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Eligibility for
InitiationofCOVID-
19 OralAntiviral
Clinical StagingofCOVID-19
Clinical
Stage
Disease Severity
1 Asymptomatic
2 Symptomatic, No Pneumonia
3 Symptomatic, Pneumonia
4 Symptomatic, Pneumonia, Requiíing supplemental
oxygen*
5 Critically ill with multi-organ involvement
*In patients who present with hypoxia, it is important to determine if the
cause is due to COVID-19 pneumonia or other causes (e.g. bronchial asthma,
fluid overload and heart failure). Positive SST does not necessarily categorize
the patients as category 4.
Nirmatrelvir 300mg / Ritonavir
100mg (Paxlovid) BD for 5 days
FirstLine
COVID-19OralAntiviralTreatment
02
Patients
onoxygen
Liverfailure
Age<18
years old
Symptoms
onset>5days
Endstage
renalfailure
Pregnancy/
Breastfeeding
01
03
04
05
06
NonIndications/Contraindications
Not eligible
Not to start
No
Yes
Eligible
GUIDEFORINITIATINGCOVID-19ORALANTIVIRALIN
PRIMARYCARE(CAC/HEALTHCLINIC)
Process
Start
Physical arrival of COVID-19
positive patient
Meet criteria of starting oral antiviral
(≥18 years old, symptomatic and
onset within 5 days)
*Assessment based on 
eligibility & check for
absolute
contraindication(s):
-Pregnant/ breastfeeding
-Drug-drug interactions
-Severe liver/renal disease
Responsibilities
Family Medicine Specialist/
Medical Officer
Family Medicine Specialist/
Medical Officer
Process
**Patient education and
initiation of antiviral
Approval to initiate antiviral
Continue MySejahtera HAT
until digital Release Order
Responsibilities
End
Family Medicine Specialist
Medical Officer &
Pharmacist
Virtual CAC Team
Checklist
Table5:SevereImmunocompromisedConditions
• Patients who are within 1 year of receiving B-cell
depleting therapies (e.g., rituximab, ocrelizumab,
ofatumumab, alemtuzumab)
• Bone marrow transplant / Solid organ transplant on
immunosuppressive therapy
• Patients with hematologic malignancies/ cancer who
are on active chemotherapy
• Patients with severe combined immunodeficiencies
• Patients with untreated HIV who have a CD4 T
lymphocyte cell count <50 cells/mm
• Chronic lymphocytic leukaemia and multiple myeloma
with hypogammaglobulinemia
Paxlovid™ Summary
10
• Paxlovid™ reduced COVID-19 related hospitalization and death by 88% when
given within 5 days of symptom onset, without concerning safety findings, in
the clinical trial EPIC-HR.
• Key Things to Remember When Prescribing:
– Multiple drug interactions
– Reduced dose for moderate renal impairment
– Contraindicated in patients with severe renal impairment or severe hepatic
impairment, pregnant patients, and patients requiring oxygen
– Not indicated in patients below 18 and patients with symptom onset > 5 days
Data on Safety: EPIC-HR*
11
• Adverse events (AEs) seen in ≥1% of Paxlovid™ recipients
(n=1,109) with a higher frequency (≥5 subject difference)
versus placebo recipients (n=1,115):
– Dysgeusia (6% versus <1%)
– Diarrhea (3% versus 2%)
– Hypertension (1% versus <1%)
– Myalgia (1% versus <1%)
*The study population excluded children, pregnant women, individuals with GFR <45 mL/min/1.73 m2, individuals with active liver
disease, and individuals taking concomitant medications that could have clinically significant drug interactions with Paxlovid™.
Drug Interactions
12
• As a healthcare provider, you should:
– Inform patients that Paxlovid™ may interact with some drugs and is
contraindicated for use with some drugs
– Obtain a complete medication list from your patient (including
nonprescription drugs and herbals)
– Check for clinically significant drug interactions:
– Based on the drug interactions, decide if:
• Paxlovid™ use is appropriate versus an alternative authorized treatment
• If appropriate, whether your patient should hold, change, or dose-reduce other
medications while taking Paxlovid™, or if additional monitoring may be needed
Specific Populations: Renal Impairment
13
eGFR* PAXLOVID™Dose
Greater than 60 mL/min
(normal renal function or mild renal impairment)
300 mg nirmatrelvir with 100 mg ritonavir, taken
twice daily for 5 days
>30 to <60
mL/min
(moderate renal
impairment)
150 mg nirmatrelvir with 100 mg ritonavir, taken
twice daily for 5 days
<30mL/min
(severe renal impairment)
PAXLOVID™ is not recommended (the appropriate
dose has not been determined)
*
eGFR = estimated glomerular filtration rate based on the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI)
formula
TakeHomeMessage
OralAntiviralis only
effectiveifinitiatedwithin
5daysofsymptoms
ContinueroutineHome
AssessmentTooland
managementas percurrent
guideline
OralAntiviralis notto
replacevaccinationand
preventivemeasures
InitiationofOral
Antiviralaccordingto
thecurrentEligibility
System
Case Samples
CaseStudy1
Not having any symptoms
34 yeaís old
No known medical illness
Self Test is positive
Not Indicated
16 years old
Bíonchial Asthma
Self Test is positive
Fever for 1 day
CaseStudy2 Contraindicated
CaseStudy3
65 years old
Self Test is positive
Having fever and headache
(Day 2 of symptoms)
Hypertension
Indicated
CaseStudy4
50 years old, incomplete
vaccination, has diabetes with
morbid obesity
Self Test is positive
Has fever for 2 days and
sore
throat for 3 days
Indicated
CaseStudy5
72 years old
Self Test is positive
Fever and diarrhea for 2 days
Diabetes, CKD Stage
1
Indicated
PCR SARS CoV-2 is negative
Fever and diarrhea for 2 days
60 years old
Diabetes, Hypertension
CaseStudy6
Thankyou
Anyquestions?

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CME Paxlovid.pptx

  • 2. Clinical StagingofCOVID-19 Clinical Stage Disease Severity 1 Asymptomatic 2 Symptomatic, No Pneumonia 3 Symptomatic, Pneumonia 4 Symptomatic, Pneumonia, Requiíing supplemental oxygen* 5 Critically ill with multi-organ involvement *In patients who present with hypoxia, it is important to determine if the cause is due to COVID-19 pneumonia or other causes (e.g. bronchial asthma, fluid overload and heart failure). Positive SST does not necessarily categorize the patients as category 4.
  • 3. Nirmatrelvir 300mg / Ritonavir 100mg (Paxlovid) BD for 5 days FirstLine COVID-19OralAntiviralTreatment
  • 4.
  • 6. Not eligible Not to start No Yes Eligible GUIDEFORINITIATINGCOVID-19ORALANTIVIRALIN PRIMARYCARE(CAC/HEALTHCLINIC) Process Start Physical arrival of COVID-19 positive patient Meet criteria of starting oral antiviral (≥18 years old, symptomatic and onset within 5 days) *Assessment based on eligibility & check for absolute contraindication(s): -Pregnant/ breastfeeding -Drug-drug interactions -Severe liver/renal disease Responsibilities Family Medicine Specialist/ Medical Officer Family Medicine Specialist/ Medical Officer
  • 7. Process **Patient education and initiation of antiviral Approval to initiate antiviral Continue MySejahtera HAT until digital Release Order Responsibilities End Family Medicine Specialist Medical Officer & Pharmacist Virtual CAC Team
  • 9. Table5:SevereImmunocompromisedConditions • Patients who are within 1 year of receiving B-cell depleting therapies (e.g., rituximab, ocrelizumab, ofatumumab, alemtuzumab) • Bone marrow transplant / Solid organ transplant on immunosuppressive therapy • Patients with hematologic malignancies/ cancer who are on active chemotherapy • Patients with severe combined immunodeficiencies • Patients with untreated HIV who have a CD4 T lymphocyte cell count <50 cells/mm • Chronic lymphocytic leukaemia and multiple myeloma with hypogammaglobulinemia
  • 10. Paxlovid™ Summary 10 • Paxlovid™ reduced COVID-19 related hospitalization and death by 88% when given within 5 days of symptom onset, without concerning safety findings, in the clinical trial EPIC-HR. • Key Things to Remember When Prescribing: – Multiple drug interactions – Reduced dose for moderate renal impairment – Contraindicated in patients with severe renal impairment or severe hepatic impairment, pregnant patients, and patients requiring oxygen – Not indicated in patients below 18 and patients with symptom onset > 5 days
  • 11. Data on Safety: EPIC-HR* 11 • Adverse events (AEs) seen in ≥1% of Paxlovid™ recipients (n=1,109) with a higher frequency (≥5 subject difference) versus placebo recipients (n=1,115): – Dysgeusia (6% versus <1%) – Diarrhea (3% versus 2%) – Hypertension (1% versus <1%) – Myalgia (1% versus <1%) *The study population excluded children, pregnant women, individuals with GFR <45 mL/min/1.73 m2, individuals with active liver disease, and individuals taking concomitant medications that could have clinically significant drug interactions with Paxlovid™.
  • 12. Drug Interactions 12 • As a healthcare provider, you should: – Inform patients that Paxlovid™ may interact with some drugs and is contraindicated for use with some drugs – Obtain a complete medication list from your patient (including nonprescription drugs and herbals) – Check for clinically significant drug interactions: – Based on the drug interactions, decide if: • Paxlovid™ use is appropriate versus an alternative authorized treatment • If appropriate, whether your patient should hold, change, or dose-reduce other medications while taking Paxlovid™, or if additional monitoring may be needed
  • 13. Specific Populations: Renal Impairment 13 eGFR* PAXLOVID™Dose Greater than 60 mL/min (normal renal function or mild renal impairment) 300 mg nirmatrelvir with 100 mg ritonavir, taken twice daily for 5 days >30 to <60 mL/min (moderate renal impairment) 150 mg nirmatrelvir with 100 mg ritonavir, taken twice daily for 5 days <30mL/min (severe renal impairment) PAXLOVID™ is not recommended (the appropriate dose has not been determined) * eGFR = estimated glomerular filtration rate based on the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) formula
  • 14. TakeHomeMessage OralAntiviralis only effectiveifinitiatedwithin 5daysofsymptoms ContinueroutineHome AssessmentTooland managementas percurrent guideline OralAntiviralis notto replacevaccinationand preventivemeasures InitiationofOral Antiviralaccordingto thecurrentEligibility System
  • 16. CaseStudy1 Not having any symptoms 34 yeaís old No known medical illness Self Test is positive Not Indicated
  • 17. 16 years old Bíonchial Asthma Self Test is positive Fever for 1 day CaseStudy2 Contraindicated
  • 18. CaseStudy3 65 years old Self Test is positive Having fever and headache (Day 2 of symptoms) Hypertension Indicated
  • 19. CaseStudy4 50 years old, incomplete vaccination, has diabetes with morbid obesity Self Test is positive Has fever for 2 days and sore throat for 3 days Indicated
  • 20. CaseStudy5 72 years old Self Test is positive Fever and diarrhea for 2 days Diabetes, CKD Stage 1 Indicated
  • 21. PCR SARS CoV-2 is negative Fever and diarrhea for 2 days 60 years old Diabetes, Hypertension CaseStudy6