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CDC updates clinical guidance on treating COVID-19 recurrence after antiviral pill

The Centers for Disease Control and Prevention recently released updated guidance for clinicians treating COVID-19 in patients who received the Pfizer COVID-19 antiviral pill Paxlovid.

“There is currently no evidence that additional treatment is needed with Paxlovid or other anti-SARS-CoV-2 therapies in cases where COVID-19 rebound is suspected,” CDC said, noting that a brief return of symptoms may be part of the natural history of SARS-CoV-2 infection in some individuals, “independent of treatment with Paxlovid and regardless of vaccination status.”

CDC continues to recommend Paxlovid to treat mild to moderate COVID-19 in patients at high risk for progressing to severe disease and isolating patients when COVID-19 rebounds to manage transmission risk.

Background

Paxlovid (nirmatrelvir tablets; ritonavir tablets) is a prescription oral antiviral drug that reduces the risk of hospitalization and death for patients with mild-to-moderate COVID-19 who are at risk of disease progression and severe illness (1). It is available under Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or 88 pounds). Treatment should be initiated as soon as possible and within 5 days of symptom onset among persons eligible to receive the treatment under the EUA who:
  • Test positive for SARS-CoV-2 infection;
  • Have mild to moderate illnessexternal icon;
  • Have one or more risk factors for progression to severe disease;
  • Do not require hospitalization due to severe or critical COVID-19 at the time of treatment initiation; and
  • Do not have evidence of severe renal or hepatic impairment
Recommendations for Healthcare Providers

For patients with COVID-19 rebound
  • There is currently no evidence that additional treatment for COVID-19 is needed for COVID-19 rebound. Based on data available at this time, patient monitoring continues to be the most appropriate management for patients with recurrence of symptoms after completion of a treatment course of Paxlovid.
  • Advise people with COVID-19 rebound to follow CDC’s guidance on isolation and take precautions to prevent further transmission. Patients should re-isolate for at least 5 days. Per CDC guidance, they can end their re-isolation period after 5 full days if fever has resolved for 24 hours (without the use of fever-reducing medication) and symptoms are improving. The patient should wear a mask for a total of 10 days after rebound symptoms started.
  • Consider clinical evaluation of patients who have COVID-19 rebound and symptoms that persist or worsen.
  • Healthcare providers are encouraged to report cases of COVID-19 rebound to Pfizer after Paxlovid treatment using the following online tool: Pfizer Safety Reporting and to FDA MedWatch. Complete and submit a  FDA Form 3500 (health professional) by fax (1-800-FDA-0178). Call 1-800-FDA-1088 for questions.

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