Wisconsin DHS Health Alert #38: Molnupiravir and Paxlovid are now available in limited supply for Wisconsin
Bureau of Communicable Diseases
January 5, 2022
- Two new antiviral treatments, molnupiravir and nirmatrelvir/ritonavir (PaxlovidTM), have been granted emergency use authorization by the U.S. Food and Drug Administration for the treatment of mild to moderate COVID-19.
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Criteria for authorized use, instructions for storage and administration (including potentially severe drug-drug interactions), and data reporting requirements are described in the molnupiravir and Paxlovid fact sheets for healthcare providers.
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A total of 4,320 molnupiravir treatment courses and 940 Paxlovid treatment courses have been allocated to Wisconsin. Supplies are extremely limited and demand will likely exceed supply. Shipments will occur every two weeks. Healthcare providers are encouraged to prioritize patients who are most likely to benefit from treatment, as described in the National Institutes of Health COVID-19 treatment recommendations.
- These medications are being distributed to retail pharmacies and healthcare facilities across the state. Healthcare providers can refer to the DHS therapeutics webpage for a list of retail pharmacies that have received an allocation of these medications.
Dear Colleagues,
Molnupiravir and Paxlovid are new oral antiviral medications which have received emergency use authorization (EUA) for the treatment of mild-to-moderate COVID-19. Molnupiravir is a nucleoside analogue that inhibits SARS-CoV-2 replication by viral mutagenesis. The Phase 3 MOVe-OUT clinical trial showed a 30% relative risk reduction in hospitalization or death among subjects who received molnupiravir compared to placebo. Paxlovid is a combination of nirmatrelvir, a SARS-CoV-2-specific protease inhibitor, co-packaged with ritonavir, an HIV-1 protease and CYP3A inhibitor used as a pharmacologic booster. The EPIC-HR Phase 2/3 clinical trial showed an 88% relative risk reduction in hospitalization or death among subjects who received Paxlovid compared to placebo.
Patient Eligibility Criteria
Patient eligibility criteria are briefly summarized in Table 1. Prescribers should review EUA fact sheets for full prescribing details.
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Table 1. Patient Eligibility Criteria
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Molnupiravir
Molnupiravir is authorized for treatment of mild-to-moderate COVID-19 among adults aged 18 years and older with positive results of SARS-CoV-2 testing and:
- Who are at high risk for progressing to severe COVID-19;
- Symptom onset is within 5 days of initiating treatment; and
- Alternative treatment options are not accessible or appropriate
Molnupiravir is not authorized for:
- Initiation of treatment in patients requiring hospitalization due to COVID-19. Benefit has not been observed when treatment is initiated after hospitalization due to COVID-19.
- Pre-exposure or post-exposure prophylaxis for prevention of COVID-19
- Patients younger than 18
- Use for longer than 5 consecutive days
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Paxlovid
Paxlovid is authorized for treatment of mild-to-moderate COVID-19 among adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of SARS-CoV-2 testing and:
- Who are at high risk for progressing to severe COVID-19; and
- Symptom onset is within 5 days of initiating treatment.
Paxlovid is not authorized for:
- Initiation of treatment in patients requiring hospitalization for severe or critical COVID-19
- Pre-exposure or post-exposure prophylaxis for prevention of COVID-19
- Pediatric patients younger than 12 or who weigh less than 40 kg.
- Use for longer than 5 consecutive days
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Healthcare providers should be familiar with all contraindications, warnings, and precautions for both medications.
Molnupiravir is not recommended for use during pregnancy or while breastfeeding. Males of reproductive potential who are sexually active should use a reliable method of contraception during treatment and for at least 3 months after the last dose.
Paxlovid may result in significant drug interactions. Co-administration with drugs highly dependent on CYP3A for clearance may result in with serious and/or life-threatening reactions. Providers should consult the full prescribing information prior to treatment, and be aware of medications for which co-administration is contraindicated (e.g. simvastatin, midazolam, carbamazepine, among others). NIH has developed a concise guide to assist providers in assessing the potential for drug-drug interactions.
Dosage and Administration
Molnupiravir dosage is 800 mg (four 200 mg captures) orally every 12 hours for 5 days.
Paxlovid is 300 mg nirmatrelvir (two 10 mg tablets) co-packaged with 100 mg ritonavir (one 100 mg tablet), all three tablets taken together twice daily for 5 days.
Other Instructions for Providers
Healthcare providers who prescribe molnupiravir and Paxlovid under the emergency use authorization are required to provide patients and/or their caregivers with information consistent with the conditions of authorization listed in the EUA, and provide a copy of the molnupiravir or Paxlovid Fact Sheet for Patients, Parents and Caregivers.
Prescribing health care providers and/or their designee are responsible for mandatory reporting of all medication errors and serious adverse events potentially related to molnupiravir or Paxlovid treatment within 7 calendar days by submitting FDA form 3500 online.
Distribution to Wisconsin healthcare facilities and pharmacies
The federal government has allocated an initial supply of both medications to state health departments based on the population of each state. Shipments will occur every two weeks. Supplies of Paxlovid are expected to increase in the weeks ahead.
DHS is receiving 4,320 molnupiravir treatment courses and 940 Paxlovid treatment courses for its initial allocation and is making it rapidly available throughout the state. Each Healthcare Emergency Readiness Coalition (HERC) region is receiving an allocation proportional to HERC population. The majority of treatment courses will be allocated to retail pharmacies, with smaller allocations to hospitals for use in emergency departments, long-term care pharmacies, and correctional facilities. The US Department of Health and Human Services is providing a separate allocation for federally-qualified health centers.
Guidance for Prescribers
Healthcare providers seeking information on which retail pharmacies have received an allocation of these drugs should consult the DHS therapeutics webpage. This webpage will be updated regularly as supplies increase and more pharmacies are included in the state allocation process.
Due to the limited supply of molnupiravir and Paxlovid nationally, the number of patients meeting criteria for authorized use will likely exceed the number of available doses. Healthcare providers are encouraged to prioritize patients who are at highest risk of clinical progression. The National Institutes of Health has released recommendations for prioritization based on vaccination status, immune status, and clinical risk factors. Risk groups are stratified into 4 tiers in order of decreasing priority, as shown in Table 2.
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Table 2. NIH Patient Prioritization Tiers
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Tier
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Risk Group
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1
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- Immunocompromised individuals not expected to mount an adequate immune response to COVID-19 vaccination or SARS-CoV-2 infection due to their underlying conditions, regardless of vaccine status (see Immunocompromising Conditions below); or
- Unvaccinated individuals at the highest risk of severe disease (anyone aged ≥75 years or anyone aged ≥65 years with additional risk factors).
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2
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- Unvaccinated individuals at risk of severe disease not included in Tier 1 (anyone aged ≥65 years or anyone aged <65 years with clinical risk factors).
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3
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- Vaccinated individuals at high risk of severe disease (anyone aged ≥75 years or anyone aged ≥65 years with clinical risk factors).
Note: Vaccinated individuals who have not received a COVID-19 vaccine booster dose are likely at higher risk for severe disease; patients in this situation within this tier should be prioritized for treatment.
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4
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- Vaccinated individuals at risk of severe disease (anyone aged ≥65 years or anyone aged <65 with clinical risk factors).
Note: Vaccinated individuals who have not received a COVID-19 vaccine booster dose are likely at higher risk for severe disease; patients in this situation within this tier should be prioritized for treatment.
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Providers and pharmacists seeking guidance about individual patient treatment requests should not contact DHS but should instead discuss those situations within their organization. Administrators involved with ordering, shipping, and receiving drug from DHS may contact DHSOperations@dhs.wisconsin.gov with any questions.
Jonathan Meiman, MD
Chief Medical Officer and State Epidemiologist for Environmental and Occupational Health Wisconsin Department of Health Services
Ryan Westergaard, MD, PhD
Chief Medical Officer and State Epidemiologist for Communicable Diseases
Wisconsin Department of Health Services
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