Monoclonal Antibodies for COVID-19
New Avenues to Pre-Exposure Prophylaxis
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Anti-SARS-CoV-2 Monoclonal Antibodies, Pre-exposure Prophylaxis, and the Omicron Variant: 22 Update
Immunocompromised people require additional protection against COVID-19 because they are unlikely to mount a full response to COVID-19 vaccinations and have a higher risk of severe outcomes if infected. In December 2021, an Emergency Use Authorization (EUA) was granted for pre-exposure prophylaxis in immunocompromised people. Here, Dr. Jonathan Li reviews trial data, EUA criteria, efficacy against the Omicron variant, and patient prioritization strategies.
What Does BA.2 Mean for Anti-SARS-CoV-2 Monoclonal Antibodies?
The rapid rise of the Omicron BA.2 subvariant around the world has led to an increase in cases, though the United States has thus far not need a surge as we did with the Omicron variant. BA.2 now makes up the vast majority of cases in the United States. Its mutations, differing from BA.1, have reduced activity of some anti-SARS-CoV-2 monoclonal antibodies, further limiting treatment options. Clinicians struggle to remain up-to-date on the constantly-changing data about anti-SARS-CoV-2 monoclonal antibodies that remain available for treatment and prophylaxis. Dr. Jonathan Li describes what we know thus far about the BA.2 subvariant, changes to monoclonal antibody use for treatment, and dosing changes for pre-exposure prophylaxis.
Preventing COVID-19 in Immunocompromised Patients
Immunocompromised patients have a much higher risk of contracting SARS-CoV-2 and progressing to severe COVID-19, including hospitalization or death. This group, however, is not homogeneous. Certain patients, such as those receiving organ transplants, have a much lower response to COVID-19 vaccinations. This population as a whole requires additional means of prophylaxis. Tixagevimab + cilgavimab anti-SARS-CoV-2 monoclonal antibody combination received an Emergency Use Authorization from the FDA for pre-exposure prophylaxis in immunocompromised patients. Drs Lewis Teperman and Jonathan Li discuss why immunocompromised patients have a higher risk of COVID-19, which patients are eligible for tixagevimab + cilgavimab, and how to prioritize patients in the face of logistical or supply constraints.
What Does BA.2 Mean for Anti-SARS-CoV-2 Monoclonal Antibodies?
The rapid rise of the Omicron BA.2 subvariant around the world has led to an increase in cases, though the United States has thus far not need a surge as we did with the Omicron variant. BA.2 now makes up the vast majority of cases in the United States. Its mutations, differing from BA.1, have reduced activity of some anti-SARS-CoV-2 monoclonal antibodies, further limiting treatment options. Clinicians struggle to remain up-to-date on the constantly-changing data about anti-SARS-CoV-2 monoclonal antibodies that remain available for treatment and prophylaxis. Dr. Jonathan Li describes what we know thus far about the BA.2 subvariant, changes to monoclonal antibody use for treatment, and dosing changes for pre-exposure prophylaxis.
Impact of Rising Viral Variants BQ.1 and BQ.1.1 on Immunocompromised Patients
Dr. Jonathan Li reviews the prevalence of BQ.1, BQ.1.1, and other viral variants in November 2022, implications of these variants, and potential changes to COVID-19 treatment and prevention. Immunocompromised patients will be disproportionally affected by any changes to treatment and prevention.
Clinical Practice Guidelines
COVID-19 Treatment Guidelines.
National Institutes of Health (NIH)
Clinician Resources
Federal response to COVID-19: monoclonal antibody clinical implementation guide.
Department of Health and Human Services (DHHS).
Talking with patients about monoclonal antibodies for COVID-19: tips and frequently asked questions.
DHHS.
Fact Sheet for Healthcare Providers: Emergency Use Authorization for bebtelovimab.
US Food and Drug Administration (FDA).
Fact Sheet for Healthcare Providers: Emergency Use Authorization of EVUSHELD™ (tixagevimab/cilgavimab).
FDA.
Fact Sheet for Healthcare Providers: Emergency Use Authorization of sotrovimab.
FDA.
OpenData Portal.
NIH.
Suggested Readings
Broadly neutralizing antibodies overcome SARS-CoV-2 Omicron antigenic shift.
Cameroni E, Bowen JE, Rosen LE, et al. Nature. 2022;602(7898):664-670.
The effectiveness of the two-dose BNT162b2 vaccine: analysis of real-world data.
Chodick G, Tene L, Rotem RS, et al. Clin Infect Dis. 2021;74(3):472-478.
Outcomes of laboratory-confirmed SARS-CoV-2 infection in the Omicron-driven fourth wave compared with previous waves in the Western Cape Province, South Africa.
Davies MA, Kassanjee R, Rosseau P, et al. medRxiv. 2022. [Epub ahead of print]
Evaluation of COVID-19 vaccine breakthrough infections among immunocompromised patients fully vaccinated with BNT162b2.
Di Fusco M, Moran MM, Cane A, et al. J Med Econ. 2021;24(1):1248-1260.
Antibody and T-cell responses to SARS-CoV-2 vaccination in myeloproliferative neoplasm patients.
How J, Gallagher KME, Liu Y, et al. Leukemia. 2022:1-4.
At the heart of the matter: unmasking and addressing the toll of COVID-19 on diverse populations.
Haynes N, Cooper LA, Albert MA. Circulation. 2020;142(2):105-107.
Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients.
Kamar N, Abravanel F, Marion O, Couat C, Izopet J, Del Bello A. N Engl J Med. 2021;385(7):661-662.
PROVENT: Phase 3 study of efficacy and safety of AZD7442 (tixagevimab/cilgavimab) for pre-exposure prophylaxis of COVID-19 in adults.
Levin M, et al. IDWeek; September 29-October 3, 2021. Virtual conference.
AZD7442 demonstrates prophylactic and therapeutic efficacy in non-human primates and extended half-life in humans.
Loo Y-M, McTamney PM, Arends RH, et al. Sci Transl Med. 2022. [Epub ahead of print].
Data and clinical considerations for additional doses in immunocompromised people.
Oliver S. Advisory Committee on Immunization Practices, Centers for Disease Control and Prevention; July 22, 2021.
Association between immune dysfunction and COVID-19 breakthrough infection after SARS-CoV-2 vaccination in the US.
Sun J, Zheng Q, Madhira V, et al. JAMA Intern Med. 2022;182(2):153-162.
Racial and ethnic disparities in receipt of medications for treatment of COVID-19—United States, March 2020-August 2021.
Wiltz JL, Feehan AK, Molinari NM, et al. MMWR Morb Mortal Wkly Rep. 2022;71(3):96-102.
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