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}
Ilesh V Jani, Issa Sabi, Kira Elsbernd, Bindiya Meggi, Arlete Mahumane, Anange Fred Lwilla, Kassia Pereira, Siriel Boniface, Raphael Edom, Joaquim Lequechane, Falume Chale, Nhamo Chiwerengo, Nyanda E Ntinginya, Chishamiso Mudenyanga, Mariana Mueller, Martina Rauscher, Michael Hoelscher, Nuno Taveira, W Chris Buck, Arne Kroidl
Background: We assessed the impact of point-of-care (PoC) test-and-treat at birth on clinical outcomes and viral suppression among HIV-positive infants in Mozambique and Tanzania.
Methods: This cluster-randomized trial allocated health facilities to intervention, providing PoC-testing and antiretroviral treatment (ART) at birth and week 4-8, or control, starting these at week 4-8. The primary outcome was proportions of clinical events (mortality, morbidity, retention, virological failure, toxicity) among HIV-positive infants at month-18. We estimated incidence rate ratios adjusted for timing of HIV-detection (aIRR) and reported viral suppression <1000 copies/mL.
Findings: Among 6602 neonates enrolled October 2019-September 2021, 125 were diagnosed HIV-positive by week 12. In the intervention arm, 38/69 (55.1%) were diagnosed at birth with 35 initiating ART within two days. In the control arm, 27/56 (48.2%) were retrospectively detected HIV-positive at birth, of whom 6/56 (10.7%) died or were lost to follow-up before testing. Median age at ART initiation was 6 (intervention) versus 33 days (control). Birth test-and-treat was not associated with a significant reduction in clinical outcomes up to month-18 [53 (76.8%) versus 48 (85.7%); aIRR 0.857; 95% CI 0.505-1.492], but showed a 68% relative reduction in 6-month mortality. Viral suppression was poor overall, but improved in the intervention group at month 18 (65.7% versus 29.6%; p=0.005).
Interpretation: PoC test-and-treat at birth is feasible in resource-poor settings and resulted in clinically-relevant reduction of early infant mortality, though improved clinical outcomes were not sustained to month-18. Poor viral suppression may undermine early survival benefits, calling for better paediatric treatments and tailored adherence interventions.
{"title":"Impact of point-of-care birth test-and-treat on clinical outcomes among infants with HIV: A cluster randomized trial in Mozambique and Tanzania.","authors":"Ilesh V Jani, Issa Sabi, Kira Elsbernd, Bindiya Meggi, Arlete Mahumane, Anange Fred Lwilla, Kassia Pereira, Siriel Boniface, Raphael Edom, Joaquim Lequechane, Falume Chale, Nhamo Chiwerengo, Nyanda E Ntinginya, Chishamiso Mudenyanga, Mariana Mueller, Martina Rauscher, Michael Hoelscher, Nuno Taveira, W Chris Buck, Arne Kroidl","doi":"10.1093/cid/ciae530","DOIUrl":"https://doi.org/10.1093/cid/ciae530","url":null,"abstract":"<p><strong>Background: </strong>We assessed the impact of point-of-care (PoC) test-and-treat at birth on clinical outcomes and viral suppression among HIV-positive infants in Mozambique and Tanzania.</p><p><strong>Methods: </strong>This cluster-randomized trial allocated health facilities to intervention, providing PoC-testing and antiretroviral treatment (ART) at birth and week 4-8, or control, starting these at week 4-8. The primary outcome was proportions of clinical events (mortality, morbidity, retention, virological failure, toxicity) among HIV-positive infants at month-18. We estimated incidence rate ratios adjusted for timing of HIV-detection (aIRR) and reported viral suppression <1000 copies/mL.</p><p><strong>Findings: </strong>Among 6602 neonates enrolled October 2019-September 2021, 125 were diagnosed HIV-positive by week 12. In the intervention arm, 38/69 (55.1%) were diagnosed at birth with 35 initiating ART within two days. In the control arm, 27/56 (48.2%) were retrospectively detected HIV-positive at birth, of whom 6/56 (10.7%) died or were lost to follow-up before testing. Median age at ART initiation was 6 (intervention) versus 33 days (control). Birth test-and-treat was not associated with a significant reduction in clinical outcomes up to month-18 [53 (76.8%) versus 48 (85.7%); aIRR 0.857; 95% CI 0.505-1.492], but showed a 68% relative reduction in 6-month mortality. Viral suppression was poor overall, but improved in the intervention group at month 18 (65.7% versus 29.6%; p=0.005).</p><p><strong>Interpretation: </strong>PoC test-and-treat at birth is feasible in resource-poor settings and resulted in clinically-relevant reduction of early infant mortality, though improved clinical outcomes were not sustained to month-18. Poor viral suppression may undermine early survival benefits, calling for better paediatric treatments and tailored adherence interventions.</p>","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":" ","pages":""},"PeriodicalIF":8.2,"publicationDate":"2024-11-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142603613","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":"OPAT and Severe Sepsis Mortality.","authors":"Michael P Dailey","doi":"10.1093/cid/ciae553","DOIUrl":"10.1093/cid/ciae553","url":null,"abstract":"","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":" ","pages":""},"PeriodicalIF":8.2,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142590181","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}
Matthew Davis, William Towner, Elliot DeHaan, Qin Jiang, Wen Li, Farah Rahman, Michael Patton, Hayley Wyper, Maria Maddalena Lino, Uzma N Sarwar, Zaynah Majid-Mahomed, Saumil Mehta, William Howitt, Kevin Cannon, Elena Kalinina, David Cooper, Kena A Swanson, Annaliesa S Anderson, Alejandra Gurtman, Iona Munjal
Background Older individuals and adults with certain chronic or immunocompromising health conditions are at increased risk of severe RSV disease. Methods In this phase 3 randomized trial of RSVpreF safety and immunogenicity in 18−59-year-olds at high-risk of severe RSV disease, participants were randomized 2:1 to 1 RSVpreF (120 µg) or placebo dose. Primary safety endpoints included reactogenicity events and adverse events (AEs) through 7 days and 1 month after vaccination, respectively, and serious AEs (SAEs) and newly diagnosed chronic medical conditions (NDCMCs) throughout the study. In primary analyses, immunogenicity elicited 1 month after RSVpreF was bridged to a randomly selected subset of ≥60-year-olds receiving RSVpreF from the immunogenicity subset in the pivotal phase 3 RENOIR trial, which demonstrated RSVpreF efficacy. Noninferiority was declared if 95% CI lower bounds were >0.667 (neutralizing titer adjusted geometric mean ratios) and >−10% (seroresponse rate differences) for RSV-A and RSV-B. Results Overall, 678 participants received RSVpreF (n=453) or placebo (n=225). Most reactogenicity events were mild/moderate; severe events occurred in ≤2.0% of participants overall. AE frequencies were similar in RSVpreF (7.1%) and placebo recipients (7.6%). No vaccine-related SAEs or NDCMCs were reported. One month after RSVpreF administration, noninferiority criteria were met in 18−59-year-olds versus ≥60-year-olds for RSV-A and RSV-B neutralizing titers and seroresponse rates. Conclusion RSVpreF was well tolerated with no safety concerns and demonstrated immunobridging to efficacy in 18−59-year-olds at high-risk of severe RSV disease versus ≥60-year-olds in whom efficacy was previously demonstrated, supporting use of RSVpreF to prevent RSV-associated disease in this population. NCT05842967.
{"title":"Bivalent RSVpreF Vaccine in Adults 18 to <60 Years Old With High-Risk Conditions","authors":"Matthew Davis, William Towner, Elliot DeHaan, Qin Jiang, Wen Li, Farah Rahman, Michael Patton, Hayley Wyper, Maria Maddalena Lino, Uzma N Sarwar, Zaynah Majid-Mahomed, Saumil Mehta, William Howitt, Kevin Cannon, Elena Kalinina, David Cooper, Kena A Swanson, Annaliesa S Anderson, Alejandra Gurtman, Iona Munjal","doi":"10.1093/cid/ciae550","DOIUrl":"https://doi.org/10.1093/cid/ciae550","url":null,"abstract":"Background Older individuals and adults with certain chronic or immunocompromising health conditions are at increased risk of severe RSV disease. Methods In this phase 3 randomized trial of RSVpreF safety and immunogenicity in 18−59-year-olds at high-risk of severe RSV disease, participants were randomized 2:1 to 1 RSVpreF (120 µg) or placebo dose. Primary safety endpoints included reactogenicity events and adverse events (AEs) through 7 days and 1 month after vaccination, respectively, and serious AEs (SAEs) and newly diagnosed chronic medical conditions (NDCMCs) throughout the study. In primary analyses, immunogenicity elicited 1 month after RSVpreF was bridged to a randomly selected subset of ≥60-year-olds receiving RSVpreF from the immunogenicity subset in the pivotal phase 3 RENOIR trial, which demonstrated RSVpreF efficacy. Noninferiority was declared if 95% CI lower bounds were &gt;0.667 (neutralizing titer adjusted geometric mean ratios) and &gt;−10% (seroresponse rate differences) for RSV-A and RSV-B. Results Overall, 678 participants received RSVpreF (n=453) or placebo (n=225). Most reactogenicity events were mild/moderate; severe events occurred in ≤2.0% of participants overall. AE frequencies were similar in RSVpreF (7.1%) and placebo recipients (7.6%). No vaccine-related SAEs or NDCMCs were reported. One month after RSVpreF administration, noninferiority criteria were met in 18−59-year-olds versus ≥60-year-olds for RSV-A and RSV-B neutralizing titers and seroresponse rates. Conclusion RSVpreF was well tolerated with no safety concerns and demonstrated immunobridging to efficacy in 18−59-year-olds at high-risk of severe RSV disease versus ≥60-year-olds in whom efficacy was previously demonstrated, supporting use of RSVpreF to prevent RSV-associated disease in this population. NCT05842967.","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":"10 1","pages":""},"PeriodicalIF":11.8,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142598226","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}
Qianlai Luo, Marie-Josèphe Horner, Cameron B Haas, Jennifer K McGee-Avila, Ruth M Pfeiffer, Eric A Engels, Karen Pawlish, Analise Monterosso, David J Riedel, Xiao-Cheng Wu, Lou Gonsalves, Suzanne Speers, Colby Cohen, Meredith S Shiels
Background Cancer risk among people with HIV (PWH) has declined over time as a result of antiretroviral therapy, but it is unclear whether all racial/ethnic groups and transmission risk groups have experienced equal declines. Methods We used data on PWH aged ≥20 years old from the HIV/AIDS Cancer Match Study during 2001–2019. We used Poisson regression to assess time trends in incidence rates for each cancer site by racial/ethnicity and risk group, adjusting for age, registry, and sex. We also estimated adjusted rate ratios across racial and ethnic and risk groups in 2001-2004 and 2015-2019. Results Trends in age-standardized rates differed across Black, White and Hispanic PWH, and across risk groups for some cancers. For example, liver cancer rates declined 23% per 5-year period among White PWH, 11% in Black PWH and 18% in Hispanic PWH. Anal cancer rates declined among men who have sex with men, were stable among people who inject drugs, and increased among other risk groups Between 2001-2004 and 2015-2019, relative difference in cancer incidence rates by race/ethnicity increased for HL and liver cancer but decreased for NHL; by risk group, relative differences increased for NHL and liver cancer, and decreased for HL, lung and anal cancers. Conclusions Among PWH in the US, during 2001–2019, HL, lung, liver, and cervical cancer rate trends were different across racial/ethnic groups. HL, lung, anal, and liver cancer rates trends were different across risk groups. Future work should examine underlying causes of the differences in trends.
{"title":"Differences in Trends in Cancer Incidence Rates Among People with HIV during 2001–2019 By Race and Ethnicity and By Risk Group in the United States","authors":"Qianlai Luo, Marie-Josèphe Horner, Cameron B Haas, Jennifer K McGee-Avila, Ruth M Pfeiffer, Eric A Engels, Karen Pawlish, Analise Monterosso, David J Riedel, Xiao-Cheng Wu, Lou Gonsalves, Suzanne Speers, Colby Cohen, Meredith S Shiels","doi":"10.1093/cid/ciae555","DOIUrl":"https://doi.org/10.1093/cid/ciae555","url":null,"abstract":"Background Cancer risk among people with HIV (PWH) has declined over time as a result of antiretroviral therapy, but it is unclear whether all racial/ethnic groups and transmission risk groups have experienced equal declines. Methods We used data on PWH aged ≥20 years old from the HIV/AIDS Cancer Match Study during 2001–2019. We used Poisson regression to assess time trends in incidence rates for each cancer site by racial/ethnicity and risk group, adjusting for age, registry, and sex. We also estimated adjusted rate ratios across racial and ethnic and risk groups in 2001-2004 and 2015-2019. Results Trends in age-standardized rates differed across Black, White and Hispanic PWH, and across risk groups for some cancers. For example, liver cancer rates declined 23% per 5-year period among White PWH, 11% in Black PWH and 18% in Hispanic PWH. Anal cancer rates declined among men who have sex with men, were stable among people who inject drugs, and increased among other risk groups Between 2001-2004 and 2015-2019, relative difference in cancer incidence rates by race/ethnicity increased for HL and liver cancer but decreased for NHL; by risk group, relative differences increased for NHL and liver cancer, and decreased for HL, lung and anal cancers. Conclusions Among PWH in the US, during 2001–2019, HL, lung, liver, and cervical cancer rate trends were different across racial/ethnic groups. HL, lung, anal, and liver cancer rates trends were different across risk groups. Future work should examine underlying causes of the differences in trends.","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":"8 1","pages":""},"PeriodicalIF":11.8,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142597848","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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