Lena van der Wekken-Pas, Fabian Weiss, Charlotte Simon-Zuber, Rena Sebisch, Carmen Wiese, Elisabeth van Leeuwen, David Burger, Angela Colbers
{"title":"Trial versus real world circumstances and how to interpret pharmacokinetic data.","authors":"Lena van der Wekken-Pas, Fabian Weiss, Charlotte Simon-Zuber, Rena Sebisch, Carmen Wiese, Elisabeth van Leeuwen, David Burger, Angela Colbers","doi":"10.1093/cid/ciae636","DOIUrl":"https://doi.org/10.1093/cid/ciae636","url":null,"abstract":"","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":" ","pages":""},"PeriodicalIF":8.2,"publicationDate":"2024-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142945260","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}
Thomas Montrouge, Mélanie Bertine, Gilles Peytavin, Thibault Saint Joannis, Antoine Bachelard, Pierre De Truchis, Sylvie Lariven, Philippe Morlat, Cécile Pouderoux, Florence Damond, Naomi Sayre, Roland Tubiana, Nadia Valin, Charlotte Charpentier, Diane Descamps, Jade Ghosn, Quentin Le Hingrat
{"title":"Rapid Selection of HIV-2 Capsid Mutations in Salvage Therapy with Lenacapavir-Containing Regimen","authors":"Thomas Montrouge, Mélanie Bertine, Gilles Peytavin, Thibault Saint Joannis, Antoine Bachelard, Pierre De Truchis, Sylvie Lariven, Philippe Morlat, Cécile Pouderoux, Florence Damond, Naomi Sayre, Roland Tubiana, Nadia Valin, Charlotte Charpentier, Diane Descamps, Jade Ghosn, Quentin Le Hingrat","doi":"10.1093/cid/ciae650","DOIUrl":"https://doi.org/10.1093/cid/ciae650","url":null,"abstract":"Lenacapavir is the first capsid inhibitor, its use is currently approved for multidrug resistant HIV-1 infection. We report that, despite an initial efficacy of a LEN-containing regimen in patients with multi-drug resistant HIV-2 viruses, virological suppression was not achieved after a year and most patients selected capsid drug-resistance associated mutations.","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":"35 1","pages":""},"PeriodicalIF":11.8,"publicationDate":"2024-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142905161","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}
Christina Gao, Shirajh Satheakeerthy, Carolyn Qian, Brittany Suann, Christina Guo, Andrew E C Booth, Sarah Howson, Shaun Evans, Brandon Stretton, Weng Onn Chan, Alyssa Pradhan, Stephen Bacchi
{"title":"A generalisable risk factor: Socioeconomic status and multi-resistant organism colonisation.","authors":"Christina Gao, Shirajh Satheakeerthy, Carolyn Qian, Brittany Suann, Christina Guo, Andrew E C Booth, Sarah Howson, Shaun Evans, Brandon Stretton, Weng Onn Chan, Alyssa Pradhan, Stephen Bacchi","doi":"10.1093/cid/ciae651","DOIUrl":"https://doi.org/10.1093/cid/ciae651","url":null,"abstract":"","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":" ","pages":""},"PeriodicalIF":8.2,"publicationDate":"2024-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142945256","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":"Expanded Insights from a Case Study on Long-Acting Injectable Cabotegravir and Rilpivirine in Pregnancy.","authors":"Lauren Ziemba,Rachel Ketchum,Sean Brummel","doi":"10.1093/cid/ciae635","DOIUrl":"https://doi.org/10.1093/cid/ciae635","url":null,"abstract":"","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":"25 1","pages":""},"PeriodicalIF":11.8,"publicationDate":"2024-12-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142887318","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}
Stefania Cheli, Alessandro Torre, Marco Schiuma, Cristina Montrasio, Aurora Civati, Miriam Galimberti, Vera Battini, Ilaria Mariani, Giulia Mosini, Carla Carnovale, Sonia Radice, Emilio Clementi, Andrea Gori, Spinello Antinori
{"title":"NAT2 Slow Acetylator Phenotype as a Significant Risk Factor for Hepatotoxicity Caused by Antituberculosis Drugs: Results From a Multiethnic Nested Case-Control Study","authors":"Stefania Cheli, Alessandro Torre, Marco Schiuma, Cristina Montrasio, Aurora Civati, Miriam Galimberti, Vera Battini, Ilaria Mariani, Giulia Mosini, Carla Carnovale, Sonia Radice, Emilio Clementi, Andrea Gori, Spinello Antinori","doi":"10.1093/cid/ciae583","DOIUrl":"https://doi.org/10.1093/cid/ciae583","url":null,"abstract":"Background Under standard therapies, the incidence of drug-induced liver injury (DILI) in patients with tuberculosis ranges from 2% to 28%. Numerous studies have identified the risk factors for antituberculosis DILI; however, none have been conducted in a multiethnic real-world setting. The primary outcome of the current study was to identify the risk factors that could be used as the best predictors of DILI in a multiethnic cohort. Methods A nested case-control study was conducted in patients at the tuberculosis clinic of Luigi Sacco Hospital in Milan. Results The study included 102 patients (mean age [SD], 45.6 [15.6] years). For each patient with hepatotoxicity, 2 controls were matched for sex, age, body mass index, tuberculosis/tuberculosis infection diagnosis, and index date. We found that N-acetyltransferase 2 gene (NAT2) slow acetylator status was the best independent predictor of DILI (odds ratio, 5.97 [95% confidence interval, 1.38–25.76]; P = .02]. Conclusions NAT2 genotype–guided dosing may help optimize antituberculosis drug treatment and prevent treatment failure. Clinical Trials Registration ClinicalTrials.gov NCT06539455","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":"308 1","pages":""},"PeriodicalIF":11.8,"publicationDate":"2024-12-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142887773","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}
Morgan Birabaharan, Scott T Johns, David C Kaelber, Thomas C S Martin, Sanjay R Mehta
{"title":"Atrial Fibrillation after RSV Vaccination Among Older Adults","authors":"Morgan Birabaharan, Scott T Johns, David C Kaelber, Thomas C S Martin, Sanjay R Mehta","doi":"10.1093/cid/ciae649","DOIUrl":"https://doi.org/10.1093/cid/ciae649","url":null,"abstract":"RSV vaccine clinical trials reported higher frequencies of atrial fibrillation in intervention groups compared to control. In this large, population-based, propensity-matched study, we found RSV vaccine was not associated with increased risk of new-onset or recurrent atrial fibrillation within 1-42 days compared to influenza or Tdap vaccines.","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":"31 1","pages":""},"PeriodicalIF":11.8,"publicationDate":"2024-12-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142887776","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}
Andrea Perez Navarro, Cameron T Nutt, Mark J Siedner, Suzanne M McCluskey, Andrew Hill
{"title":"Virologic failure and emergent integrase strand transfer inhibitor drug resistance with long acting cabotegravir for HIV treatment: A meta-analysis","authors":"Andrea Perez Navarro, Cameron T Nutt, Mark J Siedner, Suzanne M McCluskey, Andrew Hill","doi":"10.1093/cid/ciae631","DOIUrl":"https://doi.org/10.1093/cid/ciae631","url":null,"abstract":"Background The long-acting injectable regimen of cabotegravir plus rilpivirine (CAB/RPV) emerged as an alternative to oral standard of care integrase strand transfer inhibitor (INSTI)-based regimens for individuals with adherence challenges or preference for reduced dosing schedules. Although oral INSTI regimens have a high barrier to emergent resistance, less is known about the potency and durability of CAB/RPV. Methods We reviewed clinical trial registries, PubMed, EMBASE, and conference abstract databases to identify published reports of CAB/RPV for HIV therapy. We abstracted data on virologic failure (VF) and treatment-emergent INSTI resistance at 48 weeks (range 24-52 weeks). We used single-proportion meta-analysis to summarize outcomes in three populations: 1) antiretroviral (ART)-naïve individuals initiating CAB/RPV following suppression on oral ART, 2) ART-experienced individuals switched to CAB/RPV with virologic suppression, and 3) ART-experienced individuals switched to CAB/RPV with detectable viremia. Cochrane’s RoB2.0 and ROBINS-1 tools assessed risk of bias. PROSPERO registration CRD42024543919. Results Thirty-three studies (N=9224) reported VF prevalence. Nineteen studies (N=5662) reported resistance data. VF prevalence was 1% (95% confidence intervals [CI] 1-3%) in induction-maintenance studies, 1% (CI 1-2%) in switch-suppressed studies, and 5% (CI 3-10%) in switch-viraemic studies. INSTI resistance prevalence among successfully genotyped participants at failure was 71% (CI 25-95%), 61% (CI 44-75%), and 41% (CI 20-65%) respectively. Dolutegravir cross-resistance was common (64% of those with emergent resistance). Discussion Although VF rates with CAB/RPV were low, INSTI resistance emerged in approximately 40-70% of individuals experiencing VF. These rates are significantly higher than those for oral INSTI-based regimens. Both individual-level and broader resistance surveillance may be warranted in individuals and populations with expanding CAB/RPV use.","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":"638 1","pages":""},"PeriodicalIF":11.8,"publicationDate":"2024-12-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142887692","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}
Terry Nolan,Chiranjiwi Bhusal,Alejandro Hoberman,Conrado J Llapur,Olga Voloshyna,Ezekiel Fink,Angela Gentile,Garry Wallace,Peter C Richmond,Joseph B Domachowske,Thembile Mzolo,Maria Lattanzi,Daniela Toneatto,
{"title":"Immunogenicity, Reactogenicity, and Safety of a Pentavalent Meningococcal ABCWY Vaccine in Adolescents and Young Adults who had Previously Received a Meningococcal ACWY Vaccine: Phase 3, Randomized, Controlled Clinical Study.","authors":"Terry Nolan,Chiranjiwi Bhusal,Alejandro Hoberman,Conrado J Llapur,Olga Voloshyna,Ezekiel Fink,Angela Gentile,Garry Wallace,Peter C Richmond,Joseph B Domachowske,Thembile Mzolo,Maria Lattanzi,Daniela Toneatto,","doi":"10.1093/cid/ciae622","DOIUrl":"https://doi.org/10.1093/cid/ciae622","url":null,"abstract":"BACKGROUNDA MenABCWY vaccine containing 4CMenB and MenACWY-CRM vaccine components has been developed to protect against the five meningococcal serogroups that cause most invasive disease cases.METHODSIn this phase 3 study (NCT04707391), healthy participants aged 15-25 years, who had received MenACWY vaccination ≥4 years previously, were randomized (1:1) to receive two MenABCWY doses six months apart or one MenACWY-CRM dose. Primary objectives were to demonstrate the non-inferiority of MenABCWY 1 month post-vaccination versus MenACWY-CRM, with a lower limit of 2-sided 95% confidence interval above -10% for group differences in 4-fold rise in human serum bactericidal antibody (hSBA) titers against serogroups ACWY, and to evaluate reactogenicity and safety. Secondary endpoints included percentages of participants with hSBA titers ≥lower limit of quantitation (LLOQ) against serogroups ACWY and vaccine antigen-specific serogroup B (MenB) indicator strains.RESULTSNon-inferiority of MenABCWY versus MenACWY-CRM was demonstrated following each MenABCWY dose. Percentages of participants with hSBA titers ≥LLOQ for serogroups ACWY were 97.9-98.9% and 99.5-100% following one and two MenABCWY doses, respectively, and 96.8-99.0% following one MenACWY-CRM dose. After two MenABCWY doses, 75.6-96.3% of participants had hSBA titers ≥LLOQ against MenB indicator strains. The MenABCWY vaccine was well tolerated in MenACWY-primed individuals with a favorable safety profile.CONCLUSIONSImmune responses against serogroups ACWY following one and two doses of investigational MenABCWY vaccine are non-inferior to those following MenACWY-CRM in MenACWY-primed adolescents and young adults. Robust immune responses were observed against MenB indicator strains after two MenABCWY doses administered 6 months apart.","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":"154 1","pages":""},"PeriodicalIF":11.8,"publicationDate":"2024-12-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142887689","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}
Supavit Chesdachai, Larry M Baddour, Daniel C DeSimone
{"title":"LVAD versus CIED Infections: Distinct Entities, Distinct Suppression Strategies.","authors":"Supavit Chesdachai, Larry M Baddour, Daniel C DeSimone","doi":"10.1093/cid/ciae647","DOIUrl":"https://doi.org/10.1093/cid/ciae647","url":null,"abstract":"<p><p>A distinction between infections of left ventricular assist devices (LVADs) and cardiac implantable electronic devices (CIEDs) is warranted as they differ markedly in incidence, microbiologic profiles, clinical presentations, and extraction feasibility. These differences necessitate tailored suppressive antibiotic therapy (SAT) strategies. This commentary highlights the need for device-specific SAT approaches.</p>","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":" ","pages":""},"PeriodicalIF":8.2,"publicationDate":"2024-12-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142880668","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":"The Current and Future State of Vaccines for Lyme Disease","authors":"Stanley A Plotkin, Eugene D Shapiro","doi":"10.1093/cid/ciae639","DOIUrl":"https://doi.org/10.1093/cid/ciae639","url":null,"abstract":"Lyme disease is caused by Borrelia species that are transmitted by Ixodes ticks prevalent in parts of the United States and Europe. A Lyme vaccine containing the OspA antigens from the single Borrelia species most prevalent in the United States was marketed in the 1990s, but was withdrawn because of unproven concerns about safety, which led to insufficient sales. Since then, the incidence of Lyme disease has increased in the United States owing to the geographical spread of infected ticks. Lyme disease due to multiple different species of Borrelia also is widely prevalent in many European countries. New Lyme vaccines, using OspA antigens from multiple species of American and European Borrelia, are in advanced clinical development, and one such vaccine is in phase 3 trials. When licensed, new vaccines are likely to have an impact in preventing Lyme disease, although the need for periodic boosters remains to be defined.","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":"64 1","pages":""},"PeriodicalIF":11.8,"publicationDate":"2024-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142874517","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}