This past week the US Food and Drug Administration (FDA) gave Emergency Use Authorization (EUA) to two oral, outpatient drugs to be used against Covid-19. Both are for the treatment of mild-to-moderate coronavirus disease in patients with positive test results and who are at high risk of progression to severe Covid-19 infection, including hospitalization and death.
Until now, the best outpatient treatments for Covid-19 have been monoclonal antibody (MCA) therapies that require intravenous infusions. Unfortunately, MCA treatments have been in short supply and difficult to arrange, and the newer variants of Covid-19 are often proving to be resistant to these drugs.
The new oral medications utilize different mechanisms of action that may be both more effective and also less likely to lose effectiveness than MCA. Both new drugs should be started within 5 days of the onset of illness, are to be taken for 5 days, and have been shown to significantly reduce death and hospitalization compared to similar untreated groups. Neither drug is a substitute for vaccination in individuals for whom Covid-19 vaccination and a booster dose are recommended.
Lagevrio (molnupiravir), discussed in an earlier blog, is approved by the FDA via EUA for use in adults 18 and over. This drug works by introducing errors in the Covid-19 virus’ genetic code, preventing the virus from reproducing itself. Lagevrio is NOT recommended for use in pregnancy. Due to possible effects on cartilage development it also NOT recommended for patients below the age of 18.
Paxlovid (nirmatrelvir and ritonavir) is approved by the FDA via EUA for use in adults and also in pediatric patients age 12 and up. Paxlovid inhibits a Covid-19 protein to stop the virus from reproducing itself. Paxlovid may interact with many other medications. For a list of drugs that should not be taken in combination with Paxlovid, see this this FDA fact sheet: Click here. Paxlovid can also cause impaired taste, diarrhea, high blood pressure and muscle aches, and it may not be right for patients with kidney and/or liver disease.
These two new drugs offer exciting new outpatient options to treat suitable patients with Covid-19. Contact your doctor with any questions and if you think they may be right for you.