AFMC : A CLOSER LOOK
This was based on clinical trial data , which showed an 81 % reduction in the development of symptomatic COVID 19 when this therapy was used in household contacts of infected individuals 6 .
In Arkansas , monoclonal antibody therapy for COVID 19 is provided in a wide variety of settings , including hospital-associated infusion clinics , ERs , urgent care clinics , doctors ’ offices and pharmacy locations . Mobile clinics have been organized in correctional facilities and nursing homes in response to outbreaks of COVID 19 . In-home therapy through home infusion services is available in some parts of the state . Statewide utilization of REGEN-CoV increased by > 1000 % between July and August 2021 ( data supplied by HHS through tele-tracking ).
While significant strides have been made in the widespread availability of monoclonal antibody therapy in Arkansas , several challenges remain . Twenty-one ( 28 %) out of 75 Arkansas counties still do not have a local site where patients can access early treatment . In addition , patients who do not have an established primary care provider often encounter barriers in accessing care in the more rural parts of the state .
Real-world data from Arkansas has shown that monoclonal antibody therapy is safe and highly effective in the early treatment of COVID-19 infection . We believe that innovative approaches will be needed to overcome barriers , e . g ., using telehealth services for patient evaluation followed by subcutaneous therapy in local pharmacies or home infusions . Collaborative agreements between primary care practices and local pharmacies may be a model , which allows care to be made available closer to the patient ’ s home . As our current delta surge subsides , we expect the demand for monoclonal antibody therapy to drop . However , we must remain ever vigilant against newer viral variants and be prepared to reactivate the existing infrastructure of infusion clinics , pharmacies and home infusions in future surges . Newer monoclonal antibody therapies are in the pipeline and may offer more options to patients and providers in the face of a rapidly evolving virus . Monoclonal antibody therapy has changed our paradigm from test and isolate to test and treat . s
Table 1 : Indications for post-exposure prophylaxis with REGEN CoV :
• Individuals who are not fully vaccinated or who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination ( for example , people with immunocompromising conditions , including those taking immunosuppressive medications 1 ), and
• have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per Centers for Disease Control and Prevention ( CDC ), or
• who are at high risk of exposure to an individual infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting ( for example , nursing homes or prisons )
Prophylaxis with REGEN-COV is not a substitute for vaccination against COVID-19 . REGEN-COV is not authorized for pre-exposure prophylaxis to prevent COVID-19 before being exposed to the SARS- CoV-2 virus – only after exposure to the virus .
1 . www . cdc . gov / coronavirus / 2019-ncov / science / science-briefs / fully-vaccinated-people . html
REFERENCES :
1 . Salazar G , Zhang N , Fu TM , An Z . Antibody therapies for the prevention and treatment of viral infections . NPJ Vaccines . 2017 ; 2:19 .
2 . Pepper M . Monoclonal antibodies could fill the COVID-19 treatment gap until vaccines arrive — but at a cost 2020 [ www . seattletimes . com / seattle-news / health / monoclonal-antibodies-could-fill-the-covid- 19-treatment-gap-until-vaccines-arrive-butat-a-cost /.
3 . An EUA for Bamlanivimab-A Monoclonal Antibody for COVID-19 . JAMA . 2021 ; 325 ( 9 ): 880-1 .
4 . An EUA for casirivimab and imdevimab for COVID-19 . Med Lett Drugs Ther . 2020 ; 62 ( 1614 ): 201-2 .
5 . An EUA for bamlanivimab and etesevimab for COVID-19 . Med Lett Drugs Ther . 2021 ; 63 ( 1621 ): 49-50 .
6 . O ’ Brien MP , Forleo-Neto E , Musser BJ , Isa F , Chan KC , Sarkar N , et al . Subcutaneous REGEN-COV Antibody Combination to Prevent Covid-19 . N Engl J Med . 2021 .
7 . Dougan M , Nirula A , Azizad M , Mocherla B , Gottlieb RL , Chen P , et al . Bamlanivimab plus Etesevimab in Mild or Moderate Covid-19 . N Engl J Med . 2021 .
8 . FACT SHEET FOR HEALTH CARE PROVIDERS EMERGENCY USE AUTHORIZATION ( EUA ) OF REGEN-COVTM ( casirivimab and imdevimab ) 2021 [ FDA EUA Fact Sheet ]. www . fda . gov / media / 145611 / download .
9 . FACT SHEET FOR HEALTH CARE PROVIDERS EMERGENCY USE AUTHORIZATION ( EUA ) OF BAMLANIVIMAB AND ETESEVIMAB 2021 [ FDA EUA Fact Sheet ]. www . fda . gov / media / 145802 / download .
10 . Hinton DM . U . S . Food and Drug Administration Emergency Use Authorization Revocation for bamlanivimab 2021 [ www . fda . gov / news-events / press-announcements / coronaviruscovid-19-update-fda-revokes-emergencyuse-authorization-monoclonal-antibodybamlanivimab .
11 . An EUA for sotrovimab for treatment of COVID-19 . Med Lett Drugs Ther . 2021 ; 63 ( 1627 ): 97-xx8 .
12 . FACT SHEET FOR HEALTHCARE PROVIDERS EMERGENCY USE AUTHORIZATION ( EUA ) OF SOTROVIMAB 2021 [ FDA EUA Fact Sheet ]. www . fda . gov / media / 149534 / download .
Author affiliations : 1 . Arkansas Department of Health , Little Rock , AR 72205 2 . Department of Medicine , University of Arkansas for Medical Sciences ,
Little Rock , AR 72205 3 . Department of Bioinformatics , University of
Arkansas for Medical Sciences , Little Rock , AR 72205 4 . Baptist Health Medical Center , Little Rock , AR 72205 “ The views expressed in this paper are not necessarily those of the Arkansas Department of Health .”
Volume 118 • Number 5 nOVEMBER 2021 • 109