How effective is Paxlovid for COVID-19?
How effective is Pfizer's COVID-19 pill?
- Paxlovid lowers the risk of hospitalization or death from COVID-19 by 86% for adult patients who are at high risk of COVID-19 progressing to severe illness when Paxlovid is started within the first 3 days of COVID-19 symptoms. These results were from the study EPIC-HR (NCT04960202), which was a Phase 2/3, randomized, double-blind, placebo-controlled trial in non-hospitalized symptomatic adult subjects with a laboratory-confirmed diagnosis of SARS-CoV-2 infection.
- Paxlovid contains two co-packaged medicines: nirmatrelvir (previously known as PF-07321332) and ritonavir.
- Paxlovid contains oral tablets that are best taken at the first sign of symptoms of COVID-19.
- Paxlovid is taken to help decrease the number and severity of symptoms or avoid severe illness, which may lead to hospitalization or death.
Is Paxlovid FDA approved?
- Yes, Paxlovid is an FDA-approved medication.
- Paxlovid received FDA approval on May 25, 2023, for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.
- Paxlovid is available under an Emergency Use Authorisation (EUA) to treat patients 12 to 18 years old for mild-to-moderate COVID-19 who are at high risk for progression to severe COVID-19, including hospitalization or death.
- PAXLOVID is not approved for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19.
How does Paxlovid work?
- Paxlovid contains co-packaged nirmatrelvir tablets and ritonavir tablets that are taken orally at the first sign of COVID-19 illness after a positive Sars-CoV-2 viral test.
- Nirmatrelvir works by blocking an enzyme (called SARS-CoV-2-3CL protease) that the coronavirus needs to replicate.
- As the virus can not reproduce itself, this reduces the severity of symptoms and so decreases the number of hospitalizations and deaths in high-risk patients.
- Ritonavir is an HIV medication that slows the metabolism of nirmatrelvir, which helps nirmatrelvir stay in the body longer and at a higher concentration, making it more effective.
How do you take Paxlovid?
Paxlovid is prescribed as a medicine to be taken at home for high-risk patients to avoid severe COVID-19 illness, including hospitalization and death. Paxlovid will be one box containing a full five-day treatment course with oral nirmatrelvir tablets and ritonavir tablets.
- Paxlovid should be started as soon as possible after a positive Sars-CoV-2 viral test and within 5 days of the first symptoms.
- Nirmatrelvir 300mg (two 150mg tablets) taken twice daily for five days.
- Ritonavir 100mg taken twice daily for five days.
Clinical Trials for Paxlovid.
Patients at HIGH RISK of hospitalization with COVID-19
Paxlovid is FDA-approved for treating mild to moderate COVID-19 in adult patients at high risk of severe COVID-19.
Final results from Phase 2/3 ERIC-HR study of the antiviral pill Paxlovid show it successfully decreases the risk of being hospitalized by 89% for patients at high risk of COVID-19 progressing to severe illness. Paxlovid or placebo was taken within 3 days of the first COVID-19 symptoms, and the results were:
- 0.7% (5 out of 697) of the Paxlovid patients were hospitalized with no deaths.
- 6.5% (44 out of 682) of the placebo patients were hospitalized with 9 deaths.
- Paxlovid patients also had a 10-fold decrease in viral load compared to the placebo group.
Patients at STANDARD RISK of hospitalization with COVID-19
Paxlovid is NOT authorized for COVID-19 patients who have the standard risk of hospitalization with COVID-19
Early results from a trial (Phase 2/3 EPIC-SR) looking at Paxlovid use in Covid-19 patients at standard risk of hospitalization showed a 70% reduction in hospitalization in the Paxlovid patients compared to placebo.
- 0.7% (3 out of 428) of the Paxlovid patients were hospitalized with no deaths.
- 2.4% (10 out of 426) of the placebo patients were hospitalized with no deaths.
- Paxlovid patients also had a 10-fold decrease in viral load compared to the placebo group, which was the same as the Phase 2/3 ERIC-HR study.
Related questions
- Paxlovid side effects: 8 key things to know
- How fast does Paxlovid work?
- Can you take Paxlovid twice if COVID rebounds?
Can Paxlovid prevent COVID-19?
Post-Exposure Prophylaxis of COVID-19 using Paxlovid
Paxlovid is not authorized to be used to prevent COVID-19.
The study, Phase 2/3 EPIC-PEP, looked at how well Paxlovid worked in adults at preventing COVID-19 after being exposed to the virus through household contact. The percentage of adults who developed COVID-19 was lower in the Paxlovid-treated groups compared to the placebo group, but it was not statistically significant.
The percentage of subjects who had developed COVID-19 up to Day 14 was 2.6% for the 5-day Paxlovid group and 2.4% for the 10-day Paxlovid group, compared to 3.9% for placebo; however, these results were not statistically significant.
Click here for more information on: Paxlovid: Uses, Doses, Side Effects and Interactions.
Bottom Line:
- Paxlovid is effective at lowering the risk of hospitalization or death by 86% for adult patients who are at high risk of COVID-19 progressing to severe illness when Paxlovid is started within the first 3 days of COVID-19 symptoms.
- Paxlovid received FDA approval on May 25, 2023, for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.
- Paxlovid is available under an Emergency Use Authorisation (EUA) to treat patients 12 to 18 years old for mild-to-moderate COVID-19 who are at high risk for progression to severe COVID-19, including hospitalization or death.
References
- Pfizer’s Novel COVID-19 Antiviral Treatment Candidate Reduced Risk of Hospitalization or Death by 89% in Interim Analysis of Phase ⅔ EPIC-HR Study [Accessed December 14, 2021] https://www.pfizer.com/news/press-release/press-release-detail/pfizers-novel-covid-19-oral-antiviral-treatment-candidate
- PF-07321332 Early Data suggest Pfizer Pill May Prevent Severe COVID-19 [Accessed December 14, 2021] https://directorsblog.nih.gov/tag/pf-07321332/
- Pfizer Announces Additional Phase 2/3 Study Results Confirming Robust Efficacy of Novel COVID-19 Oral Antiviral Treatment Candidate in Reducing Risk of Hospitalization or Death. [Accessed December 15, 2021] https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-additional-phase-23-study-results
- FDA Grants Emergency Use Authorization for Pfizer's Paxlovid Pill as First At-Home COVID-19 Treatment. [Accessed December 23, 2021] https://www.drugs.com/news/fda-oks-pfizer-pill-first-home-covid-102454.html
- Coronavirus (COVID-19) Update: FDA Authorizes First Oral Antiviral for Treatment of COVID-19 [Accessed December 23, 2021] https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-oral-antiviral-treatment-covid-19?utm_medium=email&utm_source=govdelivery
- FACT SHEET FOR HEALTHCARE PROVIDERS: EMERGENCY USE AUTHORIZATION FOR PAXLOVID. [Accessed December 23, 2021] https://www.fda.gov/media/155050/download?utm_medium=email&utm_source=govdelivery
- Food and Drug Administration (FDA) Paxlovid Product Label https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217188s000lbl.pdf
- FDA Approves First Oral Antiviral for Treatment of COVID-19 in Adults https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-antiviral-treatment-covid-19-adults
- FDA FACT SHEET FOR HEALTHCARE PROVIDERS:
EMERGENCY USE AUTHORIZATION FOR PAXLOVID https://www.fda.gov/media/155050/download
Read next
Does Paxlovid make you less contagious?
Taking Paxlovid (nirmatrelvir and ritonavir) to treat COVID-19 within 5 days of symptoms can make you less contagious sooner than if you do not take it, but it is still important to follow public health recommendations if you are sick. One study found that taking Paxlovid three days after symptoms started reduced how contagious people were by 12% in those who did not experience rebound. Continue reading
How do Paxlovid and molnupiravir compare for COVID-19?
Paxlovid (nirmatrelvir and ritonavir) and Lagevrio (molnupiravir) are two oral treatment options for mild-to-moderate coronavirus disease 2019 (COVID-19) in people who are at high risk for severe COVID-19 disease. However, they have some key differences. Continue reading
When should you take Paxlovid?
If you have been prescribed Paxlovid (nirmatrelvir and ritonavir), you should take it as soon as possible. Paxlovid works best if it is taken within 5 days of the start of COVID-19 symptoms. Continue reading
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