Real-World Effectiveness of Ensitrelvir in Reducing Severe Outcomes in Outpatients at High Risk for COVID-19

Introduction This study aimed to evaluate the effectiveness of ensitrelvir, an oral antiviral, in reducing hospitalization risk in outpatients at high-risk for severe COVID-19 during the Omicron era. Methods This was a retrospective study using a large Japanese health insurance claims database. It i...
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Autor*in:	Takazono, Takahiro [verfasserIn] Fujita, Satoki [verfasserIn] Komeda, Takuji [verfasserIn] Miyazawa, Shogo [verfasserIn] Yoshida, Yuki [verfasserIn] Kitanishi, Yoshitake [verfasserIn] Kinoshita, Masahiro [verfasserIn] Kojima, Satoshi [verfasserIn] Shen, Huilian [verfasserIn] Uehara, Takeki [verfasserIn] Hosogaya, Naoki [verfasserIn] Iwanaga, Naoki [verfasserIn] Mukae, Hiroshi [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2024

Schlagwörter:	Ensitrelvir Hospitalization COVID-19 Japanese nationwide database

Anmerkung:	© The Author(s) 2024

Übergeordnetes Werk:	Enthalten in: Infectious diseases and therapy - Springer Healthcare, 2012, 13(2024), 8 vom: 28. Juni, Seite 1821-1833
Übergeordnetes Werk:	volume:13 ; year:2024 ; number:8 ; day:28 ; month:06 ; pages:1821-1833

Links:	Volltext

DOI / URN:	10.1007/s40121-024-01010-4

Katalog-ID:	SPR056699182

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520			\|a Introduction This study aimed to evaluate the effectiveness of ensitrelvir, an oral antiviral, in reducing hospitalization risk in outpatients at high-risk for severe COVID-19 during the Omicron era. Methods This was a retrospective study using a large Japanese health insurance claims database. It included high-risk outpatients for severe symptoms who received their first COVID-19 diagnosis between November 2022 and July 2023. The study included outpatients aged ≥ 18 years. The primary endpoint was all-cause hospitalization during the 4-week period from the date of outpatient diagnosis and medication, comparing the ensitrelvir group (n = 5177) and the no antiviral treatment group (n = 162,133). The risk ratio and risk difference were evaluated after adjusting patient background distribution by the inverse probability of treatment weight (IPTW) method. Secondary endpoints were incidence of respiratory and heart rate monitoring, oxygen therapy, ventilator use, intensive care admission, and all-cause death. Results The risk ratio for all-cause hospitalization between the ensitrelvir group (n = 167,385) and the no antiviral treatment group (n = 167,310) after IPTW adjustment was 0.629 [95% confidence interval (CI) 0.420, 0.943]. The risk difference was − 0.291 [95% CI − 0.494, − 0.088]. The incidence of both respiratory and heart rate monitoring and oxygen therapy was lower in the ensitrelvir group. Ventilator use, intensive care admission, and all-cause death were difficult to assess because of the limited events. Conclusions The incidence of all-cause hospitalization was significantly lower in the ensitrelvir group than in the no antiviral treatment group, suggesting ensitrelvir is an effective treatment in patients at risk of severe COVID-19.
520			\|a Plain Language Summary COVID-19 still poses a risk for patients with serious health conditions and weakened immune systems, who are more likely to develop severe illness. Several studies have indicated that some oral antiviral medications might be effective in preventing severe disease. This study aimed to evaluate if ensitrelvir, an oral antiviral medication, can help prevent hospitalization in outpatients who are at risk of developing severe symptoms from the Omicron variant of the SARS-CoV-2 virus. The hospitalization rates of patients who received ensitrelvir was compared with those who did not receive any antiviral treatment, using medical records from a large health insurance database in Japan focused on outpatients who were at risk of severe symptoms and were diagnosed with COVID-19 between November 2022 and July 2023. Respiratory and heart rate monitoring, oxygen therapy, ventilator use, intensive care admission, and all-cause death were also evaluated. The study found that patients who received ensitrelvir had a lower risk of being hospitalized compared to those who did not receive any antiviral treatment. The ensitrelvir group also had lower rates of respiratory and heart rate monitoring and oxygen therapy. However, it was challenging to assess the effects on ventilator use, intensive care admission, and all-cause death due to the small number of events in the population under evaluation. Based on these findings, ensitrelvir appears to be an effective treatment for reducing the risk of hospitalization in patients at risk of severe COVID-19.
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allfields	10.1007/s40121-024-01010-4 doi (DE-627)SPR056699182 (SPR)s40121-024-01010-4-e DE-627 ger DE-627 rakwb eng 610 VZ Takazono, Takahiro verfasserin aut Real-World Effectiveness of Ensitrelvir in Reducing Severe Outcomes in Outpatients at High Risk for COVID-19 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2024 Introduction This study aimed to evaluate the effectiveness of ensitrelvir, an oral antiviral, in reducing hospitalization risk in outpatients at high-risk for severe COVID-19 during the Omicron era. Methods This was a retrospective study using a large Japanese health insurance claims database. It included high-risk outpatients for severe symptoms who received their first COVID-19 diagnosis between November 2022 and July 2023. The study included outpatients aged ≥ 18 years. The primary endpoint was all-cause hospitalization during the 4-week period from the date of outpatient diagnosis and medication, comparing the ensitrelvir group (n = 5177) and the no antiviral treatment group (n = 162,133). The risk ratio and risk difference were evaluated after adjusting patient background distribution by the inverse probability of treatment weight (IPTW) method. Secondary endpoints were incidence of respiratory and heart rate monitoring, oxygen therapy, ventilator use, intensive care admission, and all-cause death. Results The risk ratio for all-cause hospitalization between the ensitrelvir group (n = 167,385) and the no antiviral treatment group (n = 167,310) after IPTW adjustment was 0.629 [95% confidence interval (CI) 0.420, 0.943]. The risk difference was − 0.291 [95% CI − 0.494, − 0.088]. The incidence of both respiratory and heart rate monitoring and oxygen therapy was lower in the ensitrelvir group. Ventilator use, intensive care admission, and all-cause death were difficult to assess because of the limited events. Conclusions The incidence of all-cause hospitalization was significantly lower in the ensitrelvir group than in the no antiviral treatment group, suggesting ensitrelvir is an effective treatment in patients at risk of severe COVID-19. Plain Language Summary COVID-19 still poses a risk for patients with serious health conditions and weakened immune systems, who are more likely to develop severe illness. Several studies have indicated that some oral antiviral medications might be effective in preventing severe disease. This study aimed to evaluate if ensitrelvir, an oral antiviral medication, can help prevent hospitalization in outpatients who are at risk of developing severe symptoms from the Omicron variant of the SARS-CoV-2 virus. The hospitalization rates of patients who received ensitrelvir was compared with those who did not receive any antiviral treatment, using medical records from a large health insurance database in Japan focused on outpatients who were at risk of severe symptoms and were diagnosed with COVID-19 between November 2022 and July 2023. Respiratory and heart rate monitoring, oxygen therapy, ventilator use, intensive care admission, and all-cause death were also evaluated. The study found that patients who received ensitrelvir had a lower risk of being hospitalized compared to those who did not receive any antiviral treatment. The ensitrelvir group also had lower rates of respiratory and heart rate monitoring and oxygen therapy. However, it was challenging to assess the effects on ventilator use, intensive care admission, and all-cause death due to the small number of events in the population under evaluation. Based on these findings, ensitrelvir appears to be an effective treatment for reducing the risk of hospitalization in patients at risk of severe COVID-19. Ensitrelvir (dpeaa)DE-He213 Hospitalization (dpeaa)DE-He213 COVID-19 (dpeaa)DE-He213 Japanese nationwide database (dpeaa)DE-He213 Fujita, Satoki verfasserin aut Komeda, Takuji verfasserin aut Miyazawa, Shogo verfasserin aut Yoshida, Yuki verfasserin aut Kitanishi, Yoshitake verfasserin aut Kinoshita, Masahiro verfasserin aut Kojima, Satoshi verfasserin aut Shen, Huilian verfasserin aut Uehara, Takeki verfasserin aut Hosogaya, Naoki verfasserin aut Iwanaga, Naoki verfasserin aut Mukae, Hiroshi verfasserin aut Enthalten in Infectious diseases and therapy Springer Healthcare, 2012 13(2024), 8 vom: 28. Juni, Seite 1821-1833 (DE-627)735690766 (DE-600)2701611-0 2193-6382 nnns volume:13 year:2024 number:8 day:28 month:06 pages:1821-1833 https://dx.doi.org/10.1007/s40121-024-01010-4 X:SPRINGER Resolving-System kostenfrei Volltext SYSFLAG_0 GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 13 2024 8 28 06 1821-1833
spelling	10.1007/s40121-024-01010-4 doi (DE-627)SPR056699182 (SPR)s40121-024-01010-4-e DE-627 ger DE-627 rakwb eng 610 VZ Takazono, Takahiro verfasserin aut Real-World Effectiveness of Ensitrelvir in Reducing Severe Outcomes in Outpatients at High Risk for COVID-19 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2024 Introduction This study aimed to evaluate the effectiveness of ensitrelvir, an oral antiviral, in reducing hospitalization risk in outpatients at high-risk for severe COVID-19 during the Omicron era. Methods This was a retrospective study using a large Japanese health insurance claims database. It included high-risk outpatients for severe symptoms who received their first COVID-19 diagnosis between November 2022 and July 2023. The study included outpatients aged ≥ 18 years. The primary endpoint was all-cause hospitalization during the 4-week period from the date of outpatient diagnosis and medication, comparing the ensitrelvir group (n = 5177) and the no antiviral treatment group (n = 162,133). The risk ratio and risk difference were evaluated after adjusting patient background distribution by the inverse probability of treatment weight (IPTW) method. Secondary endpoints were incidence of respiratory and heart rate monitoring, oxygen therapy, ventilator use, intensive care admission, and all-cause death. Results The risk ratio for all-cause hospitalization between the ensitrelvir group (n = 167,385) and the no antiviral treatment group (n = 167,310) after IPTW adjustment was 0.629 [95% confidence interval (CI) 0.420, 0.943]. The risk difference was − 0.291 [95% CI − 0.494, − 0.088]. The incidence of both respiratory and heart rate monitoring and oxygen therapy was lower in the ensitrelvir group. Ventilator use, intensive care admission, and all-cause death were difficult to assess because of the limited events. Conclusions The incidence of all-cause hospitalization was significantly lower in the ensitrelvir group than in the no antiviral treatment group, suggesting ensitrelvir is an effective treatment in patients at risk of severe COVID-19. Plain Language Summary COVID-19 still poses a risk for patients with serious health conditions and weakened immune systems, who are more likely to develop severe illness. Several studies have indicated that some oral antiviral medications might be effective in preventing severe disease. This study aimed to evaluate if ensitrelvir, an oral antiviral medication, can help prevent hospitalization in outpatients who are at risk of developing severe symptoms from the Omicron variant of the SARS-CoV-2 virus. The hospitalization rates of patients who received ensitrelvir was compared with those who did not receive any antiviral treatment, using medical records from a large health insurance database in Japan focused on outpatients who were at risk of severe symptoms and were diagnosed with COVID-19 between November 2022 and July 2023. Respiratory and heart rate monitoring, oxygen therapy, ventilator use, intensive care admission, and all-cause death were also evaluated. The study found that patients who received ensitrelvir had a lower risk of being hospitalized compared to those who did not receive any antiviral treatment. The ensitrelvir group also had lower rates of respiratory and heart rate monitoring and oxygen therapy. However, it was challenging to assess the effects on ventilator use, intensive care admission, and all-cause death due to the small number of events in the population under evaluation. Based on these findings, ensitrelvir appears to be an effective treatment for reducing the risk of hospitalization in patients at risk of severe COVID-19. Ensitrelvir (dpeaa)DE-He213 Hospitalization (dpeaa)DE-He213 COVID-19 (dpeaa)DE-He213 Japanese nationwide database (dpeaa)DE-He213 Fujita, Satoki verfasserin aut Komeda, Takuji verfasserin aut Miyazawa, Shogo verfasserin aut Yoshida, Yuki verfasserin aut Kitanishi, Yoshitake verfasserin aut Kinoshita, Masahiro verfasserin aut Kojima, Satoshi verfasserin aut Shen, Huilian verfasserin aut Uehara, Takeki verfasserin aut Hosogaya, Naoki verfasserin aut Iwanaga, Naoki verfasserin aut Mukae, Hiroshi verfasserin aut Enthalten in Infectious diseases and therapy Springer Healthcare, 2012 13(2024), 8 vom: 28. Juni, Seite 1821-1833 (DE-627)735690766 (DE-600)2701611-0 2193-6382 nnns volume:13 year:2024 number:8 day:28 month:06 pages:1821-1833 https://dx.doi.org/10.1007/s40121-024-01010-4 X:SPRINGER Resolving-System kostenfrei Volltext SYSFLAG_0 GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 13 2024 8 28 06 1821-1833
allfields_unstemmed	10.1007/s40121-024-01010-4 doi (DE-627)SPR056699182 (SPR)s40121-024-01010-4-e DE-627 ger DE-627 rakwb eng 610 VZ Takazono, Takahiro verfasserin aut Real-World Effectiveness of Ensitrelvir in Reducing Severe Outcomes in Outpatients at High Risk for COVID-19 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2024 Introduction This study aimed to evaluate the effectiveness of ensitrelvir, an oral antiviral, in reducing hospitalization risk in outpatients at high-risk for severe COVID-19 during the Omicron era. Methods This was a retrospective study using a large Japanese health insurance claims database. It included high-risk outpatients for severe symptoms who received their first COVID-19 diagnosis between November 2022 and July 2023. The study included outpatients aged ≥ 18 years. The primary endpoint was all-cause hospitalization during the 4-week period from the date of outpatient diagnosis and medication, comparing the ensitrelvir group (n = 5177) and the no antiviral treatment group (n = 162,133). The risk ratio and risk difference were evaluated after adjusting patient background distribution by the inverse probability of treatment weight (IPTW) method. Secondary endpoints were incidence of respiratory and heart rate monitoring, oxygen therapy, ventilator use, intensive care admission, and all-cause death. Results The risk ratio for all-cause hospitalization between the ensitrelvir group (n = 167,385) and the no antiviral treatment group (n = 167,310) after IPTW adjustment was 0.629 [95% confidence interval (CI) 0.420, 0.943]. The risk difference was − 0.291 [95% CI − 0.494, − 0.088]. The incidence of both respiratory and heart rate monitoring and oxygen therapy was lower in the ensitrelvir group. Ventilator use, intensive care admission, and all-cause death were difficult to assess because of the limited events. Conclusions The incidence of all-cause hospitalization was significantly lower in the ensitrelvir group than in the no antiviral treatment group, suggesting ensitrelvir is an effective treatment in patients at risk of severe COVID-19. Plain Language Summary COVID-19 still poses a risk for patients with serious health conditions and weakened immune systems, who are more likely to develop severe illness. Several studies have indicated that some oral antiviral medications might be effective in preventing severe disease. This study aimed to evaluate if ensitrelvir, an oral antiviral medication, can help prevent hospitalization in outpatients who are at risk of developing severe symptoms from the Omicron variant of the SARS-CoV-2 virus. The hospitalization rates of patients who received ensitrelvir was compared with those who did not receive any antiviral treatment, using medical records from a large health insurance database in Japan focused on outpatients who were at risk of severe symptoms and were diagnosed with COVID-19 between November 2022 and July 2023. Respiratory and heart rate monitoring, oxygen therapy, ventilator use, intensive care admission, and all-cause death were also evaluated. The study found that patients who received ensitrelvir had a lower risk of being hospitalized compared to those who did not receive any antiviral treatment. The ensitrelvir group also had lower rates of respiratory and heart rate monitoring and oxygen therapy. However, it was challenging to assess the effects on ventilator use, intensive care admission, and all-cause death due to the small number of events in the population under evaluation. Based on these findings, ensitrelvir appears to be an effective treatment for reducing the risk of hospitalization in patients at risk of severe COVID-19. Ensitrelvir (dpeaa)DE-He213 Hospitalization (dpeaa)DE-He213 COVID-19 (dpeaa)DE-He213 Japanese nationwide database (dpeaa)DE-He213 Fujita, Satoki verfasserin aut Komeda, Takuji verfasserin aut Miyazawa, Shogo verfasserin aut Yoshida, Yuki verfasserin aut Kitanishi, Yoshitake verfasserin aut Kinoshita, Masahiro verfasserin aut Kojima, Satoshi verfasserin aut Shen, Huilian verfasserin aut Uehara, Takeki verfasserin aut Hosogaya, Naoki verfasserin aut Iwanaga, Naoki verfasserin aut Mukae, Hiroshi verfasserin aut Enthalten in Infectious diseases and therapy Springer Healthcare, 2012 13(2024), 8 vom: 28. Juni, Seite 1821-1833 (DE-627)735690766 (DE-600)2701611-0 2193-6382 nnns volume:13 year:2024 number:8 day:28 month:06 pages:1821-1833 https://dx.doi.org/10.1007/s40121-024-01010-4 X:SPRINGER Resolving-System kostenfrei Volltext SYSFLAG_0 GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 13 2024 8 28 06 1821-1833
allfieldsGer	10.1007/s40121-024-01010-4 doi (DE-627)SPR056699182 (SPR)s40121-024-01010-4-e DE-627 ger DE-627 rakwb eng 610 VZ Takazono, Takahiro verfasserin aut Real-World Effectiveness of Ensitrelvir in Reducing Severe Outcomes in Outpatients at High Risk for COVID-19 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2024 Introduction This study aimed to evaluate the effectiveness of ensitrelvir, an oral antiviral, in reducing hospitalization risk in outpatients at high-risk for severe COVID-19 during the Omicron era. Methods This was a retrospective study using a large Japanese health insurance claims database. It included high-risk outpatients for severe symptoms who received their first COVID-19 diagnosis between November 2022 and July 2023. The study included outpatients aged ≥ 18 years. The primary endpoint was all-cause hospitalization during the 4-week period from the date of outpatient diagnosis and medication, comparing the ensitrelvir group (n = 5177) and the no antiviral treatment group (n = 162,133). The risk ratio and risk difference were evaluated after adjusting patient background distribution by the inverse probability of treatment weight (IPTW) method. Secondary endpoints were incidence of respiratory and heart rate monitoring, oxygen therapy, ventilator use, intensive care admission, and all-cause death. Results The risk ratio for all-cause hospitalization between the ensitrelvir group (n = 167,385) and the no antiviral treatment group (n = 167,310) after IPTW adjustment was 0.629 [95% confidence interval (CI) 0.420, 0.943]. The risk difference was − 0.291 [95% CI − 0.494, − 0.088]. The incidence of both respiratory and heart rate monitoring and oxygen therapy was lower in the ensitrelvir group. Ventilator use, intensive care admission, and all-cause death were difficult to assess because of the limited events. Conclusions The incidence of all-cause hospitalization was significantly lower in the ensitrelvir group than in the no antiviral treatment group, suggesting ensitrelvir is an effective treatment in patients at risk of severe COVID-19. Plain Language Summary COVID-19 still poses a risk for patients with serious health conditions and weakened immune systems, who are more likely to develop severe illness. Several studies have indicated that some oral antiviral medications might be effective in preventing severe disease. This study aimed to evaluate if ensitrelvir, an oral antiviral medication, can help prevent hospitalization in outpatients who are at risk of developing severe symptoms from the Omicron variant of the SARS-CoV-2 virus. The hospitalization rates of patients who received ensitrelvir was compared with those who did not receive any antiviral treatment, using medical records from a large health insurance database in Japan focused on outpatients who were at risk of severe symptoms and were diagnosed with COVID-19 between November 2022 and July 2023. Respiratory and heart rate monitoring, oxygen therapy, ventilator use, intensive care admission, and all-cause death were also evaluated. The study found that patients who received ensitrelvir had a lower risk of being hospitalized compared to those who did not receive any antiviral treatment. The ensitrelvir group also had lower rates of respiratory and heart rate monitoring and oxygen therapy. However, it was challenging to assess the effects on ventilator use, intensive care admission, and all-cause death due to the small number of events in the population under evaluation. Based on these findings, ensitrelvir appears to be an effective treatment for reducing the risk of hospitalization in patients at risk of severe COVID-19. Ensitrelvir (dpeaa)DE-He213 Hospitalization (dpeaa)DE-He213 COVID-19 (dpeaa)DE-He213 Japanese nationwide database (dpeaa)DE-He213 Fujita, Satoki verfasserin aut Komeda, Takuji verfasserin aut Miyazawa, Shogo verfasserin aut Yoshida, Yuki verfasserin aut Kitanishi, Yoshitake verfasserin aut Kinoshita, Masahiro verfasserin aut Kojima, Satoshi verfasserin aut Shen, Huilian verfasserin aut Uehara, Takeki verfasserin aut Hosogaya, Naoki verfasserin aut Iwanaga, Naoki verfasserin aut Mukae, Hiroshi verfasserin aut Enthalten in Infectious diseases and therapy Springer Healthcare, 2012 13(2024), 8 vom: 28. Juni, Seite 1821-1833 (DE-627)735690766 (DE-600)2701611-0 2193-6382 nnns volume:13 year:2024 number:8 day:28 month:06 pages:1821-1833 https://dx.doi.org/10.1007/s40121-024-01010-4 X:SPRINGER Resolving-System kostenfrei Volltext SYSFLAG_0 GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 13 2024 8 28 06 1821-1833
allfieldsSound	10.1007/s40121-024-01010-4 doi (DE-627)SPR056699182 (SPR)s40121-024-01010-4-e DE-627 ger DE-627 rakwb eng 610 VZ Takazono, Takahiro verfasserin aut Real-World Effectiveness of Ensitrelvir in Reducing Severe Outcomes in Outpatients at High Risk for COVID-19 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2024 Introduction This study aimed to evaluate the effectiveness of ensitrelvir, an oral antiviral, in reducing hospitalization risk in outpatients at high-risk for severe COVID-19 during the Omicron era. Methods This was a retrospective study using a large Japanese health insurance claims database. It included high-risk outpatients for severe symptoms who received their first COVID-19 diagnosis between November 2022 and July 2023. The study included outpatients aged ≥ 18 years. The primary endpoint was all-cause hospitalization during the 4-week period from the date of outpatient diagnosis and medication, comparing the ensitrelvir group (n = 5177) and the no antiviral treatment group (n = 162,133). The risk ratio and risk difference were evaluated after adjusting patient background distribution by the inverse probability of treatment weight (IPTW) method. Secondary endpoints were incidence of respiratory and heart rate monitoring, oxygen therapy, ventilator use, intensive care admission, and all-cause death. Results The risk ratio for all-cause hospitalization between the ensitrelvir group (n = 167,385) and the no antiviral treatment group (n = 167,310) after IPTW adjustment was 0.629 [95% confidence interval (CI) 0.420, 0.943]. The risk difference was − 0.291 [95% CI − 0.494, − 0.088]. The incidence of both respiratory and heart rate monitoring and oxygen therapy was lower in the ensitrelvir group. Ventilator use, intensive care admission, and all-cause death were difficult to assess because of the limited events. Conclusions The incidence of all-cause hospitalization was significantly lower in the ensitrelvir group than in the no antiviral treatment group, suggesting ensitrelvir is an effective treatment in patients at risk of severe COVID-19. Plain Language Summary COVID-19 still poses a risk for patients with serious health conditions and weakened immune systems, who are more likely to develop severe illness. Several studies have indicated that some oral antiviral medications might be effective in preventing severe disease. This study aimed to evaluate if ensitrelvir, an oral antiviral medication, can help prevent hospitalization in outpatients who are at risk of developing severe symptoms from the Omicron variant of the SARS-CoV-2 virus. The hospitalization rates of patients who received ensitrelvir was compared with those who did not receive any antiviral treatment, using medical records from a large health insurance database in Japan focused on outpatients who were at risk of severe symptoms and were diagnosed with COVID-19 between November 2022 and July 2023. Respiratory and heart rate monitoring, oxygen therapy, ventilator use, intensive care admission, and all-cause death were also evaluated. The study found that patients who received ensitrelvir had a lower risk of being hospitalized compared to those who did not receive any antiviral treatment. The ensitrelvir group also had lower rates of respiratory and heart rate monitoring and oxygen therapy. However, it was challenging to assess the effects on ventilator use, intensive care admission, and all-cause death due to the small number of events in the population under evaluation. Based on these findings, ensitrelvir appears to be an effective treatment for reducing the risk of hospitalization in patients at risk of severe COVID-19. Ensitrelvir (dpeaa)DE-He213 Hospitalization (dpeaa)DE-He213 COVID-19 (dpeaa)DE-He213 Japanese nationwide database (dpeaa)DE-He213 Fujita, Satoki verfasserin aut Komeda, Takuji verfasserin aut Miyazawa, Shogo verfasserin aut Yoshida, Yuki verfasserin aut Kitanishi, Yoshitake verfasserin aut Kinoshita, Masahiro verfasserin aut Kojima, Satoshi verfasserin aut Shen, Huilian verfasserin aut Uehara, Takeki verfasserin aut Hosogaya, Naoki verfasserin aut Iwanaga, Naoki verfasserin aut Mukae, Hiroshi verfasserin aut Enthalten in Infectious diseases and therapy Springer Healthcare, 2012 13(2024), 8 vom: 28. Juni, Seite 1821-1833 (DE-627)735690766 (DE-600)2701611-0 2193-6382 nnns volume:13 year:2024 number:8 day:28 month:06 pages:1821-1833 https://dx.doi.org/10.1007/s40121-024-01010-4 X:SPRINGER Resolving-System kostenfrei Volltext SYSFLAG_0 GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 13 2024 8 28 06 1821-1833
language	English
source	Enthalten in Infectious diseases and therapy 13(2024), 8 vom: 28. Juni, Seite 1821-1833 volume:13 year:2024 number:8 day:28 month:06 pages:1821-1833
sourceStr	Enthalten in Infectious diseases and therapy 13(2024), 8 vom: 28. Juni, Seite 1821-1833 volume:13 year:2024 number:8 day:28 month:06 pages:1821-1833
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Ensitrelvir Hospitalization COVID-19 Japanese nationwide database
dewey-raw	610
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container_title	Infectious diseases and therapy
authorswithroles_txt_mv	Takazono, Takahiro @@aut@@ Fujita, Satoki @@aut@@ Komeda, Takuji @@aut@@ Miyazawa, Shogo @@aut@@ Yoshida, Yuki @@aut@@ Kitanishi, Yoshitake @@aut@@ Kinoshita, Masahiro @@aut@@ Kojima, Satoshi @@aut@@ Shen, Huilian @@aut@@ Uehara, Takeki @@aut@@ Hosogaya, Naoki @@aut@@ Iwanaga, Naoki @@aut@@ Mukae, Hiroshi @@aut@@
publishDateDaySort_date	2024-06-28T00:00:00Z
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topic_title	610 VZ Real-World Effectiveness of Ensitrelvir in Reducing Severe Outcomes in Outpatients at High Risk for COVID-19 Ensitrelvir (dpeaa)DE-He213 Hospitalization (dpeaa)DE-He213 COVID-19 (dpeaa)DE-He213 Japanese nationwide database (dpeaa)DE-He213
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title	Real-World Effectiveness of Ensitrelvir in Reducing Severe Outcomes in Outpatients at High Risk for COVID-19
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title_full	Real-World Effectiveness of Ensitrelvir in Reducing Severe Outcomes in Outpatients at High Risk for COVID-19
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author_browse	Takazono, Takahiro Fujita, Satoki Komeda, Takuji Miyazawa, Shogo Yoshida, Yuki Kitanishi, Yoshitake Kinoshita, Masahiro Kojima, Satoshi Shen, Huilian Uehara, Takeki Hosogaya, Naoki Iwanaga, Naoki Mukae, Hiroshi
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title_sort	real-world effectiveness of ensitrelvir in reducing severe outcomes in outpatients at high risk for covid-19
title_auth	Real-World Effectiveness of Ensitrelvir in Reducing Severe Outcomes in Outpatients at High Risk for COVID-19
abstract	Introduction This study aimed to evaluate the effectiveness of ensitrelvir, an oral antiviral, in reducing hospitalization risk in outpatients at high-risk for severe COVID-19 during the Omicron era. Methods This was a retrospective study using a large Japanese health insurance claims database. It included high-risk outpatients for severe symptoms who received their first COVID-19 diagnosis between November 2022 and July 2023. The study included outpatients aged ≥ 18 years. The primary endpoint was all-cause hospitalization during the 4-week period from the date of outpatient diagnosis and medication, comparing the ensitrelvir group (n = 5177) and the no antiviral treatment group (n = 162,133). The risk ratio and risk difference were evaluated after adjusting patient background distribution by the inverse probability of treatment weight (IPTW) method. Secondary endpoints were incidence of respiratory and heart rate monitoring, oxygen therapy, ventilator use, intensive care admission, and all-cause death. Results The risk ratio for all-cause hospitalization between the ensitrelvir group (n = 167,385) and the no antiviral treatment group (n = 167,310) after IPTW adjustment was 0.629 [95% confidence interval (CI) 0.420, 0.943]. The risk difference was − 0.291 [95% CI − 0.494, − 0.088]. The incidence of both respiratory and heart rate monitoring and oxygen therapy was lower in the ensitrelvir group. Ventilator use, intensive care admission, and all-cause death were difficult to assess because of the limited events. Conclusions The incidence of all-cause hospitalization was significantly lower in the ensitrelvir group than in the no antiviral treatment group, suggesting ensitrelvir is an effective treatment in patients at risk of severe COVID-19. Plain Language Summary COVID-19 still poses a risk for patients with serious health conditions and weakened immune systems, who are more likely to develop severe illness. Several studies have indicated that some oral antiviral medications might be effective in preventing severe disease. This study aimed to evaluate if ensitrelvir, an oral antiviral medication, can help prevent hospitalization in outpatients who are at risk of developing severe symptoms from the Omicron variant of the SARS-CoV-2 virus. The hospitalization rates of patients who received ensitrelvir was compared with those who did not receive any antiviral treatment, using medical records from a large health insurance database in Japan focused on outpatients who were at risk of severe symptoms and were diagnosed with COVID-19 between November 2022 and July 2023. Respiratory and heart rate monitoring, oxygen therapy, ventilator use, intensive care admission, and all-cause death were also evaluated. The study found that patients who received ensitrelvir had a lower risk of being hospitalized compared to those who did not receive any antiviral treatment. The ensitrelvir group also had lower rates of respiratory and heart rate monitoring and oxygen therapy. However, it was challenging to assess the effects on ventilator use, intensive care admission, and all-cause death due to the small number of events in the population under evaluation. Based on these findings, ensitrelvir appears to be an effective treatment for reducing the risk of hospitalization in patients at risk of severe COVID-19. © The Author(s) 2024
abstractGer	Introduction This study aimed to evaluate the effectiveness of ensitrelvir, an oral antiviral, in reducing hospitalization risk in outpatients at high-risk for severe COVID-19 during the Omicron era. Methods This was a retrospective study using a large Japanese health insurance claims database. It included high-risk outpatients for severe symptoms who received their first COVID-19 diagnosis between November 2022 and July 2023. The study included outpatients aged ≥ 18 years. The primary endpoint was all-cause hospitalization during the 4-week period from the date of outpatient diagnosis and medication, comparing the ensitrelvir group (n = 5177) and the no antiviral treatment group (n = 162,133). The risk ratio and risk difference were evaluated after adjusting patient background distribution by the inverse probability of treatment weight (IPTW) method. Secondary endpoints were incidence of respiratory and heart rate monitoring, oxygen therapy, ventilator use, intensive care admission, and all-cause death. Results The risk ratio for all-cause hospitalization between the ensitrelvir group (n = 167,385) and the no antiviral treatment group (n = 167,310) after IPTW adjustment was 0.629 [95% confidence interval (CI) 0.420, 0.943]. The risk difference was − 0.291 [95% CI − 0.494, − 0.088]. The incidence of both respiratory and heart rate monitoring and oxygen therapy was lower in the ensitrelvir group. Ventilator use, intensive care admission, and all-cause death were difficult to assess because of the limited events. Conclusions The incidence of all-cause hospitalization was significantly lower in the ensitrelvir group than in the no antiviral treatment group, suggesting ensitrelvir is an effective treatment in patients at risk of severe COVID-19. Plain Language Summary COVID-19 still poses a risk for patients with serious health conditions and weakened immune systems, who are more likely to develop severe illness. Several studies have indicated that some oral antiviral medications might be effective in preventing severe disease. This study aimed to evaluate if ensitrelvir, an oral antiviral medication, can help prevent hospitalization in outpatients who are at risk of developing severe symptoms from the Omicron variant of the SARS-CoV-2 virus. The hospitalization rates of patients who received ensitrelvir was compared with those who did not receive any antiviral treatment, using medical records from a large health insurance database in Japan focused on outpatients who were at risk of severe symptoms and were diagnosed with COVID-19 between November 2022 and July 2023. Respiratory and heart rate monitoring, oxygen therapy, ventilator use, intensive care admission, and all-cause death were also evaluated. The study found that patients who received ensitrelvir had a lower risk of being hospitalized compared to those who did not receive any antiviral treatment. The ensitrelvir group also had lower rates of respiratory and heart rate monitoring and oxygen therapy. However, it was challenging to assess the effects on ventilator use, intensive care admission, and all-cause death due to the small number of events in the population under evaluation. Based on these findings, ensitrelvir appears to be an effective treatment for reducing the risk of hospitalization in patients at risk of severe COVID-19. © The Author(s) 2024
abstract_unstemmed	Introduction This study aimed to evaluate the effectiveness of ensitrelvir, an oral antiviral, in reducing hospitalization risk in outpatients at high-risk for severe COVID-19 during the Omicron era. Methods This was a retrospective study using a large Japanese health insurance claims database. It included high-risk outpatients for severe symptoms who received their first COVID-19 diagnosis between November 2022 and July 2023. The study included outpatients aged ≥ 18 years. The primary endpoint was all-cause hospitalization during the 4-week period from the date of outpatient diagnosis and medication, comparing the ensitrelvir group (n = 5177) and the no antiviral treatment group (n = 162,133). The risk ratio and risk difference were evaluated after adjusting patient background distribution by the inverse probability of treatment weight (IPTW) method. Secondary endpoints were incidence of respiratory and heart rate monitoring, oxygen therapy, ventilator use, intensive care admission, and all-cause death. Results The risk ratio for all-cause hospitalization between the ensitrelvir group (n = 167,385) and the no antiviral treatment group (n = 167,310) after IPTW adjustment was 0.629 [95% confidence interval (CI) 0.420, 0.943]. The risk difference was − 0.291 [95% CI − 0.494, − 0.088]. The incidence of both respiratory and heart rate monitoring and oxygen therapy was lower in the ensitrelvir group. Ventilator use, intensive care admission, and all-cause death were difficult to assess because of the limited events. Conclusions The incidence of all-cause hospitalization was significantly lower in the ensitrelvir group than in the no antiviral treatment group, suggesting ensitrelvir is an effective treatment in patients at risk of severe COVID-19. Plain Language Summary COVID-19 still poses a risk for patients with serious health conditions and weakened immune systems, who are more likely to develop severe illness. Several studies have indicated that some oral antiviral medications might be effective in preventing severe disease. This study aimed to evaluate if ensitrelvir, an oral antiviral medication, can help prevent hospitalization in outpatients who are at risk of developing severe symptoms from the Omicron variant of the SARS-CoV-2 virus. The hospitalization rates of patients who received ensitrelvir was compared with those who did not receive any antiviral treatment, using medical records from a large health insurance database in Japan focused on outpatients who were at risk of severe symptoms and were diagnosed with COVID-19 between November 2022 and July 2023. Respiratory and heart rate monitoring, oxygen therapy, ventilator use, intensive care admission, and all-cause death were also evaluated. The study found that patients who received ensitrelvir had a lower risk of being hospitalized compared to those who did not receive any antiviral treatment. The ensitrelvir group also had lower rates of respiratory and heart rate monitoring and oxygen therapy. However, it was challenging to assess the effects on ventilator use, intensive care admission, and all-cause death due to the small number of events in the population under evaluation. Based on these findings, ensitrelvir appears to be an effective treatment for reducing the risk of hospitalization in patients at risk of severe COVID-19. © The Author(s) 2024
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title_short	Real-World Effectiveness of Ensitrelvir in Reducing Severe Outcomes in Outpatients at High Risk for COVID-19
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author2	Fujita, Satoki Komeda, Takuji Miyazawa, Shogo Yoshida, Yuki Kitanishi, Yoshitake Kinoshita, Masahiro Kojima, Satoshi Shen, Huilian Uehara, Takeki Hosogaya, Naoki Iwanaga, Naoki Mukae, Hiroshi
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