The ‘game-changing’ Covid pill may soon launch in the US, but its success will depend on rapid testing

news7g11/24/2021

3 5 minutes read

The 'game-changing' Covid pill may soon launch in the US, but its success will depend on rapid testing

Currently under federal review, both drugs are hailed by infectious disease physicians as not being superlatives.

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

New regimens, which require 30 or 40 tablets to be taken by mouth for 5 days, have been shown to significantly reduce hospital admissions and prevent death in adults with mild to moderate tubal obstruction who have risk of serious illness due to age or underlying medical conditions. But experts say the success of the treatments will depend on one element of uncertainty: whether patients at high risk for fallopian tube infections can be tested – and then treated. value – fast enough to make a difference or not.

“Early, accessible testing and access to results in a time frame that allows us to make real decisions will be key for these drugs,” said Dr Erica Johnson, chair of the Infectious Diseases Council. of the American Board of Internal Medicine. Medicine. “It drives our public health strategy to deliver these things.”

In clinical trials, molnupiravir, an antiviral drug developed by Merck & Co. and Ridgeback Biotherapeutics, administered to unvaccinated, high-risk adult patients within five days of their first symptoms of tubal occlusion. Pfizer’s product, Paxlovid, was tested on similar patients as early as three days – just 72 hours – after symptoms appeared.

The FDA will soon decide on Merck's Covid-19 antiviral drug. It shows promise, but also concerns

Results from the Merck test, released last month, showed that the drug reduced the risk of hospitalization by about 50% and completely prevented all deaths. It will be reviewed by an advisory panel to the federal Food and Drug Administration on Nov. 30. Pfizer officials, who requested FDA emergency authorization for their drug on November 16, Paxlovid reported an 89% reduction in the risk of hospitalization and death. Both drugs work by interfering with the way the covid virus reproduces, although they do so at different points in the process.

But those promising results assume the drug can be given over the narrow timescales used in the trials, a proven challenge when it comes to antiviral treatment of actual patients. Similar medicines can prevent serious consequences from the flu if taken early, but from research found that only about 40% of high-risk patients during the last five flu seasons received medical care within three days of becoming ill.

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

Even as patients seek care early, access to covid testing has varied greatly since the start of the pandemic. US testing capacity continues to be hampered by a host of issues, including supply chain bottlenecks, staffing shortages, spikes in demand, and results that can take hours – or longer.

Pfizer seeks FDA emergency use authorization for its experimental Covid-19 antiviral drug

PCR, or polymerase chain reaction testing, the gold standard for SARS-CoV-2 detection, may require scheduled appointments at a medical office or urgent care center, and patients often wait a long time. days for results. Rapid antigen tests are faster but less accurate, and some healthcare providers are hesitant to rely on them. Over-the-counter tests can be used at home for quick results but Hard to find in stores and still expensive. And it remains unclear how those results will be validated and whether they will be accepted as a rationale for treatment.

“Get ready,” Griffin said. “You don’t want to call someone four days later to say, ‘Oh, you’re out the window now,’ and the effectiveness of this oral drug has been lost because we had problems getting results. there.”

The situation is expected to improve after the Biden administration pushes to invest $3 billion in rapid testing, including $650 million to increase production capacity for rapid tests. But it may take several months before the change is apparent.

“The supply is going to get better and better, but it will slow down,” said Mara Aspinall, co-founder of Arizona State University’s biomedical diagnostics program. a weekly newsletter national testing capacity monitoring.

Antiviral for Covid-19 - not a cure, but a great tool

If testing is going to be difficult, getting the dose of the antiretroviral is expected to be harder, at least at first. The federal government has agreed to buy about 3.1 million courses of molnupiravir for $2.2 billion, which works out to about $700 per course. The Biden administration is planning to announce a deal to pay $5 billion for 10 million courses of Pfizer, paying about $500 per course of treatment. According to The Washington Post.

Doses of drugs dispensed by the federal government will be provided to states and patients free of charge. But only a fraction of the planned inventory will be available to begin with, said Dr. Lisa Piercey, Tennessee’s health commissioner, who is part of a small group of state health officials working on the distribution plan. distribute, said.

Under a scenario in which 100,000 courses of Merck are available as early as December 6, Piercey said Tennessee would receive only 2,000 patient courses even if the state reports an average of more than 1,200 new cases. every week. Deciding which patients get those scarce supplies will be “an educated stab in the dark,” says Piercey.

U.S. Department of Health and Human Services officials say antiviral treatments will be delivered through same state based system applied to monoclonal antibody treatments. Lab-generated molecules, delivered by infusion or intravenous injection, mimic human antibodies against the covid virus and reduce the risk of severe illness and death. Federal officials took over the distribution in September, after an increase in crowding in Southern states with low vaccination rates led to run on national supply. They are now allocated to states based on recent spasms and hospitalizations and past usage.

Antiviral drugs will be cheaper than monoclonal antibody treatments, which cost the government about $1,250 per dose and can charge infusion fees that cost patients hundreds of dollars. copayment. These pills are much easier to take, and pharmacies will likely be allowed to order and distribute them for home use.

Antiviral drugs will not be able to replace 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 drug in some populations. Merck’s molnupiravir works by causing mutations that prevent the virus from reproducing. Pfizer treatment, which includes Paxlovid and a low dose of ritonavir, an HIV antiretroviral drug, can cause interactions with other medications or even over-the-counter supplements, Webb said.

Therefore, antiviral drugs probably will not be used by children, people with kidney or liver disease, or pregnant women. They will need to be used for patients who are likely to take multiple pills at once, several times a day, and those patients must be monitored to ensure that they complete therapy.

“We will have an interesting interview in which we will try to identify patients who are eligible early to treat them with antivirals,” Webb said. “We just need to be nimble and ready to move.”

KHN (Kaiser Health News) is a national newsroom specializing in the production of in-depth coverage of health issues. Along with Policy Analysis and Exploration, KHN is one of three main activities at KFF (Kaiser Family Foundation). KFF is a nonprofit organization privileged to provide information on health issues to the nation.

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