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
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
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