11 min read.Updated: 07 Dec 2021, 06:03 PM ISTJared S. Hopkins, The Wall Street Journal
Some therapies have been shown to work in clinical studies and other research
Within a few weeks, the US could have access to the first antiviral pills to treat Covid-19, either from Pfizer Inc. or Merck & Co. and partner Ridgeback Biotherapeutics LP. The Merck-Ridgeback drug, molnupiravir, received a positive recommendation on Nov. 30 from a panel of experts advising the Food and Drug Administration. The pill had been found in a late-stage study to cut the risk of hospitalization or death by about 30% in high-risk people with mild to moderate Covid-19. The U.K. cleared the drug for use earlier in November.
The recommendation comes on the heels of a new variant emerging, the B.1.1.529 variant, also known as the Omicron variant. The Centers for Disease Control and Prevention identified the first confirmed U.S. case of the Omicron variant in California on Dec. 1. The threat of the possibly more transmissible variant has made the FDA consider authorizing Covid-19 boosters from Pfizer-BioNTech for use in 16- and 17-year-olds as soon as next week, The Wall Street Journal has reported.
Public-health experts say the best preventive measure to decrease the likelihood of contracting Covid-19 is to get vaccinated. The CDC has recommended that everyone 18 and older get an additional shot after completing a primary series of Covid-19 vaccination.
Nearly two years into the pandemic, doctors have few effective treatments for patients, especially early in the disease. Still, some therapies have been shown to work in clinical studies and other research. Here’s what public-health and infectious-disease experts say abouthow to treat Covid-19.
I’ve contracted Covid-19; what should I do? How can I treat mild symptoms from home?
Doctors say an initial step is to monitor symptoms to determine whether infected people could be considered at low or high risk for developing severe disease. Individuals who are typically considered to be at low risk for severe disease include people who are young and healthy. They should stay at home away from others, drink plenty of fluids to stay hydrated and take over-the-counter medicines such as acetaminophen or ibuprofen to reduce fevers, according to physicians and the CDC. Physicians say people who are young, otherwise healthy and at low risk of developing severe disease should recover if they take the right steps.
People who are at high risk include those with underlying health conditions and the elderly, according to doctors. These individuals should pay close attention to any change in their health, including symptoms of fever, cough, fatigue or difficulty breathing. If high-risk individuals need medical attention, they should seek it right away.
“The management of Covid continues to depend on what your risk of progression is," said Carlos del Rio, a professor of global health at Emory University. “Treatment has to be individualized."
Additionally, people who are vaccinated and become infected—what is known as a breakthrough case—are unlikely to develop severe disease or need hospitalization, according to doctors and studies.
Are there any drugs approved or authorized for administration at home or in clinics?
There are currently no authorized treatments for Covid-19 that people can take at home, although antiviral pills from Merck-Ridgeback and Pfizer that could be dispensed by pharmacies for use at home are under review by U.S. health regulators.
Monoclonal antibody treatments are available for people who develop symptoms and are considered to be at high risk of severe disease. As many as 75% of U.S. adults are eligible to take the drugs under FDA guidelines, according to experts. The drugs are lab-engineered molecules that mimic the natural antibodies produced by the immune system to fight off viruses. They are usually administered by infusion or injection at hospitals or clinics.
The FDA has authorized treatments from Regeneron Pharmaceuticals Inc. and Eli Lilly & Co. that were found to reduce the risk of hospitalization and death by 70%, and GlaxoSmithKline PLC and partner Vir Biotechnology, whose drug, sotrovimab, comes with an 85% reduction.
Lilly’s antibody drug was cleared for emergency use in children under the age of 12 by the FDA on Dec. 3.
The authorization is the first for an antibody treatment to give youngsters and newborns who have tested positive for Covid-19 or been exposed to the virus, and who are at high risk of developing severe cases including hospitalization or death.
In some parts of the U.S. the antibody treatments may be available for administration at home or through mobile clinics. Some states are also allowing low-risk patients to receive monoclonal antibodies, but it is not recommended by the National Institutes of Health. “The juice is not worth the squeeze," Dr. del Rio said.
The drugs are effective against the most common strains of Covid-19 circulating in the U.S. But researchers say some antibody therapies are likely to be especially vulnerable to Omicron if it becomes widespread because the variant contains mutations to the spike protein that the Regeneron and Lilly drugs target, while other drugs should hold up well because they attack elements of the virus unchanged in the variant. Regeneron has said preliminary testing suggests the drug loses effectiveness against Omicron. The drug cocktail from Lilly may not be as effective, say some scientists from outside the company, although the company says it is still conducting testing.
Early laboratory studies suggest that the antibody treatment developed by Glaxo and Vir is effective against the Omicron variant, the companies said.
My loved one is hospitalized. Are there any FDA-approved treatments for hospitalized Covid-19 patients?
Most research has found that monoclonal antibodies aren’t effective once people become hospitalized and they are currently not recommended at that point.
The FDA has approved Veklury, also known as remdesivir, for treatment of people who are hospitalized with Covid-19. The antiviral was first developed for treating Ebola.
Patients who may be at risk of advancing to severe disease may also be given dexamethasone, a steroid first approved in the 1950s that is successful at treating inflammation. The steroid has been found in studies of hospitalized Covid-19 patients to reduce the risk of death. It is recommended for treatment by the NIH and the Infectious Diseases Society of America.
Patients who don’t respond to dexamethasone may be given an immune-suppressing rheumatoid arthritis drug called Olumiant, which received an emergency-use authorization from the FDA after a study showed it helped hospitalized patients recover more quickly.
A similar rheumatoid arthritis drug, Actemra, made by Roche Holding AG, is also used to tamp down the potentially lethal inflammation seen in some hospitalized patients.
Doctors sometimes administer blood-thinners to hospitalized patients, which can reduce blood clots and inflammation that develop in some Covid-19 patients. Some studies have found that such treatments can also reduce the risk of patients needing mechanical ventilation and could help them leave the hospital sooner.
What are Covid-19 antiviral pills? When can I get one to treat myself?
Antivirals are treatments designed to impede a virus’s replication cycle, allowing people to recover from the illness, and they are most effective if they are taken by patients early in the course of disease.
Merck and partner Ridgeback say their oral antiviral, molnupiravir, reduced the risk of hospitalization and death by about 30%. Pfizer said its oral antiviral, called Paxlovid, which is taken with another antiviral called ritonavir, reduced the risk by 89%. Both drugs are under review by the FDA, and should be cleared for use before the end of the year, according to analysts.
The U.S. has purchased 10 million courses of treatment of Pfizer’s pill and about 2.1 million courses of the Merck-Ridgeback pill, but supply is expected to be limited initially as the companies increase manufacturing.
Should the FDA clear either pill for use, the agency would have to decide which patients will be permitted to be prescribed treatment. The companies studied their drugs in people who are at high risk of developing severe disease. They excluded certain people from their tests: Both left out pregnant women while Pfizer excluded people who take certain common medications such as heart drugs.
Both treatments are taken over five days, with Pfizer’s totaling 30 pills and Merck-Ridgeback clocking in at 40 capsules.
Will antiviral pills be effective against the Omicron variant?
The antiviral manufacturers say they expect the treatments to be effective against Omicron, although they plan to conduct tests to verify. Both drugs target different parts of the virus than vaccines and other treatments, which are targeting the spike protein that plays a key role in infecting cells.
Pfizer has said so far its researchers haven’t seen any changes in the variant that suggests Paxlovid, which is given with the antiviral ritonavir, is less effective than against previous strains.
Merck has said it is working to collect samples of the new strain to study whether molnupiravir is effective against Omicron and expects results before the end of the year. Molnupiravir targets machinery the virus uses to replicate, rather than the spike protein, the structure that helps the virus infiltrate cells.
Merck expects molnupiravir to be effective against Omicron because testing has found the drug to be effective against other circulating variants. “Molnupiravir retains activity across all of these variants of concern, and there’s no difference in its antiviral activity," said Daria Hazuda, vice president of infectious disease discovery at Merck. “There shouldn’t be any more or less concern about its effectiveness against Omicron versus any other variants."
Which Covid-19 treatments are being tested?
A monoclonal antibody from AstraZeneca PLC,which failed an earlier study as a post-infection treatment, showed in a clinical trial that it could prevent symptomatic Covid-19 for at least six months when given to people who are not yet infected, and is under consideration for emergency use as a prophylactic. Bristol-Myers Squibb Co. is also testing a monoclonal antibody and expects Phase 2 results in the coming months, according to the company.
Researchers studying the antidepressant fluvoxamine recently reported in the Lancet, a peer-reviewed medical journal, that patients who took the widely available drug were significantly less likely to require hospitalization than those who didn’t. The drug is still being studied, and isn’t yet recommended by the NIH or IDSA.
Some research has suggested steroid inhalers are helpful at reducing symptoms early in the course of the disease, said David Boulware, an infectious-diseases specialist at the University of Minnesota. He said it is unlikely manufacturers would seek an emergency use authorization because they are widely available, although the NIH and IDSA hasn’t recommended them.
An oral antiviral from Japanese drugmaker Shionogi & Co. is also in clinical trials.
Is ivermectin effective in treating Covid-19?
Most research hasn’t shown that the antiparasitic drug ivermectin is an effective Covid-19 treatment, physicians say, and the drug isn’t authorized for that use. The FDA has approved ivermectin to treat some parasitic worms, as well as a topical treatment for head lice and skin conditions such as rosacea. It is also used in the U.S. to treat or prevent parasites in animals.
The drug, which was developed years ago by Merck, has been used to prevent river blindness and other diseases in Africa and other places where parasites are common. Prescriptions of the drug have shot up in recent months, and federal health regulators have warned doctors and veterinarians against the unauthorized use of ivermectin to treat Covid-19.
Can my doctor treat me with hydroxychloroquine?
Numerous studies have found that hydroxychloroquine and chloroquine, approved decades ago to treat and prevent malaria, don’t reduce the severity of Covid-19 symptoms or provide a benefit to patients. Doctors, however, are permitted to write so-called off-label prescriptions, to treat ailments that the FDA hasn’t approved, and some doctors have done so with hydroxychloroquine and chloroquine.
The drugs, which are also used to treat ailments such as lupus and rheumatoid arthritis, initially received emergency-use authorization, although the FDA later revoked it after concluding the therapies were unlikely to help fight the disease.
Early in the pandemic hospitals and doctors around the world began treating Covid-19 patients with hydroxychloroquine after several small studies suggested a benefit.
The NIH recommends against the use of hydroxychloroquine in hospitalized or nonhospitalized people, as does the IDSA, which also recommends against it as a prophylactic.
I’m vaccinated but I contracted Covid-19. Can I use any of the approved treatments?
“Vaccination remains one of the most important factors for us to consider," said Dr. Abhijit Duggal, a staff ICU physician and director for critical care research for the medical ICU at the Cleveland Clinic. “Anything that we do after that is really trying to minimize the damage associated with the viral infection."
He said factors that affect treatment decisions in vaccinated people included whether someone has any underlying immunity as well as any comorbidities. Doctors say that while it remains unlikely that vaccinated people will end up in the hospital, those who do will likely be eligible for similar treatments.
“Once you get hospitalized in breakthrough cases you will get all the usual therapies," Dr. Duggal said. “Vaccination not only prevents the disease but also ameliorates the severity of disease." He said some doctors in the U.S. have administered antibody treatments but it isn’t standard treatment and may not be appropriate since the virus infected the patient despite the presence of antibodies from the vaccines.
What if I am immunocompromised and become infected?
Most of the hospitalized patients who were previously vaccinated are immunocompromised, according to doctors. Hospitalized patients who are immunocompromised are eligible to receive convalescent plasma, a highly concentrated solution of antibodies taken from recovered Covid-19 patients. There is limited data that suggests monoclonal antibody treatments will benefit the immunocompromised, even if they are vaccinated, said Dr. Duggal.
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