COVID-19 Outpatient Treatments

January 18, 2022

Outpatient COVID-19 Treatment Updates

There are several therapies meant to prevent COVID-19 patients with high-risk medical conditions from becoming hospitalized, as follows:

  • Antiviral pills: Two oral therapies for the treatment of COVID-19, Pfizer’s Paxlovid and Merck’s molnupiravir, recently received FDA emergency use authorization. A limited supply of these antiviral pills will be distributed by L.A. County to select clinics and pharmacies, including those operated by UCLA Health.
  • Monoclonal antibody therapies: Effective monoclonal antibody therapies to treat symptomatic, high-risk COVID-19 patients are also extremely limited in supply at this time due to a national shortage. UCLA Health receives a limited weekly supply of sotrovimab, the only monoclonal antibody therapy that works against the omicron variant, from L.A. County. Casirivimab/imdevimab (manufactured by Regeneron) and bamlanivimab/etesevimab (manufactured by Eli Lilly), are not effective against the omicron variant.
  • Remdesivir: If we cannot offer sotrovimab due to supply limitations, a process is in place to offer high-risk patients a three-day course of remdesivir via IV. While sotrovimab is easier to administer, as it only requires a one-day infusion, the National Institutes of Health (NIH) lists three days of remdesivir as an option for patients at risk of COVID-19 disease progression.

Please note that individuals with good immune responses to vaccination and the booster are unlikely to develop severe COVID-19.

Guidelines for who to treat with outpatient therapies:

UCLA Health is following the recommendations put forth by the NIH regarding whom to treat with the available outpatient therapies. The NIH panel organized patients into four tiers, and prioritized them based on age, vaccination status, immune status and clinical risk factors.

Currently, we are only able to offer therapies to those patients who meet Tier 1 and Tier 2 criteria. Tiers 1 and 2 include immunocompromised individuals not expected to mount an adequate immune response to COVID-19 vaccination and unvaccinated individuals with additional risk factors.

Tier 1 and 2 conditions are as follows:

Tier 1:

  • Patients who are within one year of receiving B-cell depleting therapies (e.g., rituximab, ocrelizumab, ofatumumab, alemtuzumab)
  • Patients receiving Bruton tyrosine kinase inhibitors (e.g. ibrutinib, acalabrutinib, zanubrutinib)
  • Chimeric antigen receptor T cell recipients (CAR-T)
  • Post-hematopoietic cell transplant recipients who have chronic graft versus host disease or who are taking immunosuppressive medications for another indication
  • Patients with hematologic malignancies who are on or within 3 months of active therapy
  • Lung transplant recipients
  • Patients who are within one year of receiving a solid-organ transplant (other than lung transplant)
  • Solid-organ transplant recipients with recent treatment for acute rejection with T or B cell depleting agents
  • Patients with severe combined immunodeficiencies
  • Patients with untreated HIV who have a CD4 T lymphocyte cell count <50 cells/mm3
  • Unvaccinated patients who are 75 or older — or 65 and older with additional risk factors

Tier 2:

  • Unvaccinated patients who are 65 or older, or under 65 with additional clinical risk factors
  • Patients in active cancer treatment for non-hematologic malignancies (e.g. myelosuppressive chemotherapy)
  • Patients who received a solid-organ transplant more than one year ago and are on immunosuppressive drugs
  • Post-hematopoietic cell transplant recipients who received treatment within two years without GVHD / not taking immunosuppressive medications for another indication
  • Patients receiving treatment for moderate primary immunodeficiency
  • Patients with untreated/advanced HIV who have a CD4 T lymphocyte cell count <200 but >50 cells/mm3
  • Patients actively being treated with high-dose corticosteroids in less than or equal to 20 mg daily for at least two weeks, or actively taking other drugs (within one month) that may suppress their immune response

Monoclonal antibody therapy for pre-exposure prophylaxis

On Dec. 8, 2021, the FDA issued an emergency use authorization for a new combination monoclonal antibody therapy, Evusheld (tixagevimab/cilgavimab). Evusheld (manufactured by AstraZeneca) is authorized for pre-exposure prevention of COVID-19 in select high-risk individuals, such as those who are immunosuppressed and have not had an adequate response to vaccination, or those who are unvaccinated. Please note that this drug is not meant to replace vaccination.

UCLA Health will offer this therapy to select high-risk patients. A centralized team will allocate the limited supply based on risk of severe disease and risk of significant ongoing exposure.

This drug will not be available to patients by request or via provider order.