DOCSLIB.ORG

Year in Clinical Microbiology

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Year in Clinical Microbiology Madrid, April 21-24 SY024 - Year in Clinical Microbiology Prof. Carlo Federico Perno ESCMID eLibrary © by author Contributors • Claudia Alteri, PhD University of Rome Tor Vergata • Stefania Carta, PhD Niguarda Hospital, Milan • Valeria Cento, MD PhD University of Milan • Luna Colagrossi, PhD UniversityESCMIDof Milan eLibrary © by author Game-changers in the setting of diagnosis- treatment integration • Microbiome: a new tool for disease prediction and intervention??? • Cytomegalovirus: from pre-emptive therapy to effective prophylaxis??? • ViralESCMIDhepatitis and HIV eLibrary: new approaches for the cure??? © by author INCREASED INTEREST AND PUBLICATIONS ON MICROBIOME Search term on PubMed "Microbiome" 1950- 2017 pubmed - MICROBIOME Published papers in PubMed Most frequent category, pubmed - GUT MICROBIOME after «microbiome» 10000 9000 8000 7000 6000 5000 4000 3000 2000 1° «Microbiome» paper 1000 ESCMID0 eLibrary 1956 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 © by author KEY QUESTIONS RELATED TO THE HUMAN MICROBIOME • What is the identity of the microbes (bacteria, archea, fungi, eukaryotic viruses and phages, protozoa) that populate their host? • Which is their role? • How is the host responding to them? • What are the forces that maintain equilibrium among the populations? • Can we define a core health microbiome? • Is the microbiome the cause or the effect of the disease? • Can we use the microbiome as diagnostic tool for diseases? ESCMID eLibrary © by author Blaser, Cell 2018 The Role of the Microbiome in cancer: • A “causative” agent?????? Science 2018 Science 2018 ESCMID eLibrary Cancer Discovery 2018 © by author Science 2018 ESCMID eLibrary © by author ESCMID eLibrary © by author Tumor prone mice co-colonized with E.coli (expressing clbB) end heterotoxigenic B. fragilis (ETBF) showed increased IL-17 in the colon, DNA damage in colonic epithelium, faster tumor onset, and greater mortality compared to mice with either bacterial strain alone A: Total colon tumor detected in sham (placebo), ETBF monocolonized, pks+E.coli monocolonized and co-conolized mice. C: Histopathology of an invasive adenocarcinoma in a cocolonized AOM mouse at 15 weeks..D: KM survival plot in ETBF monocolonized, ESCMID eLibrarypks+E.coli monocolonized and co -conolized mice © by author • These results arise the possibility that persistent co-colonization in the colon mucosa from a young age contributes to the pathogenesis of familial adenomatous polyposis (FAP). • Cause-effect phenomenon? ESCMID eLibrary © by author Gopalakrishanan et al., Science 2018 The landscape of the oral and gut microbiome was assessed in all samples available in patients (n=122) with metastatic melanoma via 16S sequencing ESCMID eLibrary © by author • Diversity of the gut microbiome was significantly higher in individuals responding to anti-PD1 therapy (R) compared to non responders (NR). • Higher abundance of Bacteroidales was found in non-responders respect to responders, while enrichment of Ruminococcaceae bacteria was found in responding patients ESCMID eLibrary C: Diversity scores of the gut microbiome in R and NR. D: LDA scores for differentially-abundant taxa in fecal microbiomes of R and NR. © by authorGopalakrishanan et al., Science 2018 Favorable gut microbiome is associated with enhanced systemic and anti-tumor immunity ESCMID eLibrary © by authorGopalakrishanan et al., Science 2018 ESCMID eLibrary © by author ESCMID eLibrary © by authorRouty et al., Science 2018 Kaplan-Meier estimates for progression-free survival (PFS) or overall ESCMIDsurvival (OS) of cancer eLibrarypatients. (D) patients with advanced non–small cell lung cancer (NSCLC, n = 140) © by author ESCMID eLibrary © by authorRouty et al., Science 2018 ESCMIDCystic Fibrosis eLibraryand Microbiome © by author • Subjects affected by cystic fibrosis (CF) experience a progressive loss of pulmonary functions accompanied by an increased burden of chronic infections. • The respiratory microbial composition is particularly relevant for patients with CF. In fact, bacterial lung infections reduce life expectancy in patients with CF (the median predicted survival age is equal to 41.6, as reported in the Cystic Fibrosis Foundation Patient Registry), and represent the primary cause of morbidity and mortality in CF patients. • In the last decade, the emergence of high-throughput sequencing approaches, coupled with the development of new bioinformatics pipelines designed to cope with metagenomics data, has revolutionized the study of complex bacterial communities such as the airway microbiota of CF patients, thereby improving our understanding of this largely unknown “microbial black-box”. We aimedESCMIDto investigate whether patients witheLibrarydifferent disease severities may indeed have a different representation of “keystone genes” in their lung microbiota. © by authorBacci G. et al., Int J Med Sci 2017 Microbes in CF airways encode a diverse set of antibiotic resistance mechanisms; among them, the multidrug resistance efflux pumps are the most represented ESCMID eLibrary © by authorBacci G. et al., Int J Med Sci 2017 • Understanding the threats and stopping the damage are the first orders of business. • Interventions could be drugs, prebiotics, or combinations of these compounds, and even some vaccines. • We will have to restore our lost microbiota to optimize human health and to reverse the disease epidemics. ESCMID eLibraryM. Blaser, Cell 2018 © by author GAME-CHANGERS IN CMV MANAGEMENT: Prophylaxis or Pre-emptive therapy??? ESCMID eLibrary © by author PROPHYLAXIS PRE-EMPTIVE THERAPY . Primary prophylaxis with ganciclovir is . Gancclovir is recommended as first line pre- not generally recommended as toxicity emptive therapy for CMV in HSCT patients outweighs efficacy in HSCT patients (Grade 1A). (Grade 1B). Oral valganciclovir is a valid alternative when . Primary prophylaxis with acyclovir or gastrointestinal absorption is normal or only valaciclovir can be deployed but only in minimally impaired (Grade 1A). conjunction with appropriate monitoring . Foscarnet is recommended as an alternative of CMV in blood (Grade 1B). first-line agent if neutropenia is present or for . Valacyclovir or valgancyclovir are valid ganciclovir treatment failure (Grade 1A). treatment options for secondary . Pre-emptive therapy with cidofovir can be prophylaxis with appropriate monitoring considered as third-line in patients of CMV in blood (Grade 1C). unresponsive to, or intolerant of, both a . Intravenous immunoglobulin is not ganciclovir preparation and foscarnet (Grade recommended for prophylaxis of CMV 2B). infection (Grade 1A). In patients in whom CMV DNA loads in blood increase by 1 log10 over 2 weeks of pre- ESCMID eLibraryemptive therapy with a first line drug, an alternative agent and drug resistance profiling should be considered (Grade 2C). © by author Emery et al., bjh 2013 ESCMID eLibrary © by author Trial Design Prophylaxis Follow-up Randomization Week 14 (≈100 days) Week 24 Week 48 (within 28 days post-transplant (6 months) post-transplant post-transplant) (end of study therapy) post-transplant (final follow-up visit) Letermovir arm n=373 Dose: 240 mg qd w/ cyclosporine or 480 mg qd w/o cyclosporine Placebo arm n=192 ESCMID eLibrary QD=once daily. Marty FM et al. N Engl J Med. 2017. doi:10.1056/NEJMoa1706640. 2 © by author 5 End-points Primary end point Secondary end point Prespecified exploratory end pointsESCMID eLibrary © by author Marty et al., N Engl J Med 2017 Incidence of Clinically Significant CMV Infection ESCMID eLibrary 27 © by authorMarty FM et al. N Engl J Med. 2017. doi:10.1056/NEJMoa1706640. The lower mortality among letermovir recipients than among placebo recipients was more pronounced among high-risk patients than among low-risk patients ESCMID eLibrary 28 © by authorMarty FM et al. N Engl J Med. 2017. doi:10.1056/NEJMoa1706640. In conclusion In a diverse population of patients who had undergone hematopoietic- cell transplantation, letermovir prophylaxis was effective in preventing clinically significant CMV infection when used through day 100 after transplantation. Letermovir was associated with only mild toxic effects, which allows for the administration before hematologic engraftment, was not associated with a higher rate of myelotoxic or nephrotoxic events, and was associated with lower all-cause mortality than placebo. ESCMID eLibrary © by author Marty et al., N Engl J Med 2017 ESCMID eLibrary 30 Correspondence. F.M. Marty, J. Maertens, C. Badshah. © N Engl J Med 378;10by nejm.org March author 8, 2018 The combination of UL56 and terminase complex UL51 mutations can increase significantly the overall level of letermovir resistance ESCMID eLibrary © by author Viral hepatitis B and HIV: new approaches for the cure??? ESCMID eLibrary © by author cccDNA plays a pivotal role allowing HBV to establish a persistent infection ESCMID eLibraryTong et al., J Hepatol 2016 © by author New therapeutic approaches to achieve HBV functional cure ESCMID eLibrary © by Levreroauthor et al., Current Opin Virol 2018 • This highlights the need to identify novel virological markers to better measure cccDNA metabolic activity and cccDNA silencing HBV Core related Antigen -To monitor treatment response -To predict HCC risk HBV-RNA: - To monitor treatment response qHBeAg: - To monitor treatment response in e+patients ESCMID eLibrary © by author The correlations of serum qHBcrAg (A), qHBsAg (B) and HBV DNA (C) with intrahepatic cccDNA among different phases of CHB ESCMID eLibrary © by
Load more

Recommended publications
  • COMMISSION DE LA TRANSPARENCE Avis 5 Septembre 2018
    COMMISSION DE LA TRANSPARENCE Avis 5 septembre 2018 Date d’examen par la Commission : 20 juin 2018 L’avis de la commission de la Transparence adopté le 11 juillet 2018 a fait l’objet d’une audition le 5 septembre 2018. letermovir PREVYMIS 240 mg, comprimés pelliculés Boîte de 28 (CIP : 34009 301 272 3 0) PREVYMIS 240 mg, solution à diluer pour perfusion Boite de 1 (CIP : 34009 301 272 5 4) PREVYMIS 480 mg, comprimés pelliculés Boîte de 28 (CIP : 34009 301 272 4 7) PREVYMIS 480 mg, solution à diluer pour perfusion Boite de 1 (CIP : 34009 301 272 6 1) Laboratoire MSD France Code ATC J05AX18 (Antiviral) Motif de l’examen Inscription Sécurité Sociale (CSS L.162-17) pour les formes comprimés uniquement Listes concernées Collectivités (CSP L.5123-2) pour l’ensemble des présentations « PREVYMIS est indiqué dans la prophylaxie de la réactivation du cytomégalovirus (CMV) et de la maladie à CMV chez les adultes séropositifs au CMV receveurs [R+] d’une greffe allogénique de cellules Indication concernée souches hématopoïétiques (GCSH). Il convient de tenir compte des recommandations officielles concernant l’utilisation appropriée des agents antiviraux. » HAS - Direction de l'Evaluation Médicale, Economique et de Santé Publique 1/18 Avis3 SMR Important Compte tenu : - de la démonstration de l’efficacité de PREVYMIS en prophylaxie de la réactivation du CMV par rapport au placebo et notamment la diminution des instaurations de traitements préemptifs exposant les patients à une toxicité hématologique ou rénale importante, - de l’absence d’impact démontré
    [Show full text]
  • Subtherapeutic Posaconazole Prophylaxis in a Gastric Bypass Patient Following Hematopoietic Stem Cell Transplantation
    applyparastyle “fig//caption/p[1]” parastyle “FigCapt” CASE REPORT Subtherapeutic posaconazole prophylaxis in a gastric bypass patient following hematopoietic stem cell transplantation Emily A. Highsmith, PharmD, BCCCP, Department of Pharmacy, University Purpose. A case of invasive fungal infections (IFIs) with subtherapeutic of Texas MD Anderson Cancer Center, Houston, TX, USA posaconazole prophylaxis in a gastric bypass patient following hemato- poietic stem cell transplantation (HSCT) is reported. Downloaded from https://academic.oup.com/ajhp/article/78/14/1282/6245082 by BINASSS user on 15 July 2021 Vi P. Doan, PharmD, BCOP, Department of Pharmacy, University of Texas MD Anderson Cancer Center, Summary. A 52-year-old malnourished male with a medical history of Houston, TX, USA Roux-en-Y gastric bypass for obesity developed acute myelogenous leu- Todd W. Canada, PharmD, BCNSP, kemia and underwent allogeneic HSCT approximately 17 months later. He BCCCP, FASHP, FTSHP, FASPEN, was admitted 1 month after HSCT for failure to thrive and initiated on par- Department of Pharmacy, University of Texas MD Anderson Cancer Center, enteral nutrition due to worsening diarrhea and suspected gastrointestinal Houston, TX, USA graft-versus-host disease (GI GVHD). During admission, the patient was continued on daily oral posaconazole for antifungal prophylaxis and was found to have subtherapeutic posaconazole and deficient vitamin levels, likely secondary to his gastrojejunostomy and increased gastric transit time. The oral posaconazole was altered to twice-daily dosing in an effort to increase serum drug levels and prevent IFIs. Conclusion. Patients with a history of gastric bypass are at increased risk for malabsorption of oral posaconazole and nutrients, especially following HSCT with suspected GI GVHD.
    [Show full text]
  • R&D Briefing 76
    The Impact of Recent Regulatory Developments on the Mexican Therapeutic Landscape Access to innovative medicines is key to El acceso a medicamentos innovadores es clave para improving overall population health, reducing mejorar la salud de toda la población, para reducir los hospitalisation time and decreasing morbidity and tiempos de hospitalización, la morbilidad y la mortalidad mortality. An efficient regulatory process can be de un país. Un proceso regulatorio eficiente tiene un reflected in measurable positive health impacts; impacto positivo medible en la salud, y por el contrario, conversely, activities that slow or impede acciones que retrasan o impiden la eficiencia regulatoria y regulatory efficiency and predictability can be su predictibilidad pueden ser perjudiciales. La parálisis detrimental. Recent developments in the Mexican reciente del Sistema regulatorio mexicano respecto a la regulatory system for the assessments of evaluación de nuevos medicamentos innovadores innovative new products have had a negative conlleva un impacto negativo en la salud de la población impact on Mexican public health. mexicana. This Briefing addresses the impact of suspending Este informe analiza el impacto de la suspensión de las the activities of the New Molecules Committee actividades del Comité de Moléculas Nuevas (NMC, por (NMC) on the Mexican therapeutic landscape. sus siglas en inglés) sobre el horizonte terapéutico de First, we compared the way that “new medicines” México. En primer lugar, comparamos la definición de are defined within the context of the Mexican nuevos medicamentos según el contexto regulatorio regulatory system, with definitions used by mexicano con las definiciones adoptadas por otras comparable regulators and health organisations. agencias reguladoras u organizaciones de salud del We have also investigated the extent to which mundo.
    [Show full text]
  • 11-2018 BMT Pharmacists Johnson FINAL 2 12 18
    2018 BMT Pharmacists Conference Infection Prophylaxis in the HCT patient Melissa D. Johnson, PharmD, AAHIVP Associate Professor of Medicine Duke University Medical Center Liaison Clinical Pharmacist Duke Antimicrobial Stewardship Outreach Network Durham, North Carolina [email protected] @idpharmacist Disclosures • Research grants: Merck, Charles River Laboratories Objectives • Assess the factors influencing risk of infection in hematopoietic cell transplant recipients • Compare and contrast current, recently approved and emerging antimicrobials for prophylaxis in hematopoietic cell transplant recipients • Discuss recent studies evaluating antimicrobials for prophylaxis in hematopoietic cell transplant recipients • Identify important monitoring parameters and supportive strategies for prophylaxis in hematopoietic cell transplant recipients Hematopoietic Cell Transplantation Transplant Variables and Infection Risk • Underlying disease Pre-Tx Stem cells • Type of transplant Therapy +/- GVHD Autologous, Allogeneic • HLA matching Conditioning • Conditioning regimen Engraftment • Source of stem cells • Graft manipulation • Graft versus host disease • Donor & recipient age Bacterial Viruses Fungal INFECTIOUS PATHOGENS Respiratory Pneumocystis Viruses Other Case Question 1 • 37-year-old male with AML Initial presentation: • 45,000 WBC, normal cytogenetics, FLT3/ITD genes (+), NPM1 (-) Treatment plan: Standard induction followed by allogeneic hematopoietic peripheral blood stem-cell transplant • Which of the following pathogens is he at greatest
    [Show full text]
  • Hinge Region in DNA Packaging Terminase Pul15 of Herpes Simplex Virus: a Potential Allosteric Target for Antiviral Drugs
    Louisiana State University LSU Digital Commons Faculty Publications School of Renewable Natural Resources 10-1-2019 Hinge Region in DNA Packaging Terminase pUL15 of Herpes Simplex Virus: A Potential Allosteric Target for Antiviral Drugs Lana F. Thaljeh Louisiana State Univ, Dept Biol Sci, [email protected] J. Ainsley Rothschild Louisiana State Univ, Div Elect & Comp Engn, [email protected] Misagh Naderi Louisiana State Univ, Dept Biol Sci, [email protected] Lyndon M. Coghill Louisiana State Univ, Dept Biol Sci, [email protected] Follow this and additional works at: https://digitalcommons.lsu.edu/agrnr_pubs Part of the Biology Commons Recommended Citation Thaljeh, Lana F.; Rothschild, J. Ainsley; Naderi, Misagh; and Coghill, Lyndon M., "Hinge Region in DNA Packaging Terminase pUL15 of Herpes Simplex Virus: A Potential Allosteric Target for Antiviral Drugs" (2019). Faculty Publications. 4. https://digitalcommons.lsu.edu/agrnr_pubs/4 This Article is brought to you for free and open access by the School of Renewable Natural Resources at LSU Digital Commons. It has been accepted for inclusion in Faculty Publications by an authorized administrator of LSU Digital Commons. For more information, please contact [email protected]. biomolecules Article Hinge Region in DNA Packaging Terminase pUL15 of Herpes Simplex Virus: A Potential Allosteric Target for Antiviral Drugs Lana F. Thaljeh 1, J. Ainsley Rothschild 1, Misagh Naderi 1, Lyndon M. Coghill 1,2 , Jeremy M. Brown 1 and Michal Brylinski 1,2,* 1 Department of Biological Sciences, Louisiana State University, Baton Rouge, LA 70803, USA; [email protected] (L.F.T.); [email protected] (J.A.R.); [email protected] (M.N.); [email protected] (L.M.C.); [email protected] (J.M.B.) 2 Center for Computation & Technology, Louisiana State University, Baton Rouge, LA 70803, USA * Correspondence: [email protected]; Tel.: +225-578-2791; Fax: +225-578-2597 Received: 10 September 2019; Accepted: 8 October 2019; Published: 12 October 2019 Abstract: Approximately 80% of adults are infected with a member of the herpesviridae family.
    [Show full text]
  • Where Do We Stand After Decades of Studying Human Cytomegalovirus?
    microorganisms Review Where do we Stand after Decades of Studying Human Cytomegalovirus? 1, 2, 1 1 Francesca Gugliesi y, Alessandra Coscia y, Gloria Griffante , Ganna Galitska , Selina Pasquero 1, Camilla Albano 1 and Matteo Biolatti 1,* 1 Laboratory of Pathogenesis of Viral Infections, Department of Public Health and Pediatric Sciences, University of Turin, 10126 Turin, Italy; [email protected] (F.G.); gloria.griff[email protected] (G.G.); [email protected] (G.G.); [email protected] (S.P.); [email protected] (C.A.) 2 Complex Structure Neonatology Unit, Department of Public Health and Pediatric Sciences, University of Turin, 10126 Turin, Italy; [email protected] * Correspondence: [email protected] These authors contributed equally to this work. y Received: 19 March 2020; Accepted: 5 May 2020; Published: 8 May 2020 Abstract: Human cytomegalovirus (HCMV), a linear double-stranded DNA betaherpesvirus belonging to the family of Herpesviridae, is characterized by widespread seroprevalence, ranging between 56% and 94%, strictly dependent on the socioeconomic background of the country being considered. Typically, HCMV causes asymptomatic infection in the immunocompetent population, while in immunocompromised individuals or when transmitted vertically from the mother to the fetus it leads to systemic disease with severe complications and high mortality rate. Following primary infection, HCMV establishes a state of latency primarily in myeloid cells, from which it can be reactivated by various inflammatory stimuli. Several studies have shown that HCMV, despite being a DNA virus, is highly prone to genetic variability that strongly influences its replication and dissemination rates as well as cellular tropism. In this scenario, the few currently available drugs for the treatment of HCMV infections are characterized by high toxicity, poor oral bioavailability, and emerging resistance.
    [Show full text]
  • List of Drugs Not Repackaged by Safecor Health
    Drugs Not Repackaged by Safecor Health The following tables list specific medications that are not repackaged by Safecor Health due to regulatory restrictions or specific manufacturer requirements. The items not repackaged are alphabetically listed below, both by brand name (table 1) and generic name (table 2). Please note: Safecor Health cannot repackage any beta lactam antibiotics (such as penicillins, amoxicillin and cephalosporins) or potent chemotherapeutic agents. Also, due to FDA restrictions, we cannot repackage half- or quarter-tabs, compounded or diluted drugs, powders, and ointments or creams. Safecor Health can repackage most hazardous drugs on the NIOSH list. Contact us for a complete list of hazardous drugs repackaged by Safecor Health. Table 1. Do Not Repackage Drugs Sorted Alphabetically by Brand Name Brand Name(s) Generic Name(s) Reason Item Cannot Be Repackaged Adrucil Fluorouracil Potent chemotherapy agent Aspirin and Extended-Release Specific manufacturer recommendations for very Aggrenox Dipyridamole limited expiration dating Albenza Albendazole Cost per dose prohibitive Alkeran Melphalan Potent chemotherapy agent Augmentin Amoxicillin and Clavulanate Potassium Safecor Health does not repackage this drug class Manufacturer states, "dispense in original container," Belsomra Suvorexant on the drug label Manufacturer states, "dispense in original container," Biktarvy Bictegravir, Emtricitabine and Tenofovir Alafenamide on the drug label Bion Tears Dextran, Hypromellose Ophthalmic Drops Sterile and unpreserved CeeNU Lomustine
    [Show full text]
  • Human Cytomegalovirus Primary Infection and Reactivation: Insights from Virion-Carried Molecules
    fmicb-11-01511 July 16, 2020 Time: 8:16 # 1 REVIEW published: 14 July 2020 doi: 10.3389/fmicb.2020.01511 Human Cytomegalovirus Primary Infection and Reactivation: Insights From Virion-Carried Molecules Yu-Qing Wang1,2 and Xiang-Yu Zhao1* 1 Peking University People’s Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Key Laboratory of Hematopoietic Stem Cell Transplantation, Beijing, China, 2 PKU-THU Center for Life Sciences, Academy for Advanced Interdisciplinary Studies, Peking University, Beijing, China Human cytomegalovirus (HCMV), a ubiquitous beta-herpesvirus, is able to establish lifelong latency after initial infection. Periodical reactivation occurs after immunosuppression, remaining a major cause of death in immunocompromised patients. HCMV has to reach a structural and functional balance with the host at Edited by: its earliest entry. Virion-carried mediators are considered to play pivotal roles in viral Akio Adachi, adaptation into a new cellular environment upon entry. Additionally, one clear difference Kansai Medical University, Japan between primary infection and reactivation is the idea that virion-packaged factors are Reviewed by: Eain Anthony Murphy, already formed such that those molecules can be used swiftly by the virus. In contrast, SUNY Upstate Medical University, virion-carried mediators have to be transcribed and translated; thus, they are not readily United States Sarah Elizabeth Jackson, available during reactivation. Hence, understanding virion-carried
    [Show full text]
  • Innovationsreport 2019 Kurzfassung
    Innovationsreport 2019 Auswertungsergebnisse von Routinedaten der Techniker Krankenkasse aus den Jahren 2016 bis 2017 Herausgeber: Gerd Glaeske und Wolf‐Dieter Ludwig Erstellt mit freundlicher Unterstützung der Techniker Krankenkasse (TK) 2 Herausgeber Prof. Dr. Gerd Glaeske Prof. Dr. Wolf‐Dieter Ludwig Experten für ausgewählte Kapitel Prof. Dr. med. Manfred Anlauf, Bremerhaven Prof. Dr. med. Peter Berlit, Berlin Prof. Dr. med. Winfried V. Kern, Freiburg Prof. Dr. med. Joachim Labenz, Siegen Prof. Dr. med. Ulrich A. Müller, MSc, Jena Prof. Dr. med. Bruno Müller‐Oerlinghausen, Berlin Prof. Dr. med. Wolfgang Schramm, München Prof. Dr. med. Dieter Ukena, Bremen PD Dr. med. Tobias Weberschock, Frankfurt am Main Autoren der Wirkstoffkapitel Dr. Stanislava Dicheva‐Radev, Dörte Fuchs, Dr. Iris Hinneburg, Anja Lübs, André S. Morawetz, Lutz Muth, Saskia Ritter, Dr. Kristin Sauer unter Mitarbeit von Eleonora Durakovic, Friederike Höfel, Linda Jespersen, Linda Richter, Marle Wilhelm Anschrift: Universität Bremen, SOCIUM, Mary‐Somerville‐Str. 5, 28359 Bremen Aus Gründen der besseren Lesbarkeit wurde auf die Nennung beider geschlechtsspezifischer Formen verzichtet. Im Allgemeinen ist aber das jeweils andere Geschlecht ebenfalls gemeint. 3 4 Glossar ........................................................................................... 6 Vorwort zum Innovationsreport 2019 ........................................... 13 Zweites Vorwort zum Innovationsreport 2019 .............................. 15 1 Einleitung ...............................................................................
    [Show full text]
  • Letermovir for the Prevention of Cytomegalovirus Infection in Sero-Positive Patients Undergoing Allogeneic Haematopoietic Stem Cell Transplantation
    Horizon Scanning Research April 2016 & Intelligence Centre Letermovir for the prevention of cytomegalovirus infection in sero-positive patients undergoing allogeneic haematopoietic stem cell transplantation LAY SUMMARY This briefing is based on information Cytomegalovirus is a common virus and most people become infected available at the time in childhood. The virus is spread through bodily fluids, such as saliva of research and a or urine, and can easily be spread by close contact with children, such limited literature as when changing nappies. Once someone becomes infected, the search. It is not cytomegalovirus will stay in their body for the rest of their lives without intended to be a causing problems. Most people do not have symptoms and will not definitive statement need treatment. However, people with weakened immune systems on the safety, need to be treated to avoid complications. efficacy or effectiveness of the Letermovir is a new drug that is taken by mouth as a tablet to prevent health technology cytomegalovirus infection. Some studies have suggested that this drug covered and should can help prevent infection in people undergoing allogeneic stem cell not be used for transplantation (sometimes called a bone marrow transplant), and if commercial letermovir is licensed for use in the UK, it could be a new treatment purposes or option for people undergoing this procedure. commissioning without additional information. NIHR HSRIC ID: 6485 This briefing presents independent research funded by the National Institute for Health Research (NIHR). The views expressed are those of the author and not necessarily those of the NHS, the NIHR or the Department of Health.
    [Show full text]
  • PREVYMIS, Through the Centralised Procedure Falling Within the Article 3(1) and Point 4 of Annex of Regulation (EC) No 726/2004
    9 November 2017 EMA/CHMP/490007/2017 Committee for Medicinal Products for Human Use (CHMP) Assessment report PREVYMIS International non-proprietary name: letermovir Procedure No. EMEA/H/C/004536/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520 Send a question via our website www.ema.europa.eu/contact An agency of the European Union © European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged. Table of contents 1. Background information on the procedure .............................................. 5 1.1. Submission of the dossier ..................................................................................... 5 1.2. Steps taken for the assessment of the product ........................................................ 6 2. Scientific discussion ................................................................................ 8 2.1. Problem statement ............................................................................................... 8 2.2. Quality aspects .................................................................................................... 9 2.2.1. Introduction...................................................................................................... 9 2.2.2. Active Substance ..............................................................................................
    [Show full text]
  • PREVYMIS, INN-Letermovir
    ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT PREVYMIS 240 mg film-coated tablets PREVYMIS 480 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION PREVYMIS 240 mg film-coated tablets Each film-coated tablet contains 240 mg of letermovir. PREVYMIS 480 mg film-coated tablets Each film-coated tablet contains 480 mg of letermovir. Excipients with known effect Each 240 mg film-coated tablet contains 4 mg of lactose (as monohydrate). Each 480 mg film-coated tablet contains 6.4 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) PREVYMIS 240 mg film-coated tablets Yellow oval tablet of dimensions 16.5 mm x 8.5 mm, debossed with “591” on one side and MSD logo on the other side. PREVYMIS 480 mg film-coated tablets Pink oval, bi-convex tablet of dimensions 21.2 mm x 10.3 mm, debossed with “595” on one side and MSD logo on the other side. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications PREVYMIS is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT). Consideration should be given to official guidance on the appropriate use of antiviral agents. 4.2 Posology and method of administration PREVYMIS should be initiated by a physician experienced in the management of patients who have had an allogeneic haematopoietic stem cell transplant.
    [Show full text]