Within a few weeks, perhaps before many Americans finish decorating for the holidays, the U.S. could have access to a new antiviral pill from Merck expected to alter the deadly trajectory of the covid-19 pandemic — with a second option from Pfizer to follow shortly after.
Both pills are now under federal review and being praised by infectious-disease physicians who are not prone to using 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 require either 30 or 40 pills over five days. They have been shown to dramatically reduce hospitalizations as well as prevent deaths in adults with mild-to-moderate covid who are at high risk of severe disease due to age or other 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 released lastMonth, the drug was shown to reduce hospitalizations by approximately 50% and prevent deaths entirely. The federal Food and Drug Administration will consider the proposal on November 30. Officials at Pfizer who requested FDA emergency authorization for their drug on Nov. 16Paxlovid claimed that the risk of death and hospitalizations was cut by 89%. Both drugs work by stopping the covidvirus from reproducing, although they act at different points.
However, these promising results assume that the drugs can be administered within the timeframe used in the trials. This is a challenge when it comes to administering antiviral treatment to actual patients. Similar drugs can be used to prevent serious complications from influenza if they are given early. research showsOnly 40% of high-risk patients fell ill during the five most recent flu seasons. They sought medical attention within three days.
“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 seek early care, access has been very variable to covid screening since the outbreak. 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.
The gold standard for detecting SARS-CoV-2 is PCR. Patients may need to schedule appointments at urgent care centers or medical offices. They can also require PCR (or polymerase chain reaction) tests. Results can take days to get. Some medical providers are reluctant to trust rapid antigen tests, which are quicker but less accurate. You can also use over-the-counter tests at home to get results quickly, but these tests are not reliable. hard to find in storesThese treatments are still very 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 improve following a push by the Biden administration to invest $3B in rapid testing. including $650 millionRapid testing requires rapid production capacity. It could take several months before the change becomes 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 a weekly newsletterMonitoring national testing capacity.
Even though it will be difficult to get tested, getting the antiviral drug doses is expected to be easier, at least for the first time. The federal government agreed to buy approximately 3.1 million molnupiravir courses for $2.2billion, which is roughly $700 per course. Biden’s administration will announce a deal to pay $5B for 10,000,000 courses of Pfizer drug. It will cost approximately $500 per treatment course. according to The Washington Post.
The federal government would distribute drugs at no cost to patients and states. 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.
Piercey stated that Tennessee would receive only 2,000 patient courses if 100,000 Merck drug courses are available by Dec. 6. This is despite the fact that the state reports more than 1,200 new cases per week. Deciding which sick patients receive those scarce supplies will be “an educated stab in the dark,” Piercey said.
Officials at the U.S. Department of Health and Human Services stated that the antiviral treatment will be distributed through the U.S. Department of Health and Human Services. same state-based systemMonoclonal antibody treatments can be adopted. The lab-made molecules are administered via IV infusion or injection and mimic human antibodies. They fight the covid virus and reduce the chance of severe disease and even death. After a covid epidemic in Southern states, where vaccination rates were low, federal officials took control of distribution in September. 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 are cheaper than monoclonal antibody treatment, which can cost hundreds of dollars per dose and cost the government approximately $1,250 per dosage. The pills are easier to use and pharmacies will likely be allowed to order them and dispense them at home.
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.
There are still questions about the safety of certain drugs in certain populations. Merck’s molnupiravir works by causing mutations that prevent the virus from reproducing. Webb indicated that interactions between other drugs, including over-the-counter or prescription supplements, could occur with the Pfizer treatment. It includes Paxlovid, a low-dose of ritonavir, an HIV-antiretroviral.
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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