Updated May 25, 2022
Paxlovid treatment helps prevent hospitalization and death due to COVID-19. COVID-19 rebound has been reported to occur between 2 and 8 days after initial recovery and is characterized by a recurrence of COVID-19 symptoms or a new positive viral test after having tested negative. A brief return of symptoms may be part of the natural history of SARS-CoV-2 (the virus that causes COVID-19) infection in some persons, independent of treatment with Paxlovid and regardless of vaccination status. Limited information is currently available.
This information can help physicians in decision making for adult and patients 12 years and older with mild-to-moderate COVID-19. It can help answer questions like, How should I assess a patient for high risk for progression to severe COVID-19?
The FDA has also released a Patient Eligibility Screening Checklist, along with a list of other drugs with potentially significant drug interactions. Early treatment of at-risk patients with Paxlovid and other available authorized or approved therapeutics could make a difference.
Evidence indicates that masks, along with vaccination and physical distancing, are still the best ways to slow the spread of COVID-19. With highly contagious variants like Omicron, high-quality KN95/KF94 masks, and N95 respirators, are more effective than cloth and surgical masks. In late February, the CDC announced it would use different metrics to support masking and other COVID mitigation guidance. People in areas of high transmission, regardless of vaccination status, should wear masks indoors.
These guidelines provide recommendations for treatment of patients in the hospital and outpatient setting and are updated as new evidence is available. Currently there is only one treatment (remdesivir) that is approved for treatment of COVID-19. On Jan. 21, the FDA expanded the remdesivir EUA to outpatients 12 years and older. All others are available for use under emergency use authorization (EUA).
Currently there is only one treatment (remdesivir) that is approved for treatment of COVID-19; all others are available for use under EUA.
The changes in approval and authorization for use of remdesivir in the outpatient setting were based on a randomized control trial with 562 patients that demonstrated decreased hospitalization compared to placebo (0.7% vs 5.3%).
The FDA has updated the Evusheld EUA to increase the dosage after data showed Evusheld may be less active against certain Omicron subvariants. Patients receiving the original dose should be called back to receive an additional dose. This extends duration of protection and overcomes resistance from several Omicron subvariants.
With the rapid spread of the Omicron variant, limited supplies of tests and therapeutics, and changing information on treatments, COVID-19 remains a challenging space for AAFP members. Replay the conversation to hear more about COVID-19 treatments, including evidence, benefits and risks to patients, and other information to support patient care.
The FDA has issued an Emergency Use Authorization (EUA) for several monoclonal antibody treatments for COVID-19. On Feb. 11, the FDA issued an EUA for bebtelovimab for treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older) who are at high risk for progression to severe COVID-19. More information can be found here:
As of Jan. 24, the FDA is limiting use of two treatments for patients are likely to have been infected with, or exposed to, a variant that responds to these treatments. Data show bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab) treatments are highly unlikely to be active against the omicron variant. On April, 5, the FDA halted Somtrovimab distribution in U.S when the CDC estimated COVID-19 cases caused by the Omicron BA.2 variant was above 50% in all HHS regions. The use of sotrovimab is not authorized at this time.
Distribution and use of the monoclonal antibodies will vary by region in response to changes in circulating variants. These treatments are only available following a prescription and must be administered by a clinician via intravenous infusion or subcutaneous injections. Watch the AAFP's Monoclonal Antibody Treatments for COVID-19 web page for additional updates.
The FDA has given EUAs to two oral medications to treat COVID-19. Physicians should discuss the benefits and risks with patients before prescribing. These medications are for the treatment of mild-to-moderate COVID-19 in individuals at risk for progression to severe COVID-19:
On Dec. 21, 2021, the FDA gave Emergency Use Authorization for Paxlovid, an antiviral oral medication which may reduce hospitalization and death due to COVID-19. The EUA was based on limited data in slightly over 2,000 adults who received paxlovid twice daily for five days following positive PCR test (within 5 days of symptom onset). The number of individuals hospitalized for COVD-19 was significantly lower in the treatment group (n = 8) compared to placebo (n = 66). Note: there are not specific data for the use of paxlovid in individuals who are pregnant or lactating or for children/adolescents younger than 18.
Paxlovid is not recommended in patients with severe kidney or severe liver impairment. In patients with moderate renal impairment, a reduced Paxlovid dose is needed. Side effects observed include impaired sense of taste, diarrhea, high blood pressure and muscle aches. There are potentially significant drug interactions—clinicians should review the full list of drug interactions.
Specifically, use in individuals with uncontrolled or undiagnosed HIV infection may lead to HIV drug resistance and there is a potential for liver damage so use in individuals with liver disease, liver inflammation, or liver enzyme abnormalities should be done with caution. Paxlovid can decrease hormonal contraception effectiveness, so patients will need to be counseled to use back up contraception. More information can be found in the EUA fact sheet.
On May 4, 2022, the FDA released new guidance on Paxlovid to provide more information on how and when it should be used as a treatment. They also provided a tool to help health care providers determine who is eligible.
There have been reported cases of rebound COVID-19 after treatment with Paxlovid. Read more in the CDC Health Alert.
The FDA gave emergency use authorization for a second oral medication, molnupiravir, which may prevent hospitalization. The authorization is limited to individuals aged 18 and older for whom other COVID-19 treatments are not an option.
It is not recommended for individuals who are pregnant based on results of animal studies and should only be prescribed following a discussion of the benefits and risks for the pregnant individual. Individuals of childbearing age should use contraception to prevent pregnancy and individuals who are lactating should discontinue or pump and discard during and for four days after completing treatment.
Authorization of molnupiravir was based on limited data in approximately 1,400 adults who received molnupiravir twice daily for five days following positive PCR test (within 5 days of symptom onset). The number of individuals hospitalized for COVD-19 was slightly lower in the treatment group (n = 48) compared to placebo (n = 68). Please note that there are not specific data for individuals who are pregnant or lactating. More information can be found in the fact sheet.
This locator site by HHS displays public locations that have received shipments of U.S. Government-procured COVID-19 therapeutics under EUA. The locations displayed in the locator have reported stock on hand within the last day.