FDA Approves Paxlovid for Treating COVID-19 in High-risk Outpatients

FDA Approves Paxlovid for Treating COVID-19 in High-risk Outpatients

The United States Food and Drug Administration (FDA) has granted full approval for nirmatrelvir-ritonavir (Paxlovid), an antiviral medication, for the treatment of mild to moderate COVID-19 in adult outpatients who are at risk of severe disease. The approval follows an endorsement from the FDA’s Antimicrobial Drugs Advisory Committee and is a critical component of President Biden’s test-to-treat pandemic strategy.

Prescription Guidelines and Benefits

The FDA has confirmed that Paxlovid is a safe and effective treatment option for those at high risk of progression to severe COVID-19, including those with prior immunity. The antiviral medication has been shown to help prevent hospitalization and death in high-risk patients. While prescribing Paxlovid, healthcare providers should review all medications taken by the patient to assess for potential drug-drug interactions and determine if other medicines require a dose adjustment, interruption, and/or additional monitoring.

Prescribers should also consider the benefits of Paxlovid treatment in reducing hospitalization and death and whether the risk of potential drug-drug interactions for an individual patient can be appropriately managed.

Study Results and Availability

The FDA has approved the medication based on the results of the EPIC-HR trial, which demonstrated an 86% reduction in the risk of hospitalization or death at 28 days compared to placebo. The study included unvaccinated adults aged 18 and over with a medical condition(s) placing them at high risk of severe disease, or adults aged 60 and over with or without a chronic condition.

In the final analysis of the EPIC-HR trial, 0.9% of those who received nirmatrelvir-ritonavir and 6.5% of those on placebo were hospitalized due to COVID-19 or died through 28 days. The medication has already been taken by millions of people with COVID-19, including President Biden, since its emergency use authorization (EUA) in late 2021.

The FDA has stated that previous packages distributed under the EUA will remain available for use. High-risk children aged 12 and above will also continue to be eligible for the drug under the EUA, although the approval does not cover this group.

Limitations and Side Effects

The FDA has cautioned that nirmatrelvir-ritonavir is not intended for use as a preventive therapy either pre- or post-exposure to COVID-19. Patients should have symptoms and a confirmed case before using the medication.

The drug has a boxed warning on its label and fact sheet for healthcare providers due to concerns about rebound cases and a host of drug-drug interactions. The most common side effects with treatment were impaired sense of taste and diarrhea.

The FDA has granted full approval to nirmatrelvir-ritonavir (Paxlovid) for treating adult outpatients with mild to moderate COVID-19 who are at risk for severe disease. The medication has met the agency’s rigorous standards for safety and effectiveness and remains an important treatment option for people at high risk of progression to severe COVID-19, including those with prior immunity. The FDA has recommended that prescribers review all medications taken by the patient to assess for potential drug-drug interactions and determine if other medicines require a dose adjustment, interruption, and/or additional monitoring.

Health

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