In late January we saw the FDA Remove Authorization For Two Monoclonal Antibody Therapies Due To Omicron, which was followed two months later by FDA Limits Use Of Sotrovimab Monoclonal Antibody As Rising BA.2 Erodes Effectiveness.
At that time, sotrovimab was the last remaining monoclonal antibody believed effective against Omicron. Since then Lilly has begun shipping bebtelovimab, which reportedly retains some effectiveness (in vitro) against BA.2, but clinical data remains in short supply.
This left two oral antivirals (Paxlovid and molnupiravir) still available, but supplies of Paxlovid were initially quite limited, while molnupiravir provides significantly less effectiveness (30% vs 88%), and has several use restrictions (including in pregnant women, women who are breastfeeding, pediatric patients, etc.).
Due to the perceived paucity of therapeutics, there are reports that some doctors have been prescribing systemic corticosteroids and antibiotics to treat COVID outpatients with mild to moderate symptoms, neither of which are routinely recommended by the NIH or CDC.
Today the CDC has released an updated HAN advisory that discusses the current availability and recommended use of therapeutics against mild-to-moderate Omicron infection in outpatients.
I've just posted the highlights, clinicians will want to follow the link to read it in its entirety. I'll have a brief update after the break.
Updated Information on Availability and Use of Treatments for Outpatients with Mild to Moderate COVID-19 Who are at Increased Risk for Severe Outcomes of COVID-19
Distributed via the CDC Health Alert Network
Monday, April 25, 2022, 1:00 PM ET
CDCHAN-00463
Summary
The Centers for Disease Control and Prevention (CDC) is issuing this Health Alert Network (HAN) Health Advisory to update healthcare providers, public health departments, and the public about the availability and use of recommended therapies for COVID-19 and to advise against using unproven treatments that have known or potential harms for outpatients with mild to moderate COVID-19. For patients with mild to moderate COVID-19 who are not hospitalized and who are at increased risk for severe COVID-19 outcomes, several treatment options are now widely available and accessible.
Systemic corticosteroids are not recommend to treat patients with mild to moderate COVID-19 who do not require supplemental oxygen; patients who are receiving dexamethasone or another corticosteroid for other indications should continue therapy for their underlying conditions as directed by their healthcare providers. Antibacterial therapy is not recommended for the treatment of COVID-19 in the absence of another indication.
Staying up to date with COVID-19 vaccination is still the best way to prevent serious outcomes of COVID-19, including severe disease, hospitalization, and death.
Background
Early outpatient treatment of COVID-19 can avert serious, potentially life-threatening illness and reduce burden on the healthcare system. CDC issued a HAN Health Advisory on December 31, 2021 to address using therapeutics in the outpatient setting for people with COVID-19. At that time, Omicron cases were increasing rapidly in the United States and some COVID-19 therapeutics were in short supply. Now antivirals for COVID-19 are widely available and can be accessed with a provider prescription at pharmacies nationwide and at Test to Treat locations.
Data from CDC (1, 2) (highlighted in a February 13, 2021 CDC/ Infectious Diseases Society of America COVID-19 Clinical Call) and the Food and Drug Administration (3) suggest that there has been increasing use of systemic corticosteroids and antibiotics to treat outpatients with COVID-19.
However, these drugs can cause harm and provide no demonstrated benefit in patients with COVID-19 with no supplemental oxygen requirement or bacterial coinfection. Short courses of systemic corticosteroids have been associated with adverse events such as hyperglycemia, gastrointestinal bleeding, psychosis, infections, and longer-term effects (4–7).
The National Institutes of Health (NIH) provides COVID-19 Treatment Guidelines. The guidelines panel provides treatment options and recommends against using systemic corticosteroids to treat patients with mild to moderate COVID-19 who do not require supplemental oxygen (Figure). Patients who are receiving dexamethasone or another corticosteroid for other indications should continue therapy for their underlying conditions as directed by their healthcare providers. Systemic corticosteroids are recommended for hospitalized patients with COVID-19 who require supplemental oxygen or higher-level respiratory support.
The guidelines panel also recommends against using antibacterial therapy for COVID-19 in the absence of another indication. Antibacterial drugs have no benefit in treating viral infections and can cause harm.
(SNIP)
Recommendations for the Public
- If you test positive and are an older adult or someone who is at increased risk of getting very sick from COVID-19, treatment is available. Contact a healthcare provider right away after a positive test to determine if you are eligible for treatment, even if your symptoms are mild. You can also visit a Test to Treat location and, if eligible, receive a prescription from a provider at that location.
- Follow CDC guidance on testing for COVID-19 and use the Test to Treat locator or call 1-800-232-0233 (TTY 1-888-720-7489) to find a testing location that can provide treatment if you test positive.
- Don’t delay: Treatment must be started within the first few days of when your symptoms started to be effective.
- Staying up to date with COVID-19 vaccination is still the best way to prevent serious outcomes of COVID-19, including severe disease, hospitalization, and death.
It should be noted that vaccines still appear to provide significant protection against severe illness, hospitalization, and death, even though their ability to prevent breakthrough infection has fallen sharply.
Viruses have managed to exist for hundreds of millions of years because they are able to adapt to an ever-changing, and often hostile, environment.
Which is why it would be foolhardy for us to underestimate COVID's next move.
