New Oral Antivirals for COVID-19 on the Horizon
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Patients with COVID-19 deemed to be at high risk for severe disease are currently eligible for intravenous monoclonal antibody treatments provided at certain health care systems, typically in hospitals. These medications are administered over a period of about an hour in an infusion center staffed by nurses and doctors.
When given early in the disease, they reduce the chances by as much as 70 percent that an individual with COVID-19 will require hospitalization. Yet, there are several reasons why this treatment alone is far from ideal and not sustainable in controlling the disease.
The monoclonal antibodies for COVID-19 are expensive to manufacture; although, the direct cost goes to the federal government rather than the individual. They must be given intravenously or injected under the skin in a medical setting using nurses and resources from an already strained heath care system. Obtaining the medication remains arduous, requiring testing, contacting a doctor to provide an order, scheduling a time at a select center offering the infusion, and arranging transportation, steps that favor the affluent who have contacts and resources to help in the process. The medications also have strict storage criteria and can run short during times of high demand. It is clear we need something better.
You likely heard a few weeks ago that pharmaceutical companies Merck and Ridgeback provided data on the use of an oral antiviral called molnupiravir created at Emory University in Atlanta. The medication is named after Thor's hammer, Mjolnir, to imply the drug is a hammer against SARS-CoV-2.
Subsequently, data was released from a drug trial using another antiviral, Paxlovid, manufactured by Pfizer. Both medications substantially reduced hospitalization and death due to COVID-19. Each requires a 5-day course to be started as soon as symptoms develop and the diagnosis of COVID-19 is confirmed.
The drugs produced little to no side effects, and DNA sequencing showed the results extended over known variants. Similar antiviral medications have proven to reduce the severity and duration of symptoms in a variety of other diseases, including influenza (e.g., oseltamivir) and herpes simplex (e.g., valacyclovir, acyclovir).
Because both molnupiravir and Paxlovid may be taken by mouth at home, they are clearly advantageous to current intravenous treatment. They are also easier to manufacture, ship, store, and are likely to be less expensive.
FDA authorization for molnupiravir will likely come at the end of this month, followed within a few weeks by Paxlovid.
The drugs are likely much more effective when given within a few days of symptom onset. Unfortunately, the complexity of our health care system will be the biggest barrier to timely treatment. Getting tested, contacting a doctor or visiting a walk-in clinic or emergency department, determining whether conditions for treatment are met, obtaining the prescription, and getting the medication is a process that is too complex for most anyone to follow over a day or two. Further, primary care doctor offices and emergency departments are already overstretched. They are not equipped to handle the increased responsibility of getting prescriptions to the entirety of the eligible population effectively.
We need a novel approach to providing oral medications for COVID-19 during this time of the pandemic when high levels of community transmission exists. We need to continue with the centralization that served us well in administering vaccine to a large percentage of the population in an organized, rapid manner. Temporary call centers run by state health departments should be created in a manner similar to the poison control centers operated by individuals trained in following algorithms. Clinical staff would screen callers for severe illness to direct those needing immediate attention, determine whether an individual meets criteria for oral therapy, and prescribe the treatment when indicated. Such an approach would significantly improve access and timeliness to treatment.
While it is too early to make bold assertions, these medications and others released in the near future show promise in serving as adjuncts to vaccine, significantly reducing the prevalence and impact of the virus. COVID-19 will then become similar to influenza and other respiratory viruses that typically exhibit minimal effects on healthy individuals with treatment alternatives for those at risk of severe disease.
Trey Dobson, MD, is chief medical officer at Southwestern Vermont Medical Center in Bennington.
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