Linzy V Rosen, Acadia M Thielking, Caitlin M Dugdale, Grace Montepiedra, Emma Kalk, Soyeon Kim, Sylvia M LaCourse, Jyoti S Mathad, Kenneth A Freedberg, C Robert Horsburgh, A David Paltiel, Robin Wood, Andrea L Ciaranello, Krishna P Reddy
Background: Although prior studies of tuberculosis-preventive treatment (TPT) for pregnant people with human immunodeficiency virus (PPWH) report conflicting adverse pregnancy outcome (APO) risks, international guidelines recommend TPT for PPWH.
Methods: We used a microsimulation model to evaluate 5 TPT strategies among PPWH receiving antiretroviral therapy in South Africa: No TPT; 6 months of isoniazid (6H) or 3 months of isoniazid-rifapentine (3HP) during pregnancy (Immediate 6H or Immediate 3HP) or post partum (Deferred 6H or Deferred 3HP). The primary outcomes were maternal, fetal/infant, and combined deaths from causes potentially influenced by TPT (maternal tuberculosis, maternal hepatotoxicity, stillbirth, low birth weight [LBW], and infant tuberculosis). Tuberculosis during pregnancy confers 250% and 81% higher modeled risks of stillbirth and LBW, respectively. In lower-risk or higher-risk scenarios, immediate TPT confers 38% lower or 92% higher risks of stillbirth and 16% lower or 35% higher risks of LBW.
Results: Immediate TPT would minimize deaths among PPWH. When TPT confers higher stillbirth and LBW risks, immediate TPT would produce the most combined maternal and fetal/infant deaths, even with low maternal CD4 cell count and high tuberculosis incidence. If immediate TPT yields a <4% or <20% increase in stillbirth or LBW, immediate TPT would produce fewer combined deaths than deferred TPT (sensitivity analysis range, <2%-22% and <11%-120%, respectively).
Conclusions: If APO risks are below identifiable thresholds, TPT during pregnancy could decrease combined maternal and fetal/infant deaths. Given uncertainty around isoniazid's risks, and the low threshold at which APO risks could outweigh benefits from tuberculosis deaths averted, studies of newer TPT regimens among PPWH are warranted to inform guidelines.
{"title":"Tuberculosis Preventive Treatment for Pregnant People With Human Immunodeficiency Virus in South Africa: A Modeling Analysis of Clinical Benefits and Risks.","authors":"Linzy V Rosen, Acadia M Thielking, Caitlin M Dugdale, Grace Montepiedra, Emma Kalk, Soyeon Kim, Sylvia M LaCourse, Jyoti S Mathad, Kenneth A Freedberg, C Robert Horsburgh, A David Paltiel, Robin Wood, Andrea L Ciaranello, Krishna P Reddy","doi":"10.1093/cid/ciae508","DOIUrl":"10.1093/cid/ciae508","url":null,"abstract":"<p><strong>Background: </strong>Although prior studies of tuberculosis-preventive treatment (TPT) for pregnant people with human immunodeficiency virus (PPWH) report conflicting adverse pregnancy outcome (APO) risks, international guidelines recommend TPT for PPWH.</p><p><strong>Methods: </strong>We used a microsimulation model to evaluate 5 TPT strategies among PPWH receiving antiretroviral therapy in South Africa: No TPT; 6 months of isoniazid (6H) or 3 months of isoniazid-rifapentine (3HP) during pregnancy (Immediate 6H or Immediate 3HP) or post partum (Deferred 6H or Deferred 3HP). The primary outcomes were maternal, fetal/infant, and combined deaths from causes potentially influenced by TPT (maternal tuberculosis, maternal hepatotoxicity, stillbirth, low birth weight [LBW], and infant tuberculosis). Tuberculosis during pregnancy confers 250% and 81% higher modeled risks of stillbirth and LBW, respectively. In lower-risk or higher-risk scenarios, immediate TPT confers 38% lower or 92% higher risks of stillbirth and 16% lower or 35% higher risks of LBW.</p><p><strong>Results: </strong>Immediate TPT would minimize deaths among PPWH. When TPT confers higher stillbirth and LBW risks, immediate TPT would produce the most combined maternal and fetal/infant deaths, even with low maternal CD4 cell count and high tuberculosis incidence. If immediate TPT yields a <4% or <20% increase in stillbirth or LBW, immediate TPT would produce fewer combined deaths than deferred TPT (sensitivity analysis range, <2%-22% and <11%-120%, respectively).</p><p><strong>Conclusions: </strong>If APO risks are below identifiable thresholds, TPT during pregnancy could decrease combined maternal and fetal/infant deaths. Given uncertainty around isoniazid's risks, and the low threshold at which APO risks could outweigh benefits from tuberculosis deaths averted, studies of newer TPT regimens among PPWH are warranted to inform guidelines.</p>","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":" ","pages":""},"PeriodicalIF":8.2,"publicationDate":"2024-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616166","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ralph Habis, Anna Kolchinski, Ashley N Heck, Paris Bean, John C Probasco, Rodrigo Hasbun, Arun Venkatesan
{"title":"Encephalitis: playing with (bio)fire.","authors":"Ralph Habis, Anna Kolchinski, Ashley N Heck, Paris Bean, John C Probasco, Rodrigo Hasbun, Arun Venkatesan","doi":"10.1093/cid/ciae568","DOIUrl":"https://doi.org/10.1093/cid/ciae568","url":null,"abstract":"","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":" ","pages":""},"PeriodicalIF":8.2,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616162","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rebecca Grant, Marlieke E A de Kraker, Niccolò Buetti, Holly Jackson, Mohamed Abbas, Jonathan Aryeh Sobel, Rami Sommerstein, Marcus Eder, Carlo Balmelli, Nicolas Troillet, Peter W Schreiber, Philipp Jent, Laurence Senn, Domenica Flury, Sarah Tschudin-Sutter, Michael Buettcher, Maria Süveges, Laura Urbini, Olivia Keiser, Ursina Roder, Stephan Harbarth, Marie-Céline Zanella
Background: As COVID-19 is integrated into existing infectious disease control programs, it is important to understand the comparative clinical impact of COVID-19 and other respiratory diseases.
Methods: We conducted a retrospective cohort study of patients with symptomatic healthcare-associated COVID-19 or influenza reported to the nationwide, hospital-based surveillance system in Switzerland. Included patients were adults (≥18 years) hospitalized for ≥3 days in tertiary care and large regional hospitals. Patients had COVID-19 symptoms and a RT-PCR-confirmed SARS-CoV-2 infection ≥3 days after hospital admission between 1 February 2022 and 30 April 2023, or influenza symptoms and a RT-PCR-confirmed influenza A or B infection ≥3 days after hospital admission between 1 November 2018 and 30 April 2023. Primary and secondary outcomes were 30-day in-hospital mortality and admission to intensive care unit (ICU), respectively. Cox regression (Fine-Gray model) was used to account for time-dependency and competing events, with inverse probability weighting to adjust for confounding.
Results: We included 2901 patients with symptomatic healthcare-associated COVID-19 (Omicron) and 868 patients with symptomatic healthcare-associated influenza from nine hospitals. We found a similar case fatality ratio between healthcare-associated COVID-19 (Omicron) (6.2%) and healthcare-associated influenza (6.1%) patients; after adjustment, patients had a comparable subdistribution hazard ratio for 30-day in-hospital mortality (0.91, 95%CI 0.67-1.24). A similar proportion of patients were admitted to ICU (2.4% COVID-19; 2.6% influenza).
Conclusions: COVID-19 and influenza continue to cause severe disease among hospitalized patients. Our results suggest that in-hospital mortality risk of healthcare-associated COVID-19 (Omicron) and healthcare-associated influenza are comparable.
{"title":"In-hospital outcomes of healthcare-associated COVID-19 (Omicron) versus healthcare-associated influenza: a retrospective, nationwide cohort study in Switzerland.","authors":"Rebecca Grant, Marlieke E A de Kraker, Niccolò Buetti, Holly Jackson, Mohamed Abbas, Jonathan Aryeh Sobel, Rami Sommerstein, Marcus Eder, Carlo Balmelli, Nicolas Troillet, Peter W Schreiber, Philipp Jent, Laurence Senn, Domenica Flury, Sarah Tschudin-Sutter, Michael Buettcher, Maria Süveges, Laura Urbini, Olivia Keiser, Ursina Roder, Stephan Harbarth, Marie-Céline Zanella","doi":"10.1093/cid/ciae558","DOIUrl":"https://doi.org/10.1093/cid/ciae558","url":null,"abstract":"<p><strong>Background: </strong>As COVID-19 is integrated into existing infectious disease control programs, it is important to understand the comparative clinical impact of COVID-19 and other respiratory diseases.</p><p><strong>Methods: </strong>We conducted a retrospective cohort study of patients with symptomatic healthcare-associated COVID-19 or influenza reported to the nationwide, hospital-based surveillance system in Switzerland. Included patients were adults (≥18 years) hospitalized for ≥3 days in tertiary care and large regional hospitals. Patients had COVID-19 symptoms and a RT-PCR-confirmed SARS-CoV-2 infection ≥3 days after hospital admission between 1 February 2022 and 30 April 2023, or influenza symptoms and a RT-PCR-confirmed influenza A or B infection ≥3 days after hospital admission between 1 November 2018 and 30 April 2023. Primary and secondary outcomes were 30-day in-hospital mortality and admission to intensive care unit (ICU), respectively. Cox regression (Fine-Gray model) was used to account for time-dependency and competing events, with inverse probability weighting to adjust for confounding.</p><p><strong>Results: </strong>We included 2901 patients with symptomatic healthcare-associated COVID-19 (Omicron) and 868 patients with symptomatic healthcare-associated influenza from nine hospitals. We found a similar case fatality ratio between healthcare-associated COVID-19 (Omicron) (6.2%) and healthcare-associated influenza (6.1%) patients; after adjustment, patients had a comparable subdistribution hazard ratio for 30-day in-hospital mortality (0.91, 95%CI 0.67-1.24). A similar proportion of patients were admitted to ICU (2.4% COVID-19; 2.6% influenza).</p><p><strong>Conclusions: </strong>COVID-19 and influenza continue to cause severe disease among hospitalized patients. Our results suggest that in-hospital mortality risk of healthcare-associated COVID-19 (Omicron) and healthcare-associated influenza are comparable.</p>","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":" ","pages":""},"PeriodicalIF":8.2,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616164","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Oral antibiotics for S. aureus bacteremia including endocarditis: sauce for the goose is sauce for the gander.","authors":"Todd C Lee, Brad Spellberg, Emily G McDonald","doi":"10.1093/cid/ciae565","DOIUrl":"https://doi.org/10.1093/cid/ciae565","url":null,"abstract":"","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":" ","pages":""},"PeriodicalIF":8.2,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616165","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Elena Ferran, Cathleen Chan, Noorann Sheikh, Martin Dedicoat, Eliza Alexander, Ana Gibertoni-Cruz, James Brown, Esther Robinson, Marc Lipman
Fluoroquinolones are an important component of anti-tuberculosis treatment and identifying fluoroquinolone resistance is essential. We present the first survey of fluoroquinolone resistance in England from sequencing of over 16,000 unselected isolates. Fluoroquinolone resistance was 1.4% overall and 23.9% in multidrug-resistant TB. Routine sequencing allows resistance surveillance and should be widely adopted.
{"title":"Population-level frequency of fluoroquinolone resistance by whole-genome sequencing drug predictions in Mycobacterium tuberculosis complex isolates in England from 2017-2023","authors":"Elena Ferran, Cathleen Chan, Noorann Sheikh, Martin Dedicoat, Eliza Alexander, Ana Gibertoni-Cruz, James Brown, Esther Robinson, Marc Lipman","doi":"10.1093/cid/ciae560","DOIUrl":"https://doi.org/10.1093/cid/ciae560","url":null,"abstract":"Fluoroquinolones are an important component of anti-tuberculosis treatment and identifying fluoroquinolone resistance is essential. We present the first survey of fluoroquinolone resistance in England from sequencing of over 16,000 unselected isolates. Fluoroquinolone resistance was 1.4% overall and 23.9% in multidrug-resistant TB. Routine sequencing allows resistance surveillance and should be widely adopted.","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":"5 1","pages":""},"PeriodicalIF":11.8,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142610065","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Generalizability of oral therapy for S. aureus bacteremia or endocarditis: don't cook the goose.","authors":"Ahmad Mourad, Thomas L Holland, Timothy C Jenkins","doi":"10.1093/cid/ciae566","DOIUrl":"https://doi.org/10.1093/cid/ciae566","url":null,"abstract":"","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":" ","pages":""},"PeriodicalIF":8.2,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616163","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rachel L Epstein, Sarah Munroe, Lynn E Taylor, Patrick R Duryea, Benjamin Buzzee, Tannishtha Pramanick, Jordan J Feld, Dimitri Baptiste, Matthew Carroll, Laurent Castera, Richard K Sterling, Aurielle Thomas, Philip A Chan, Benjamin P Linas
Background Liver disease assessment is a key aspect of chronic hepatitis C virus (HCV) infection pre-treatment evaluation but guidelines differ on the optimal testing modality given trade-offs in availability and accuracy. We compared clinical outcomes and cost-effectiveness of common fibrosis staging strategies. Methods We simulated adults with chronic HCV receiving care at US health centers through a lifetime microsimulation across five strategies: (1) no staging or treatment (comparator), (2) indirect serum biomarker testing (Fibrosis-4 index [FIB-4]) only, (3) transient elastography (TE) only, (4) staged approach: FIB-4 for all, TE only for intermediate FIB-4 scores (1.45–3.25), and (5) both tests for all. Outcomes included infections cured, cirrhosis cases, liver-related deaths, costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs). We used literature-informed loss to follow-up (LTFU) rates and 2021 Medicaid perspective and costs. Results FIB-4 alone generated the best clinical outcomes: 87.7% cured, 8.7% developed cirrhosis, and 4.6% had liver-related deaths. TE strategies cured 58.5%–76.6%, 16.8%–29.4% developed cirrhosis, and 11.6%–22.6% had liver-related deaths. All TE strategies yielded worse clinical outcomes at higher costs per QALY than FIB-4 only, which had an ICER of $12 869 per QALY gained compared with no staging or treatment. LTFU drove these findings: TE strategies were only cost-effective with no LTFU. In a point-of-care HCV test-and-treat scenario, treatment without any staging was most clinically and cost-effective. Conclusions FIB-4 staging alone resulted in optimal clinical outcomes and was cost-effective. Treatment for chronic HCV should not be delayed while awaiting fibrosis staging with TE.
{"title":"Clinical- and Cost-Effectiveness of Liver Disease Staging in Hepatitis C Virus Infection: A Microsimulation Study","authors":"Rachel L Epstein, Sarah Munroe, Lynn E Taylor, Patrick R Duryea, Benjamin Buzzee, Tannishtha Pramanick, Jordan J Feld, Dimitri Baptiste, Matthew Carroll, Laurent Castera, Richard K Sterling, Aurielle Thomas, Philip A Chan, Benjamin P Linas","doi":"10.1093/cid/ciae485","DOIUrl":"https://doi.org/10.1093/cid/ciae485","url":null,"abstract":"Background Liver disease assessment is a key aspect of chronic hepatitis C virus (HCV) infection pre-treatment evaluation but guidelines differ on the optimal testing modality given trade-offs in availability and accuracy. We compared clinical outcomes and cost-effectiveness of common fibrosis staging strategies. Methods We simulated adults with chronic HCV receiving care at US health centers through a lifetime microsimulation across five strategies: (1) no staging or treatment (comparator), (2) indirect serum biomarker testing (Fibrosis-4 index [FIB-4]) only, (3) transient elastography (TE) only, (4) staged approach: FIB-4 for all, TE only for intermediate FIB-4 scores (1.45–3.25), and (5) both tests for all. Outcomes included infections cured, cirrhosis cases, liver-related deaths, costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs). We used literature-informed loss to follow-up (LTFU) rates and 2021 Medicaid perspective and costs. Results FIB-4 alone generated the best clinical outcomes: 87.7% cured, 8.7% developed cirrhosis, and 4.6% had liver-related deaths. TE strategies cured 58.5%–76.6%, 16.8%–29.4% developed cirrhosis, and 11.6%–22.6% had liver-related deaths. All TE strategies yielded worse clinical outcomes at higher costs per QALY than FIB-4 only, which had an ICER of $12 869 per QALY gained compared with no staging or treatment. LTFU drove these findings: TE strategies were only cost-effective with no LTFU. In a point-of-care HCV test-and-treat scenario, treatment without any staging was most clinically and cost-effective. Conclusions FIB-4 staging alone resulted in optimal clinical outcomes and was cost-effective. Treatment for chronic HCV should not be delayed while awaiting fibrosis staging with TE.","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":"33 1","pages":""},"PeriodicalIF":11.8,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142601305","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jennifer M Davis, Aadia Rana, Paul E Sax, Sara H Bares
Long-acting injectable cabotegravir plus rilpivirine (LA CAB/RPV) is currently US Food and Drug Administration (FDA)-approved and HIV treatment guideline-endorsed as a switch strategy for patients with HIV (PWH) who are virologically suppressed on oral ART without a history of treatment failure. Recent changes to the International Antiviral Society-USA (IAS-USA) and U.S. Department of Health and Human Services’ (DHHS) Panel on Antiretroviral Guidelines recommend the consideration of LA CAB/RPV in select PWH with viremia who are unable to achieve suppression with oral ART due to suboptimal medication adherence. In this article, we review the existing data on this off-label use of LA CAB/RPV, discuss the motivations and specific caveats implicit in the guidelines change, and propose next steps in exploring this novel treatment in this vulnerable patient population.
长效注射用卡博替拉韦加利匹韦林（LA CAB/RPV）目前已获得美国食品药品管理局（FDA）批准，并被艾滋病治疗指南认可为口服抗逆转录病毒疗法病毒学抑制且无治疗失败史的艾滋病病毒感染者（PWH）的转换策略。最近，美国国际抗病毒协会（IAS-USA）和美国卫生与公众服务部（DHHS）抗逆转录病毒治疗指南小组建议，对于因服药依从性不佳而无法通过口服抗逆转录病毒疗法达到病毒抑制的特定病毒携带者，可考虑使用 LA CAB/RPV。在本文中，我们回顾了有关 LA CAB/RPV 标签外使用的现有数据，讨论了指南变更的动机和具体注意事项，并提出了在这一易感患者群体中探索这种新型治疗方法的下一步措施。
{"title":"Long-Acting Cabotegravir Plus Rilpivirine in People with HIV with Adherence Challenges and Viremia: Current Data and Future Directions","authors":"Jennifer M Davis, Aadia Rana, Paul E Sax, Sara H Bares","doi":"10.1093/cid/ciae557","DOIUrl":"https://doi.org/10.1093/cid/ciae557","url":null,"abstract":"Long-acting injectable cabotegravir plus rilpivirine (LA CAB/RPV) is currently US Food and Drug Administration (FDA)-approved and HIV treatment guideline-endorsed as a switch strategy for patients with HIV (PWH) who are virologically suppressed on oral ART without a history of treatment failure. Recent changes to the International Antiviral Society-USA (IAS-USA) and U.S. Department of Health and Human Services’ (DHHS) Panel on Antiretroviral Guidelines recommend the consideration of LA CAB/RPV in select PWH with viremia who are unable to achieve suppression with oral ART due to suboptimal medication adherence. In this article, we review the existing data on this off-label use of LA CAB/RPV, discuss the motivations and specific caveats implicit in the guidelines change, and propose next steps in exploring this novel treatment in this vulnerable patient population.","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":"95 1","pages":""},"PeriodicalIF":11.8,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142601306","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction The efficacy and safety of corticosteroids in patients with human immunodeficiency virus (HIV) and tuberculosis (TB) remain controversial. Method PubMed, Embase, Web of Science, and the Cochrane Database were searched on September 19, 2024. The primary outcome was all-cause mortality, while secondary outcomes included serious adverse events. A random-effects model calculated risk ratios (RR) with 95% confidence intervals (CIs). Result Seven RCTs involving 1,410 HIV-positive TB patients were included. Corticosteroid use was not significantly reduce all-cause mortality (RR = 0.91, 95% CI: 0.79-1.04, P = 0.17) and did not significantly increase serious adverse events (RR = 0.96, 95% CI: 0.82-1.13, P = 0.63). Conclusion This meta-analysis of seven RCTs involving 1,410 HIV-positive TB patients found that corticosteroid treatment neither significantly reduced all-cause mortality nor increased serious adverse events. Further large-scale RCTs with extended follow-up are needed to explore potential benefits in subgroups, optimize treatment protocols, and inform clinical guidelines.
{"title":"Efficacy and Safety of Systematic Corticosteroids treatment among HIV-Positive Patients with Tuberculosis: a systematic review and meta-analysis of randomized controlled trials","authors":"Jiaqi Pu, Shouquan Wu, Jian-Qing He","doi":"10.1093/cid/ciae563","DOIUrl":"https://doi.org/10.1093/cid/ciae563","url":null,"abstract":"Introduction The efficacy and safety of corticosteroids in patients with human immunodeficiency virus (HIV) and tuberculosis (TB) remain controversial. Method PubMed, Embase, Web of Science, and the Cochrane Database were searched on September 19, 2024. The primary outcome was all-cause mortality, while secondary outcomes included serious adverse events. A random-effects model calculated risk ratios (RR) with 95% confidence intervals (CIs). Result Seven RCTs involving 1,410 HIV-positive TB patients were included. Corticosteroid use was not significantly reduce all-cause mortality (RR = 0.91, 95% CI: 0.79-1.04, P = 0.17) and did not significantly increase serious adverse events (RR = 0.96, 95% CI: 0.82-1.13, P = 0.63). Conclusion This meta-analysis of seven RCTs involving 1,410 HIV-positive TB patients found that corticosteroid treatment neither significantly reduced all-cause mortality nor increased serious adverse events. Further large-scale RCTs with extended follow-up are needed to explore potential benefits in subgroups, optimize treatment protocols, and inform clinical guidelines.","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":"16 1","pages":""},"PeriodicalIF":11.8,"publicationDate":"2024-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142599659","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jennifer Hammond, Heidi Leister-Tebbe, Annie Gardner, Paula Abreu, Weihang Bao, Wayne Wisemandle, Wajeeha Ansari, Magdalena Alicja Harrington, Abraham Simón-Campos, Kara W Chew, Rienk Pypstra, James M Rusnak
Background Nirmatrelvir/ritonavir (NMV/r) is an oral antiviral treatment for mild to moderate COVID-19. Methods This phase 2/3, double-blind, randomized (1:1) study assessed oral NMV/r 300 mg/100 mg versus placebo every 12 hours for 5 days in high-risk, unvaccinated, nonhospitalized, symptomatic adults with COVID-19 from 343 sites across 21 countries. In testing the primary endpoint of COVID-19‒related hospitalization and all-cause deaths and key secondary endpoints including symptom duration and COVID-19‒related medical visits, Type I error was controlled with prespecified sequential testing and the Hochberg procedure. Results Among 2113 randomized patients enrolled from July 2021 through December 2021, 1966 (NMV/r, n=977; placebo, n=989) were included in the prespecified analysis population (symptom onset ≤5 days, did not receive monoclonal antibodies). NMV/r significantly reduced times to sustained alleviation (median, 13 vs 15 days; hazard ratio [HR]=1.27, p<0.0001) and resolution (16 vs 19 days; HR=1.20, p=0.0022) through Day 28 and significantly reduced the number of COVID-19‒related medical visits and the proportion of patients with such visits. Hospitalized patients treated with NMV/r had shorter stays, none required ICU admission or mechanical ventilation, and all were discharged to home/self-care. Fewer NMV/r-treated patients required additional treatment for COVID-19. No NMV/r-treated patients died through Week 24 compared with 15 placebo-treated patients. Conclusions In addition to reducing COVID-19‒related hospitalization or death from any cause through Day 28, NMV/r was found to also reduce duration of COVID-19 symptoms and utilization of healthcare resources versus placebo in patients at high risk of progressing to severe disease. Clinical Trial Information ClinicalTrials.gov, NCT04960202, https://clinicaltrials.gov/study/NCT04960202
{"title":"Alleviation of COVID-19 Symptoms and Reduction in Healthcare Utilization Among High-Risk Patients Treated With Nirmatrelvir/Ritonavir (NMV/R): A phase 3 randomized trial","authors":"Jennifer Hammond, Heidi Leister-Tebbe, Annie Gardner, Paula Abreu, Weihang Bao, Wayne Wisemandle, Wajeeha Ansari, Magdalena Alicja Harrington, Abraham Simón-Campos, Kara W Chew, Rienk Pypstra, James M Rusnak","doi":"10.1093/cid/ciae551","DOIUrl":"https://doi.org/10.1093/cid/ciae551","url":null,"abstract":"Background Nirmatrelvir/ritonavir (NMV/r) is an oral antiviral treatment for mild to moderate COVID-19. Methods This phase 2/3, double-blind, randomized (1:1) study assessed oral NMV/r 300 mg/100 mg versus placebo every 12 hours for 5 days in high-risk, unvaccinated, nonhospitalized, symptomatic adults with COVID-19 from 343 sites across 21 countries. In testing the primary endpoint of COVID-19‒related hospitalization and all-cause deaths and key secondary endpoints including symptom duration and COVID-19‒related medical visits, Type I error was controlled with prespecified sequential testing and the Hochberg procedure. Results Among 2113 randomized patients enrolled from July 2021 through December 2021, 1966 (NMV/r, n=977; placebo, n=989) were included in the prespecified analysis population (symptom onset ≤5 days, did not receive monoclonal antibodies). NMV/r significantly reduced times to sustained alleviation (median, 13 vs 15 days; hazard ratio [HR]=1.27, p&lt;0.0001) and resolution (16 vs 19 days; HR=1.20, p=0.0022) through Day 28 and significantly reduced the number of COVID-19‒related medical visits and the proportion of patients with such visits. Hospitalized patients treated with NMV/r had shorter stays, none required ICU admission or mechanical ventilation, and all were discharged to home/self-care. Fewer NMV/r-treated patients required additional treatment for COVID-19. No NMV/r-treated patients died through Week 24 compared with 15 placebo-treated patients. Conclusions In addition to reducing COVID-19‒related hospitalization or death from any cause through Day 28, NMV/r was found to also reduce duration of COVID-19 symptoms and utilization of healthcare resources versus placebo in patients at high risk of progressing to severe disease. Clinical Trial Information ClinicalTrials.gov, NCT04960202, https://clinicaltrials.gov/study/NCT04960202","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":"34 1","pages":""},"PeriodicalIF":11.8,"publicationDate":"2024-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142598225","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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