Atul Kothari MD FIDSA Medical Director Healthcare Associated Infections Program Associate Medical Director Infectious Diseases Branch Disclosures Off label use of some FDA EUA products will be discussed ID: 920066
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Slide1
Delta Variant and Monoclonal Antibodies: An Update
Atul Kothari, MD FIDSA
Medical Director Healthcare Associated Infections Program
Associate Medical Director Infectious Diseases Branch
Slide2Disclosures
Off label use of some FDA EUA products will be discussed
Slide3Case 1
32 y F, fully vaccinated with Pfizer, returned back to work after trip from Florida. As she had been fully vaccinated, no mask requirements were in place. On day 2 after return, she mentioned to a co worker about mild headache and congestion. She was asked to take off from work immediately and test for SARS COV 2. Testing returned back same day as positive. All co workers were fully vaccinated, case was working in her own office with no significant exposures to other co workers.
Case developed fevers up to 102, chills and flu like symptoms
Slide4Case 1…cont
Day 4 after initial test: 2 co workers reported mild congestion and tested positive on a rapid test, send home.
Day 4: 20 other co-workers tested, all negative
Remote working for 1 week
SNP sequencing on Case 1: Delta Variant identified
Slide5B.1.617.2
WHO Label: Delta*
First identified in India
Spike Protein Substitutions:
T19R, (G142D*), 156del, 157del, R158G,
L452R
, T478K, D614G,
P681R
, D950N
Increased transmissibility
Some monoclonal antibody treatments can be less effective
Risk of reduced effeciveness of currently available vaccines
* Delta also includes Pango lineage AY.1 and AY.2; these have additional
K417N
mutation, colloquially
delta plus
Slide6R0 estimates= number of people infected without masks or vaccines
Original Wuhan strain= 2.5
Alpha B.1.1.7= 4-5
Delta= 8
Delta: Transmissibility
Public Health England Technical Bulletin
Slide7Delta: Clinical Symptoms
Top symptoms: Headache, runny nose, sore throat
Fever and cough are less common
Slide8Delta: Severity of Infection
Cases often present faster and are sicker
Public Health England Report:
“significantly increased risk of hospitalization within 14 days of specimen date (HR
2.26
, 95% CI 1.32-3.89, p=0.003), and emergency care attendance or hospitalization within 14 days (HR 1.45,95% CI 1.08-1.95, p=0.015), for Delta cases compared to Alpha cases after adjustment for confounders”
Public Health England Technical Bulletin
Slide9Delta: Vaccine Effectiveness
Public Health England Technical Bulletin
Slide10Delta: Risk Assessment PHE
Public Health England Technical Bulletin
Slide11CDC: Level of Community Transmission
CDC COVID Data Tracker
Slide12Growth of Delta Variant: CDC Modelling and ADH Variant Report
CDC COVID Data Tracker, ADH Variant Report
Slide13Case 2
34
yo
M, physician, returned to Little Rock after spending time in India in late April 2021. He and his wife were fully vaccinated. They had tested negative before travel from India. They had a 1 day layover in New Delhi before travel. The physician started work after returning despite jetlag. Reported some flu like symptoms and tested positive for COVID 19. Both husband and wife developed more fevers and flu like symptoms. Wife was in 1
st
trimester. After discussion, both received monoclonal antibodies (within 3 days of diagnosis). Both improved and returned to work after completing isolation.
Sequencing identified Case 2 as B.1.617.1
Slide14Monoclonal Antibodies
The Seattle Times
Slide15Vaccination Uptake: Arkansas
Slide16Efficacy of Mab in Mild to Moderate COVID-19 (COV-2067)
Regeneron EUA HealthCare Provider Sheet
Slide17Who Should Get Mab Treatment
Slide18Who cannot get Mab treatment
Slide19RECOVERY Trial UK
www.Recoverytrial.net
Slide20ASPR/HHS Mab Distribution
Slide21Susceptibility of Mabs to Delta
Slide22June 3: REGEN-COV EUA Revisions
Slide23Subcutaneous Route: REGEN COV
Approved using PK PD data
Slide24REGEN COV Availability and Utilization: Arkansas
Slide25Regional Patterns
Slide26Take Home Points
More than 1 of 2 infections currently are due to delta, in
some counties
3 of 4
Highly transmissible, masks are protective
Vaccine breakthroughs are common with delta, though hospitalizations are infrequent
Monoclonal antibody therapy is effective given early in disease course
Monoclonal antibody therapy is underutilized in Arkansas
Consider discussing monoclonal antibody therapy and COVID 19 testing in your high risk patients even during routine care appointments
Slide27ADH Delta Map
Slide28Monoclonals Timeline FDA
EUA granted for
bamlanivimab
Nov 9, 2020, revoked April 16
EUA granted for
casirivimab
/
imdevimab
cocktail Nov 21, 2020 (reissued Feb 3, Feb 25 and June 3)
EUA granted for
bamlanivimab
and
etesevimab Feb 25, 2021; pause in nationwide distribution by ASPR and FDA Jun 25 2021EUA granted for Sotrovimab May 26 2021
HHS/ASPR oversees allocation and distribution of Regeneron monoclonal antibody cocktail
FDA Website
Slide29Overall Mab Availability and Utilization: Arkansas