine, nefróloga de la Escuela de Medicina de la Universidad de Saint Louis.

Pero eso fue solo una instantánea a fines de la primavera y, como todas las prácticas relacionadas con covid, está “cambiando rápidamente”, agregó Lentine.

UCHealth en Denver comenzó a requerir vacunas contra covid para pacientes de transplantes a fines de agosto, citando la recomendación de ese mismo mes de la Sociedad Estadounidense de Trasplantes de que “todos los receptores de trasplantes de órganos sólidos deberían estar vacunados contra el SARS-CoV-2”.

Los pacientes que se someten a un trasplante tienen su sistema inmunológico artificialmente suprimido durante la recuperación, para evitar que sus cuerpos rechacen el nuevo órgano. Eso deja a los pacientes no vacunados en “riesgo extremo” de enfermedad grave por covid si se infectan, con tasas de mortalidad estimadas en 20% a 30%, según el estudio, dijo Dan Weaver, vocero de UCHealth.

Por la misma razón, los pacientes trasplantados que reciben vacunas contra covid después de la cirugía pueden no desarrollar una respuesta inmune fuerte, muestra .

UW Medicine en Seattle comenzó a exigir vacunas contra covid este verano, dijo el doctor Ajit Limaye, director del programa de enfermedades infecciosas de trasplante de órganos sólidos. Los pacientes ya debían cumplir con otros criterios estrictos para ser considerados para un trasplante, incluido recibir vacunas contra varias enfermedades, como la hepatitis B y la influenza.

“Básicamente, la estamos requiriendo para cualquiera que no tenga una contraindicación médica”, dijo. “Hay una idea fuerte para convertirlo en un requisito, como todos los demás”.

Por el contrario, Northwestern Medicine en Chicago, donde los médicos realizaron el primer trasplante doble de pulmón en un paciente con covid en junio de 2020, está alentando la vacunación contra la enfermedad pandémica, pero no es un requisito.

“No rechazamos la atención del trasplante en base al estatus de vacunación”, dijo Jenny Nowatzke, gerenta de relaciones con los medios nacionales de Northwestern. “El paciente tampoco obtiene puntuaciones más bajas”.

La falta de una norma única para todos los programas envía un mensaje contradictorio al público, opinó el doctor Kapilkumar Patel, director del programa de trasplante de pulmón en el Hospital General de Tampa, en Florida, donde no se requieren las vacunas.

“Exigimos vacunas contra la hepatitis y la influenza, y nadie tiene problemas con eso”, dijo. “Y ahora tenemos esta vacuna que puede salvar vidas y tener un impacto en la fase de recuperación posterior al trasplante. Y tenemos este gran alboroto del público”.

Casi 107,000 candidatos esperan órganos en los Estados Unidos; decenas mueren cada día durante la espera. Los centros de trasplantes evalúan qué pacientes pueden ser incluidos en la lista nacional, teniendo en cuenta los criterios médicos, y otros factores como los medios económicos y el apoyo social para garantizar que los órganos de donantes no fallen.

“Realmente hacemos todo tipo de juicios de valor selectivos”, dijo el doctor David Weill, ex director del programa de trasplante de pulmón y corazón-pulmón del Centro Médico de la Universidad de Stanford que ahora trabaja como consultor. “Cuando el comité selecciona, escucho los juicios más subjetivos, basados ​​en valores sobre la vida de las personas. Esto es solo una cosa más”.

Los centros pueden optar por colocar a los candidatos en estado inactivo por una variedad de razones, incluido el incumplimiento médico, según datos de United Network for Organ Sharing (UNOS), que supervisa los trasplantes. Al 30 de septiembre, esa categoría contaba con 738 de los más de 47,000 solicitantes que esperaban en estado inactivo, aunque no está claro cuántos están vinculados al estatus de vacunación.

Una pregunta particularmente espinosa involucra a personas no vacunadas que necesitan trasplantes específicamente porque las infecciones por covid destruyeron sus órganos. A fines de septiembre, más de 200 pulmones, así como al menos seis corazones y dos combinaciones de corazón y pulmón, habían sido trasplantados por razones relacionadas con covid, según datos de UNOS.

Muchos de esos órganos fueron trasplantados al comienzo de la pandemia, antes de que cualquier vacuna estuviera disponible. Ese ya no es el caso, dijo Weill. “Si recién te acabas de vacunarte, en realidad lo has hecho a punta de pistola”, dijo. “No es solo una elección personal; están mostrando su punto de vista”.

Estos pacientes suelen ser más jóvenes y más sanos que otros candidatos a trasplantes, más allá del daño relacionado con covid, y a menudo están lo suficientemente enfermos como para llegar a lo más alto de cualquier lista de trasplantes. “El paciente enfermo con covid podría estar adelante del paciente estable con fibrosis quística”, dijo Weill.

Patel, de Tampa, dijo que realizó un trasplante de pulmón a un paciente que fue trasladado a Florida después de ser excluido de la lista en otro centro porque no estaba vacunado contra covid. “Básicamente le ordené con un apretón de manos que recibiera su vacuna después del trasplante”, dijo Patel. “¿Pero su familia? No han estado de acuerdo”.

Patel piensa que, con el tiempo, todos los programas de trasplantes exigirán la vacunación contra covid, en gran parte porque los centros se evalúan en función de la supervivencia a largo plazo de sus pacientes.

“Creo que se extenderá en todo el país”, dijo. “Si comienzas a perder pacientes en un año por covid, será obligatorio más temprano que tarde.

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Across the country, growing numbers of transplant programs have chosen to either bar patients who refuse to take the widely available covid vaccines from receiving transplants, or give them lower priority on crowded organ waitlists. Other programs, however, say they plan no such restrictions — for now.

At issue is whether transplant patients who refuse the shots are not only putting themselves at greater risk for serious illness and death from a covid infection, but also squandering scarce organs that could benefit others. The argument echoes the demands that smokers quit cigarettes for six months before receiving lung transplants or that addicts refrain from alcohol and drugs before receiving new livers.

“It is a matter of active debate,” said Dr. Deepali Kumar, an expert in transplant infectious diseases at the University of Toronto and president-elect of the American Society of Transplantation. “It’s really an individual program decision. In many programs, it’s in flux.”

Leilani Lutali, 56, a late-stage kidney disease patient from Colorado Springs, Colorado, learned in a Sept. 28 letter from UCHealth in Denver that if she didn’t begin a covid vaccine series within 30 days, she would lose her spot on the transplant waiting list. Both she and her living donor, Jaimee Fougner, 45, of Peyton, Colorado, refused to get vaccinated, citing religious objections and uncertainty about the safety and effectiveness of the vaccines.

“I have too many questions that remain unanswered at this point. I feel like I’m being coerced into not being able to wait and see and that I have to take the shot if I want this lifesaving transplant,” Lutali said.

She said she offered to be tested for covid before the surgery or to sign a waiver absolving the hospital of legal risk for her refusal of the vaccine. “At what point do you no longer become a partner in your own care regardless of your own concerns?” she said.

Lutali now hopes to take her transplant quest to Texas, where several hospitals, including Houston Methodist and Baylor University Medical Center in Dallas, said they don’t require covid vaccinations to approve active candidates for the national waiting list.

The difference between policies in Denver and Dallas — and elsewhere — underscore a tense national divide. As of late April, fewer than 7% of transplant programs nationwide reported inactivating patients who were unvaccinated or partially vaccinated against covid, by Dr. Krista Lentine, a nephrologist at the Saint Louis University School of Medicine.

But that was just a snapshot in late spring, and like all covid-related practices, it’s “rapidly changing,” Lentine said.

UCHealth in Denver began requiring covid vaccinations for transplant patients in late August, citing the American Society of Transplantation’s August recommendation that “all solid organ transplant recipients should be vaccinated against SARS-CoV-2.”

Patients who undergo transplant surgery have their immune systems artificially suppressed during recovery, to keep their bodies from rejecting the new organ. That leaves unvaccinated transplant patients at “extreme risk” of severe illness if they are infected by covid, with mortality rates estimated at 20% to 30%, depending on the study, Dan Weaver, a spokesperson for UCHealth said. For the same reason, transplant patients who receive covid vaccines after surgery may fail to mount a strong immune response,

UW Medicine in Seattle began mandating covid vaccines this summer, said Dr. Ajit Limaye, director of the solid organ transplant infectious diseases program. Patients were already required to meet other stringent criteria to be considered for transplantation, including receiving inoculations against several illnesses, such as hepatitis B and influenza.

“For anyone who does not have a medical contraindication, basically, we’re requiring it,” he said. “There’s a very strong sense to make it a requirement, like all the other hoops, straight up.”

By contrast, Northwestern Medicine in Chicago, where doctors performed the first double-lung transplant on a covid patient in June 2020, is encouraging — but not requiring — vaccination against the pandemic disease.

“We don’t decline care of transplant based on vaccine status,” said Jenny Nowatzke, Northwestern’s manager of national media relations. “The patient also doesn’t get any lower scores.”

The lack of consistent practice across programs sends a mixed message to the public, said Dr. Kapilkumar Patel, director of the lung transplant program at Tampa General Hospital in Florida, where covid vaccines are not required.

“We mandate hepatitis and influenza vaccines, and nobody has an issue with that,” he said. “And now we have this one vaccination that can save lives and make an impact on the post-transplant recovery phase. And we have this huge uproar from the public.”

Nearly are waiting for organs in the U.S.; dozens die each day still waiting. Transplant centers evaluate which patients are allowed to be placed on the national list, taking into account medical criteria and other factors like financial means and social support to ensure that donor organs won’t fail.

“We really make all kinds of selective value judgments,” said Dr. David Weill, former director of Stanford University Medical Center’s lung and heart-lung transplant program who now works as a consultant. “When we’re selecting in the committee room, I hear the most subjective, value-based judgments about people’s lives. This is just another thing.”

The centers can choose to place candidates on inactive status for a variety of reasons, including medical noncompliance, according to data from the United Network for Organ Sharing, which oversees transplants. As of Sept. 30, that category accounted for 738 of more than 47,000 registrants waiting in inactive status, though it’s not clear how many are tied to vaccination status.

A particularly thorny question involves unvaccinated people who need transplants specifically because covid infections destroyed their organs. As of late September, more than 200 lungs, as well as at least six hearts and two heart-lung combinations, had been transplanted for covid-related reasons in the U.S., according to UNOS data.

Many of those organs were transplanted earlier in the pandemic, before any covid vaccine was widely available. That’s no longer the case, Weill said. “If you’re just now getting vaccinated, you’ve done it at gunpoint, actually,” he said. “It’s not just a personal choice; they’re making some kind of a statement.”

Such patients are usually younger and healthier than other transplant candidates, aside from the covid-related damage, and they’re often acutely ill enough to go to the top of any transplant list. “The sick covid patient might go ahead of the stable cystic fibrosis patient,” Weill said.

Tampa General’s Patel said he performed a lung transplant on a patient who was transferred to Florida after being delisted at another center because he wasn’t vaccinated for covid. “I mandated with him basically on a handshake that he will get his vaccine post-transplant,” Patel said. “But his family? They haven’t agreed.”

Eventually, Patel said, he thinks nearly all transplant programs will mandate covid vaccination, largely because transplant centers are evaluated on the longer-term survival of their patients.

“I think it’s going to spread like wildfire across the country,” he said. “If you start losing patients in a year due to covid, it will be mandated sooner rather than later.”

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Cuando su esposo, Joe, de 46, también se enfermó con el virus, realmente se preocupó, especialmente por sus cinco hijos adolescentes: “Pensé, ‘Espero por Dios que no terminemos con ventiladores. ¿Quién va a criar a estos niños?”.

Pero los Kelly, que viven en Seattle, Washington, acordaron justo después de sus diagnósticos unirse a un ensayo clínico en el cercano centro de investigación del cáncer Fred Hutch que es parte de un para probar un tratamiento antiviral que podría detener a covid en una etapa temprana de la infección.

Al día siguiente, la pareja estaba tomando cuatro pastillas, dos veces al día. Aunque no se les dijo si habían recibido un medicamento activo o un placebo, en una semana, dijeron, sus síntomas mejoraron.

En dos semanas, se habían recuperado.

“No sé si recibimos el tratamiento, pero siento que sí”, dijo Miranda Kelly. “Por tener todas estas condiciones subyacentes, sentí que la recuperación fue muy rápida”.

Los Kelly juegan un papel en el desarrollo de lo que podría ser la próxima oportunidad del mundo para frustrar a covid: un régimen a corto plazo de píldoras diarias que pueden combatir el virus temprano después del diagnóstico y, posiblemente, prevenir el desarrollo de síntomas después de la exposición.

“Los antivirales orales no solo tienen el potencial de reducir la duración del síndrome de covid-19, sino también de limitar la transmisión a las personas en el hogar si estás enfermo”, dijo Timothy Sheahan, virólogo de la Universidad de Carolina del Norte-Chapel Hill, quien ha ayudado a promover estas investigaciones.

Los antivirales ya son tratamientos esenciales para otras infecciones virales, incluidas la hepatitis C y el VIH. Una de las más conocidas es Tamiflu, la píldora ampliamente recetada que puede acortar la duración de la gripe y reducir el riesgo de hospitalización si se administra rápidamente.

Estos medicamentos, desarrollados para tratar y prevenir infecciones virales en personas y animales, funcionan de manera diferente según el tipo. Pero pueden diseñarse para estimular el sistema inmunológico para combatir infecciones, bloquear los receptores para que los virus no puedan ingresar a las células sanas o reducir la cantidad de virus activo en el cuerpo.

Se están probando al menos tres antivirales prometedores para covid en ensayos clínicos, y los resultados se esperan para fines del otoño o el invierno, dijo Carl Dieffenbach, director de la División de SIDA del Instituto Nacional de Alergias y Enfermedades Infecciosas, que supervisa el desarrollo de estos fármacos.

“Creo que tendremos respuestas sobre lo que estas píldoras son capaces de hacer en los próximos meses”, dijo Dieffenbach.

El principal contendiente en esta carrera es un medicamento de Merck & Co. y Ridgeback Biotherapeutics llamado molnupiravir, dijo Dieffenbach. Este es el producto que se está probando en el ensayo de los Kelly en Seattle. Otros dos incluyen un candidato de Pfizer, conocido como PF-07321332; y AT-527, un antiviral producido por Roche y Atea Pharmaceuticals.

Actúan interfiriendo con la capacidad del virus para replicarse en las células humanas. En el caso del molnupiravir, la enzima que copia el material genético viral se ve obligada a cometer tantos errores que el virus no puede reproducirse. Eso, a su vez, reduce la carga viral del paciente, acorta el tiempo de infección y previene el tipo de respuesta inmunitaria peligrosa que puede causar una enfermedad grave o la muerte.

Hasta ahora, solo un medicamento antiviral, remdesivir, . Pero se administra por vía intravenosa a pacientes lo suficientemente enfermos como para ser hospitalizados, y no está destinado a un uso temprano y generalizado.

Por el contrario, los nuevos contendientes bajo estudio se pueden empaquetar en forma de píldoras.

Sheahan, quien también realizó un trabajo preclínico sobre remdesivir, dirigió un que mostró que el molnupiravir podría prevenir la enfermedad temprana causada por el SARS-CoV-2, el virus que causa covid. La fórmula fue descubierta en la Universidad de Emory y luego la adquirió Ridgeback y Merck.

Se han realizado ensayos clínicos, incluido la primavera pasada que mostró que el molnupiravir reducía rápidamente los niveles de virus infecciosos. El director ejecutivo de Merck, Robert Davis, dijo este mes que la compañía espera datos de sus ensayos de fase 3 más grandes en las próximas semanas, con el potencial de solicitar la autorización de uso de emergencia de la Administración de Alimentos y Medicamentos (FDA) “antes de fin de año”.

Pfizer lanzó una de su producto el 1 de septiembre, y ejecutivos de Atea dijeron que esperan de fase 2 y 3 a finales de este año.

Si los resultados son positivos y se otorga el uso de emergencia para cualquier producto, dijo Dieffenbach, “la distribución podría comenzar rápidamente”.

Eso significaría que millones de estadounidenses pronto podrían tener acceso a un medicamento de consumo diario por vía oral, idealmente una sola pastilla, que podría tomarse durante cinco a 10 días apenas se confirma la infección por covid.

“Esa es la idea”, dijo el doctor Daniel Griffin, experto en inmunología y enfermedades infecciosas de la Universidad de Columbia. “Tener esto en todo el país, para que la gente lo reciba el mismo día en que recibe el diagnóstico”.

Alguna vez marginados por falta de interés, los antivirales orales para tratar las infecciones por coronavirus ahora son objeto de una feroz competencia y financiación.

En junio, la administración Biden anunció que había acordado obtener alrededor de de Merck, a un costo de $1,2 mil millones, si el producto recibe autorización de emergencia o aprobación total.

El mismo mes, la administración dijo que invertiría en el Programa Antiviral para Pandemias, cuyo objetivo es desarrollar antivirales para la crisis de covid y más allá, dijo Dieffenbach.

La pandemia revitalizó el esfuerzo en la investigación de antivirales. Aunque en 2003 el virus del Síndrome Agudo Respiratorio Severo (SARS) dio un susto a los científicos, seguido por el Síndrome Respiratorio de Oriente Medio (MERS), en 2012, los esfuerzos de investigación se desaceleraron cuando estos brotes no persistieron.

“El impulso comercial para desarrollar cualquier producto simplemente desapareció”, dijo Sheahan.

Los medicamentos antivirales ampliamente disponibles se unirían a las terapias con anticuerpos monoclonales que ya se usan para tratar y prevenir enfermedades graves y hospitalizaciones causadas por covid. Los anticuerpos monoclonales producidos en laboratorio, que imitan la respuesta natural del cuerpo a las infecciones, fueron más fáciles de desarrollar, pero deben administrarse principalmente por vía intravenosa.

El gobierno federal está cubriendo el costo de la mayoría de los productos monoclonales a $2,000 por dosis. Todavía es demasiado pronto para saber el precio de los antivirales.

Al igual que los anticuerpos monoclonales, las píldoras antivirales no sustituyen a la vacunación, dijo Griffin. Serían otra herramienta para luchar contra covid.

Un desafío en el desarrollo rápido de medicamentos antivirales ha sido reclutar suficientes participantes para los ensayos clínicos, que deben reclutar a cientos de personas, explicó la doctora Elizabeth Duke, investigadora asociada de Fred Hutch que supervisa el ensayo de molnupiravir.

Los participantes no deben estar vacunados y deben estar inscritos en el ensayo dentro de los cinco días posteriores a una prueba de covid positiva. Solo en un cualquiera, pasantes hacen 100 llamadas a personas recientemente covid-positivas en el área de Seattle, y la mayoría dice que no.

“En términos generales, hay mucha desconfianza sobre el proceso científico”, dijo Duke. “Algunas personas les dicen cosas desagradables a los pasantes”.

Si las píldoras antivirales resultan efectivas, el próximo desafío será impulsar un sistema de distribución por el que puedan llegar a las personas tan pronto como den positivo para covid. Griffin dijo que se necesitará algo similar al , que aceleró los kits de Tamiflu a 200,000 pacientes en riesgo inscritos en los planes Medicare Advantage de la aseguradora.

Ejecutivos de Merck predijeron que la compañía podría producir para fin de año. Atea y Pfizer no han publicado estimaciones similares.

¿Aún más prometedor? Estudios que evalúan si los antivirales pueden prevenir la infección después de la exposición.

“Piensa en eso”, dijo Duke, quien también supervisa un ensayo profiláctico. “Podrías dárselo a todos en un hogar, o a todos en una escuela. Entonces, ahí sí estaríamos hablando tal vez de un regreso a la vida normal”.

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When her husband, Joe, 46, fell ill with the virus, too, she really got worried, especially about their five teenagers at home: “I thought, ‘I hope to God we don’t wind up on ventilators. We have children. Who’s going to raise these kids?”

But the Kellys, who live in Seattle, had agreed just after their diagnoses to join a clinical trial at the nearby Fred Hutch cancer research center that’s part of an to test an antiviral treatment that could halt covid early in its course.

By the next day, the couple were taking four pills, twice a day. Though they weren’t told whether they had received an active medication or placebo, within a week, they said, their symptoms were better. Within two weeks, they had recovered.

“I don’t know if we got the treatment, but I kind of feel like we did,” Miranda Kelly said. “To have all these underlying conditions, I felt like the recovery was very quick.”

The Kellys have a role in developing what could be the world’s next chance to thwart covid: a short-term regimen of daily pills that can fight the virus early after diagnosis and conceivably prevent symptoms from developing after exposure.

“Oral antivirals have the potential to not only curtail the duration of one’s covid-19 syndrome, but also have the potential to limit transmission to people in your household if you are sick,” said Timothy Sheahan, a virologist at the University of North Carolina-Chapel Hill who has helped pioneer these therapies.

Antivirals are already essential treatments for other viral infections, including hepatitis C and HIV. One of the best known is Tamiflu, the widely prescribed pill that can shorten the duration of influenza and reduce the risk of hospitalization if given quickly.

The medications, developed to treat and prevent viral infections in people and animals, work differently depending on the type. But they can be engineered to boost the immune system to fight infection, block receptors so viruses can’t enter healthy cells, or lower the amount of active virus in the body.

At least three promising antivirals for covid are being tested in clinical trials, with results expected as soon as late fall or winter, said Carl Dieffenbach, director of the Division of AIDS at the National Institute of Allergy and Infectious Diseases, who is overseeing antiviral development.

“I think that we will have answers as to what these pills are capable of within the next several months,” Dieffenbach said.

The top contender is a medication from Merck & Co. and Ridgeback Biotherapeutics called molnupiravir, Dieffenbach said. This is the product being tested in the Kellys’ Seattle trial. Two others include a candidate from Pfizer, known as PF-07321332, and AT-527, an antiviral produced by Roche and Atea Pharmaceuticals.

They work by interfering with the virus’s ability to replicate in human cells. In the case of molnupiravir, the enzyme that copies the viral genetic material is forced to make so many mistakes that the virus can’t reproduce. That, in turn, reduces the patient’s viral load, shortening infection time and preventing the kind of dangerous immune response that can cause serious illness or death.

So far, only one antiviral drug, remdesivir, . But it is given intravenously to patients ill enough to be hospitalized, and is not intended for early, widespread use. By contrast, the top contenders under study can be packaged as pills.

Sheahan, who also performed preclinical work on remdesivir, led an that showed that molnupiravir could prevent early disease caused by SARS-CoV-2, the virus that causes covid. The formula was discovered at Emory University and later acquired by Ridgeback and Merck.

Clinical trials have followed, including an of 202 participants last spring that showed that molnupiravir rapidly reduced the levels of infectious virus. Merck chief executive Robert Davis said this month that the company expects data from its larger phase 3 trials in the coming weeks, with the potential to seek emergency use authorization from the Food and Drug Administration “before year-end.”

Pfizer launched a combined , and Atea officials said they from phase 2 and phase 3 trials later this year.

If the results are positive and emergency use is granted for any product, Dieffenbach said, “distribution could begin quickly.”

That would mean millions of Americans soon could have access to a daily orally administered medication, ideally a single pill, that could be taken for five to 10 days at the first confirmation of covid infection.

“When we get there, that’s the idea,” said Dr. Daniel Griffin, an infectious diseases and immunology expert at Columbia University. “To have this all around the country, so that people get it the same day they get diagnosed.”

Once sidelined for lack of interest, oral antivirals to treat coronavirus infections are now a subject of fierce competition and funding. In June, the Biden it had agreed to obtain about 1.7 million treatment courses of Merck’s molnupiravir, at a cost of $1.2 billion, if the product receives emergency authorization or full approval. The same month, the administration said it in the Antiviral Program for Pandemics, which aims to develop antivirals for the covid crisis and beyond, Dieffenbach said.

The pandemic kick-started a long-neglected effort to develop potent antiviral treatments for coronaviruses, said Sheahan. Though the original SARS virus in 2003 gave scientists a scare — followed by Middle East respiratory syndrome, or MERS, in 2012 — research efforts slowed when those outbreaks did not persist.

“The commercial drive to develop any products just went down the tubes,” said Sheahan.

Widely available antiviral drugs would join the monoclonal antibody therapies already used to treat and prevent serious illness and hospitalizations caused by covid. The lab-produced monoclonal antibodies, which mimic the body’s natural response to infection, were easier to develop but must be given primarily through intravenous infusions.

The federal government is covering the cost of most monoclonal products at $2,000 a dose. It’s still too early to know how the price of antivirals might compare.

Like the monoclonal antibodies, antiviral pills would be no substitute for vaccination, said Griffin. They would be another tool to fight covid. “It’s nice to have another option,” he said.

One challenge in developing antiviral drugs quickly has been recruiting enough participants for the clinical trials, each of which needs to enroll many hundreds of people, said Dr. Elizabeth Duke, a Fred Hutch research associate overseeing its molnupiravir trial.

Participants must be unvaccinated and enrolled in the trial within five days of a positive covid test. Any given day, interns make 100 calls to newly covid-positive people in the Seattle area — and most say no.

“Just generally speaking, there’s a lot of mistrust about the scientific process,” Duke said. “And some of the people are saying kind of nasty things to the interns.”

If the antiviral pills prove effective, the next challenge will be ramping up a distribution system that can rush them to people as soon as they test positive. Griffin said it will take something akin to by UnitedHealthcare, which sped Tamiflu kits to 200,000 at-risk patients enrolled in the insurer’s Medicare Advantage plans.

Merck officials could produce more than 10 million courses of therapy by the end of the year. Atea and Pfizer have not released similar estimates.

Even more promising? Studies evaluating whether antivirals can prevent infection after exposure.

“Think about that,” said Duke, who is also overseeing a prophylactic trial. “You could give it to everyone in a household, or everyone in a school. Then we’re talking about a return to, maybe, normal life.”

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The , led by Democratic Reps. Raja Krishnamoorthi and Katie Porter, focuses on conflicts of interest held by members of a committee currently reviewing a life-or-death matter: U.S. organ donation and distribution policy. A panel member recently resigned after accepting a consulting job that apparently created a conflict of interest. House members are asking NASEM to provide conflict-of-interest disclosure forms for all members of the committee.

Members of Congress want to ensure that reports from the national academies, chartered in 1863 to provide Congress with expert scientific advice, are widely accepted as independent and free from special-interest or financial influence.

Starting Sept. 7, NASEM is requiring committee members to disclose relevant financial relationships for the past five years, going beyond its recent policy of asking for details about current conflicts, spokesperson Dana Korsen said.

The institution conflict-of-interest policies are meant to protect it from “a situation where others could reasonably question, and perhaps discount or dismiss, the work of the committee simply because of the existence of such conflicting interests.”

This summer, the national academies declined to provide KHN with conflict-of-interest forms completed by committee members studying the packaging of liquid drugs, which often go to waste ― along with millions of taxpayer dollars paid to pharmaceutical firms for them. The final report declared conflicts for two members, but not for two others who had extensive and recent financial ties to drug companies. At that time, the organization said those committee members had no “current” conflicts while they drafted the report, mostly in 2020.

A review of public records showed that one member reported for medical journals in 2021 and 2020 that he had consulted for a dozen pharmaceutical firms. Another member had been paid about $1.4 million as a pharmaceutical company board member in 2019, according to a Securities and Exchange Commission filing. Both told KHN they had fully reported their financial relationships to the national academies.

In addition, NASEM itself had disclosed in obscure treasurer that pharmaceutical companies ― many with a direct interest in drug-waste policy ― had given the nonprofit organization at least $10 million in donations since 2015.

The final NASEM drug-waste in February concluded that drug companies should not refund taxpayers for the cost of wasted medications packaged in “-sized” vials that contain more drugs than can be used. What’s more, Medicare should not track the cost of the wasted drugs, the report concluded.

On Friday, on the resignation of a former organ transplant doctor from a NASEM committee reviewing organ transplant policies. Dr. Yolanda Becker resigned from the organ donation committee after the Post asked her and NASEM questions about a possible conflict of interest.

Becker’s resignation comes amid continued scrutiny of the U.S. organ transplant system, which is overseen by the United Network for Organ Sharing, or UNOS, a nonprofit federal contractor.Ìý

Critics, including members of Congress, have questioned the performance of many of the nation’s 57 organ procurement organizations, or OPOs, which hold federal charters that guarantee their monopolies to collect and distribute organs in specific geographic areas of the United States.

“The organ transplant industry has long been a haven for fraud, waste, and abuse,” Rep. Porter said in a statement to KHN. “I’m grateful NASEM is also working to hold OPOs accountable, but I’m concerned that potential conflicts of interest could cloud their judgement.”

Jennifer Erickson, a senior fellow and director of the organs initiative at the nonpartisan Federation of American Scientists, raised questions about conflicts of interest with NASEM during a

“Disclosure is critical. The public deserves to know about conflicts of interest and undisclosed payments,” she said. “A good start would be for all members of this committee to publicly disclose their business relationships related to organ contractors, [organ] tissue businesses and trade associations so that the public can be aware.”

The Trump administration in an effort to boost the numbers of organs transplanted by OPOs by more than 7,000 a year. Nearly 107,000 people in the United States are awaiting organs, and dozens die each day for lack of a transplant. About 39,000 organs were transplanted from donors in the U.S. last year.

In May, chaired by Krishnamoorthi held a hearing on problems in the organ transplant system, including issues revealed by reporting from KHN and Reveal that found that donated organs ― mostly kidneys ― are repeatedly lost or damaged when shipped via commercial flights. From 2014 to 2019, nearly 170 organs failed to be transplanted and almost 370 endured “near misses” with delays of two hours or more, jeopardizing their usefulness for ailing patients.

Reps. Krishnamoorthi and Porter have asked NASEM to provide them with an explanation of whether it plans to disclose any committee conflicts in the forthcoming organ report. They also requested any record of donations to NASEM from organ procurement organizations or related businesses or associations.

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At 63, McGee undergoes dialysis sessions three times each week at a Northwest Kidney Centers site near her Burien, Washington, home to rid her blood of waste and water. She has endured the placement of more than a dozen ports, or access sites, in her arms and chest as sites became scarred and unusable. Late last month, doctors performed surgery to install yet another port near her left elbow, but no one is certain it will hold.

“Because of scar tissue, I was told this is my last viable access,” she said.

Without ongoing dialysis, McGee knows she could face death within days or weeks. But, unlike many of the U.S. patients who require dialysis, McGee said she’s had help making peace with the process.

“I know that things are coming,” she said. “I’m in awe of death, but I’m not afraid of it anymore.”

That’s largely attributed to a novel effort in Washington state that embeds palliative care within a kidney center whose clinics treat patients living with kidney disease; and then later pair dying patients with hospice care without forcing them to forgo the comfort that dialysis may still provide.

Traditional hospice services require kidney patients to abandon dialysis, a decision that hastens death, and almost inevitably comes with acute symptoms, including muscle spasms and nausea.

McGee is one of 400 patients enrolled since 2019 in a first-in-the-nation palliative care program housed at Northwest Kidney Centers, a Seattle-based operation with clinics throughout the region. The organization founded the first dialysis center in the U.S. — and the world — nearly 50 years ago.

Chronic kidney disease, or CKD, encompasses five stages, from mild damage in the organs’ functioning in stage 1 to complete kidney failure in stage 5. Most patients start preparing for dialysis — and kidney failure — in stage 4. Dialysis does not cure kidney failure. The only other option for treatment is an organ transplant.

Dialysis patients typically face distressing physical, emotional and spiritual symptoms throughout their treatment, ranging from pain, shortness of breath and intense itching to depression and panic. The symptoms can grow dire as years pass.

But only a fraction of those patients, , ever receive specialized palliative care that can effectively target those issues, said Dr. Daniel Lam, the University of Washington nephrologist and palliative care expert who launched the program with the help of a two-year, $180,000 grant from the Cambia Health Foundation. Attention to palliative care in nephrology has lagged behind its use for advanced cancer, for instance.

That’s especially true for Black patients and other minorities, who are disproportionately more likely than white patients to require dialysis, but far less likely to receive quality palliative or end-of-life care.

“We’re trying to address this current and projected gap,” Lam said. “What we are doing is asking people how do they want to live their lives and what’s most important to them.”

If McGee’s condition deteriorates to the point that she has a prognosis of six months or less to live, she will then be a candidate for a related partnership between the kidney center and the nonprofit which would allow her to continue to receive dialysis even after hospice care begins.

While the goal of both hospice and palliative care is pain and symptom relief, hospice has traditionally been regarded as comfort care without the intent to treat or cure the primary disease. The nuance with dialysis is that it is central to keeping a kidney patient’s body functioning; discontinuing it abruptly results in death within days.

“The goal of this program is to provide kind of a smooth off-ramp from curative dialysis to the end of their lives,” said Mackenzie “Mack” Daniek, who co-directs the hospice.

Most dialysis patients face a harrowing choice between continuing dialysis or receiving hospice services. That’s because the , which took effect in 1983, provides palliative care and support for terminally ill patients who have six months or less to live — and who agree to forgo curative or life-prolonging care.

That rigid requirement could change in the future. The Centers for Medicare & Medicaid Services has approved an that will allow concurrent care for some patients starting next year. But, for now, Medicare will not simultaneously pay for dialysis and hospice care for patients with a terminal diagnosis of kidney failure.

Hospices receive a daily per-patient rate from Medicare, typically $200 or less, and must use it to cover all services related to the terminal diagnosis. Dialysis can easily cost $250 a session, which means only the largest hospices, those with 500 or more patients, can absorb the costs of providing concurrent care. Only hospices in the U.S. meet that mark.

The result? About receive hospice care, compared with about half of the general Medicare population. And their median time spent in hospice care is about five days compared with more than 17 days for the general population. This means that dialysis patients often receive aggressive medical treatment until the very end of life, missing out on the comfort of targeted end-of-life care.

“What’s happened through the years is when a dialysis patient is ready to stop treatment, that’s when they come to hospice,” said Dr. Keith Lagnese, chief medical officer of the University of Pittsburgh Medical Center Family Hospice. “They’re forced to draw that line in the sand. Like many things in life, it’s not easy to do.”

Lagnese said the Seattle program is among the first in the U.S. to address palliative and hospice care among dialysis patients. His UPMC program, which has experimented with concurrent care, allows patients up to 10 dialysis treatments after they enter hospice care.

In the Washington state program, there’s no limit on the number of sessions a patient can receive. That helps ease the patient into the new arrangement, instead of abruptly halting the treatment they’ve been receiving, often for years.

“If they’re faced with immediately stopping, they feel like they’re falling off of a cliff,” said Lam, the program’s founder.

In McGee’s case, she’s had the benefit of palliative care for three years to help negotiate the daily struggles that come with dialysis. The care focuses on relieving the physical side effects, and emotional symptoms such as depression and anxiety. It also addresses spiritual needs, which McGee said has helped augment the comfort she finds as a member of the Baha’i religious faith.

“They provide mental support, and they inform you what you need to do to do things properly, and they’re your liaisons,” McGee said. “Basically, I was just living before without knowing the information.”

When she considers her degenerating medical condition and the possibility that it will become too difficult, even impossible, to continue dialysis long term, she said she welcomes the option to ease into the final stage of her life.

“Do I feel scared? At one point, I did,” McGee said. “But they are assuring me that my rights will be honored, they will be advocates for me when it happens. By having that support, it gives me my time to live.”

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