You may have heard that the pandemic is over in the United States. (It’s not.) Masks are no longer mandatory in most places, and large gatherings are becoming commonplace again. Most of the country is green, according to the US Centers for Disease Control and Prevention tracking site, which monitors the rate of transmission and hospitalization of COVID-19. Many people rely on vaccines to control outbreaks and are once again focusing on getting new treatments for sick people.
But the incidence of coronavirus is increasing again more than a quarter of the counties accounting for high transmission levels. And these are official figures. Nobody really knows how many tests at home are positive and never reported (SN: 22.04.22). These cases increase the hospitalization rate, with yellow and orange pockets appearing on the CDC card, indicating that hospitals are entering a dangerous congestion zone. Deaths remain relatively low. This may change if another wave of infection spreads to the country.
“We may think we’re on the edge of the woods, but we’re not out of it yet,” said Mark Denison, a coronavirus researcher at Vanderbilt University Medical Center in Nashville.
Preventing hospitalizations and deaths is what vaccines are designed for, but even very good vaccines against COVID-19 are not perfect. And with the new immune-avoiding variants of the coronavirus, even vaccinated people and those who have previously had COVID-19 – especially the elderly or people with weakened immune systems or other health problems – may end up in hospital.
The next line of defense against this bad result is three antiviral drugs and one monoclonal antibody, which can prevent people recently diagnosed with COVID-19 from becoming seriously ill and dying.
The test treatment initiative
About 20,000 pharmacies, hospitals, emergency centers and other locations have Paxlovid antiviral pills (a combination of two drugs) manufactured by Pfizer. The federal government plans to expand that number to 40,000 in the coming weeks, Ashish Ja, director of the White House, told COVID Response on April 26 during a briefing. Many of these sites also have antiviral pills Molnupiravir (Logevrio), manufactured by Merck (SN: 12/2/21). Enlargement is part of the federal government treatment test initiative to make testing and treatment widely available.
In much more limited supply are intravenous doses of monoclonal antibodies and the antiviral drug remdesivir, the only antiviral drug fully approved by the US Food and Drug Administration for the treatment of COVID-19.
One preventative treatment is a monoclonal antibody called Evushold. It is for people with weakened immune systems who may not respond to vaccines or who cannot be vaccinated. In a clinical trial this reduces the risk of developing symptomatic infections with COVID-19 by 82 percent compared with placebo, the researchers said on April 20 New England Medical Journal. This treatment is plentiful, but not used much.
Remdesivir, or Veklury, as its manufacturer Gilead Sciences calls it, was approved by the FDA in 2020 for the treatment of hospitalized patients (SN: 4/29/20). A recent clinical trial showed that the drug reduces the chance of hospitalization by 87 percent in non-hospitalized people at high risk of serious illness, researchers said on January 27 New England Medical Journal. Such positive results prompted FDA to extend its approval for outpatient use in people 12 years of age and older. Then on April 25 the FDA allowed the drug to be used in children 12 and youngermaking it the first antiviral treatment for COVID-19 available to young children.
The main disadvantage of Remdesivir is that it must be administered intravenously. “There’s nothing convenient about that,” said Abraar Karan, an infectious disease doctor at Stanford University. Researchers are working on an oral form of remdesivir. Early experiments show that this is the case effective for protecting mice against a serious illness. Tests still need to be done to see if it works for people.
Two other drugs, Paxlovid and molnupiravir, are available in pill form. Theoretically, they are more affordable, but many people do not know about them or how to get them. And a few posts on social networks suggest that it is not as easy as it sounds for everyone to get their hands on drugs after a positive COVID-19 test, even when they know about them.
“It’s not as simple as” We have a pill, now it’s all settled, “Karan said.
This is partly due to the fact that some doctors are unaware that they can or should prescribe drugs to their high-risk patients who become infected with coronavirus, said Jason Gallagher, a pharmacist and infectious disease physician at Temple University in Philadelphia. “There’s a lot of medical education that needs to happen,” he said.
Ideally, people would talk to their doctors about whether they are candidates for the drugs before they become infected, Karan said. And people who don’t have a doctor need to know their options, because time is important: the pill should start within three to five days of the onset of symptoms.
Access to medicines is improving, but it is still uneven. In the interest of preparation I went to COVID.gov to find out where I can get my medication in case I get a coronavirus. I am relatively lucky. There are seven treatment testing sites within five miles of my house just outside Washington, D.C., although one is a military hospital that is not open to the general public. And I talked to my doctor to ask if I should take Paxlovid if I got COVID-19. He said that he should and that if I did a home test, I could call with the result and he would call a prescription at my pharmacy.
My mother in Nebraska is in a different situation. She will have to drive more than 25 miles to the nearest test site for treatment. Many other rural areas have pharmacies that can fill prescriptions, but people will have to go elsewhere to be tested and find a doctor to prescribe the medicine. For example, residents of Gipsum, Colorado, will have to test somewhere, get a prescription from a doctor, drive about six miles to complete a prescription, or travel nearly 100 miles to the suburbs of Denver for a test treatment site.
Disadvantages of these drugs
There are other wrinkles besides access to medication. “For all therapeutics, they have been studied mainly in unvaccinated people who are at risk of developing a serious illness,” says Gallagher. “So we end up projecting this data on the population we have now, which is largely vaccinated. It is not clear that everyone who has health problems that put them at risk needs medication, especially if they have received a booster vaccine. Medications can reduce symptoms, but there is no real evidence that they are effective in making people feel better faster, he said.
However, medicines are good for keeping people out of the hospital. Paxlovid reduces the relative risk of hospitalization and death from about 89 percentthe researchers announced on April 14 New England Medical Journal. Its side effects include a distorted sense of taste and a small number of people develop diarrhea.
A major drawback is one of the drugs in the combination Paxlovid. Paxlovid’s main medicine, nirmatrelvir, works by inhibiting an enzyme that the virus needs to replicate. It is taken with a medicine called ritonavir, which prevents nirmatrelvir from being broken down by enzymes in the body. Ritonavir can react with other medicines, such as cholesterol-lowering statins, which makes the levels of these medicines in the body dangerously high. But there are ways to get around that, Gallagher said. For example, cholesterol-lowering drugs can be stopped for a short time. “I can’t think of a single person who can’t stop taking them for a week or two,” while he was being treated for COVID-19, he said.
Another wrinkle is recurrence. one prepress and other anecdotal accounts reported that some people had relapses a few days after stopping Paxlovid. No one really knows how often this is or why it happens. The U.S. National Institutes of Health is working with the CDC and the FDA to better understand the phenomenon, according to a statement sent to me by the National Institute of Allergy and Infectious Diseases. But the agencies have no official research in progress.
The experts I spoke to had some ideas about what might happen. It may be that the immune system “cools down” as people take the drug, which allows the virus to recover once the drug is stopped, Gallagher speculates. Or the virus can hide in certain places in the body that are difficult for the drug to reach, Denison said. Both of these situations can be resolved by giving people the drug for longer, they say.
But The FDA rejected this proposal in a post quoting John Farley, director of the agency’s Office of Infectious Diseases. Similar relapses have occurred in people taking placebo pills in a clinical trial of Pfizer, so the viral rebound may not be related to taking the drug, Farley said. And there are no indications that people are getting sick and hospitalized after a relapse. There are also no data on whether people would benefit from taking Paxlovid for longer or from taking another dose of the pill if they relapsed, he said.
Drug resistance is another cause of recurrence of infections. “I think drug resistance is the least likely explanation,” Denison said. In order to develop resistance, the virus must replicate, which it cannot do when the drug is around. However, researchers need to watch for mutations in viruses taken from relapsed patients who may show resistance, he said.
None of the drugs can prevent waves of infection. For example, Paxlovid slightly reduces the likelihood of infection with COVID-19 in people who have been exposed to infected household members but the result is not statistically significant, Pfizer reported on April 29 in a press release. This means that it is not great as a preventative measure and will not affect the number of cases.
“What [the drugs] “The jump in hospitalizations and deaths could be reduced,” Gallagher said. But, he notes, people at high risk for serious illness should not rely solely on drugs to save them. “I don’t think any of these therapies are as good as a booster.”