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5MinuteConsult Journal Club

Paxlovid for SARS-CoV-2 Infection

References

https://www.fda.gov/media/155050/download

N Engl J Med 2021; 385:1941-1950

Study Summary

Paxlovid, is Pfizer’s oral anti-viral for COVID-19 infection; it recently received Emergency Use Authorization from the FDA. Their EPIC-HR study over 2000 adults found when Paxlovid was started within 5 days of symptom onset, the NNT to prevent hospitalization was 17 and to prevent death was 125.

In those over 65, the NNT to prevent hospitalization was 15, and to prevent death is 167.

This drug has many drug-drug interactions, including some anti-arrhythmic agents, older statins, some anti-psychotics, sildenafil and many others & requires a reduced dose in renal insufficiency.

Prescribing and dosing is not straightforward. For those with normal renal function and no contraindication, it is dosed 300 mg nirmatrelvir (two 150 mg tablets) with 100 mg ritonavir (one 100 mg tablet) with all three tablets taken together orally twice daily for 5 days.  Please review the FDA fact sheet for details (https://www.fda.gov/media/155050/download).

Molnupiravir, Merck’s oral COVID-19 treatment also received FDA Emergency authorization but based upon current data is significantly less effective.

Sotrovimab, the monoclonal antibody with activity against the Omicron variant, when compared to placebo resulted in a NNT of 17 for “disease progression leading to hospitalization or death,” (N Engl J Med 2021; 385:1941-1950).

Conclusions

Paxlovid may become a viable option against the Omicron variant, and COVID-29 in general.  Currently, access is extremely limited. Stay tuned for more as it becomes available.

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