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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
- 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
- 8. Checklist
- 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
- 15. Case Samples
- 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