“Paxlovid is still the gold standard,” although it may not be appropriate for everyone, said Dr. Priya Nori, an infectious disease physician at Montefiore Health System.
Paxlovid is a Pfizer drug to combat COVID-19 Photo: Kaiser Health News
When President Joe Biden tested positive for covid-19 on July 21, his doctor recommended that he take the antiviral drug Paxlovidwhich significantly reduces the likelihood of hospitalization or death for someone at high risk of developing severe covid.
Biden began the five-day course immediately and, according to the White House, within six days tested negative for the virus and was authorized to leave isolation.
Biden’s top medical adviser, Dr. Anthony Fauci, also took Paxlovid when he contracted covid in June, but soon tested positive for the disease again. He then took a second round of the drug even though he is not approved for it.
Since Paxlovid became available seven months ago, it has overshadowed other therapies available to prevent severe 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 worried about a possible rebound of the disease, while others have difficulty convincing their doctors that they are good candidates for the drug.
“Paxlovid is still the gold standard,” although it may not be appropriate for everyone, said the doctora Priya Noriinfectious disease physician at Montefiore Health System.
In a clinical trial, people who had mild to moderate covid and a high risk of severe illness reduced their risk of being hospitalized or dying from the disease by and 88% if they took Paxlovid within five days of the onset of symptoms.
But even as infectious disease specialists praise the treatment’s effectiveness, many doctors want better data. Here are answers to some common questions about Paxlovid.
What is Paxlovid and how does it work?
Paxlovid It is an antiviral medicine made up of two drugs: one blocks a key enzyme that the coronavirus needs to replicate, and the second blocks the metabolism of the first drug in the liver so that it does not leave the body as quickly. Patients take three pills twice a day for five days.
Who should take Paxlovid?
When the Food and Drug Administration (FDA) authorized the emergency use of Paxlovid, specified that the drug would be prescribed for people at high risk of severe illness. Is list is long and includes those over 65 and those with chronic or serious illnesses, such as cancer, obesity, diabetes and heart disease.
However, seven months after its approval, some patients have the protection of two booster doses against covid, and many were previously infected with the omicron variant. So doctors must assess how much a patient’s history raises or lowers a patient’s risk of serious infection, weighing it against the usefulness of prescribing a drug that also has drawbacks.
Some people who are in a high-risk category may not be able to take Paxlovid if they take any of a long list of medications that could interact with the antiviral.
The temporary pause of some drugs on the list, such as those that treat high cholesterol or high blood pressure, until a cycle of Paxlovid may not cause problems. But others, such as heartbeat or transplant drugs, “could cause catastrophic complications” if taken with PaxlovidHe said doctor Scott Robertsassistant professor of infectious diseases at the Yale School of Medicine.
Paxlovid not recommended for people who they are not at risk of severe covid. In June, Pfizer, the drug’s maker, announced it was suspending a clinical trial for people at standard risk because Paxlovid it did not significantly reduce hospitalization and death in that group. The trial included vaccinated and unvaccinated people.
Perhaps those results are not surprising, since “for low-risk people, their risk of being hospitalized is so low that taking Paxlovid doesn’t add any advantage,” said the doctor Daniel Kuritzkeschief of the division of infectious diseases at Brigham and Women’s Hospital in Boston.
Also in June, Pfizer announced that it had applied to the FDA for full approval of Paxlovid.
What are the options for someone who cannot take Paxlovid?
Other antiviral drugs (Veklury y Lagevrio) and a monoclonal antibody drug (Bebtelovimab) also reduce the risk of hospitalization and death from covid. But they are less convenient than Paxlovidrequire injections or infusions, or are not as effective.
How often do people experience rebound infections after taking Paxlovid?
A small percentage of people show symptoms of covid and test positive for coronavirus again after completing a five-day course of Paxlovid. But how many patients are affected, and why rebounds occur, is up for debate.
In the Pfizer clinical trial, between 1% and 2% of participants retested positive for covid after completing a course of Paxlovid. Because rebound occurred in people who received the drug and those who received a placebo, the FDA concluded that “at this time it is not clear if this is related to drug treatment.”
A June study from Mayo Clinic researchers found that less than 1% of 483 high-risk patients who had received Paxlovid experienced rebound symptoms.
However, anecdotal reports suggest the rebound figure is higher. Several prominent people in the medical community have reported experiencing rebound infections and symptoms, although these are usually mild. In addition to Fauci, director of the National Institute of Allergy and Infectious Diseases, the group includes Dr David Hodirector of the Aaron Diamond AIDS Research Center at Columbia University, and doctor Peter Hotezdean of the National School of Tropical Medicine at Baylor College of Medicine.
“I’m still confused about it, and most of the people I talk to are still confused, because we don’t know exactly why it happens,” he said. doctor Robert Wachter, professor and head of the Department of Medicine at the University of California-San Francisco. In May, Wachter tweeted about the experience of recovery of his wife, the writer Katie Hafner. “Public data on frequency is not in sync with everyone’s experience.”
There are several theories as to why bounces occur. Some experts suspect the drug doesn’t completely clear the virus in some people who have a high viral load, leading to a resurgence after five days of treatment. Or it could be that some people clear the antiviral drug from their bodies faster than others.
“If you have a faster kill, you may not have the exposure you need to kill the virus,” he said. Ashley Browna virologist at the University of Florida in Orlando.
“We continue to monitor the data, but to date we have not seen any resistance emerge in patients treated with Paxlovid and we believe that redetection of elevated nasal viral RNA is rare and not associated solely with treatment,” Kit Longley, a Pfizer spokesperson, said in an email.
Given the rebound effect, is it necessary to revise the prescribing guidelines?
Some experts question whether adjusting the time or length of a cycle of Paxlovid could eliminate the rebound effect that some patients experience. If people started taking Paxlovid on day 3 of symptoms, instead of immediately, for example, their body’s defenses could kick in, bolstered by previous vaccinations or infections, Nori said.
Many believe a five-day course is too short, said Wachter, who wants more data. “You would think it wouldn’t be that hard to do a five-day versus seven-day versus 10-day study,” he added.
According to Pfizer, “there may be some patient populations that may benefit from longer duration or recurring treatments, and we are considering additional studies to evaluate this in some populations.”
Fauci took a second course of Paxlovid after experiencing a rebound effect. Is it something other patients can do?
Generally not.
Fauci said he took a second course of Paxlovid after testing positive for covid and feeling even sicker in the second round with the virus.
The prescribing guidelines clearly state that “Paxlovid is not authorized for use for more than five consecutive days.”
Not all doctors agree with the guidelines. “For people who are really high risk, it’s hard to say ‘just take Tylenol,'” said Dr. doctor David Wohla professor of medicine in the division of infectious diseases at the University of North Carolina-Chapel Hill.
At Brigham and Women’s Hospital, doctors generally do not recommend a second cycle of Paxlovid for patients experiencing rebound, Kuritzkes said, “although there is some diversity of opinion.
In the FDA’s May guidance to providers, Dr. John Farley, director of the Office of Infectious Diseases, said: “There is no evidence of benefit at this time for a longer course of treatment (for example, 10 days in place 5) recommended in the Data Sheet for suppliers of Paxlovid) or repeat a course of treatment of Paxlovid in patients with recurrent symptoms of COVID-19 after completing a course of treatment.”
Fauci’s move was puzzling to some doctors.
“I was a little surprised and baffled that the country’s leading physician would go against the guideline,” said Yale’s Roberts. “That sends me a mixed message. I imagine I’ll have patients say, ‘Dr. Fauci took two courses. Why not me?'”
Are people contagious if they have a rebound? Should they isolate themselves?
If people test positive again after treatment with Paxlovidthey are supposed to be contagious and should be isolated from others, experts explained.
Will Paxlovid become resistant to the coronavirus?
It’s a concern, experts say, but there’s no evidence yet that it has happened.
“The virus is mutating in all regions of its genome at all times, so at some point Paxlovid probably become less effective than when the study was done a year ago,” Roberts said.
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