COVID-19 Therapeutic Recommendations

Updated May 5, 2022

The following treatment recommendations are intended to assist Orange County providers in making COVID-19 treatment decisions. 

There are multiple anti-SARS-CoV-2 products that can be used for treatment or prophylaxis of COVID-19 that have received Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA).  However, providers should be aware of factors that have important implications for use of these products in patient care:

Community Sites Where Medications Have Been Distributed

  1. Area pharmacies that are designated by the Department of Health and Human Services to receive Paxlovid and molnupiravir, as well as facilities that receive distributions of monoclonal antibody products can be found through the Therapeutic Distribution Locator

Updated Recommendations

On April 25, 2022 the FDA expanded it approval of remdesivir (Veklury) for the treatment of COVID-19 to include pediatric patients 28 days of age and older weighing at least 3 kilograms (about 7 pounds) with positive results of direct SARS-CoV-2 viral testing who are:

Hospitalized, or

Not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.

On April 14, 2022 Pfizer released a Dear Healthcare Provider letter to make providers aware of modifications to the EUA and the availability of a PAXLOVID 150 mg ; 100 mg Dose Pack that may be used for patients with moderate renal impairment (eGFR ≥30 to <60 mL/min). In addition, healthcare providers should be aware of the possibility of differences in the ritonavir tablet appearance, including shape, color, and debossing, depending on the package.

On March 30, 2022 the FDA limited the use of Sotrovimab in additional U.S. regions due to the BA.2 Omicron sub-variant. With this revision Sotrovimab is no longer authorized for use in California.  As such we have removed it from our list of therapeutic agents for non-hospitalized patients with COVID-19.

On February 24, 2022 the FDA revised its EUA for Evusheld (tixagevimab co-packaged with cilgavimab). Based on recent data Evusheld may be less active against certain Omicron subvariants. The FDA increased the initial authorized dose to 300mg of tixagevimab and 300 mg of cilgavimab.  Patients who have already received the previously authorized dose (150 mg of tixagevimab and 150 mg of cilgavimab as soon as possible.


Recommendations for Treatment of Nonhospitalized patients with COVID-19: NIH Guidelines

The National Institutes of Health (NIH) COVID-19 Treatment Guidelines Panel is regularly updating its recommendations for Therapeutic Management of Nonhospitalized Adults With COVID-19.  The panel recommends using one of the following therapeutics (listed in order of NIH preference, with the NIH panel’s comments on each product included):

  1. Nirmatrelvir 300 mg with ritonavir 100 mg (Paxlovid) for information on dosing, administration, and safety, including information on drug interactions for Paxlovid review the FDA Fact Sheet for Healthcare Providers Emergency Use Authorization (EUA) of PAXLOVID.
    1. Ritonavir-boosted nirmatrelvir (Paxlovid) has significant and complex drug-drug interactions, primarily due to the ritonavir component of the combination.
    2. Before prescribing ritonavir-boosted nirmatrelvir (Paxlovid), clinicians should carefully review the patient’s concomitant medications, including over-the-counter medications and herbal supplements, to evaluate potential drug-drug interactions. See the Panel’s statement on the drug-drug interactions for ritonavir-boosted nirmatrelvir (Paxlovid) for details.
    3. For those with moderate renal impairment (eGFR ≥30 to <60 mL/min) a 150 mg Nirmatrelvir with 100 mg ritonavir dose pack is now available.
  2. Bebtelovimab For information on dosing, administration, and safety of Bebtelovimab, review the FACT Sheet for Healthcare Providers: Emergency Use Authorization for Bebtelovimab
    1. Bebtelovimab may only be administered in settings in which healthcare providers have  immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary.
    2. Clinically monitor patients for possible infusion-related reactions during administration and observe patients for at least 1 hour after injection is complete.
  3. Remdesivir (Veklury) For information on dosing administration and safety and use of remdesivir for both pediatric and adult populations  review the FDA approved package insert
    1. Remdesivir should be administered in a setting where severe hypersensitivity reactions, such as anaphylaxis, can be managed. Patients should be monitored during the infusion and observed for at least 1 hour after infusion.
  4. Molnupiravir For information on dosing, administration and safety of Molnupiravir review the Fact Sheet for Healthcare Providers: Emergency Use Authorization (EUA) for Molnupiravir.
    1. The FDA EUA states that molnupiravir is not recommended for use in pregnant patients due to concerns about the instances of fetal toxicity observed during animal studies. However, when other therapies are not available, pregnant people with COVID-19 who are at high risk of progressing to severe disease may reasonably choose molnupiravir therapy after being fully informed of the risks, particularly those who are beyond the time of embryogenesis (i.e., >10 weeks’ gestation). The prescribing clinician should document that a discussion of the risks and benefits occurred and that the patient chose this therapy.
    2. There are no data on the use of molnupiravir in patients who have received COVID-19 vaccines, and the risk-to-benefit ratio is likely to be less favorable because of the lower efficacy of this drug. 

Recommendations for Pre-Exposure Prophylaxis for COVID-19

Tixagevimab plus cilgavimab (Evusheld) For information on dosing, administration and safety of Evusheld review the Fact Sheet for Healthcare Providers: Emergency Use Authorization for Evusheld.

  • Evusheld is authorized for use as SARS-CoV-2 PrEP for individuals who have moderate to severe immunocompromising conditions that may result in an inadequate immune response to COVID-19 vaccination. Unlike anti-SARS-CoV-2 agents used for treatment, tixagevimab plus cilgavimab (Evusheld) is not authorized for use in unvaccinated individuals unless full vaccination is not possible due to a history of severe allergic reaction to the COVID-19 vaccine. Generally speaking, those who qualify for PrEP because of allergy to the vaccine or contraindication to vaccination are less likely to suffer severe consequences, unless they are also moderately to severely immunocompromised.

 

Please review The COVID-19 Treatment Guidelines Panel’s Interim Statement on Patient Prioritization for Outpatient Anti-SARS-CoV-2 Therapies or Preventive Strategies When There Are Logistical or Supply Constraints if facing issues limited supplies of medications.