Oral COVID-19 Therapy Offers Measurable Benefits
A recent conversation with Dr. John Farley, director of the U.S. FDA’s Office of Infectious Diseases, provided insights regarding Paxlovid, the preferred oral therapy for managing non-hospitalized adults with COVID-19.
The antiviral Paxlovid reduces the risk of hospitalization and death for patients with mild-to-moderate COVID-19 at high risk of disease progression.
On May 4, 2022, Dr. Farley stated ‘We recognize that risk factors have changed over time and that it is now appropriate to consider vaccination status in assessing a patient’s risk for progression to severe COVID-19.’
Adult patients who report a positive home test result from a rapid antigen diagnostic test to their provider are eligible for Paxlovid under the emergency use authorization (EUA).’
A positive result on a PCR test also meets the requirement under the EUA to have a positive test result.
Additionally, the FDA is aware of the reports of some patients developing recurrent COVID-19 symptoms after completing a treatment course of Paxlovid. In some cases, patients tested negative on a direct SARS-CoV-2 viral test and then tested positive again.
In light of these reports, additional analyses of the Paxlovid clinical trial data have been performed.
In the Paxlovid clinical trial, some patients (range 1-2%) had one or more positive SARS-CoV-2 PCR tests after testing negative or an increase in the amount of SARS-CoV-2 detected by PCR after completing their treatment course.
This finding was observed in patients treated with the drug and patients who received a placebo, so it is unclear whether this is related to Paxlovid treatment.
Additional analyses show that most of the patients did not have symptoms at the time of a positive PCR test after testing negative. Most importantly, there was no increased occurrence of hospitalization or death, or development of drug resistance.
However, there is no evidence of benefit at this time for a longer course of treatment (e.g., ten days rather than five days) or repeating a treatment course of Paxlovid in patients with recurrent COVID-19 symptoms following completion of a treatment course.
‘I would like to reiterate there is strong scientific evidence that Paxlovid reduces the risk of hospitalization and death in patients with mild-to-moderate COVID-19 at high risk for progression to severe disease. It is also expected to be effective against the Omicron variant,’ commented Dr. Farley.
Separately, during a special edition of Doctor Radio Reports on May 6, 2022, Dr. Robert M. Califf, Commissioner of Food and Drugs at the FDA, discusses the vital role Paxlovid plays in treating Covid-19.
‘With regard to the so-called rebound, there will be a lot more said about this, but at least the data so far indicates that we see the same phenomenon in the placebo groups with the antivirals.
So that means that it's not probably a drug effect, it's really a biological effect that's not fully explained. So we're going to learn a lot more about it, but it shouldn't be a reason not to treat it.
We're going to have a flood of data from real-world evidence about the treatment of already vaccinated people. Based on the small amount of data we had at the time of the EUA, I expect that we'll see the same type of effect,' the FDA Commissioner told Dr. Mark Siegel.
Paxlovid is now widely available at community pharmacies in the U.S.
The U.S. government maintains a locator tool for COVID-19 therapeutics that lists community pharmacies that have Paxlovid in stock.
Note: The FDA statements were edited for clarity and manually curated for mobile readership.
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