Literature DB >> 32134476

The Development of Therapeutics for the Treatment and Prevention of CMV Disease in the Transplant Population: A Regulatory Perspective.

Aimee C Hodowanec1, Andreas Pikis1, Mary E Singer1.   

Abstract

Cytomegalovirus (CMV) remains an important pathogen in the transplant population. As such, the US Food and Drug Administration has published a guidance to encourage and inform the development of therapeutics for the treatment and prevention of CMV disease in this population. This review summarizes important phase 3 trial design considerations for industry and provides rationale for some of the recommendations included in the guidance. Published by Oxford University Press for the Infectious Diseases Society of America 2020.

Entities:  

Keywords:  cytomegalovirus; antiviral drugs; immunocompromised; regulatory; transplant; viral infection

Year:  2020        PMID： 32134476      PMCID： PMC7057783          DOI： 10.1093/infdis/jiz389

Source DB:  PubMed          Journal:  J Infect Dis        ISSN： 0022-1899            Impact factor:   5.226


  14 in total

1.  Clinical utility of quantitative cytomegalovirus viral load determination for predicting cytomegalovirus disease in liver transplant recipients.

Authors:  A Humar; D Gregson; A M Caliendo; A McGeer; G Malkan; M Krajden; P Corey; P Greig; S Walmsley; G Levy; T Mazzulli
Journal:  Transplantation       Date:  1999-11-15       Impact factor: 4.939

2.  Oral valganciclovir is noninferior to intravenous ganciclovir for the treatment of cytomegalovirus disease in solid organ transplant recipients.

Authors:  A Asberg; A Humar; H Rollag; A G Jardine; H Mouas; M D Pescovitz; D Sgarabotto; M Tuncer; I L Noronha; A Hartmann
Journal:  Am J Transplant       Date:  2007-07-19       Impact factor: 8.086

3.  Direct and indirect effects of cytomegalovirus: can we prevent them?

Authors:  Raymund Razonable
Journal:  Enferm Infecc Microbiol Clin       Date:  2009-12-21       Impact factor: 1.731

4.  Are We There Yet? Impact of the First International Standard for Cytomegalovirus DNA on the Harmonization of Results Reported on Plasma Samples.

Authors:  Jutta K Preiksaitis; Randall T Hayden; Yupin Tong; Xiaoli L Pang; Jacqueline F Fryer; Alan B Heath; Linda Cook; Astrid K Petrich; Brian Yu; Angela M Caliendo
Journal:  Clin Infect Dis       Date:  2016-06-15       Impact factor: 9.079

5.  A collaborative study to establish the 1st WHO International Standard for human cytomegalovirus for nucleic acid amplification technology.

Authors:  Jacqueline F Fryer; Alan B Heath; Philip D Minor
Journal:  Biologicals       Date:  2016-05-11       Impact factor: 1.856

6.  A Mortality Analysis of Letermovir Prophylaxis for Cytomegalovirus (CMV) in CMV-seropositive Recipients of Allogeneic Hematopoietic Cell Transplantation.

Authors:  Per Ljungman; Michael Schmitt; Francisco M Marty; Johan Maertens; Roy F Chemaly; Nicholas A Kartsonis; Joan R Butterton; Hong Wan; Valerie L Teal; Kendra Sarratt; Yoshihiko Murata; Randi Y Leavitt; Cyrus Badshah
Journal:  Clin Infect Dis       Date:  2020-04-10       Impact factor: 9.079

7.  Letermovir Prophylaxis for Cytomegalovirus in Hematopoietic-Cell Transplantation.

Authors:  Francisco M Marty; Per Ljungman; Roy F Chemaly; Johan Maertens; Sanjeet S Dadwal; Rafael F Duarte; Shariq Haider; Andrew J Ullmann; Yuta Katayama; Janice Brown; Kathleen M Mullane; Michael Boeckh; Emily A Blumberg; Hermann Einsele; David R Snydman; Yoshinobu Kanda; Mark J DiNubile; Valerie L Teal; Hong Wan; Yoshihiko Murata; Nicholas A Kartsonis; Randi Y Leavitt; Cyrus Badshah
Journal:  N Engl J Med       Date:  2017-12-06       Impact factor: 91.245

Review 8.  Clinical utility of viral load in management of cytomegalovirus infection after solid organ transplantation.

Authors:  Raymund R Razonable; Randall T Hayden
Journal:  Clin Microbiol Rev       Date:  2013-10       Impact factor: 26.132

9.  Use of Viral Load as a Surrogate Marker in Clinical Studies of Cytomegalovirus in Solid Organ Transplantation: A Systematic Review and Meta-analysis.

Authors:  Yoichiro Natori; Ali Alghamdi; Mahmood Tazari; Veronica Miller; Shahid Husain; Takashi Komatsu; Paul Griffiths; Per Ljungman; Ani Orchanian-Cheff; Deepali Kumar; Atul Humar
Journal:  Clin Infect Dis       Date:  2018-02-01       Impact factor: 9.079

10.  Cytomegalovirus viral load and mortality after haemopoietic stem cell transplantation in the era of pre-emptive therapy: a retrospective cohort study.

Authors:  Margaret L Green; Wendy Leisenring; Hu Xie; T Christopher Mast; Yadong Cui; Brenda M Sandmaier; Mohamed L Sorror; Sonia Goyal; Sezen Özkök; Jessica Yi; Farah Sahoo; Louise E Kimball; Keith R Jerome; Morgan A Marks; Michael Boeckh
Journal:  Lancet Haematol       Date:  2016-02-20       Impact factor: 18.959
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  2 in total

1.  Human cytomegalovirus infection among treatment-naive HIV-1 infected patients in Ethiopia.

Authors:  Mulugeta Kiros; Alene Geteneh; Henok Andualem; Derbie Alemu; Abebech Tesfaye; Dessalegne Abeje Tefera; Adane Mihret; Dawit Hailu Alemayehu; Andargachew Mulu
Journal:  PLoS One       Date:  2021-02-18       Impact factor: 3.240

2.  Early immune surveillance to predict cytomegalovirus outcomes after allogeneic hematopoietic stem cell transplantation.

Authors:  Jintao Xia; Xuejie Li; Genyong Gui; Jian Wu; Shengnan Gong; Yuxin Shang; Jun Fan
Journal:  Front Cell Infect Microbiol       Date:  2022-08-03       Impact factor: 6.073
  2 in total

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