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 2/3 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.drugclasses.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
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