• CDPH Therapeutics update 03/30/2022
• VCPH Therapeutics update 04/05/2022
• CDC Interim Clinical Considerations for COVID-19 Treatment in Outpatients 06/15/2022
• HHS Assistant Secretary for Preparedness & Response Important Updates
• CDC Morbidity and Mortality Weekly Report (MMWR) 06/24/2022
  • Dispensing of Oral Antiviral Drugs for Treatment of COVID-19
  • Hospitalization and Emergency Department Encounters for COVID-19 After Paxlovid Treatment
• NIH Treatment Guidelines (updated 08/08/2022)
  • Updates posted by the COVID-19 Treatment Guidelines Panel; all recommendations included in the Guidelines are endorsed by a majority of Panel members (see Guidelines Development for additional details on the development process). Guidelines are updated in step with the rapid pace and growing volume of information regarding the treatment of COVID-19. Updated guidelines include:
    • Special Considerations in People Who Are Immunocompromised
    • Clinical Management of Children
    • Clinical Spectrum of SARS-CoV-2 Infection
    • Prevention of SARS-CoV-2 Infection
    • Therapeutic Management of Nonhospitalized Adults With COVID-19
    • Kinase Inhibitors: Janus Kinase Inhibitors and Bruton’s Tyrosine Kinase Inhibitors
• CDPH has allocated $59 million to the Test-to-Treat Grant program! Application cycle is open August 31, 2022 – September 30, 2022.
  • Providers are invited to visit the T2T Equity Grant Website for grant objectives, requirements, eligibility, funding opportunities, informational webinars, and more! Email t2t@phcdocs.org for more information.

• Do you have a clinical question about therapeutics? Email COVIDRxProviders@cdph.ca.gov.
• Receive frequent updates!
  • Register to attend biweekly webinars (Every other Monday from 12:00 pm – 1:00 pm). CDPH has a new webinar series for healthcare providers administering or interested in administering COVID therapeutics. These biweekly webinars will discuss therapeutics equity, education, clinical updates, storage and handling, and other timely and relevant topics related to COVID-19 Treatments.
  • Sign up to receive frequent email updates from CDPH.
• COVID-19 Treatments Toolkit (ca.gov)
• CDPH COVID-19 Test-to-Treat Playbook
• HHS Therapeutics Clinical Implementation Guide
• Pharmacists Resources
  • Electronic Data Transmission Prescriptions – Frequently Asked Questions – California State Board of Pharmacy
  • September 2021 Edition of The Script (ca.gov)

• Expiration Dating Extension | FDA
• Paxlovid Product Extension (4/5/22)
• Evusheld Product Extension (6/28/22)

Evusheld

AstraZeneca’s Evusheld (Tixagevimab co-packaged with Cilgavimab)
Type: A combination of two long-acting anti-SARS-CoV-2 monoclonal antibodies for Pre-Exposure Prophylaxis.
Administration Route: Intramuscular (IM) – for pre-exposure prophylaxis against COVID-19.
Timing: See Provider Fact Sheet for initial and repeat dosing.
Target Population: For individuals who have moderate to severe immunocompromised states and are not expected to mount an adequate response to vaccination or individuals for whom COVID-19 vaccination is contraindicated due to severe adverse reaction to vaccine. Must be at high risk for progression to severe COVID-19 symptoms.

• Evusheld EUA Letter
• Evusheld Fact Sheets
  • Provider Fact Sheet (Revised 06/29/2022 to recommend repeat dosing every six months)
  • Fact Sheet for Patient/Caregivers
  • Fact Sheet for Patient/Caregivers (Spanish)
• Evusheld Resources, Studies, and Related Articles
  • FAQs on the EUA
  • Efficacy of Antibodies and Antiviral Drugs against Omicron BA.2.12.1, BA.4, and BA.5 Subvariants | NEJM
  • Further humoral immunity evasion of emerging SARS-CoV-2 BA.4 and BA.5 subvariants | bioRxiv
  • Study: Evusheld Offers Significant Prevention Against Severe COVID-19 Disease, Death (pharmacytimes.com)
  • Evusheld shown to substantially decrease the risk of developing symptomatic COVID-19 infection for up to 6 months after administration. Click here to read the July 25, 2022 JAMA article.

Bebtelovimab

Eli Lilly’s Bebtelovimab
Type: Monoclonal Antibody
Administration Route: Intravenous Injection – one-time, intravenous injection over 30 seconds.
Timing: As soon as possible after diagnosis of COVID-19 and within 7 days of symptom onset.
Target Population: COVID-19 patients 12 years of age and older weighing at least 40 kg who are at high risk for progression to severe COVID-19 symptoms for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.

• Bebtelovimab EUA Letter
• Bebtelovimab Fact Sheets
  • Provider Fact Sheet
  • Fact Sheet for Patient/Caregivers
  • Fact Sheet for Patient/Caregivers (Spanish)
• Bebtelovimab Resources
  • Bebtelovimab has transitioned to the commercial marketplace. See the “How to obtain COVID-19 Therapeutics” section on this webpage for more information.

Paxlovid

Pfizer’s Paxlovid
Type: Oral antiviral – protease inhibitor.
Administration Route: By mouth (PO) – twice daily for 5 days.
Timing: As soon as possible after diagnosis of COVID-19 and within 5 days of symptom onset.
Target Population: COVID-19 patients 12 years of age and older weighing at least 40 kg who are at high risk for progression to severe COVID-19 symptoms. Many drug-drug interactions.

• Paxlovid EUA Letter (updated 08/05/2022)
  • Additional post authorization requirements for Pfizer to conduct:
    • A clinical trial in patients with “COVID-19 rebound”
      • To evaluate a subsequent 5-day treatment in patients with rebound.
    • A clinical trial evaluating different durations of treatment in immunocompromised patients with mild-to-moderate COVID-19
      • To evaluate safety and efficacy for either 5, 10, or 15 days of treatment.
• Paxlovid Fact Sheets
  • Provider Fact Sheet (updated 08/2022 with addition of new drug interactions)
  • Fact Sheet for Patient/Caregivers
  • Fact Sheet for Patient/Caregivers (Spanish)
• Paxlovid Resources
  • Information Sheet: Paxlovid Eligibility and Effectiveness (hhs.gov)
  • FAQs on the EUA for Paxlovid 07062022 (fda.gov)
  • PAXLOVID Patient Eligibility Screening Checklist and Drug Interaction Tool 08262022 (fda.gov)
  • Sample Paxlovid Prescription
  • Paxlovid Prescribing Resources
  • “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.” (CDC Health Advisory: COVID-19 Rebound After Paxlovid Treatment, 05/24/22)
  • Hospitalization and Emergency Department Encounters for COVID-19 After Paxlovid Treatment (CDC MMRW, 06/24/22)
  • Game Changer: Paxlovid Reduces Hospitalizations and Saves Lives (Epic Research, 07/26/2022)

Lagevrio (Molnupiravir)

Merck and Ridgeback’s Molnupiravir
Type: Oral antiviral – nucleoside analogue.
Administration Route: By mouth (PO) – every 12 hours for 5 days
Timing: As soon as possible after diagnosis of COVID-19 and within 5 days of symptom onset.
Target Population: COVID-19 patients 18 years of age and older who are at high risk for progression to severe COVID-19 symptoms. NOT recommended in pregnancy.

• Molnupiravir EUA Letter
• Molnupiravir Fact Sheets
  • Provider Fact Sheet (updated 08/05/2022)
    • Updated Section Microbiology (Section 12.4)
    • Addition of viral RNA rebound: Viral RNA Rebound Post treatment increases in SARS CoV 2 RNA shedding levels (i.e., viral RNA rebound) in nasopharyngeal samples were observed on Day 10, Day15, and/or Day 29 in a subset of LAGEVRIO and placebo recipients in the Phase 3MOVe OUT trial. Approximately 1% of both LAGEVRIO and placebo recipientshad evidence of recurrent COVID 19 symptoms coinciding with a rebound in viral RNA levels in nasopharyngeal samples. Post treatment viral RNA rebound wasnot associated with the primary clinical outcome of hospitalization or death through Day 29 following the single 5 day course of LAGEVRIO treatment. Posttreatment viral RNA rebound also was not associated with the detection of cell culture infectious virus in nasopharyngeal swab samples.
  • Fact Sheet for Patient/Caregivers
  • Fact Sheet for Patient/Caregivers (Spanish)
• Molnupiravir Resources
  • FAQs on the EUA

Remdesivir

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.

Not in federal allocation, providers interested in administering this treatment should contact the manufacturer directly for purchasing.

• Telehealth Resources (HHS)
• Health Equity in Telehealth
• California Telehealth Resource Center

Evusheld: At this time, providers must be reviewed and approved by the Medical Health Operational Area Coordinator (MHOAC). If approved by the MHOAC as an administering site, providers will register in the Health Partner Ordering Portal (HPOP) to receive Evusheld. To become a provider please email COVIDTherapeutics@ventura.org.

• Providers seeking small quantities of product (1-3 patient courses) may now directly order through www.OrderEvusheld.com
• A new call line is now available for Evusheld product and ordering information: 1-833-EVUSHLD (833-388-7453)

• Bebtelovimab
  • Bebtelovimab has transitioned to the commercial marketplace. To ensure there is no break in availability of Bebtelovimab to states/territories and providers, the U.S. Department of Health and Human Services has coordinated with Lilly to enable the transition from US government distributed supply to commercially available supply. Lilly has made the product commercially available for purchase through a sole distributor, AmerisourceBergen. Providers will need an existing account with AmerisourceBergen to purchase Bebtelovimab. Providers without an account may initiate the process by emailing AmerisourceBergen at asdaccountsetup@amerisourcebergen.com. For questions regarding access to Bebtelovimab please contact AmerisourceBergen at c19therapies@amerisourcebergen.com. View the U.S. Department of Health and Human Services Update and the CMS COVID-19 Vaccines and Monoclonal Antibodies webpage for reimbursement information.

• COVID-19 Uninsured Group Program (ca.gov)
• Frequently Asked Questions (FAQs) Presumptive Eligibility (PE) for Coronavirus (COVID-19) (ca.gov)
• Billing and Cost Sharing Overview for COVID-19 Vaccination, Testing, and Treatment | Bureau of Primary Health Care (hrsa.gov)
• Medi-Cal NewsFlash: Reminder: COVID-19 Oral Antivirals for Uninsured Group
• CMS COVID-19 Vaccines and Monoclonal Antibodies
• T2T Equity Grant

Click here to view the CDPH HPoP Reporting and Transfer instructions.

General inquiries: COVIDTherapeutics@ventura.org
Clinical questions: COVIDRxProviders@cdph.ca.gov
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