November 29, 2021

Antiviral Covid-19 treatments could be a 'game-changer.' But big obstacles remain.

Daily Briefing

    Some infectious disease experts have said new antiviral Covid-19 drugs could be a powerful tool in the fight against Covid-19, especially in the face of emerging coronavirus variants such as omicron. But other experts worry it will be difficult to test and treat patients quickly enough for the drugs to be effective.

    Pfizer's antiviral Covid-19 pill is a big deal. Here's why.

    Experts hail antiviral Covid-19 drugs as a 'game-changer'

    According to Kaiser Health News, several infectious disease experts have hailed new antiviral Covid-19 drugs as a potential "game-changer" in the course of the pandemic.

    "This is truly a game changer," said 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."

    So far, two antiviral drugs have shown strong evidence of efficacy against Covid-19. Merck in October released clinical trial data showing that their antiviral drug molnupiravir reduced the rate of hospitalization or death from Covid-19 by roughly 30%. Separately, Pfizer earlier this month reported that its own antiviral drug Paxlovid reduced the risk of hospitalization and death from Covid-19 by 89% in a trial of 750 people when given within three days of symptom onset.

    Both companies have requested emergency use authorization for their respective drugs from FDA, STAT News reports, and the agency's expert advisory committee is scheduled to review Merck's antiviral drug on Nov. 30. Currently, the federal government plans to purchase 3.1 million courses of molnupiravir and 10 million courses of Paxlovid if the drugs are authorized by FDA.

    Antivirals could especially become important with the rise of the new omicron coronavirus variant, as the drugs work in ways that shouldn't be affected by coronavirus mutations, Reuters reports. Albert Bourla, Pfizer's CEO, said he's confident that Paxlovid will remain effective against omicron.

    "This promising treatment could help accelerate our path out of this pandemic by offering another life-saving tool for people who get sick with Covid-19," said HHS Secretary Xavier Becerra.

    Accessing antivirals may be difficult for many patients

    However, several experts say accessing these potentially life-saving drugs may be difficult for many patients—particularly since they must be administered within a short window of time after symptoms begin.

    According to KHN, Merck administered its antiviral drug to patients within five days of symptom onset, while Pfizer administered its antiviral drug to patients within three days of symptom onset. During that short time, patients have to recognize their symptoms, receive a positive Covid-19 test, be prescribed the antiviral drugs, and then pick them up from a pharmacy, STAT News writes—a process that may face several potential setbacks.

    Kelly Wroblewski, director of infectious disease programs for the Association of Public Health Laboratories, said, "That's just not human nature … If you have a sniffle, you wait to see if it gets worse."

    And even once patients do seek medical attention, they may face routine care delays. "Our routine medical systems are not really set up for this," said Céline Gounder, a physician and professor at New York University. "These are medications that need to be started within three days of developing symptoms. It can take you longer than three days to get an appointment."

    In particular, lack of access to efficient testing may be the most significant challenge for patients seeking these antiviral treatments, STAT News writes. For example, PCR tests typically require appointments with medical providers, and patients often wait days for their results, which could put them past the window of time for the treatments. In addition, while rapid antigen tests are faster and available over-the-counter, they remain limited in supply and can be expensive.

    "Antivirals like these need 'companion' diagnostics,” said Amesh Adalja, a doctor and infectious diseases researcher at the Johns Hopkins Bloomberg School of Public Health. "The tests we have today and throughout the pandemic have not been companions, but more like Cabbage Patch dolls that you have to work hard, stand in lines, and drive all over town to find."

    So far, the Biden administration has invested $3 billion to improve access to rapid Covid-19 tests in the United States, including $650 million to increase manufacturing capacity, KHN reports. However, it may be several months before enough supply will be available to make a difference.

    "Supplies will be getting better, but it's going to be slow," said Mara Aspinall, co-founder of the biomedical diagnostics program at Arizona State University.

    Ways to proactively increase access

    According to some experts, providers and other organizations can help ensure that these antiviral drugs reach patients who need them in a timely manner.

    For example, the antiviral treatments may be preemptively prescribed to certain groups of people, such as those who are immunocompromised, so they don't have to seek a prescription themselves and potentially miss the narrow window for treatment after being exposed to the coronavirus.

    In addition, Gounder suggested that cities or states issue a "standing order" for the antiviral drugs, which would allow their residents to receive them without a prescription. The federal government has also taken steps to make it easier for people to access Covid-19 treatments, STAT News reports. In September, HHS announced that pharmacies would be able to prescribe, dispense, and administer Covid-19 therapeutics.

    "It has to be one-stop shopping," Gounder said. "There can't be multiple steps to all of it. There might be a few different such pathways: One might be that you walk into your local drugstore, which I think for a lot of people is the most likely." (Aleccia, Kaiser Health News, 11/22; Facher, STAT News, 11/23; Beasley, Reuters, 11/27; Reuters, 11/29) 

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