Nirmatrelvir/ritonavir use in pregnant women with SARS-CoV-2 Omicron infection: a target trial emulation
To date, there is a lack of randomized trial data examining the use of the antiviral nirmatrelvir/ritonavir in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-infected pregnant persons. This target trial emulation study aimed to address this gap by evaluating the use of nirmatrelvir/rit...
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| Veröffentlicht in: | Nature medicine 2024-01, Vol.30 (1), p.112-116 |
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| creator | Wong, Carlos K. H. Lau, Kristy T. K. Chung, Matthew S. H. Au, Ivan C. H. Cheung, Ka Wang Lau, Eric H. Y. Daoud, Yasmin Cowling, Benjamin J. Leung, Gabriel M. |
| description | To date, there is a lack of randomized trial data examining the use of the antiviral nirmatrelvir/ritonavir in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-infected pregnant persons. This target trial emulation study aimed to address this gap by evaluating the use of nirmatrelvir/ritonavir in nonhospitalized pregnant women with symptomatic SARS-CoV-2 Omicron variant infection. Among patients diagnosed between 16 March 2022 and 5 February 2023, exposure was defined as outpatient nirmatrelvir/ritonavir treatment within 5 days of symptom onset or coronavirus disease 2019 (COVID-19) diagnosis. Primary outcomes were maternal morbidity and mortality index (MMMI), all-cause maternal death and COVID-19-related hospitalization, while secondary outcomes were individual components of MMMI, preterm birth, stillbirth, neonatal death and cesarean section. One-to-ten propensity-score matching was conducted between nirmatrelvir/ritonavir users and nonusers, followed by cloning, censoring and weighting. Overall, 211 pregnant women on nirmatrelvir/ritonavir and 1,998 nonusers were included. Nirmatrelvir/ritonavir treatment was associated with reduced 28-day MMMI risk (absolute risk reduction (ARR) = 1.47%, 95% confidence interval (CI) = 0.21–2.34%) but not 28-days COVID-19-related hospitalization (ARR = −0.09%, 95% CI = −1.08% to 0.71%). Nirmatrelvir/ritonavir treatment was also associated with reduced risks of cesarean section (ARR = 1.58%, 95% CI = 0.85–2.39%) and preterm birth (ARR = 2.70%, 95% CI = 0.98–5.31%). No events of maternal or neonatal death or stillbirth were recorded. The findings suggest that nirmatrelvir/ritonavir is an effective treatment in symptomatic pregnant women with SARS-CoV-2 Omicron variant infection.
Analysis of electronic health records of nirmatrelvir/ritonavir use in pregnant women shows that the treatment is associated with a lower risk of pregnancy-related adverse outcomes, including maternal morbidity, premature birth and cesarean section. |
| doi_str_mv | 10.1038/s41591-023-02674-0 |
| format | Article |
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Analysis of electronic health records of nirmatrelvir/ritonavir use in pregnant women shows that the treatment is associated with a lower risk of pregnancy-related adverse outcomes, including maternal morbidity, premature birth and cesarean section.</description><identifier>ISSN: 1078-8956</identifier><identifier>EISSN: 1546-170X</identifier><identifier>DOI: 10.1038/s41591-023-02674-0</identifier><identifier>PMID: 37913816</identifier><language>eng</language><publisher>New York: Nature Publishing Group US</publisher><subject>692/308/409 ; 692/699/255/2514 ; 692/700/565/1436/2774 ; Antiretroviral drugs ; Antiviral drugs ; Biomedical and Life Sciences ; Biomedicine ; Birth ; Births ; Cancer Research ; Cesarean section ; Childbirth & labor ; Cloning ; Coronaviruses ; COVID-19 ; Death ; Electronic health records ; Electronic medical records ; Health services ; Infections ; Infectious Diseases ; Maternal mortality ; Medical treatment ; Metabolic Diseases ; Molecular Medicine ; Morbidity ; Neonates ; Neurosciences ; Pregnancy ; Premature birth ; Respiratory diseases ; Risk management ; Ritonavir ; Severe acute respiratory syndrome coronavirus 2 ; Stillbirth ; Viral diseases</subject><ispartof>Nature medicine, 2024-01, Vol.30 (1), p.112-116</ispartof><rights>The Author(s), under exclusive licence to Springer Nature America, Inc. 2023. 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The Author(s), under exclusive licence to Springer Nature America, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c375t-45bd0c7fa16ec5cb2884037faa1e77134176cf80345ac83161a276d4236cee13</citedby><cites>FETCH-LOGICAL-c375t-45bd0c7fa16ec5cb2884037faa1e77134176cf80345ac83161a276d4236cee13</cites><orcidid>0000-0002-6297-7154 ; 0000-0002-1669-4479 ; 0000-0002-2503-6283 ; 0000-0002-6895-6071</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1038/s41591-023-02674-0$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1038/s41591-023-02674-0$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37913816$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Wong, Carlos K. H.</creatorcontrib><creatorcontrib>Lau, Kristy T. K.</creatorcontrib><creatorcontrib>Chung, Matthew S. H.</creatorcontrib><creatorcontrib>Au, Ivan C. H.</creatorcontrib><creatorcontrib>Cheung, Ka Wang</creatorcontrib><creatorcontrib>Lau, Eric H. Y.</creatorcontrib><creatorcontrib>Daoud, Yasmin</creatorcontrib><creatorcontrib>Cowling, Benjamin J.</creatorcontrib><creatorcontrib>Leung, Gabriel M.</creatorcontrib><title>Nirmatrelvir/ritonavir use in pregnant women with SARS-CoV-2 Omicron infection: a target trial emulation</title><title>Nature medicine</title><addtitle>Nat Med</addtitle><addtitle>Nat Med</addtitle><description>To date, there is a lack of randomized trial data examining the use of the antiviral nirmatrelvir/ritonavir in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-infected pregnant persons. This target trial emulation study aimed to address this gap by evaluating the use of nirmatrelvir/ritonavir in nonhospitalized pregnant women with symptomatic SARS-CoV-2 Omicron variant infection. Among patients diagnosed between 16 March 2022 and 5 February 2023, exposure was defined as outpatient nirmatrelvir/ritonavir treatment within 5 days of symptom onset or coronavirus disease 2019 (COVID-19) diagnosis. Primary outcomes were maternal morbidity and mortality index (MMMI), all-cause maternal death and COVID-19-related hospitalization, while secondary outcomes were individual components of MMMI, preterm birth, stillbirth, neonatal death and cesarean section. One-to-ten propensity-score matching was conducted between nirmatrelvir/ritonavir users and nonusers, followed by cloning, censoring and weighting. Overall, 211 pregnant women on nirmatrelvir/ritonavir and 1,998 nonusers were included. Nirmatrelvir/ritonavir treatment was associated with reduced 28-day MMMI risk (absolute risk reduction (ARR) = 1.47%, 95% confidence interval (CI) = 0.21–2.34%) but not 28-days COVID-19-related hospitalization (ARR = −0.09%, 95% CI = −1.08% to 0.71%). Nirmatrelvir/ritonavir treatment was also associated with reduced risks of cesarean section (ARR = 1.58%, 95% CI = 0.85–2.39%) and preterm birth (ARR = 2.70%, 95% CI = 0.98–5.31%). No events of maternal or neonatal death or stillbirth were recorded. The findings suggest that nirmatrelvir/ritonavir is an effective treatment in symptomatic pregnant women with SARS-CoV-2 Omicron variant infection.
Analysis of electronic health records of nirmatrelvir/ritonavir use in pregnant women shows that the treatment is associated with a lower risk of pregnancy-related adverse outcomes, including maternal morbidity, premature birth and cesarean section.</description><subject>692/308/409</subject><subject>692/699/255/2514</subject><subject>692/700/565/1436/2774</subject><subject>Antiretroviral drugs</subject><subject>Antiviral drugs</subject><subject>Biomedical and Life Sciences</subject><subject>Biomedicine</subject><subject>Birth</subject><subject>Births</subject><subject>Cancer Research</subject><subject>Cesarean section</subject><subject>Childbirth & labor</subject><subject>Cloning</subject><subject>Coronaviruses</subject><subject>COVID-19</subject><subject>Death</subject><subject>Electronic health records</subject><subject>Electronic medical records</subject><subject>Health services</subject><subject>Infections</subject><subject>Infectious Diseases</subject><subject>Maternal mortality</subject><subject>Medical treatment</subject><subject>Metabolic Diseases</subject><subject>Molecular Medicine</subject><subject>Morbidity</subject><subject>Neonates</subject><subject>Neurosciences</subject><subject>Pregnancy</subject><subject>Premature birth</subject><subject>Respiratory diseases</subject><subject>Risk management</subject><subject>Ritonavir</subject><subject>Severe acute respiratory syndrome coronavirus 2</subject><subject>Stillbirth</subject><subject>Viral diseases</subject><issn>1078-8956</issn><issn>1546-170X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>8G5</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNp9kU1rVTEQhoNU7If9Ay4k0I2b2Hwnp7tyUSsUC7aU7kJu7pzblHNybpMci__eXG-r4MJFmAnzzDuZvAi9Y_Qjo8KeFslUxwjloh1tJKGv0AFTUhNm6N1ey6mxxHZK76PDUh4opYKq7g3aF6ZjwjJ9gO6_xTz6mmH4EfNpjnVKvmV4LoBjwpsM6-RTxU_TCAk_xXqPr8-_X5PFdEs4vhpjyFNqZA-hximdYY-rz2uouOboBwzjPPht5S163fuhwPFzPEI3nz_dLC7I5dWXr4vzSxKEUZVItVzRYHrPNAQVltxaSUW7ewbGMCGZ0aG3VEjlgxVMM8-NXkkudABg4gh92Mlu8vQ4Q6lujCXAMPgE01xc01NKGCFlQ0_-QR-mOaf2OMc7ZiTnttsK8h3VFi0lQ-82OY4-_3SMuq0NbmeDaza43zY42preP0vPyxFWf1pe_r0BYgeUVkpryH9n_0f2F9--kko</recordid><startdate>20240101</startdate><enddate>20240101</enddate><creator>Wong, Carlos K. 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H.</au><au>Lau, Kristy T. K.</au><au>Chung, Matthew S. H.</au><au>Au, Ivan C. H.</au><au>Cheung, Ka Wang</au><au>Lau, Eric H. Y.</au><au>Daoud, Yasmin</au><au>Cowling, Benjamin J.</au><au>Leung, Gabriel M.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Nirmatrelvir/ritonavir use in pregnant women with SARS-CoV-2 Omicron infection: a target trial emulation</atitle><jtitle>Nature medicine</jtitle><stitle>Nat Med</stitle><addtitle>Nat Med</addtitle><date>2024-01-01</date><risdate>2024</risdate><volume>30</volume><issue>1</issue><spage>112</spage><epage>116</epage><pages>112-116</pages><issn>1078-8956</issn><eissn>1546-170X</eissn><abstract>To date, there is a lack of randomized trial data examining the use of the antiviral nirmatrelvir/ritonavir in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-infected pregnant persons. This target trial emulation study aimed to address this gap by evaluating the use of nirmatrelvir/ritonavir in nonhospitalized pregnant women with symptomatic SARS-CoV-2 Omicron variant infection. Among patients diagnosed between 16 March 2022 and 5 February 2023, exposure was defined as outpatient nirmatrelvir/ritonavir treatment within 5 days of symptom onset or coronavirus disease 2019 (COVID-19) diagnosis. Primary outcomes were maternal morbidity and mortality index (MMMI), all-cause maternal death and COVID-19-related hospitalization, while secondary outcomes were individual components of MMMI, preterm birth, stillbirth, neonatal death and cesarean section. One-to-ten propensity-score matching was conducted between nirmatrelvir/ritonavir users and nonusers, followed by cloning, censoring and weighting. Overall, 211 pregnant women on nirmatrelvir/ritonavir and 1,998 nonusers were included. Nirmatrelvir/ritonavir treatment was associated with reduced 28-day MMMI risk (absolute risk reduction (ARR) = 1.47%, 95% confidence interval (CI) = 0.21–2.34%) but not 28-days COVID-19-related hospitalization (ARR = −0.09%, 95% CI = −1.08% to 0.71%). Nirmatrelvir/ritonavir treatment was also associated with reduced risks of cesarean section (ARR = 1.58%, 95% CI = 0.85–2.39%) and preterm birth (ARR = 2.70%, 95% CI = 0.98–5.31%). No events of maternal or neonatal death or stillbirth were recorded. The findings suggest that nirmatrelvir/ritonavir is an effective treatment in symptomatic pregnant women with SARS-CoV-2 Omicron variant infection.
Analysis of electronic health records of nirmatrelvir/ritonavir use in pregnant women shows that the treatment is associated with a lower risk of pregnancy-related adverse outcomes, including maternal morbidity, premature birth and cesarean section.</abstract><cop>New York</cop><pub>Nature Publishing Group US</pub><pmid>37913816</pmid><doi>10.1038/s41591-023-02674-0</doi><tpages>5</tpages><orcidid>https://orcid.org/0000-0002-6297-7154</orcidid><orcidid>https://orcid.org/0000-0002-1669-4479</orcidid><orcidid>https://orcid.org/0000-0002-2503-6283</orcidid><orcidid>https://orcid.org/0000-0002-6895-6071</orcidid></addata></record> |
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| subjects | 692/308/409 692/699/255/2514 692/700/565/1436/2774 Antiretroviral drugs Antiviral drugs Biomedical and Life Sciences Biomedicine Birth Births Cancer Research Cesarean section Childbirth & labor Cloning Coronaviruses COVID-19 Death Electronic health records Electronic medical records Health services Infections Infectious Diseases Maternal mortality Medical treatment Metabolic Diseases Molecular Medicine Morbidity Neonates Neurosciences Pregnancy Premature birth Respiratory diseases Risk management Ritonavir Severe acute respiratory syndrome coronavirus 2 Stillbirth Viral diseases |
| title | Nirmatrelvir/ritonavir use in pregnant women with SARS-CoV-2 Omicron infection: a target trial emulation |
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