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COVID-19

Monoclonal & Antiviral Therapy for Non-Hospitalized Patients


Introduction

This summary of recommendations is adapted from information provided by the California Department of Public Health (CDPH). It has been updated as of late December 2021 as Omicron has surpassed Delta in most regions of California to become the most predominant variant.

See the NIH COVID-19 Treatment Guidelines for comprehensive information and the CDC Health Advisory (12-31-21): Using Therapeutics to Prevent and Treat COVID-19

Who should receive outpatient therapy for COVID-19?
Individuals should be considered for outpatient therapy for COVID-19 if they meet the criteria below:
  • Are symptomatic with mild-moderate COVID-19 illness AND
  • Have a positive SARS-CoV-2 viral test result, AND
  • Are at high risk for progressing to severe COVID-19 and/or hospitalization.

The NIH definition of mild and moderate disease is below:

  • Mild Illness:
    Individuals who have any of the various signs and symptoms of COVID-19 (e.g., fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell) but who do not have shortness of breath, dyspnea, or abnormal chest imaging.
  • Moderate Illness:
    Individuals who show evidence of lower respiratory disease during clinical assessment or imaging and who have an oxygen saturation (SpO2) ≥94% on room air at sea level.

The Centers for Disease Control and Prevention (CDC) provides a list of risk factors for severe COVID-19. Some of the most important risk factors include (listed alphabetically): age (risk increases with each decade after age 50), cancer, cardiovascular disease, chronic kidney disease, chronic lung disease, diabetes, immunocompromising conditions or receipt of immunosuppressive medications, obesity (body mass index ≥30), pregnancy, and sickle cell disease.

For a complete list of risk factors for disease progression, including information on the relative risk of severe disease, see the CDC webpage Underlying Medical Conditions Associated with High Risk for Severe COVID-19. Of note, the likelihood of developing severe COVID-19 increases when a person has multiple comorbidities.

How to prioritize patients for treatment if not enough medication is available for all ill persons

Treatment should be prioritized in unvaccinated or incompletely vaccinated individuals and vaccinated individuals who are not expected to mount an adequate immune response (e.g., individuals who are immunocompromised or on immunosuppressive medications or individuals aged ≥65 years).

If supply remains limited after applying the above criteria, CDPH recommends additionally prioritizing high-risk patients with moderate illness as defined above in the following order:

  1.  Immunocompromised or on immunosuppressive medications
  2.  Incompletely vaccinated AND >65 years of age with risk factors for severe disease
  3.  >65 years of age with risk factors for severe disease

Molnupiravir is only authorized for use if alternative COVID-19 treatment options authorized by the FDA are not accessible or are not clinically appropriate. In cases where Paxlovid or sotrovimab are not available for treatment and the patient is at high risk, consideration should be given to Remdesivir IV daily for three days or molnupiravir can be considered.

For more information, see the California Health Alerts for Paxlovid and for Molnupiravir. For resources to aid in selecting patient clinical populations that should be prioritized for Evusheld administration, see below.

Additional guidance on patient prioritization can be found in the NIH 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.

Currently available treatments

In order of suggested use:

1) Sotrovimab

Sotrovimab (GSK) — 500 mg IV as a single infusion administered as soon as possible after diagnosis of COVID-19 and within 10 days of symptom onset.

  • Sotrovimab is a monoclonal antibody therapy
  • Treatment only; not approved for pre- or post-exposure prophylaxis
  • Supply is currently very limited
  • Allocation system to certain facilities, guided by local Medical Health Operational Area Coordinators (MHOACs). See Procuring medication for your patients for locations.
  • Use in persons 12 years of age and older weighing at least 40 kg

FDA: Fact sheet for health providers  |  Fact sheet for patient/caregivers

2) Paxlovid

Paxlovid (Pfizer) — nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use. If normal renal function, 300 mg nirmatrelvir (two 150 mg tablets) with 100 mg ritonavir (one 100 mg tablet), with all three tablets taken together twice daily for 5 days. Treatment started as soon as possible after diagnosis of COVID-19 and within 5 days of symptom onset.

Paxlovid is an oral protease inhibitor. Pfizer announced the results from a trial of 2,246 adults who received either Paxlovid or placebo. All patients had not received a COVID-19 vaccine and had not been previously infected with COVID-19. In the study, Paxlovid significantly reduced the proportion of people with COVID-19 related hospitalization or death from any cause by 88% compared to placebo among patients treated within five days of symptom onset. Paxlovid has received an EUA authorizing use for the treatment of mild to moderate COVID-19 in patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

  • Treatment only; not approved for pre- or post-exposure prophylaxis
  • Supply is currently limited
  • Allocations to pharmacies (with a healthcare provider prescription) and clinical sites is determined by LA County DPH. See Procuring medication for your patients.
  • Use in persons 12 years of age and older and older weighing at least 40 kg
  • Many drug-drug interactions
  • Paxlovid may lead to a risk of HIV-1 developing resistance to HIV protease inhibitors in individuals with uncontrolled or undiagnosed HIV-1 infection.
  • Providers should carefully review the Fact sheet for health providers before prescribing to ensure that the patient’s condition warrants treatment, that there are no drug interactions, and that there are no contraindications to therapy.

FDA: Letter of authorization | FAQs on the EUA  |  Fact sheet for health providers  |  Fact sheet for patient/caregivers

CDPH Health Alert (12-23-21): Authorization of Paxlovid for Treatment of Mild to Moderate COVID-19, Distribution, Patient Prioritization, and Ethical Considerations

3) Remdesivir

Remdesivir (Veklury – Gilead Sciences) — IV infusion for a total of 3 days initiated as soon as possible and within 7 days of symptom onset

  • Treatment only; FDA expanded EUA approval to include both inpatient and outpatient use in adults and children including those under 12 years of age and weighing at least 3.5 kg.
  • Ample supply. For additional information regarding purchasing or how to access remdesivir, please email remdesivir@amerisourcebergen.com, or call 1-800-746-6273 or reach out directly to your AmerisourceBergen representative.
  • Use in persons 12 years of age and older weighing at least 40 kg
  • CMS has created the Healthcare Common Procedure Coding System (HCPCS) code J0248 for reimbursement when administered in an outpatient setting. This code is available for use by all payers and is effective for dates of service on or after December 23, 2021. Additional information is available here.

FDA: EUA Letter of Authorization | Frequently Asked Questions for Veklury (remdesivir) | EUA fact sheet for health care providers | EUA fact sheet for parents/caregivers

4) Molnupiravir

Molnupiravir (Merck) — 800 mg (four 200 mg capsules) taken orally every 12 hours for 5 days. Treatment started as soon as possible after diagnosis of COVID-19 and within 5 days of symptom onset.

Molnupiravir is a nucleoside analogue that inhibits SARS-CoV-2 replication by viral mutagenesis. Merck announced results from a trial of 1,433 patients. Enrolled participants had not received a COVID-19 vaccination and had at least one risk factor associated with poor disease outcomes and symptom onset within five days prior to study enrollment. The risk of hospitalization for any cause or death through day 29 was lower with molnupiravir (6.8%) than with placebo (9.7%), for a relative risk reduction of 30%. Molnupiravir is authorized for treatment of mild-to-moderate COVID-19 in adults with positive results of direct SARS-CoV-2 viral testing who are at high risk for progressing to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by FDA are not accessible or clinically appropriate.

  • Treatment only; not approved for pre- or post-exposure prophylaxis.
  • Due to concern for side effects and decreased risk reduction compared to other available medications, Molnupiravir should only be used if other treatments are not available or not clinically appropriate (see How to prioritize patients above).
  • Supply expected to be initially more than Paxlovid.
  • Allocations to pharmacies (with a healthcare provider prescription) and clinical sites is determined by LA County DPH. See Procuring medication for your patients.
  • Use in adults 18 and older only, not recommended in pregnancy. If the provider and patient choose to use the product during pregnancy, it is advised the patient be registered in the Merck Pregnancy Surveillance Program.
  • Females of childbearing potential should use a reliable method of contraception correctly and consistently, as applicable, for the duration of treatment and for 4 days after the last dose of molnupiravir.
  • Males of reproductive potential who are sexually active with females of childbearing potential should use a reliable method of contraception correctly and consistently during treatment and for at least 3 months after the last dose.
  • Providers should carefully review the Fact sheet for health providers before prescribing to ensure that the patient’s condition warrants treatment, that there are no drug interactions, and that there are contraindications to therapy.

FDA: Letter of authorization | FAQs on the EUA  | Fact sheet for health providers  |  Fact sheet for patient/caregivers

CDPH Health Alert (12-24-21): Authorization of Molnupiravir for Treatment of Mild to Moderate COVID-19, Distribution, Patient Prioritization, and Ethical Considerations

Pre-exposure prophylaxis
Evusheld

Evusheld (Tixagevimab/cilgavimab)( (AstraZeneca) - has an EUA for pre-exposure prophylaxis against COVID-19. A combination of two long-acting anti-SARS-CoV-2 monoclonal antibodies administered via intramuscular injection, Evusheld is intended to protect individuals who are unable to mount an adequate immune response to COVID-19 vaccination or are unable to receive a COVID-19 vaccine due to severe adverse reaction.

Supplies are expected to be very limited. In California, CDPH is initially allocating product to Mutual Aid Regions with instructions to send treatment courses to transplant and cancer centers and other identified priority locations across their region. See Procuring medication for your patients.

As defined in the EUA, Evusheld is authorized as a pre-exposure prophylaxis in the following:

  • Adults and pediatric individuals (12 years of age and older weighing at least 40 kg):
    • Who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS-CoV-2 and either:
      • Who have moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination or
      • For whom vaccination with any available COVID-19 vaccine, according to the approved or authorized schedule, is not recommended due to a history of severe adverse reaction (e.g., severe allergic reaction) to a COVID-19 vaccine(s) and/or COVID-19 vaccine component(s).

According to the EUA, the medical conditions or treatments that may result in moderate to severe immune compromise and an inadequate immune response to COVID-19 vaccination include but are not limited to:

  • Active treatment for solid tumor and hematologic malignancies
  • Receipt of solid-organ transplant and taking immunosuppressive therapy
  • Receipt of chimeric antigen receptor (CAR)-T-cell or hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppression therapy)
  • Moderate or severe primary immunodeficiency (e.g., DiGeorge syndrome, Wiskott-Aldrich syndrome)
  • Advanced or untreated HIV infection (people with HIV and CD4 cell counts <200 /mm3, history of an AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV)
  • Active treatment with high-dose corticosteroids (i.e., ≥20 mg prednisone or equivalent per day when administered for ≥2 weeks), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor-necrosis (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory (e.g., B-cell depleting agents)

Prioritizing Evusheld administration: Given the overall limited supply, resources to aid in selecting patient clinical populations that should be prioritized for Evusheld administration include:

FDA: Letter of authorization | FAQs on the EUA  | Fact sheet for health providers  |  Fact sheet for patient/caregivers

 

Post-exposure prophylaxis
  • At this time there are no therapeutics authorized for post-exposure prophylaxis that are active against Omicron
Procuring medication for your patients
SUPPLIES ARE VERY LIMITED

Supplies of Paxlovid, Molnupiravir, Evusheld, and Sotrovimab are currently very limited.

This information is intended for medical providers. Information for the public is available here.

Supplies of Paxlovid are extremely limited. In LA County, only a few clinical sites and pharmacies are receiving supplies initially. The current list of available sites is below. Providers/patients should call ahead to check that product is available.

  • Angeles Community Health Center
    6120 Seville Ave
    Huntington Park, CA 90255
    Phone: (213) 413-4888
  • LA Christian Health Centers
    11625 E 4th St
    Los Angeles, CA 90033
    Phone: (213) 225-2671
  • Kaiser SC - Baldwin Park Medical Office Building 1
    1011 Baldwin Park Blvd.
    Baldwin Park, CA 91706
    Phone: (866) 319-4265
  • Mercy South Gate Pharmacy
    8116 California Ave Ste A
    South Gate, CA 90280
    Phone: (323) 206-4177
  • The Children's Clinic - SMTF
    455 E Columbia St, Ste 201
    Long Beach, CA 90806
    Phone: (562) 264-3558
  • Pico Care Pharmacy
    6650 Rosemead Blvd, #6652
    Pico Rivera, CA 90660
    Phone: (562) 364-7922
  • The Children's Clinic FHC Bellflower
    17660 Lakewood Blvd
    Bellflower, CA 90706
    Phone: (562) 264-3558
  • Herald Christian HC - El Monte
    33401 Aerojet Ave
    El Monte, CA 91731
    Phone: (626) 286-8700
  • SCMC - El Monte
    12100 Valley Blvd. Ste 109A
    El Monte, CA 91732
    Phone: (818) 203-5561
  • CVS Pharmacy 08854
    7101 Atlantic Ave
    Bell, CA 90201
    Phone: (323) 773-2025
  • Kedren Primary Care Clinic
    4211 Avalon Blvd
    Los Angeles, CA 90011
    Phone: (832) 687-3242
  • Martin Luther King Jr. Community Hospital
    11680 E 120th St
    Los Angeles, CA 90059
    Phone: (424) 338-8054
  • St. John's Well Child and Family Center
    8808 W. 58th Street
    Los Angeles, CA 90037
    Phone: (213) 549-1514
  • CVS Pharmacy #04018
    5837 S Central Ave
    Los Angeles, CA 90001
    Phone: (323) 233-2493
  • CVS Pharmacy #05808
    4775 W Rosecrans Ave
    Hawthorne, CA 90250
    Phone: (310) 263-7330
  • Rite Aid #06214
    1001 N Central Ave
    Compton, CA 90222
    Phone: (310) 639-1278
  • Rite Aid #06288
    959 Crenshaw Blvd
    Los Angeles, CA 90019
    Phone: (323) 939-7911
  • CVS Pharmacy #09120
    33800 Martin Luther King Jr Blvd
    Lynwood, CA 90262
    Phone: (310) 637-2509
  • CVS Pharmacy #09581
    4345 West Century Blvd
    Inglewood, CA 90304
    Phone: (310) 672-6078
  • Center for Family Health & Education
    8727 Van Nuys Blvd
    Panorama City, Ste 101, CA 91402
    PPhone: (818) 812-5410
  • Cosmed Pharmacy
    6521 Van Nuys Blvd
    Van Nuys, CA 91401
    PPhone: (818) 933-2010
  • Janeo, LLC DBA Elements Pharmacy
    12602 Ventura Blvd
    Studio City, CA 91604
    Phone: (818) 762-2055
  • John Wesley Health Center - Vermont
    954 N Vermont Ave
    Los Angeles, CA 90029
    Phone: (323) 454-4860
  • Kaiser SC - Panorama City
    113652 Cantara St, Rm 12R11
    Panorama City, CA 91402
    Phone: (866) 362-4939
  • Kaiser SC - Los Angeles Medical Center
    4867 W Sunset Blvd
    Los Angeles, CA 90027
    Phone: (323) 783-7910
  • Mid-Valley Comprehensive Health Center*
    7555 Van Nuys Blvd Pharmacy
    Van Nuys, CA 91405
    PPhone: (818) 904-5504 @dhs
  • Queenscare Health Center-Hollywood
    4618 Fountain Ave
    Los Angeles, CA 90029
    Phone: (323) 635-1140
  • SCMC - Van Nuys
    14550 Haynes St
    Van Nuys, CA 91411
    Phone: (818) 203-5561
  • Rite Aid 05456
    11321 National Blvd
    Los Angeles, CA 90064
    Phone: (310) 479-5729
  • Kaiser Permanente- South Bay
    225965 South Normandie Ave,
    Normandie North Pharm Dept 24Hr
    Harbor City, CA 90710
    Phone: (424) 328-2110
  • Los Angeles County Long Beach CHC*
    1333 Chestnut Ave, Rm 100-2
    Long Beach, CA 90813
    Phone: (562) 753-2400 @dhs
  • Paramount Family Pharmacy
    8010 2nd St
    Paramount, CA 90723
    Phone: (562) 531-1313
  • East Valley Community Health Center - Pomona
    1555 S. Garey Avenue
    Pomona, CA 91766
    Phone: (909) 802-0763
  • East Valley Community Health Center - West Covina
    420 S Glendora Ave
    West Covina, CA 91790
    Phone: (909) 802-0763
  • CVS Pharmacy #08864
    8400 Firestone Blvd
    Downey, CA 90241
    Phone: (562) 861-5460
  • Rite Aid #05525
    4525 E Pacific Coast Hwy
    Long Beach, CA 90804
    Phone: (562) 597-6520
  • Rite Aid #05591
    18993 Colima Rd
    Rowland Heights, CA 91748
    Phone: (626) 964-6714
  • High Desert Medical Group
    43839 15th St W
    Lancaster, CA 93534
    Phone: (661) 726-3806
  • High Desert Regional Health Center*
    335 E Avenue I Room 1A14
    Lancaster, CA 93535
    Phone: (661) 471-4100 @dhs
  • Huntington Hospital
    100 W. California Blvd.
    Pasadena, CA 91105
    Phone: (626) 344-6958
  • Kaiser Permanente-Antelope Valley
    43112 15th St W
    Lancaster, CA 93534
    Phone: (866) 362-5488
  • Medex Pharmacies
    8441 Foothill Boulevard
    Los Angeles, CA 91040
    Phone: (818) 925-1321
  • Bartz Altadonna CHC - Lancaster Gingham
    43322 Gingham Ave Ste 102
    Lancaster, CA 93535
    Phone: (818) 538-0429
  • Wesley Health Center Health Wellness
    45104 10th St W
    Lancaster, CA 93534
    Phone: (661) 942-4391
  • CVS Pharmacy #09709
    26861 Sierra Hwy
    Santa Clarita, CA 91321
    Phone: (661) 251-7346
  • CVS Pharmacy #09781
    2006 West Avenue J
    Lancaster, CA 93536
    Phone: (661) 945-2729
  • Rite Aid #06255
    1038 East Colorado Blvd
    Pasadena, CA 91106
    Phone: (626) 796-5539

*Available for DHS eligible patients. Patient eligibility for DHS services can be determined by visiting: https://dhs.lacounty.gov/patient-information/get-coverage/ or calling: (844)-804-0055.

Supplies of Molnupiravir are extremely limited. In LA County, only a few clinical sites and pharmacies are receiving supplies initially. The current list of available sites is below. Providers/patients should call ahead to check that product is available.

Supplies of Evusheld are currently very limited. Only the facilities in LA County listed below received the first shipment of medication. We hope to expand this network as supplies increase.

The points of contact listed below are intended for healthcare providers to use for referrals. This list is not meant for the general public, please have patients work through their healthcare provider to initiate a referral. 

 

Supplies of Sotrovimab are currently very limited. For a list of acute care hospitals that have received allocations of sotrovimab in Los Angeles County, visit the DHS EMS monoclonal antibody therapy webpage. Allocation is guided by local Medical Health Operational Area Coordinators (MHOACs). For questions and ordering information email laemsadutyofficer@dhs.lacounty.gov (for healthcare providers only).

There are ample supplies of Remdesivir. Facilities can order directly from manufacturer: vekluryhcp.com

Related resources

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