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People at considerable risk of developing severe Covid-19, including millions of Americans with weakened immune systems, now have the option of receiving preventive treatment with monoclonal antibodies if they have been or are at risk of being exposed to it. coronavirus.
Food and Drug Administration action on Friday brings hope to an estimated 3% of immunocompromised Americans, including those with autoimmune diseases, HIV patients, cancer patients and transplant recipients organs, which may still be vulnerable to Covid even after being fully immunized.
This is the first time that an injectable anti-coronavirus antibody treatment has been approved for use in the prevention of Covid after a person has been exposed to the virus.
Dr Myron Cohen, a leading coronavirus antibody researcher at the University of North Carolina at Chapel Hill and one of the researchers behind the study of REGEN-COV as a prevention, said the monoclonal antibodies protect against serious illness by crushing the coronavirus infection while it is still mostly in the nose and throat.
“It’s a race between your ability to make an antibody to protect your lungs and the rest of your body and the virus,” he said. “And if you are likely to lose the race, then you are the person for whom these antibody drugs are appropriate.”
However, the FDA said in its statement issuing the emergency extended clearance that monoclonal antibodies should not be considered a vaccine substitute. The agency urged all who are eligible to get vaccinated.
“It is good to know that for people who do not respond well to vaccines, including those who do not produce antibodies, we can now protect them against infection with SARS-CoV-2 by giving them antibodies. after exposure, ”said Dr. Ghady Haidar, an infectious disease transplant physician at the University of Pittsburgh Medical Center.
Haidar is the author of a recent prepublication that found that many people with cancer, organ transplants and autoimmune diseases do not produce antibodies against the coronavirus after receiving a Covid vaccine. Although the Pittsburgh study was not peer reviewed, there is growing evidence that people with weakened immune systems may not be protected after vaccination.
Monoclonal antibody treatments can help prevent serious illness, hospitalizations and death. But the use of the drugs has remained limited as they usually have to be given by IV infusion and must be given within 10 days of the onset of symptoms of Covid.
With expanded FDA clearance, Regeneron antibody cocktail can be administered by injection. The first dose should be administered wwithin 96 hours of exposure.
The expanded FDA clearance was based on the results of a large clinical trial of the Regeneron cocktail, which contains the monoclonal antibodies casirivimab and imdevimab. The participants, who lived in the United States, Romania and Moldova, were family contacts of people who had tested positive for the coronavirus in the previous four days. They were randomly divided into two groups: one received a single injection under the skin of the Regeneron cocktail, and the other a placebo.
Of the 1,505 participants who initially tested negative for the coronavirus, 7.8% of those who received the antibody injection developed symptoms of Covid within four weeks, compared to only 1.5% of the placebo group , an 81% reduction in risk. For people who have developed symptoms, the antibodies have helped them clear the coronavirus faster and reduce the duration of their symptoms.
Of the 204 participants who were infected with the coronavirus but had no symptoms when they entered the study, the antibody injection reduced their risk of developing symptoms of Covid by 32% over the next four weeks. .
No one who received the antibody injections ended up in the emergency room or was hospitalized, compared to 10 people who received the placebo.
There were only a few immunocompromised people in the study. Nonetheless, the FDA has identified members of this demographic as candidates for preventive treatment. Others include people at high risk of exposure to infected people at work or in nursing homes or prisons. People who are expected to have continuous exposure to the virus from close contacts may receive repeated doses of the antibody cocktail on a monthly basis.
The cost of the Regeneron treatment is covered by the federal government, according to a company spokesperson.
According to FDA clearance, individuals must be unvaccinated or immunocompromised, at high risk for severe Covid, and must have been in close contact with someone who tested positive to receive preventive treatment.
Dr. Katharine Bar, an infectious disease specialist at the University of Pennsylvania, said FDA clearance for prevention is reassuring for people at high risk for serious illness.
“The best defense against current infection rates is to vaccinate as many people as possible,” said Bar, who was also the author of the Regeneron preventative treatment. “But these very effective treatment options for early infections and their contacts also play a role.”
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