T
Takashi E. Komatsu
Researcher at Center for Drug Evaluation and Research
Publications - 19
Citations - 444
Takashi E. Komatsu is an academic researcher from Center for Drug Evaluation and Research. The author has contributed to research in topics: Medicine & Clinical trial. The author has an hindex of 9, co-authored 15 publications receiving 317 citations. Previous affiliations of Takashi E. Komatsu include Food and Drug Administration.
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Journal ArticleDOI
Definitions of Resistant and Refractory Cytomegalovirus Infection and Disease in Transplant Recipients for Use in Clinical Trials.
Roy F. Chemaly,Sunwen Chou,Hermann Einsele,Paul D. Griffiths,Robin K. Avery,Raymund R. Razonable,Kathleen M. Mullane,Camille N. Kotton,Jens D Lundgren,Takashi E. Komatsu,Peter Lischka,Filip Josephson,Cameron M. Douglas,Obi Umeh,Veronica Miller,Per Ljungman +15 more
TL;DR: The CMV Resistance Working Group of the CMV Drug Development Forum has undertaken establishing standardized consensus definitions of "resistant" and "refractory" CMV, which have emerged from the available virologic and clinical literature.
Journal ArticleDOI
Use of Viral Load as a Surrogate Marker in Clinical Studies of Cytomegalovirus in Solid Organ Transplantation: A Systematic Review and Meta-analysis.
Yoichiro Natori,Ali Alghamdi,Mahmood Tazari,Veronica Miller,Shahid Husain,Takashi E. Komatsu,Paul D. Griffiths,Per Ljungman,Ani Orchanian-Cheff,Deepali Kumar,Atul Humar,Rekha Abichandani,Barbara D. Alexander,Robin K. Avery,Fausto Baldanti,Susan Barnett,Paul Baum,M Michelle Berrey,Debra Birnkrant,Emily A. Blumberg,Michael Boeckh,David Boutolleau,Terry Bowlin,Jennifer Brooks,Roy F. Chemaly,Sunwen Chou,Gavin Cloherty,William Cruikshank,Lesia K. Dropulic,Hermann Einsele,Jay Erdman,Gary Fahle,Lynn Fallon,Heather Gillis,Dimitri Gonzalez,Kurt Gunter,Hans H. Hirsch,Aimee Hodowanec,Peter W. Hunt,Filip Josephson,Camille N. Kotton,Philip R. Krause,Frank Kuhr,Christopher Lademacher,Randall Lanier,Tadd Lazarus,John A. D. Leake,Randi Y. Leavitt,Sandra Nusinoff Lehrman,Li Li,Paula Isabelle Lodding,Jens D Lundgren,Francisco Martinez-Murillo,Howard Mayer,Megan McCutcheon,John E. McKinnon,Thomas Mertens,Kevin Modarress,Johann Mols,Sally Mossman,Yoshihiko Murata,David Murawski,Jeffrey C. Murray,Garrett Nichols,Jules O'Rear,Karl S. Peggs,Andreas Pikis,Mark N. Prichard,Raymund R. Razonable,Marcie L. Riches,Jeff Roberts,Wael Saber,Chalom Sayada,Mary Singer,Thomas Stamminger,Anna Wijatyk,Dong Yu,Bernhardt Zeiher +77 more
TL;DR: It is concluded that CMV load is an appropriate surrogate endpoint for CMV trials in organ transplant recipients due to low frequency of disease and several lines of evidence support the validity of viral load.
Journal ArticleDOI
Resistance of Human Cytomegalovirus to Ganciclovir/Valganciclovir: A Comprehensive Review of Putative Resistance Pathways
TL;DR: It is proposed that there are more potential HCMV ganciclovir/valganciclovirs resistance pathways than generally appreciated and also provided insight regarding the potential for cross-resistance to other H CMV therapies.
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Regulatory Analysis of Effects of Hepatitis C Virus NS5A Polymorphisms on Efficacy of Elbasvir and Grazoprevir.
Takashi E. Komatsu,Sarita D. Boyd,Adam Sherwat,LaRee Tracy,Lisa K. Naeger,Julian J. O'Rear,Patrick R. Harrington +6 more
TL;DR: Based on data from a small number of patients, an intensified 16-week regimen of elbasvir and grazoprevir plus ribavirin could increase efficacy in patients with HCV genotype 1a infection with NS5A polymorphisms.
Journal ArticleDOI
Impact of hepatitis C virus polymorphisms on direct-acting antiviral treatment efficacy: Regulatory analyses and perspectives.
Patrick R. Harrington,Takashi E. Komatsu,Damon J. Deming,Eric F. Donaldson,Julian J. O'Rear,Lisa K. Naeger +5 more
TL;DR: Independent regulatory analyses confirmed that baseline HCV RASs can reduce the efficacy of certain DAA‐based regimens in selected patient groups, but their impact was often minimized with the use of an intensified treatment regimen, such as a longer treatment duration and/or addition of ribavirin.