Drug updated on 5/6/2024
| Dosage Form | Tablet (oral; 150 mg nirmatrelvir/ co-packaged with 100 mg ritonavir: 150 mg/100 mg) |
| Drug Class | SARS-CoV-2 main protease inhibitors, HIV-1 protease inhibitors and CYP3A inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of pediatric patients 12 years of age and older weighing at least 40 kg with mild-to-moderate coronavirus disease 2019 (COVID-19) and who are at high risk for progression to severe COVID-19, including hospitalization or death.
Summary
- Nirmatrelvir and ritonavir (Paxlovid) is indicated for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe disease, including hospitalization or death. It has shown a significant reduction in mortality rate and hospitalization across several studies.
- Ten systematic reviews/meta-analyses provided information on Paxlovid's effectiveness compared to standard care as well as other antivirals like molnupiravir.
- Compared with molnupiravir, Paxlovid demonstrated superior efficacy in reducing all-cause mortality rates, hospitalization rates, death or hospitalization rates, and achieving a faster negative polymerase chain reaction conversion time.
- In terms of the safety profile, Paxlovid was generally well-tolerated with an increase noted in certain adverse events, such as dysgeusia (altered taste) and diarrhea. However, there were no significant differences observed regarding serious adverse events leading to treatment discontinuation when compared to molnupiravir.
- The incidence of rebound cases was not significantly different between those treated with Paxlovid versus control groups or those treated with molnupiravir, suggesting that there is no increased risk associated with using this drug.
- Population subgroup analysis showed consistent benefits from using Paxlovid across vaccinated/unvaccinated individuals, indicating its effectiveness irrespective of vaccination status. Age appeared to be a significant factor affecting efficacy, where greater benefits were seen among older adult populations, especially by reducing their mortality/hospitalization rates, making it a more cost-effective outcome.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Paxlovid (nirmatrelvir, ritonavir) Prescribing Information. | 2024 | Pfizer Laboratories, Div Pfizer Inc., New York, NY |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| COVID-19 treatment guidelines. | 2024 | National Institutes of Health |
| Pan-American guidelines for the treatment of SARS-CoV-2/COVID-19: a joint evidence-based guideline of the Brazilian Society of Infectious diseases (SBI) and the Pan-American Association of Infectious diseases (API) | 2023 | Annals of Clinical Microbiology and Antimicrobials |
| Infectious Diseases Society of America guidelines on the treatment and management of patients with COVID-19. | 2022 | Infectious Diseases Society of America |