COVID-19 News and Updates
Hello all,
Nina Duggan here with the latest COVID-19 news and updates.
This week we will be discussing a special summary of COVID-19 treatments currently authorized that has been assembled by Yale Medicine, and the FDA’s pulling Evusheld from the roster of COVID treatments.
COVID-19 Special: Update on Available Treatments
COVID-19 treatments currently available
The treatments available for COVID-19 have grown increasingly effective as we innovate and learn more about the virus. An important part of combatting the virus, especially if you are at high risk of adverse outcomes from COVID-19, is knowing the best treatment available for you and how to acquire it should you get sick. The majority of these drugs work best if taken early on in infection (within the first five days since testing positive), so make sure that you talk to your doctor about which treatment is right for you ahead of time.
Below is a summary taken directly from a document assembled by Yale Medicine on each of the currently authorized COVID-19 treatments, what they are, how to take them, and potential side effects.
It is important to note that the best way to fight COVID-19 is through preventative measures. Experts still encourage individuals to get the new bivalent vaccine if they have yet to, and to continue to partake in the current best COVID-19 prevention practices.
Paxlovid
What is it? Paxlovid is Pfizer’s brand name for an antiviral oral medication (in pill form) that combines two generic drugs, nirmatrelvir and ritonavir. It was the first COVID-19 antiviral pill to receive Food and Drug Administration (FDA) emergency use authorization (EUA), and the National Institutes of Health (NIH) has prioritized its use over other treatments for eligible patients. It is meant for people who have a current COVID-19 infection.
When it was authorized: December 2021.
Who can get it: People ages 12 and up who weigh at least 88 pounds, who have a positive COVID-19 test result, have symptoms, and are at high risk for developing severe COVID-19.
How you take it: For most people, the dose is three pills twice daily for five days, and it must be started within five days of developing COVID-19 symptoms.
Side effects: They’re usually mild, and may include altered or impaired sense of taste, diarrhea, increased blood pressure, or muscle aches. Because Paxlovid is still being studied, it’s possible that all of the risks aren’t yet known.
How it works: Paxlovid is an antiviral medication, a type of drug that stops viruses from replicating inside the body’s cells. Two of the pills in the three-pill dose are nirmatrelvir, which prevents the SARS-CoV-2 virus from replicating. The other medication is ritonavir, which gives the first drug’s levels a boost by essentially shutting down its metabolism in the liver, so that nirmatrelvir levels remain high and can work longer to fight the infection.
How well it works: In November 2022, the CDC reported on a real-world study that showed adults who took Paxlovid within five days of a COVID-19 diagnosis had a 51% lower hospitalization rate within the next 30 days than those who were not given the drug. The study included people who had been vaccinated or had a previous infection, which the CDC said implied the drug should be offered to people who are eligible regardless of their vaccination status. Previous information from Paxlovid’s clinical trial trial focused only on unvaccinated participants, and found 89% efficacy against hospitalization and death.
What else you should know: Paxlovid interacts with many medications, including common ones that are sold over the counter like St. John’s Wort, blood thinners, cholesterol medicines, and many more. In some cases, this can cause complications that are serious enough to justify not taking it. So, it’s important for health care providers to have an up-to-date medication list, including over-the-counter medications and supplements; they may consider other treatments for some patients. Pharmacists may also provide Paxlovid [with certain limitations], if they’ve opted to do so, provided you can share your electronic or printed medical records, including a list of medications you are already taking, and blood test results from the last 12 months.)
There is no experience treating pregnant women or breastfeeding mothers with Paxlovid. Women who are pregnant should discuss their options with their health care provider. It is also recommended that patients use effective barrier contraception or do not have sexual activity while taking Paxlovid.
Paxlovid is also not recommended for patients with severe liver or kidney disease and those with HIV who are not on treatment.
There have been reports of a “rebound” of COVID-19 symptoms in some people who have completed the five-day course of Paxlovid; in those cases, symptoms have recurred four or five days after completing the treatment. In June, the CDC released guidance for clinicians, saying a brief return of symptoms may be part of the natural history of SARS-CoV-2 infection in some people, independent of treatment with Paxlovid, adding that there is no evidence additional treatment is needed.
More information: FDA Paxlovid fact sheet for patients, parents, and caregivers.
Remdesivir
What is it? The antiviral treatment remdesivir, sold under the brand name Veklury, was the first COVID-19 therapy to get full FDA approval, and, so far, it's still the only one. Although originally used in COVID-19 patients only after they were hospitalized, new data suggests it can be helpful in outpatients who become infected and who are at high risk for severe disease. It is meant for people who have a current COVID-19 infection.
When it was authorized: Full approval was granted in October 2020. (It was first authorized in May 2020 for critically ill patients who were being treated with oxygen for COVID-19.) The authorization was later expanded to include other groups, and it was authorized to treat non-hospitalized patients in January 2022.
Who can get it: Fully approved for children and adults who are at high risk for severe disease. Infants and children must be at least 28 days old, weigh over 6.5 pounds or more, and be either hospitalized or at high risk for severe illness.
How you take it: Via injection or IV and administered only in a health care setting by a health care professional. For outpatients, the treatment is a three-day course of infusions that must be initiated within seven days of symptom onset.
Side effects: Nausea is the most common side effect. Hypersensitivity, including infusion-related and anaphylactic reactions, has been observed following treatment. There is insufficient data on the safety of using Remdesivir in pregnant women or women who are breastfeeding; patients should speak with their healthcare provider.
How it works: Administered intravenously to patients who are in the hospital or in an ambulatory setting, the drug inserts itself into new viral genes to block replication of the virus, shortening the time it takes seriously ill patients to recover. A number of experts believe that the drug may work best early in the course of an infection.
How well it works: 87% reduction in risk of hospitalization in non-hospitalized patients given a three-day course, according to a study published in The New England Journal of Medicine in December 2021.
What else you should know: For hospitalized patients, research in early 2020 showed that the therapy reduced the length of stay (the number of days in the hospital) from 15 days to 12. However, questions have been raised about Remdesivir’s trial results for hospitalized patients. In late 2021, the World Health Organization (WHO) recommended against Remdesivir after releasing data that showed disappointing results. Still, many U.S. hospitals continue to provide this medication.
This is one of two NIH-preferred therapies (after Paxlovid) for COVID-19.
More information: Gilead remdesivir fact sheet for patients.
Molnupiravir
What is it? Molnupiravir, also known by the brand name Lagevrio, was developed by Merck and Ridgeback Biotherapeutics. It was heralded as a potential game-changer when the companies announced their initial clinical trial results in 2021. But when the data was finalized, it showed the drug to have lower efficacy than originally reported. Its FDA authorization came after a close vote that took into account the lowered efficacy and safety profile. The Centers for Disease Control & Prevention (CDC) now recommends that this drug should be used when the above-mentioned treatments aren’t available.
When it was authorized: December 2021.
Who can get it: People ages 18 and up who are at high risk for hospitalization and death from COVID-19.
How you take it: Four capsules every 12 hours (for example, at 8 a.m. and 8 p.m.) for five days. It must be taken as soon as possible, within five days of symptom onset.
How it works: When the drug enters the bloodstream, it blocks the ability of the SARS-CoV-2 virus to replicate.
How well it works: 30% efficacy against hospitalization and death. Merck initially reported the efficacy as 50%, but later adjusted that figure. Some laboratory studies from Merck have shown that molnupiravir is effective against the Omicron variant.
Side effects: Diarrhea, nausea, and dizziness are the most common side effects. You should stop taking the pills right away if you have an allergic reaction. Because molnupiravir is still being studied, it’s possible that all of the risks aren’t yet known.
What else you should know: Molnupiravir is not recommended during pregnancy, since it has not been studied in pregnant women and has shown potential harm in in vitro studies—therefore, the true risk for harm to an unborn baby is unknown.
Individuals who are able to become pregnant should use reliable birth control during treatment and for four days after their last dose. It is also not known if molnupiravir could affect sperm, so individuals who are taking molnupiravir and who are sexually active with partners who are able to become pregnant should use reliable birth control during treatment and for three months after the last dose. (Studies to understand the risk to sperm beyond three months are ongoing.)
The NIH considers this to be an alternative treatment, which should be used only when neither of the NIH-preferred therapies (Paxlovid and remdesivir) is available, feasible to use, or clinically appropriate.
More information: FDA molnupiravir fact sheet for patients and caregivers.
For more information about various COVID-19 treatments, see the full summary of treatments assembled by Yale Medicine: COVID-19 Treatments: What We Know So Far
Important note about Evusheld: FDA pulls authorization of Evusheld following a drop in efficacy against the new variant
AstraZeneca’s antibody drug Evusheld has lost its emergency use authorization as the treatment does not effectively eliminate or reduce the omicron sub-variant XBB.1.5 currently circulating. The subvariant is currently the dominant variant in the United States. The drug had previously been used as a monoclonal antibody treatment to help those who were immunocompromised or could not obtain the vaccine fight off the virus and avoid adverse outcomes.
Source: NBC News “FDA pulls authorization for AstraZeneca’s Covid antibody drug Evusheld”.
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