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All Studies   All Outcomes       

Nirmatrelvir/Ritonavir Reduces Infection Duration in Hospitalized Hematological Malignancies Patients with Mild-to-Moderate COVID-19: A Retrospective Study

Nov 2024  
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Mortality 9% Improvement Relative Risk Recovery 34% Paxlovid for COVID-19  Yu et al.  EARLY TREATMENT Is early treatment with paxlovid beneficial for COVID-19? Retrospective 130 patients in China (December 2022 - February 2023) Improved recovery with paxlovid (p=0.041) c19early.org Yu et al., Blood, November 2024 Favorspaxlovid Favorscontrol 0 0.5 1 1.5 2+
Retrospective 130 hematological malignancy patients with mild-to-moderate COVID-19 in China showing no significant difference in 90-day mortality, but shorter infection duration with paxlovid treatment within 5 days.
Resistance. Variants may be resistant to paxlovid1-3. Use may promote the emergence of variants that weaken host immunity and potentially contribute to long COVID4.
Confounding by contraindication. Hoertel et al. find that over 50% of patients that died had a contraindication for the use of Paxlovid5. Retrospective studies that do not exclude contraindicated patients may significantly overestimate efficacy.
Black box warning. The FDA notes that "severe, life-threatening, and/or fatal adverse reactions due to drug interactions have been reported in patients treated with paxlovid"6.
AKI. Kamo et al. show significantly increased risk of acute kidney injury.
risk of death, 9.4% lower, RR 0.91, p = 0.92.
risk of no recovery, 33.8% lower, HR 0.66, p = 0.04, adjusted per study, inverted to make HR<1 favor treatment, multivariable, Cox proportional hazards.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Yu et al., 5 Nov 2024, retrospective, China, peer-reviewed, median age 51.0, 5 authors, study period 1 December, 2022 - 28 February, 2023, trial ChiCTR2300069374.
This PaperPaxlovidAll
Abstract: Blood 144 (2024) 5955–5956 The 66th ASH Annual Meeting Abstracts ONLINE PUBLICATION ONLY 615.ACUTE MYELOID LEUKEMIAS: CLINICAL AND EPIDEMIOLOGICAL Nirmatrelvir/Ritonavir Reduces Infection Duration in Hospitalized Hematological Malignancies Patients with Mild-to-Moderate COVID-19: A Retrospective Study Hongbin Yu, MD 1, Tian Chen 2, Jiawei Li, MPH 3, Xin Zhang, MMed 4, Yu Wu, MD 5 1 Department of Hematology, West China Hospital, Sichuan University, Chengdu, China West China Hospital, Sichuan University, Chengdu, China 3 West China School of Public Health and West China Fourth Hospital, Sichuan University, Chengdu, CHN 4 West China Hospital, Sichuan University, Chengdu, China 5 Department of Hematology and Hematology Research Laboratory, West China Hospital, Sichuan University, Chengdu, China 2 Background Since the COVID-19 outbreak in 2020, the virus has significantly impacted global health, particularly affecting patients with hematological malignancies (HM) due to their immunocompromised status. These patients experience higher infection rates, prolonged virus clearance, and more severe outcomes. Immunocompromised individuals with persistent infections may also serve as reservoirs for viral variants, posing public health risks due to the rapid evolution of SARS-CoV-2. Nirmatrelvir/ritonavir, an antiviral agent approved for treating COVID-19, has demonstrated efficacy in reducing severity and mortality in high-risk, non-hospitalized patients. While some reported cases support the potential benefits of nirmatrelvir/ritonavir for hospitalized patients with mild-to-moderate COVID-19 and HM, its effectiveness in this specific patient population remains undetermined. To address this knowledge gap, we conducted a single-center retrospective study to assess the efficacy of nirmatrelvir/ritonavir in hospitalized patients with mild-to-moderate COVID-19 and HM. Methods We conducted a single-center, retrospective, real-world cohort study at West China Hospital of Sichuan University to evaluate the outcomes of hospitalized patients with HM and SARS-CoV-2 infection treated with nirmatrelvir/ritonavir. Patients hospitalized for a minimum of five days in the Department of Hematology between December 1, 2022, and February 28, 2023, were included. Eligibility criteria included an active HM diagnosis within the preceding three years and SARS-CoV-2 antigen or nucleic acid positivity. Patients diagnosed with severe COVID-19, or treated with convalescent plasma, azvudine, or molnupiravir, or with unknown vaccination status, were excluded. The severity levels for COVID-19 infections in this study followed the definitions provided in the China Diagnosis and Treatment Protocol for COVID-19 Patients (Tentative 10th Version). The Institutional Review Board approved the study protocol. The study, registered with the Chinese Clinical Trial Registry (ChiCTR2300069374), was conducted following the Helsinki Declaration. Results A total of 130 HM patients hospitalized for a minimum of five days with mild-to-moderate COVID-19 between December 1, 2022, and February 28, 2023, were included in this study, corresponding to China’s first COVID-19 wave. In this study, 50% (65/130) of the patients were male, predominantly under 65 years old (n = 107, 82.3%), with a median age of 51 (16-91) years. Acute myeloid leukemia and myelodysplastic syndromes were the most common malignancies (33.1%), followed by non-Hodgkin’s lymphoma (23.8%). There was no difference in the 90-day..
{ 'indexed': { 'date-parts': [[2024, 12, 6]], 'date-time': '2024-12-06T05:21:30Z', 'timestamp': 1733462490080, 'version': '3.30.1'}, 'reference-count': 0, 'publisher': 'American Society of Hematology', 'issue': 'Supplement 1', 'content-domain': {'domain': ['ashpublications.org'], 'crossmark-restriction': True}, 'published-print': {'date-parts': [[2024, 11, 5]]}, 'abstract': '<jats:sec>\n' ' <jats:title/>\n' ' <jats:p>Background</jats:p>\n' ' <jats:p>Since the COVID-19 outbreak in 2020, the virus has significantly ' 'impacted global health, particularly affecting patients with hematological malignancies (HM) ' 'due to their immunocompromised status. These patients experience higher infection rates, ' 'prolonged virus clearance, and more severe outcomes. Immunocompromised individuals with ' 'persistent infections may also serve as reservoirs for viral variants, posing public health ' 'risks due to the rapid evolution of SARS-CoV-2. Nirmatrelvir/ritonavir, an antiviral agent ' 'approved for treating COVID-19, has demonstrated efficacy in reducing severity and mortality ' 'in high-risk, non-hospitalized patients. While some reported cases support the potential ' 'benefits of nirmatrelvir/ritonavir for hospitalized patients with mild-to-moderate COVID-19 ' 'and HM, its effectiveness in this specific patient population remains undetermined. To ' 'address this knowledge gap, we conducted a single-center retrospective study to assess the ' 'efficacy of nirmatrelvir/ritonavir in hospitalized patients with mild-to-moderate COVID-19 ' 'and HM.</jats:p>\n' ' <jats:p>Methods</jats:p>\n' ' <jats:p>We conducted a single-center, retrospective, real-world cohort ' 'study at West China Hospital of Sichuan University to evaluate the outcomes of hospitalized ' 'patients with HM and SARS-CoV-2 infection treated with nirmatrelvir/ritonavir. Patients ' 'hospitalized for a minimum of five days in the Department of Hematology between December 1, ' '2022, and February 28, 2023, were included. Eligibility criteria included an active HM ' 'diagnosis within the preceding three years and SARS-CoV-2 antigen or nucleic acid positivity. ' 'Patients diagnosed with severe COVID-19, or treated with convalescent plasma, azvudine, or ' 'molnupiravir, or with unknown vaccination status, were excluded. The severity levels for ' 'COVID-19 infections in this study followed the definitions provided in the China Diagnosis ' 'and Treatment Protocol for COVID-19 Patients (Tentative 10th Version). The Institutional ' 'Review Board approved the study protocol. The study, registered with the Chinese Clinical ' 'Trial Registry (ChiCTR2300069374), was conducted following the Helsinki ' 'Declaration.</jats:p>\n' ' <jats:p>Results</jats:p>\n' ' <jats:p>A total of 130 HM patients hospitalized for a minimum of five days ' 'with mild-to-moderate COVID-19 between December 1, 2022, and February 28, 2023, were included ' "in this study, corresponding to China's first COVID-19 wave. In this study, 50% (65/130) of " 'the patients were male, predominantly under 65 years old (n = 107, 82.3%), with a median age ' 'of 51 (16-91) years. Acute myeloid leukemia and myelodysplastic syndromes were the most ' "common malignancies (33.1%), followed by non-Hodgkin's lymphoma (23.8%). There was no " 'difference in the 90-day mortality rate between HM patients treated with ' 'nirmatrelvir/ritonavir within five days of confirmed SARS-CoV-2 infection and the control ' 'group (4.8% vs 5.3%, P = 0.916). Regarding the infection duration, Cox regression ' 'multivariate analysis showed that patients receiving chemotherapy with antibodies had a ' 'significantly prolonged infection duration (HR=0.51, 95% CI 0.29-0.81). Other treatment ' 'regimens did not achieve a statistically significant difference in time to viral clearance. ' 'Nirmatrelvir/ritonavir use within five days reduced the time to viral clearance (HR=1.51, 95% ' 'CI 1.01-2.23).</jats:p>\n' ' <jats:p>Conclusions</jats:p>\n' ' <jats:p>Nirmatrelvir/ritonavir use within five days in hospitalized HM ' 'patients with mild-to-moderate COVID-19 does not reduce mortality but shortens infection ' 'duration.</jats:p>\n' ' </jats:sec>', 'DOI': '10.1182/blood-2024-207488', 'type': 'journal-article', 'created': {'date-parts': [[2024, 12, 5]], 'date-time': '2024-12-05T20:58:08Z', 'timestamp': 1733432288000}, 'page': '5955-5955', 'update-policy': 'https://doi.org/10.1182/blood.2019cm0000', 'source': 'Crossref', 'is-referenced-by-count': 0, 'title': 'Nirmatrelvir/Ritonavir Reduces Infection Duration in Hospitalized Hematological Malignancies ' 'Patients with Mild-to-Moderate COVID-19: A Retrospective Study', 'prefix': '10.1182', 'volume': '144', 'author': [ { 'given': 'Hongbin', 'family': 'Yu', 'sequence': 'first', 'affiliation': [ { 'name': '1Department of Hematology, West China Hospital, Sichuan ' 'University, Chengdu, China'}]}, { 'given': 'Tian', 'family': 'Chen', 'sequence': 'additional', 'affiliation': [{'name': '2West China Hospital, Sichuan University, Chengdu, China'}]}, { 'given': 'Jiawei', 'family': 'Li', 'sequence': 'additional', 'affiliation': [ { 'name': '3West China School of Public Health and West China Fourth ' 'Hospital, Sichuan University, Chengdu, CHN'}]}, { 'given': 'Xin', 'family': 'Zhang', 'sequence': 'additional', 'affiliation': [{'name': '4West China Hospital, Sichuan University, Chengdu, China'}]}, { 'given': 'Yu', 'family': 'Wu', 'sequence': 'additional', 'affiliation': [ { 'name': '5Department of Hematology and Hematology Research Laboratory, ' 'West China Hospital, Sichuan University, Chengdu, China'}]}], 'member': '234', 'container-title': 'Blood', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://ashpublications.org/blood/article-pdf/144/Supplement%201/5955/2321528/blood-8784-main.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'syndication'}, { 'URL': 'https://ashpublications.org/blood/article-pdf/144/Supplement%201/5955/2321528/blood-8784-main.pdf', 'content-type': 'unspecified', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2024, 12, 5]], 'date-time': '2024-12-05T20:58:09Z', 'timestamp': 1733432289000}, 'score': 1, 'resource': { 'primary': { 'URL': 'https://ashpublications.org/blood/article/144/Supplement%201/5955/527513/Nirmatrelvir-Ritonavir-Reduces-Infection-Duration'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2024, 11, 5]]}, 'references-count': 0, 'journal-issue': {'issue': 'Supplement 1', 'published-print': {'date-parts': [[2024, 11, 5]]}}, 'URL': 'http://dx.doi.org/10.1182/blood-2024-207488', 'relation': {}, 'ISSN': ['0006-4971', '1528-0020'], 'subject': [], 'published': {'date-parts': [[2024, 11, 5]]}}
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