Antiviral drugs for treating Covid-19 have been hailed as a pandemic “game-changer” — a tool that could, perhaps, finally help life return to normal. But basic gaps in the U.S. health system could mean that two new treatments from Pfizer and Merck won’t make much of a difference after all.
The companies’ treatments, which haven’t yet received emergency authorization, could make a Covid diagnosis dramatically less threatening. But in practice, before receiving the pills, patients may need to jump through a series of hoops that often prevent Americans from accessing care: Recognizing their symptoms, taking a test, getting a prescription from a clinician, and filling the prescription at a pharmacy.
“Our routine medical systems are not really set up for this,” said Céline Gounder, a physician and NYU professor who served on President Biden’s Covid advisory board in the months before his inauguration. “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.”
The skepticism surrounding the antivirals highlights the country’s continued lack of basic pandemic-response infrastructure, even 22 months after the country’s first recorded case of Covid-19. And it highlights, too, that despite profoundly successful partnerships between the U.S. government and major pharmaceutical companies, the country’s health system often fails to deliver lifesaving vaccines and medicines to those at highest risk.
To make matters worse, access to the antiviral drugs could potentially break down across typical lines of income and race, echoing the country’s initial struggle to vaccinate many of society’s most medically vulnerable, as well as historically marginalized communities.
“Many of the people who will be at highest risk, people with chronic illnesses, people who may not have been vaccinated, individuals who largely don’t have health care, people who may not have a primary care doctor — these are the people who are most likely to benefit from antivirals, but may be those who are least likely to receive them,” said Adam Gaffney, a Harvard Medical School professor and progressive health policy advocate.
Indeed, clinical trials for both the Pfizer and Merck antivirals focused on unvaccinated people with at least one risk factor for developing severe Covid-19. Trial data, as disclosed by the drug companies, shows them to be remarkably effective: No patient in either study died after being treated with a course of antivirals.
But it might be difficult to get the drugs outside a clinical trial setting. Depending on the particular patient, it could involve four individual steps: recognizing symptoms, receiving a positive Covid-19 test result, being prescribed an antiviral by a doctor, and picking up the pills at a nearby pharmacy.
Each step could prove difficult, Gaffney said, beginning with the challenge of recognizing symptoms during winter, when early signs of Covid-19 might be easily written off as a cold, flu, or allergies. Even if patients do quickly suspect they have Covid, diagnostic tests are still sometimes hard to come by. Many of the patients who test positive won’t have primary care physicians. And perhaps worst: The antivirals are ideally taken just three days after symptom onset, meaning the four-step process can’t face any setbacks.
Of all the challenges patients will face when seeking the antiviral treatments, the lack of access to efficient testing is by far the largest.
“I have worries about how impactful [the antivirals] will be, given the fragmentation in our health care system and lack of access to care — and lack of access to testing,” Gaffney said. “Clearly our testing infrastructure is not where it needs to be, particularly for disadvantaged people.”
That puts the U.S. at odds with other high-income countries, like the United Kingdom, where the government is shipping rapid Covid-19 tests for free to anybody who asks.
And even for people who do have access to testing, some PCR diagnostics need to be shipped to a lab that won’t return a result for 24 hours, at least.
“Antivirals like these need ‘companion’ diagnostics,” said Amesh Adalja, a doctor and infectious diseases researcher at the Johns Hopkins 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.”
The Biden administration has already sought to scale up testing availability, announcing a recent $650 million investment in scaling up the manufacturing of rapid tests.
For some populations, though, testing won’t be as much of an obstacle.
Gounder suggested that some immunocompromised people, for instance, should be prescribed the antivirals preemptively, if they’re exposed to Covid but haven’t tested positive — eliminating a potentially burdensome step.
Nursing homes and long-term care facilities, too, might be uniquely equipped to execute the entire four-step process from start to finish: recognizing symptoms, administering a test, prescribing the drugs, and administering them.
Ideally, though, people who live outside congregate settings would be able to access the same level of service at retail pharmacies. Other fixes, Gounder suggested, could include issuing a “standing order” for the drugs — essentially, allowing an entire city or state’s population to receive the drugs without a prescription.
“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.”
The Biden administration has already moved to make that a reality, anticipating that the Food and Drug Administration will likely authorize the drugs for emergency use. In a little-noticed regulatory move, the Department of Health and Human Services announced on Sept. 14 that pharmacists can prescribe, dispense, and administer Covid-19 therapeutics.
An FDA advisory committee will meet on Nov. 30 to discuss the antiviral developed by Merck and Ridgeback Therapeutics, which could trigger an emergency authorization soon afterward. Pfizer formally requested an emergency authorization for its drug last week, but the agency hasn’t yet scheduled a hearing date.
Even though regulators haven’t authorized or approved either drug, the White House has aggressively sought to guarantee its future supply.
This month, the White House announced it had acquired 10 million treatment courses of Pfizer’s antiviral, for $5.3 billion. Earlier this year, the administration announced it had paid $1.2 billion for 1.7 million five-day courses of the drug developed by Merck and Ridgeback Therapeutics. Both deals are contingent on FDA authorization.
“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,” health secretary Xavier Becerra said last week in a statement announcing the Pfizer acquisition.
The administration’s move does solve one early concern about broad access to antivirals: Since the federal government has purchased them in advance, they’ll largely be free to patients, similar to Covid-19 vaccines.
Still, experts cautioned that while the antivirals, at best, are a valuable tool in the country’s Covid-fighting arsenal, they’re no cure-all.
“It’s unlikely,” Gaffney said, “that these drugs are going to be the silver bullet that ends this pandemic.”
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