Nirmatrelvir for Vaccinated or Unvaccinated Adult Outpatients with Covid-19
Copyright © 2024 Massachusetts Medical Society..
BACKGROUND: Nirmatrelvir in combination with ritonavir is an antiviral treatment for mild-to-moderate coronavirus disease 2019 (Covid-19). The efficacy of this treatment in patients who are at standard risk for severe Covid-19 or who are fully vaccinated and have at least one risk factor for severe Covid-19 has not been established.
METHODS: In this phase 2-3 trial, we randomly assigned adults who had confirmed Covid-19 with symptom onset within the past 5 days in a 1:1 ratio to receive nirmatrelvir-ritonavir or placebo every 12 hours for 5 days. Patients who were fully vaccinated against Covid-19 and who had at least one risk factor for severe disease, as well as patients without such risk factors who had never been vaccinated against Covid-19 or had not been vaccinated within the previous year, were eligible for participation. Participants logged the presence and severity of prespecified Covid-19 signs and symptoms daily from day 1 through day 28. The primary end point was the time to sustained alleviation of all targeted Covid-19 signs and symptoms. Covid-19-related hospitalization and death from any cause were also assessed through day 28.
RESULTS: Among the 1296 participants who underwent randomization and were included in the full analysis population, 1288 received at least one dose of nirmatrelvir-ritonavir (654 participants) or placebo (634 participants) and had at least one postbaseline visit. The median time to sustained alleviation of all targeted signs and symptoms of Covid-19 was 12 days in the nirmatrelvir-ritonavir group and 13 days in the placebo group (P = 0.60). Five participants (0.8%) in the nirmatrelvir-ritonavir group and 10 (1.6%) in the placebo group were hospitalized for Covid-19 or died from any cause (difference, -0.8 percentage points; 95% confidence interval, -2.0 to 0.4). The percentages of participants with adverse events were similar in the two groups (25.8% with nirmatrelvir-ritonavir and 24.1% with placebo). In the nirmatrelvir-ritonavir group, the most commonly reported treatment-related adverse events were dysgeusia (in 5.8% of the participants) and diarrhea (in 2.1%).
CONCLUSIONS: The time to sustained alleviation of all signs and symptoms of Covid-19 did not differ significantly between participants who received nirmatrelvir-ritonavir and those who received placebo. (Supported by Pfizer; EPIC-SR ClinicalTrials.gov number, NCT05011513.).
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:390 |
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| Enthalten in: |
The New England journal of medicine - 390(2024), 13 vom: 04. Apr., Seite 1186-1195 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Hammond, Jennifer [VerfasserIn] |
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| Links: |
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| Themen: |
Antiviral Agents |
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| Anmerkungen: |
Date Completed 12.04.2024 Date Revised 20.04.2024 published: Print ClinicalTrials.gov: NCT05011513 Citation Status MEDLINE |
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| doi: |
10.1056/NEJMoa2309003 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 500 | |a Date Completed 12.04.2024 | ||
| 500 | |a Date Revised 20.04.2024 | ||
| 500 | |a published: Print | ||
| 500 | |a ClinicalTrials.gov: NCT05011513 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2024 Massachusetts Medical Society. | ||
| 520 | |a BACKGROUND: Nirmatrelvir in combination with ritonavir is an antiviral treatment for mild-to-moderate coronavirus disease 2019 (Covid-19). The efficacy of this treatment in patients who are at standard risk for severe Covid-19 or who are fully vaccinated and have at least one risk factor for severe Covid-19 has not been established | ||
| 520 | |a METHODS: In this phase 2-3 trial, we randomly assigned adults who had confirmed Covid-19 with symptom onset within the past 5 days in a 1:1 ratio to receive nirmatrelvir-ritonavir or placebo every 12 hours for 5 days. Patients who were fully vaccinated against Covid-19 and who had at least one risk factor for severe disease, as well as patients without such risk factors who had never been vaccinated against Covid-19 or had not been vaccinated within the previous year, were eligible for participation. Participants logged the presence and severity of prespecified Covid-19 signs and symptoms daily from day 1 through day 28. The primary end point was the time to sustained alleviation of all targeted Covid-19 signs and symptoms. Covid-19-related hospitalization and death from any cause were also assessed through day 28 | ||
| 520 | |a RESULTS: Among the 1296 participants who underwent randomization and were included in the full analysis population, 1288 received at least one dose of nirmatrelvir-ritonavir (654 participants) or placebo (634 participants) and had at least one postbaseline visit. The median time to sustained alleviation of all targeted signs and symptoms of Covid-19 was 12 days in the nirmatrelvir-ritonavir group and 13 days in the placebo group (P = 0.60). Five participants (0.8%) in the nirmatrelvir-ritonavir group and 10 (1.6%) in the placebo group were hospitalized for Covid-19 or died from any cause (difference, -0.8 percentage points; 95% confidence interval, -2.0 to 0.4). The percentages of participants with adverse events were similar in the two groups (25.8% with nirmatrelvir-ritonavir and 24.1% with placebo). In the nirmatrelvir-ritonavir group, the most commonly reported treatment-related adverse events were dysgeusia (in 5.8% of the participants) and diarrhea (in 2.1%) | ||
| 520 | |a CONCLUSIONS: The time to sustained alleviation of all signs and symptoms of Covid-19 did not differ significantly between participants who received nirmatrelvir-ritonavir and those who received placebo. (Supported by Pfizer; EPIC-SR ClinicalTrials.gov number, NCT05011513.) | ||
| 650 | 4 | |a Clinical Trial, Phase II | |
| 650 | 4 | |a Clinical Trial, Phase III | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 7 | |a Antiviral Agents |2 NLM | |
| 650 | 7 | |a nirmatrelvir and ritonavir drug combination |2 NLM | |
| 650 | 7 | |a COVID-19 Vaccines |2 NLM | |
| 700 | 1 | |a Fountaine, Robert J |e verfasserin |4 aut | |
| 700 | 1 | |a Yunis, Carla |e verfasserin |4 aut | |
| 700 | 1 | |a Fleishaker, Dona |e verfasserin |4 aut | |
| 700 | 1 | |a Almas, Mary |e verfasserin |4 aut | |
| 700 | 1 | |a Bao, Weihang |e verfasserin |4 aut | |
| 700 | 1 | |a Wisemandle, Wayne |e verfasserin |4 aut | |
| 700 | 1 | |a Baniecki, Mary Lynn |e verfasserin |4 aut | |
| 700 | 1 | |a Hendrick, Victoria M |e verfasserin |4 aut | |
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| 700 | 1 | |a Simón-Campos, J Abraham |e verfasserin |4 aut | |
| 700 | 1 | |a Pypstra, Rienk |e verfasserin |4 aut | |
| 700 | 1 | |a Rusnak, James M |e verfasserin |4 aut | |
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