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Maribavir (Livtencity) - for the treatment of adults with post-transplant cytomegalovirus (CMV) infection/disease Skip to main contentSkip to "About this site"Basic HTML versionGovernment of CanadaSearch and menusSearch and menusYou are here:HomeAll ServicesHealthDrugs, health & consumer productsReview DecisionsSummary Basis of Decision - Livtencity - Health CanadaDrugsNatural Health is favourable for the treatment of adults with post-transplant cytomegalovirus (CMV) infection/disease who are refractory (with or without genotypic resistance) to one or more prior antiviral therapies.1 What was approved?2 Why was Livtencity approved?3 What steps led to the approval of Livtencity?4 What follow-up measures will the company take?5 What post-authorization activity has taken place for Livtencity
Relevance of adding universal screening for congenital cytomegalovirus (CMV) infection to Qu'bec newborn screening program Relevance of adding universal screening for congenital cytomegalovirus (CMV) infection to Québec newborn screening program English summary Une production de l’Institut national d’excellence en santé et en services sociaux (INESSS) MARCH 2024 1 SUMMARY Relevance of adding universal screening for congenital cytomegalovirus (CMV) infection to Québec newborn screening program Introduction The cytomegalovirus (CMV) is a common virus that belongs to the herpesvirus family (lat. herpesviridae) and has the ability to establish lifelong latency. When a pregnant woman is infected, there is a risk that her baby will be affected by a congenital
of the present dossier assessment. IQWiG employees involved in the dossier assessment Sebastian Meller Katharina Frangen Ulrich Grouven Tatjana Hermanns Simone Johner Stefan Kobza Petra Kohlepp Philip Kranz Keywords Letermovir, Cytomegalovirus Infections, Benefit Assessment, NCT03443869 Extract of dossier assessment A23-137 Version 1.0 Letermovir ( prophylaxis of CMV disease after kidney List of abbreviations Abbreviation Meaning ACT appropriate comparator therapy ADA American Diabetes Association AE adverse event ALT alanine aminotransferase APaT all participants as treated AST aspartate aminotransferase CMVcytomegalovirus CrCl creatinine clearance CSR clinical study report CTCAE Common Terminology Criteria for Adverse Events DNA deoxyribonucleic acid eGFR estimated glomerular
of the dossier assessment. IQWiG employees involved in the dossier assessment Christian Siebel Moritz Felsch Katharina Frangen Claudia Kapp Stefan Kobza Petra Kohlepp Philip Kranz Claudia Selbach Keywords Letermovir, Cytomegalovirus Infections, Benefit Assessment, NCT02137772 Extract of dossier assessment A23-139 Version 1.0 Letermovir ( prophylaxis of CMV reactivation and disease after stem (IQWiG) - I.4 - I List of abbreviations Abbreviation Meaning ACT appropriate comparator therapy AE adverse event APaT all participants as treated CMVcytomegalovirus CSR clinical study report DNA deoxyribonucleic acid FACT-BMT Functional Assessment of Cancer Therapy – Bone Marrow Transplantation FAS full analysis set G-BA Gemeinsamer Bundesausschuss (Federal Joint Committee) GVHD graft-versus-host
Maribavir (Livtencity) - cytomegalovirus (CMV) infection 1 Published 09 October 2023 1 SMC2576 maribavir film-coated tablets (Livtencity®) Takeda UK Ltd 08 September 2023 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and, following review by the SMC executive, advises NHS Boards and Area Drug and Therapeutics Committees (ADTCs) on its use in NHSScotland. The advice is summarised as follows: ADVICE: following a full submission maribavir (Livtencity®) is accepted for use within NHSScotland. Indication under review: treatment of cytomegalovirus (CMV) infection and/or disease that are refractory (with or without resistance) to one or more prior therapies, including ganciclovir, valganciclovir, cidofovir or foscarnet in adult
Prevention of Congenital Cytomegalovirus (CMV) Infection Prevention of congenital cytomegalovirus (CMV) infection (C-Obs 64) Page 1 of 15 Statement Prevention of congenital cytomegalovirus (CMV) infection This statement has been developed by the Women’s Health Committee (WHC) in 2019, and an interim update of the statement approved by the Women’s Health Committee (Appendix A). Conflict to the particular circumstances of each case and the needs of any patient. This document reflects emerging clinical and scientific advances as of the date issued and is subject to change. The document has been prepared having regard to general circumstances (Appendix_D). Objectives: To provide guidance for maternity care providers and the community on the prevention of maternal cytomegalovirus (CMV) infection
Congenital Cytomegalovirus Infection: Update on Screening, Diagnosis and Treatment (Scientific Impact Paper No. 56) obgyn.onlinelibrary.wiley.comVerify you are human by completing the action below.obgyn.onlinelibrary.wiley.com needs to review the security of your connection before proceeding.Ray ID: 8e384e1d4bf76322Performance & security by Cloudflare
Maribavir (Livtencity) - To treat post-transplant cytomegalovirus (CMV) infection/disease Drug Approval Package: LIVTENCITY * Skip to main page content * Skip to search * Skip to topics menu * Skip to common linksHHS U.S. Department of Health and Human Services U.S. Food and Drug Administration * Follow FDA * En EspañolSearch FDASubmit search * Popular Content * Home * Food * Drugs * Medical
Cytomegalovirus infection Skip to main contentSkip to searchAbout usHelpSubscribeAccess through your institutionLog inBMJ Best PracticeSearchSearchSelect languageCytomegalovirus infection MENULog in or subscribe to access all of BMJ Best PracticeLast reviewed:28 May 2023Last updated:22 Jun 2023SummaryCytomegalovirus (CMV) infection is often asymptomatic or manifests as infectious mononucleosis -like syndrome (fever, lymphadenopathy, and atypical lymphocytosis) in people with normal immune systems.In immunocompromised people (patients with AIDS and transplant recipients), disease manifests with fever, bone marrow suppression, and tissue-invasive disease such as pneumonitis, hepatitis, colitis, nephritis, and retinitis.In the fetus, CMV infection may lead to cytomegalic inclusion disease
for Quality and Efficiency in Health Care (IQWiG) - v - List of abbreviations Abbreviation Meaning ACT appropriate comparator therapy CMVcytomegalovirus G-BA Gemeinsamer Bundesausschuss (Federal Joint Committee) IQWiG Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care) RCT randomized controlled trial SGB Sozialgesetzbuch (Social Code Book Code Book V) [1]. The commission comprises the assessment of the following outcomes presented by the pharmaceutical company (hereinafter referred to as “the company” in the dossier [2]: overall survival until Week 24 initiation of pre-emptive therapy composite outcome of clinically significant cytomegalovirus (CMV) infection The responsibility for the present assessment and the assessment
Clinical Practice Guidelines for the Management of Congenital Cytomegalovirus Infection in Japan 2023: Executive Summary Congenital cytomegalovirus (cCMV) infection is the most common congenital infection in developed countries. Although a standard therapy has not yet been established, evidence for the management of cCMV infection has been accumulating. The first edition of the "Clinical Practice Guidelines for the Management of Congenital Cytomegalovirus Infection" was published in Japan in 2023. This summary outlines the clinical questions (CQs) in the guidelines, with reference to the Japanese Medical Information Distribution Service Manual. Overall, 20 CQs with statements regarding prenatal risk assessment, prevention and management at diagnosis (CQs 1-1-1-3), diagnosis (CQs 2-1-2-6), treatment
Newborn Screening for Congenital Cytomegalovirus in Canada View of Newborn Screening for Congenital Cytomegalovirus in Canada | Canadian Journal of Health TechnologiesReturn to Article DetailsNewborn Screening for Congenital Cytomegalovirus in Canada
Newborn Screening for Congenital Cytomegalovirus View of Newborn Screening for Congenital Cytomegalovirus | Canadian Journal of Health TechnologiesReturn to Article DetailsNewborn Screening for Congenital Cytomegalovirus
(CMV) polymerase chain reaction or culture testing by blood,saliva, or urinescreeningofall babiesfor the CMV infection atbirth. HT-cCMV screening programs test infants who do notpass two or more hearing screenings. Expanded targetedcCMV screening is testing that targets a range of symptomsKeywords►CMV►cCMV►congenital►cytomegalovirus►hearing loss►hearing screening►newborn►newborn screeningAbstractThe competing interests werereported by the reviewers.References1Centers for Disease Control and Prevention. Babies born withcongenital CMV. Accessed September 30, 2022 at: www.cdc.gov/cmv/congenital-infection.html2Akpan SU, Pillarisetty LS. Congenital cytomegalovirus infection.In: StatPearls [Internet]. Treasure Island: StatPearls Publishing;2022 Accessed September 30, 2022 at: www.ncbi.nlm.nih.gov/books
Prevention of Cytomegalovirus Infection in Solid Organ Transplant Recipients: Guidelines by the Korean Society of Infectious Diseases and the Korean Society for Transplantation Cytomegalovirus (CMV) is the most important opportunistic viral pathogen in solid organ transplant (SOT) recipients. The Korean guideline for the prevention of CMV infection in SOT recipients was developed jointly by the Korean Society for Infectious Diseases and the Korean Society of Transplantation. CMV serostatus of both donors and recipients should be screened before transplantation to best assess the risk of CMV infection after SOT. Seronegative recipients receiving organs from seropositive donors face the highest risk, followed by seropositive recipients. Either antiviral prophylaxis or preemptive therapy can
Incidence of ophthalmic manifestations in congenital cytomegalovirus (CMV). Congenital cytomegalovirus (CMV) infections are associated with eye manifestations, especially in patients with systemic disease. However, there are no ophthalmic screening guidelines for infants with congenital CMV. Retrospective review of pediatric patients (< 18 years old, 2010-2023) with a diagnosis of congenital CMV and at least 1 eye examination. Gestational age at birth, systemic findings, and ophthalmic findings at initial and final eye examinations were collected. Seventy-two patients (47% male) with congenital CMV underwent initial eye examination at 2.1 ± 2.9 years of age (median 0.3 years). Thirty-one patients (43%) only had one eye examination while 41 patients had follow-up (1 month-19 years). Fifty-two
Consensus Definitions of Cytomegalovirus (CMV) Infection and Disease in Transplant Patients Including Resistant and Refractory CMV for Use in Clinical Trials: 2024 Update From the Transplant Associated Virus Infections Forum. Cytomegalovirus (CMV) infection and disease are important causes of morbidity and mortality in transplant recipients. For the purpose of developing consistent reporting of CMV outcomes in clinical trials, definitions of CMV infection and disease were developed and most recently published in 2017. Since then, there have been major developments, including registration of new antiviral agents. Therefore, the Transplant Associated Virus Infections Forum, which consists of scientists, clinicians, regulators, and industry representatives, has produced an updated version