When President Joe Biden tested positive for covid-19 on July 21, his physician recommended he take the antiviral drug Paxlovid. The drug significantly reduces the likelihood of hospitalization or death for someone at high risk of developing severe covid. Biden started the five-day course that day, according to the White House, and within six days he tested negative for the virus and was cleared to leave isolation.
Biden's chief medical adviser, Dr. Anthony Fauci, also took Paxlovid when he contracted covid in June yet soon tested positive for the disease again. So he took a second round of the drug even though it isn't approved for that.
Since Paxlovid became available seven months ago, it has eclipsed other available therapies created to forestall life-threatening covid symptoms in high-risk patients. Some doctors are quick to prescribe it, but as with so much about the covid pandemic, there is controversy. Some patients are concerned about a possible rebound of the disease, while others have difficulty convincing their doctors they are good candidates for the drug.
"Paxlovid is still the go-to drug" even though it may not be appropriate for everyone, said Dr. Priya Nori, an infectious disease physician in the Montefiore Health System.
In a clinical trial, people who had mild-to-moderate covid and were at high risk for becoming seriously ill lowered their risk of being hospitalized with or dying of the disease by 88% if they took Paxlovid within five days of developing symptoms.
But even as specialists in infectious diseases praise the treatment's effectiveness, many doctors say they have questions about prescribing the drug and want better data.
Here are answers to some common questions about Paxlovid.
Q: What is Paxlovid, and how does it work?
Paxlovid is an antiviral medication that is made of two drugs: One blocks a key enzyme that the covid virus needs to replicate, and the second blocks the first drug's metabolism in the liver so it doesn't leave the body as quickly. Patients take three pills twice a day for five days.
Q: Who should take Paxlovid?
When the FDA authorized the emergency use of Paxlovid, it specified that the drug was to be prescribed to people at high risk of getting severely ill from covid. The high-risk list is long, including people older than 65 and those who have chronic or serious health conditions such as cancer, obesity, diabetes, asthma, and heart disease.
Yet seven months after Paxlovid was authorized, some patients have the protection of two booster shots of a covid vaccine, and many were previously infected by the omicron variant of the virus. So doctors are left to assess how much a patient's history elevates or lowers their risk of severe infection, balancing that against the utility of prescribing a drug that has downsides as well.
Some people who fall into a high-risk category may not be able to take Paxlovid if they take any of a long list of drugs that could interact with the antiviral. Temporarily pausing some drugs on the list — like those that treat high cholesterol or high blood pressure — until a course of Paxlovid is finished may not risk serious health problems. But for people who are on drugs such as transplant rejection drugs or antiarrhythmic drugs that regulate their heartbeats, "these could cause catastrophic complications" if taken with Paxlovid, said Dr. Scott Roberts, assistant professor of infectious diseases at Yale School of Medicine.
Paxlovid is not recommended for people who are unlikely to get seriously ill from covid. In June, the drug's manufacturer, Pfizer, announced it was discontinuing a clinical trial for standard-risk people because Paxlovid didn't significantly reduce hospitalization and death in that group. The trial included both vaccinated and unvaccinated people.
Perhaps those results aren't surprising, since "for people who are low-risk, their risk of getting hospitalized is so low that taking Paxlovid isn't adding any advantage," said Dr. Daniel Kuritzkes, chief of the division of infectious diseases at Brigham and Women's Hospital in Boston.
Also in June, Pfizer announced it had applied to the FDA for full approval for Paxlovid.
Q: What are the options for someone who can't take Paxlovid?
A couple of other antiviral medications (Veklury and Lagevrio) and a monoclonal antibody drug (Bebtelovimab) also reduce people's risk of hospitalization and death from covid. But they are less convenient than Paxlovid, requiring injections or infusions, or not as effective. Still, they are possibilities if someone can't take Paxlovid.
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