A bizarre Twilight Zone-like era has come to an end. The NIH is halting guidance on COVID treatment.
In recent times, if you contract COVID-19 and are at risk of developing serious complications, you can opt for treatments such as Paxlovid pills or antiviral infusions. These medicines have proven effective in keeping patients with mild to moderate symptoms out of the hospital. The availability of COVID-19 treatments has improved rapidly in the last four years, thanks to the accumulation of data and the efforts of scientists and doctors who have analyzed every piece of information to create evidence-based guidelines for the care of COVID-19 patients. The COVID-19 Treatment Guidelines from the National Institutes of Health (NIH) are highly influential guidelines viewed over 50 million times and used by doctors worldwide.
In the early days of the COVID-19 pandemic, the National Institutes of Health (NIH) formed a panel of over 40 experts to create the first set of guidelines. Those guidelines became a reference for doctors worldwide. According to Dr. Cliff Lane, co-chair of the panel and the director of the clinical research division at the National Institute of Allergy and Infectious Diseases (NIAID), the next few years were an “all hands on deck” effort. The panel members met several times a week to review the latest scientific literature and discuss data in preprints. They frequently updated their official guidance, sometimes two or three times a month.
The development of new COVID-19 treatments has slowed considerably, prompting the guideline group to rethink its efforts. “I don’t know that there was a perfect moment [to end it], but … the frequency of calls that we needed to have began to decrease, and then on occasion, we would be canceling one of our regularly scheduled calls,” says Dr. Lane. “It’s probably six months ago we started talking about — What will be the end? How do we end it in a way that we don’t create a void?”
It’s interesting to note that the last version of the NIH’s COVID-19 Treatment Guidelines was issued back in February. The guidelines are available online until August. They document how scientific understanding and technological progress evolved during the pandemic. According to Lane, specialty doctors groups like the American College of Physicians and the Infectious Diseases Society of America will be responsible for COVID-19 treatment guidance going forward. They are the usual stewards of best-practice guidelines, and it makes sense for them to take charge. The panel members believe that the evolution of COVID-19 treatments offers valuable lessons for dealing with new emerging infectious diseases.
During the spring of 2020, the first wave of COVID-19 patients filled up hospitals in different parts of the United States. At that time, medical professionals were still in the process of understanding how the disease progressed. The first guideline, published in April, acknowledged that they did not have enough knowledge about what worked or didn’t work. However, they quickly learned what treatments were effective, especially for hospitalized patients. By June 2020, data supported a treatment plan for severely ill patients. This involved using steroids like dexamethasone to prevent the immune system from attacking itself and combining them with antivirals to stop the virus from replicating.
Remdesivir is another antiviral drug that has been shown to be quite effective in treating mild to moderate cases of COVID-19. However, it’s administered intravenously, which makes it harder for patients to access. The drug company Gilead attempted to develop it into a pill, but unfortunately, that approach was unsuccessful.
Jenny Shen, a research scientist at the CUNY Institute for Implementation Science in Population Health, has found that the obstacles that come with outpatient treatments have led to low usage rates among the patients they’re designed to help. Shen’s study used data from 2021-2022, when the federal government purchased Molnupiravir and Paxlovid from manufacturers and made them available to states, health centers, and pharmacies for free. According to the study, during the peak of the pandemic, only 2% of COVID-19 patients reported receiving Molnupiravir, while 15% reported using Paxlovid among those considered eligible for the medications. Shen notes that since late 2023 after the drugs were moved to the commercial market, usage rates have most likely decreased further since they are no longer free and often require co-payments.
It can be challenging to manage outpatient treatments if a patient has other health problems, which is why doctors can be hesitant to prescribe them, according to Shen. And many patients with risk factors do not believe they will become seriously ill, which presents yet another challenge. “A dilemma we have observed is that patients want to see how severe their disease may become,” but in waiting, they become ill beyond the point where the treatment would help, Shen says.
Even still, when around 13,000 people are being hospitalized with COVID-19 weekly, more patient education on how the drugs work and when they’re most effective could help those who are sick make better-informed decisions, she says.
According to Dieffenbach, another COVID-19 drug, a pill course developed by the Japanese company Shionogi, is in late-stage clinical trials and showing promise. It is being tested for its efficacy against both acute and long-term COVID-19. Dieffenbach is looking forward to seeing how the trials turn out. However, he also mentions that this is the last drug in the pipeline for the near future.
Like any crisis, the COVID-19 pandemic and our responses, societally & governmentally, has plenty to teach us. Hopefully, some of the lessons we learned will allow us to minimize or mitigate whatever the next crisis to come along may be. The NIH handing the reigns back to specialty groups is an important milestone indicating that the immediate crisis really has passed… and that’s something we can all celebrate.
Sources:
https://www.covid19treatmentguidelines.nih.gov/
https://www.covid19treatmentguidelines.nih.gov/about-the-guidelines/whats-new/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10854389/
https://aspr.hhs.gov/COVID-19/Therapeutics/Pages/COVID19-Tx-Transition-Guide.aspx
https://covid.cdc.gov/covid-data-tracker/#maps_new-admissions-rate-county
https://www.shionogi.com/global/en/news/2024/03/20240305.html