None of the information provided is medical advice, and individuals should consult their providers with medical questions.
What types of medications combat COVID-19?
Two major categories of drugs combat mild-to-moderate COVID-19: antiviral drugs and monoclonal antibodies.
Antiviral medications work in three ways, according to the Cleveland Clinic:
- Block receptors so viruses can’t bind to and enter healthy cells.
- Boost the immune system, helping it fight off a viral infection.
- Lower the viral load (amount of active virus) in the body.
Monoclonal antibodies “make it more difficult for the virus to reproduce and cause harm.” according to the U.S. Department of Health and Human Services.
For monoclonal antibody therapy, a lab creates antibodies, the body’s way of fighting infections, specific to coronavirus. The dose, given as an infusion, creates “temporary, enhanced immunity which can help avoid progressing to more severe symptoms,” according to HHS.
What are the specific therapeutics currently available?
Two oral antiviral medications are available in the United States: Paxlovid and Molnipiravir.
Paxlovid is available for patients to take at home and “had an 89% reduction in the risk of hospitalization and death in clinical trials,” according to Yale Medicine. Patients take three pills twice daily for five days, and it requires a prescription. The drugs should be taken as soon as possible after a positive test and within five days of symptom onset, according to the FDA.
Paxlovid contains two drugs: “Nirmatrelvir prevents key proteins that the virus needs to make more copies of itself from functioning properly. It’s taken in combination with ritonavir, which helps keep nirmatrelvir from being broken down before it has completed its job,” according to Houston Methodist Hospital.
Molnupiravir, made by Merck, consists of four pills every 12 hours for five days. “Molnupiravir works by introducing mistakes into the virus’ genetic code, preventing the virus from replicating properly,” according to Houston Methodist Hospital.
The antiviral drug is only recommended by National Institutes of Health officials if other drugs are not readily available because Molnupiravir is not as effective as some other therapeutics. Trials showed it reduced the rate of hospitalization or death by 30%.
A third antiviral drug, Remdesivir, is available as a once-a-day infusion for 3-to-5 days. The drug prevents the virus from multiplying by “interfering with one of the key enzymes the virus needs to replicate RNA,” according to the National Institutes of Health. While it is used in hospitalized cases, it is also available for patients who are not hospitalized but who are at high risk for progression to severe disease.
Three monoclonal antibody treatments are available in the United States: Bebtelovimab, Sotrovimab and Evusheld.
Sotrovimab is given as a one-time IV infusion while Bebtelovimab is given as a one-time injection. Both should be administered within 7 days of symptom onset. Patients must go to a provider or infusion clinic to receive the monoclonal antibodies.
In clinical trials, Sotorvimab showed a 79% reduction in hospitalizations and deaths, according to the NIH. Bebtelovimab is the newest monoclonal antibody treatment to receive authorization with the FDA signing off in February 2022.
Immunocompromised patients may consider Evusheld, a two-shot monoclonal antibody treatment given prophylactically to people who are moderately to severely immunocompromised or who may not be eligible for the vaccine (if, for example, they are allergic to a component of the vaccine).
How are these drugs regulated? Are they FDA approved?
The only drug approved by the Food and Drug Administration for use against COVID-19 is Remdesivir, according to the National Institutes of Health.
Other drugs, such as Paxlovid, Sotrovimab, Molnupiravir, Bebtelovimab and Evusheld have received Emergency Use Authorization so they may be used in certain circumstances for non-hospitalized patients with COVID-19. Emergency Use Authorization is a special process for expedited use of therapeutics in an emergency where certain conditions are met, including a lack of alternative treatments.
How effective are these treatments against the latest variants?
Scientists are still assessing the effectiveness of these treatments against the latest variant, omicron BA.2. In the Southern region of the United States, which includes Alabama, Florida, Georgia, Kentucky, North Carolina, Mississippi, South Carolina and Tennessee, the latest CDC data showed omicron BA.2 accounting for about 21% of total cases.
The antiviral drugs appear to work against the latest variant, while monoclonal antibodies are less effective, according to The New York Times.
Sotrovimab was shown to effectively combat the original omicron variant, but early research shows a decline in its efficacy against omicron BA.2, according to Nature. The company that developed Sotrovimab issued a statement saying research indicates Sotrovimab “is sufficient to retain activity against the BA.2 variant” and promising more data in support of the drug soon.
Bebtelovimab is recommended by federal officials only when other treatments are not available or clinically appropriate.
A recent study showed Evusheld was the “most effective antibody treatment against the BA.2 variant.”
Who qualifies for these treatments?
For any of the antiviral drugs or monoclonal antibody treatments, a patient must be at high risk for progression to severe disease.
People who are elderly, smokers, pregnant, nursing home residents or people who have certain health conditions are considered high risk. A list of risk factors from the NC Department of Health and Human Services is here.
Paxlovid is available to patients 12 and older who weigh at least 88 pounds. Patients must be 18 or older to take Molnupiravir. The FDA does not recommend Molnupiravir for pregnant women.
People on certain medications, specifically those that inhibit or induce CYP3A, may need to adjust the timing and dosage if they are taking Paxlovid, federal officials warn. Individuals should tell their provider about any other medications or supplements they take before starting Paxlovid.
Remdesivir is FDA-approved for patients 12 and older who weigh at least 40 kg (88 lbs.). For pediatric patients under 12 who weigh at least 3.5 kg (7.7 lbs.), Remdesivir may be given under an Emergency Use Authorization if certain kidney-related tests are adequate.
Monoclonal antibody treatments Sotovimab and Bebtelovimab are available to patients who are at least 12 years old and weigh at least 40 kg (88 lbs). Sotovimab is not permitted for patients who are on oxygen because of COVID-19 or for patients who are on oxygen for a chronic condition and have had to increase oxygen due to COVID-19.
Evusheld is available to anyone 12 or older who weighs at least 40kg (88 lbs) who is moderately or severely immunocompromised or who are not recommended to receive a vaccine. Patients who opt to get Evusheld following a vaccine should wait at least two weeks after their vaccination.
How does one obtain these therapeutics?
Through a new federal government initiative, the Test of Treat program, “people who test positive for COVID-19 will be able to visit hundreds of local pharmacy-based clinics and federally-qualified community health centers (FHQCs), and residents of long-term care facilities will in one stop, be assessed by a qualified health care provider who can prescribe antiviral pills on the spot,” according to the U.S. Department of Health and Human Services.
Paxlovid and Molnupiravir will be available. Patients who test positive on a home test may also bring their test to the site to receive the drugs.
Patients who need Remdesivir or one of the monoclonal antibody treatments should go to a clinic or hospital. Find a treatment site through the searchable list provided by the North Carolina Department of Health and Human Services.
Evulsheld requires a prescription and is available in limited quantities at providers across the state.
How much do they cost?
Because the federal government purchased therapeutics from drug manufacturers and provided them to health care providers, patients may receive these medications for free.
Paxlovid, Molnupiravir, Bebtelovimab and Sotovimab are available without cost to the patient. Patients may incur expense related to the administration of monoclonal antibodies depending on provider.
Remdesivir is sold at $390 per vial or $2,340 for a 5-day regimen, while private insurance companies in the United States pay $520 per vial and $3,120 for a 5-day regimen, according to NPR. Patient costs will vary by insurance plan, and patients may incur a copay or other fee for the infusion appointment and process, NPR notes.
Evusheld is available through Medicare for about $150. For in-home administration to Medicare patients and in other specific circumstances, the injection costs about $250. For patients with private insurance, the cost may vary.
Are these treatments readily available in North Carolina?
Therapeutics for COVID-19 are allocated to states on a weekly basis.
For the week of March 21, North Carolina received 3,120 units of Paxlovid, 985 units of Bebtelovimab, 1,248 units of Molnupiravir, and 1,134 units of Sotovimab.
Are these treatments a substitute for vaccination?
No. Vaccines remain the best protection against COVID-19, according to federal and state public health officials.
As with any medical treatment, the therapeutics come with risks and side effects. Because the drugs are most effective early in infection, people who rely solely on treatments run the risk of their illness becoming severe before they seek treatment, Reuters reported.