https://news.yahoo.com/monoclonal-antibodies-free-effective-against-152854132.html?fr=sycsrp_catchall
When Mike Burton came down with a breakthrough case of covid-19 earlier this month, the infection posed a double threat to his family. At 73, the retired surgeon faced elevated risk of serious illness. His wife, Linda, has a suppressed immune system, the result of drugs she takes after two liver transplants that put her in greater danger of life-threatening illness.
The Burtons, both vaccinated, moved to separate parts of their Mt. Sterling, Ky., home, masked up and hoped for the best.
Then a friend called and insisted they ask their doctors about monoclonal antibodies - an effective, widely available covid-19 therapy that few people are receiving.
Related video: How doctors hope antibodies can help fight coronavirus
The drugs often prevent severe disease, keeping people like Mike Burton out of the hospital if taken within seven to 10 days after symptoms begin. And since last month, they can be given prophylactically to millions of people like Linda Burton who have been exposed to the coronavirus and are at high risk of serious consequences.
"That was all news [to me], when my friend Rita called," said Linda Burton, a retired nurse. "I want everybody to know about this. I'm telling people that I know that are older. I'm saying 'if you get exposed, you need to talk to your doctor about it.'"
Monoclonal antibodies are free to patients and there have been almost no side effects. They are accessible on an outpatient basis, via a single infusion or four injections. Hospitals, urgent care centers and even private doctors are authorized to dispense them.
But Regeneron Pharmaceuticals, maker of the only authorized, free monoclonal antibodies, said it is reaching fewer than 30% of eligible patients, up from fewer than 5% a month ago.
The White House COVID-19 Response Team reported last week that just more than 600,000 people have received the treatment since Regeneron and Eli Lilly received approval for separate versions in November. (Lilly's product is no longer authorized because it is not effective against the delta variant.)
"We have a long way to go on how do we reach the general public where they are," said Erin McCreary, director of stewardship innovation at the University of Pittsburgh Medical Center, which has treated 3,427 patients with the drugs since Dec. 9.
"It is absolutely the standard of care for covid-19," she said. "It is my hope that clinics know that."
In interviews, experts cited a federal government that has not done enough to promote monoclonal antibodies alongside vaccines; logistical issues that can make delivery of the drugs complicated and costly for medical facilities; and the difficulties the pandemic presents for providers of all kinds of medical care.
"Momentum is a tough thing to get going and I'm glad it's starting to," said Jason C. Gallagher, clinical professor of pharmacy practice and infectious diseases at Temple University School of Pharmacy. "But it still needs to be improved."
Earlier in the pandemic, neither the National Institutes of Health nor the Infectious Diseases Society of America included monoclonal antibodies in treatment guidelines they released for covid-19, said Alexandra Bowie, a spokesperson for Regeneron.
"Awareness was kind of low among physicians for a long time," she said.
It has been boosted this month by Florida Gov. Ron DeSantis, R, who last week vowed to expand provision of the antibodies as the virus tears through his state and Texas Gov. Greg Abbott, R, who tested positive for covid Tuesday and is being treated with monoclonals. Both governors have resisted coronavirus restrictions and worked to thwart mask or vaccine mandates.
And last year, former president Donald Trump received Regeneron's medication when he was infected with the virus, before the treatment was available to the public. Trump, who was given the drug in early October under a "compassionate use" program that allows people to receive unapproved drugs, later credited it for his recovery, inaccurately calling it a cure.
James Hildreth, president and CEO of Meharry Medical College in Nashville, Tenn., said access to monoclonal antibodies has been an issue for many people in vulnerable communities hit hardest by the pandemic - one of the reasons he found use of the treatment by Abbott unjust.
"Joe Smith, working guy, or Mary Jane, who might be vaccinated against covid, they don't have that same access," he said.
Mike Burton, the Kentucky surgeon, experienced a turnaround after he received his infusion of monoclonal antibodies last week. He went to bed that night still plagued by fever, chills, a bad cough, clogged sinuses and fatigue. He woke up the next morning without any of the symptoms except fatigue and a milder cough, Linda Burton said. She did not become infected.
It's impossible to know how Burton might have fared without the drug, but his wife credits it and prayer for their protection. "I just knew I didn't want to get sick like he got sick," she said. "I would've gotten sicker and I would not have recovered as well."
The antibodies mimic the body's own immune response to the coronavirus, moving quickly into action while the natural response is gearing up. The Regeneron product is authorized for people 12 and over with mild to moderate covid-19 who are not hospitalized and don't need supplemental oxygen.
The treatment is effective within ten days after symptoms appear, according to the Food and Drug Administration, which is why it's critical that people seek treatment as soon as they receive a positive test result. Some medical centers are reaching out to anyone who tests positive to inform them of the treatment's availability.
Regeneron's drug is a cocktail of two monoclonal antibodies, casirivimab and imdevimab. Research that has not yet been peer reviewed shows it reduced the chances of hospitalization and death by 70% and shortened the duration of symptoms by four days.
Last month, the FDA also approved it as a prophylactic medication for people who are unvaccinated or not fully vaccinated, have been exposed to the virus and are at higher risk for complications. That population includes millions of people, among them immunocompromised patients like Linda Burton, but also anyone older than 65 or with a body mass index of 25 or greater.
A study showed the medication reduced the risk of developing a symptomatic infection from an infected household contact by 81%.
The U.S. Department of Health and Human Services bought the first 300,000 doses of Regeneron's product for $1,500 per dose in July 2020, then added another 1.25 million at $2,100 per dose. It provides the medication free, but medical centers can charge to cover their costs of administering it. Those costs are covered by Medicaid, Medicare and private insurance.
Until recently, very few people were receiving it. Through the week of July 19, an average of less than 25,000 doses per week were being shipped, Bowie said. But that has jumped to more than 125,000 doses delivered the week of Aug. 9, she said, as states respond to the spread of the delta variant of the virus.
HHS data shows that 1.3 million doses have been shipped and 637,000 used. Most have gone to states where the virus is surging, including Florida, Texas, Louisiana and Arkansas.
Another single monoclonal antibody, sotrovimab, made by GlaxoSmithKline and Vir Biotechnology, was given emergency use authorization in May. It is not free to patients, with a wholesale acquisition cost of $2,100 per dose. But a spokeswoman said the company has experienced a nearly 300% increase in orders between July and August.
"The monoclonal antibodies work. They are safe, they're free, they keep people out of the hospital, and help keep them alive," Marcella Nunez-Smith, chair of the government's COVID-19 Health Equity Task Force, said at a briefing Aug. 12.
Her statement marked one of the few times since the Biden administration took office that the antibodies have been promoted by the response team. A review of its 52 briefings or news conferences shows they were discussed mostly when Anthony S. Fauci, the team's infectious-disease specialist, offered a research update.
"For the administration, mum's the word on monoclonal antibodies, rapid home tests, high quality masks . . . anything except vaccines," Eric Topol, founder and director of the Scripps Research Translational Institute, said in an email. "Which is wrong, since we need every tool in the kit to effectively take on delta; we're not doing that well at all."
An HHS spokeswoman said the agency has worked hard this year to expand access to the therapy, helping cities across the United States set up treatment centers. Weekly calls with state and territorial health officials include distribution of covid-19 therapies and a web site has been established to help consumers find the treatments, she said. The agency also has purchased ads and released information about the treatment on satellite radio, she said.
But on the ground, the effort to stand up a nationwide program has run into obstacles.
"The government sends drugs, but it doesn't send nurses," said McCreary, the University of Pittsburgh official. The medical center had to supply intravenous lines, crash carts, transportation and rescue medications. After dripping the medicine into a patient, which takes about half an hour, medical personnel must watch for another hour to ensure there is no serious reaction such as difficulty breathing. Private doctors generally do not have the capacity to do that, she said.
"None of those things are sent and none of those things are free," McCreary said. "So you have to invest in the infrastructure."
Monoclonals "are logistically difficult to get to people," said Gallagher, the Temple pharmacist. People with mild to moderate symptoms may not seek a coronavirus test for days, he said. After a positive test, they usually talk to their primary care provider, who refers them to an infusion center or hospital. By the time they get to one, the window of effectiveness may be closing, he said.
At Intermountain Healthcare in Salt Lake City, few patients want an injection in each limb or four in their abdomen, said Brandon Webb, chair of the health system's covid therapeutics committee. The subcutaneous injections have proved most useful in congregate settings such as nursing homes where health care workers offer the therapy to many people at once, he said.
The health center is also focusing on treatment rather than prophylaxis. For every seven patients offered the treatment, an average of one hospitalization is prevented, the hospital's data show. But giving the drug prophylactically prevents only one hospitalization in 100 patients, he said.
Still, the HHS is working hard to increase access, expanding the number of sites it supports from 800 in June to about 2,000 now. The drugs have been shipped to 6,288 sites during the pandemic, the department's data show.
Even with increased use, "access is still uneven and way below the number of people who could potentially benefit" from the drugs, said Mark McClellan, a former FDA commissioner and director of the Duke-Margolis Center for Health Policy.
The Biden administration has taken "some very important steps but there is still a big gap, an opportunity to get more people treated and get control of the pandemic, especially with hospitals getting full in many parts of the country," he said.
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