Pemivibart Pre-exposure Prophylaxis for COVID-19
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Quick Facts
- A new intravenous monoclonal antibody for SARS-CoV-2 pre-exposure prophylaxis was granted emergency use authorization in April 2024
- Use is restricted to adults and pediatrics ≥12 years and ≥40kg who are:
- uninfected with SARS-CoV-2 with no known recent exposure AND
- unexpected to mount an immune response to SARS-CoV-2 vaccination AND
- authorized for drug and administration coverage by their insurance plan
- The EUA is based on immunobridging studies in immunocompromised hosts demonstrating correlation between SARS-CoV-2 neutralizing antibody titers and titers associated with clinical efficacy data of the parent mAb of pemivibart. Full clinical data are pending.
- Patients must be monitored closely during and after completion of the infusion for hypersensitivity and infusion related reactions.
- The EUA Fact Sheet for Patients, Parents, and Caregivers is available here
| Medical Conditions and Treatments contributing to moderate to severe immune compromise and an inadequate immune response to COVID-19 vaccination | |
|---|---|
| A | Active treatment for solid tumor and hematologic malignancies |
| B | Hematologic malignancies associated with poor responses to COVID-19 vaccines regardless of current treatment status (e.g., chronic lymphocytic leukemia, non-Hodgkin lymphoma, multiple myeloma, acute leukemia) |
| C | Receipt of solid-organ transplant or an islet transplant and taking immunosuppressive therapy |
| D | Receipt of chimeric antigen receptor (CAR)-T-cell or hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppressive therapy) |
| E | Moderate or severe primary immunodeficiency (e.g., common variable immunodeficiency disease, severe combined immunodeficiency, DiGeorge syndrome, Wiskott-Aldrich syndrome) |
| F | 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) |
| G | 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, and biologic agents that are immunosuppressive or immunomodulatory (e.g., B-cell depleting agents) |
Pemivibart is dosed 4500mg intravenously over 60 minutes, every 3 months. No adjustment is required for renal or hepatic dysfunction. The dose is unchanged based on patient weight.
Pemivibart demonstrates activity against spike RBD proteins of ancestral SARS-CoV-2 and Omicron variants, including one of the most common circulating variants at present in the US, JN.1. Activity against the rising KP variants, also of the Omicron lineage and a descendant of JN.1, is under investigation. The FDA is closely monitoring the activity of this therapeutic against circulating variants and will provide guidance on when authorization for pemibivart will be revoked based on changes in susceptibilities. The CDC offers publicly available variant tracking and forecasting.
Yes, pemivibart may be administered to patients who have received COVID-19 vaccination. However, pemivibart should be administered at least 2 weeks after COVID-19 vaccination. Patients should wait a minimum of 28 days to receive COVID-19 vaccination after pemivibart administration.
Nine percent (27/306) of patients who received 2 doses of pemivibart experienced hypersensitivity or an infusion related reaction. Of these, 93% (25/27) had mild to moderate reactions, and 2 patients experienced anaphylaxis. Preliminary analysis of the clinical study data indicate that hypersensitivity reactions may occur with the same frequency after the 2nd dose as compared with the 1st dose of pemivibart.
Patients will be monitored closely during and for 2 hours after infusion for hypersensitivity, including anaphylaxis and infusion-related reactions. The infusion time of 60 minutes is extended from the original 30-minute infusion time used in the clinical study, to mitigate infusion-related reactions.
COVID-19 vaccination remains the only other therapy available for the prevention of infection due to SARS-CoV-2. Additional therapeutics are under development for pre-exposure prophylaxis; none are available yet for clinical use.
Providers and patients should consider the risk of infection and the benefits of antibody protection with this long-acting monoclonal antibody. Additionally, the risks of infusion related reactions and hypersensitivities, including anaphylaxis, should be discussed. Lastly, cost, insurance coverage, and coordination of administration are all important considerations for individual patient decision making. Providers must distribute an EUA patient fact sheet to patients prior to administering pemivibart.
Given the high frequency of hypersensitivity and infusion related reactions associated with pemivibart alone, we advise against co-administering with other therapeutics.
The drug cost of Pemivibart is nearly $6000. Pemivibart and its administration are covered by Medicaid and Medicare Part B with no copayment from the individual patient. At this time, coverage by other insurers is unknown and patients may have a significant out of pocket cost. Pre-authorization prior to administration is required.
Pemivibart will be administered in all Fred Hutch infusion sites.