Americans who contract the coronaviruses may be able to purchase an effective treatment at their neighborhood pharmacy before the end of the year.
The FDA is currently reviewing two new antiviral pills that have shown promise in preventing hospitalizations and deaths in people at high risk for severe Covid-19.
Emergency authorization could be given to one of the drugs developed by the pharmaceutical company. Pfizer is likely to be close behind.
The drugs are not a replacement for vaccination, but they could greatly expand access to treatments for a disease that is still killing 1,000 Americans a day.
The pills are designed to be taken as soon as possible after symptoms appear. The United States has struggled to achieve timely, accurate Covid testing since the beginning of the Pandemic. In the summer and fall of 2020, getting tested for the virus requires an hourslong wait in line, followed by a weeklong wait for results.
The supply of new drugs is likely to be limited initially. It is expected that the company will be able to provide enough of its drug to treat 3 million Americans before February.
America's shaky testing infrastructure could be put to the test by the new antivirals. The communities that have been hardest hit by Covid will need to have quick, affordable virus tests.
David Boulware, an infectious disease specialist at the University of Minnesota, said that people have to want to be tested. Can that happen?
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A patient in Alaska received therapy.
The most effective treatments for Covid in the U.S. are monoclonal antibody drugs, which bind to the virus and stop it from infecting cells. These treatments are usually administered by health care workers. Logistical challenges can be posed by this, for hospitals and for patients, who may not be able to get to clinics or infusion sites.
The new drugs are different. The senior medical director of infection prevention and control for UCHealth, a health care system in Colorado said that you could pick up your prescription and go home.
The treatments that involve taking 30 or 40 pills over the course of five days should be given early in the course of the disease.
When given within the first five days of symptoms, Pfizer's regimen reduced the risk of hospitalization and death by 89 percent, while the regimen from Merck reduced the risk by 30 percent.
People will need to act quickly if they want to duplicate these results in the real world.
When people start to have mild symptoms, they think it might be Covid-19, and they should get a test, according to an expert on public health policy at Brown University. We have to have access to tests that are affordable. People need to get their test results back quickly.
She said that all of this needs to happen in a few days.
It is not clear if patients will have to take a Covid test before they are prescribed drugs. Regulators in Britain specified only a positive test for the disease.
Most experts expected the U.S. regulators to give the same flexibility, allowing the pills to be prescribed after a positive result on either a P.C.R. test, a laboratory-based diagnostic, or a rapid antigen test.
Both kinds of tests have challenges. The biggest concern for P.C.R. tests is time. Some labs can return P.C.R. results in a day, but others take a long time.
It's not uncommon for people to have wait times of five days. Even if they got tested the moment they first felt symptoms, that delay alone could put patients at the edge of the prescription window.
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molnupiravir is a new medication from the company,Merck & Co.
Rapid antigen tests, which can return results in about 15 minutes, are likely to be an important part of getting the new pills to patients.
She accepted photos of positive at- home test results as proof of infections when she prescribed monoclonal antibodies. The idea is to keep people out of the hospital.
People who are early in the course of their infections are more prone to false negatives. Taking two tests a day or two apart can reduce the chances of missing an active infection in people who have symptoms.
The stakes of a missed diagnosis are raised by the use of the antiviral pills, according to a clinical microbiologist at the University of Southern California. She said that it wasn't just knowing her status. It is now like, "Oh, this result could get me this really life-saving medication."
When the virus becomes less prevalent, the errors that are prone to false positives will become more of a concern. Two million test kits were recalled by Ellume due to concerns about higher than expected false positives.
Asking patients to take a second confirmatory test, especially one conducted by a medical professional, could cut down on both test and user errors, but would take up more time and may not be feasible at the moment. I don't know if we have the scale to do that right now.
Finding rapid antigen tests is likely to be the biggest challenge in the near term.
You can get a box of seven tests for free in the United Kingdom. If you want to get the tests in stock at Walmart, you have to refresh the website.
Experts said the supply crunch could be easing soon. Several steps have been taken by the Biden administration to increase availability.
The production capacity from both the big players, like Abbott andQuidel, as well as some of the newer smaller players are all hitting the ramp up phase at this point.
The rising case numbers and holiday get-togethers are fueling a surge in demand, and the supply of at- home tests remains unpredictable. The availability is still a little bit in fits and starts, according to a testing expert.
Dr. Gronvall was in her car looking for rapid antigen tests after some of her son's friends tested positive for the virus. She said that the first place didn't have any and that she was about to try a second.
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The Covid-19 tests are on sale. For a pack of two, the tests can be had for $24.
The tests are not affordable for everyone. For a pack of two, the Abbott BinaxNOW costs between 14 and 24.
Although experts expect prices to come down as more companies have their tests authorized, that may not happen this winter.
If there is a lot of demand and little supply, there won't be much incentive to bring the price down.
The Covid pills are more accessible than the monoclonal antibodies, but they may not be available to Americans who cannot afford to purchase their own tests or travel to a free testing site.
Dr. Barron is concerned that certain communities will not have access to the testing and therefore will not have access to the drug.
She said that people who can't afford to miss work or stay home with a sick child may be hesitant to seek testing.
The success of the drugs would depend on early testing and diagnosis, as experts agreed that a robust messaging campaign was needed to ensure that people know that treatments are available.
The U.S. health care system has been able to pair amazing discoveries in technology with mediocre deployment strategies in terms of access and affordability.
It has been clear for a long time that Covid's toll was not equal. Black and Latino Americans have been more likely to die from the virus than white Americans, and low-income workers have been at high risk of catching it.
The antiviral pills can either reduce or reinforce the inequalities that we have seen in severe Covid outcomes, depending on how well officials address barriers to access.
