Drug updated on 12/11/2024
| Dosage Form | Tablet (oral; nirmatrelvir 150 mg, ritonavir 100 mg) |
| Drug Class | SARS-CoV-2 main protease (Mpro: also referred to as 3CLpro or nsp5 protease) inhibitors and HIV-1 protease inhibitors and CYP3A inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated 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.
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Summary
- This summary is based on the review of 15 systematic review(s)/meta-analysis(es). [1-13]
- The studies focused on adults with COVID-19, specifically analyzing the effectiveness of nirmatrelvir/ritonavir across various subgroups, including those differentiated by age (less than 65 years and 65 years or greater), vaccination status, ethnicity, and underlying high-risk conditions, showing no significant differences in treatment outcomes based on these factors, with results indicating a reduction in hospitalization and mortality across subgroups.
- Nirmatrelvir/ritonavir demonstrated consistent efficacy in reducing hospital admissions and mortality irrespective of high-risk conditions, and its effectiveness was not influenced by vaccination status (relative risk (RR) Psubgroup = 0.47), suggesting broad applicability in the treatment of COVID-19.
- Nirmatrelvir/ritonavir did not show a significant increase in adverse events with RR was 1.41, a 95% confidence interval (CI) of 0.92 to 2.14, and I² of 70.6% based on 4 randomized controlled trials (RCTs) involving 4,070 participants. and was associated with a moderate-certainty increase in treatment-related adverse events such as dysgeusia and diarrhea compared to standard-of-care (SOC) plus placebo (RR 2.06, 95% CI 1.44 to 2.95).
- Serious adverse events were not significantly increased with nirmatrelvir/ritonavir (RR = 0.82; 95% CI, 0.41-1.62; I² = 0%; 3 RCTs, 3,806 persons), and the treatment may actually reduce serious adverse events when compared to SoC plus placebo (RR 0.24, 95% CI 0.15 to 0.41; low-certainty evidence).
- Nirmatrelvir/ritonavir demonstrated effectiveness in reducing hospital admission and mortality across various subgroups, including age and vaccination status, with no significant differences observed in these populations (RR Psubgroup = 0.47) and no differences in outcomes for patients aged less than 65 years versus 65 years or greater. Additionally, treatment effectiveness was consistent regardless of high-risk conditions, with 92.1% of study participants from upper-middle-income or high-income countries.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Paxlovid (nirmatrelvir; ritonavir) Prescribing Information. | 2023 | Pfizer Laboratories, Div Pfizer Inc., New York, NY |