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4. Efficacy and Safety of Ensitrelvir for Asymptomatic or Mild COVID‐19: An Exploratory Analysis of a Multicenter, Randomized, Phase 2b/3 Clinical Trial.

Author

Ohmagari, Norio, Yotsuyanagi, Hiroshi, Doi, Yohei, Yamato, Masaya, Imamura, Takumi, Sakaguchi, Hiroki, Yamanaka, Hideki, Imaoka, Ryosuke, Fukushi, Akimasa, Ichihashi, Genki, Sanaki, Takao, Tsuge, Yuko, Uehara, Takeki, and Mukae, Hiroshi

Subjects
COVID-19
Abstract

Background: This phase 2b/3, randomized, placebo‐controlled trial explored the efficacy and evaluated the safety of ensitrelvir. This trial involved individuals with asymptomatic infection with severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) and patients with mild symptoms of coronavirus disease 2019 (COVID‐19). Methods: The trial was conducted at 57 medical institutions in Japan, South Korea, and Vietnam (study period: January 6–August 14, 2022). Eligible participants were randomized (1:1:1) to the ensitrelvir 125‐mg, ensitrelvir 250‐mg, or placebo group, received the allocated intervention orally, and were followed up until Day 28. Participants self‐rated the severity of 14 typical COVID‐19 symptoms and recorded the data in an electronic diary. Results: In total, 572 participants (194, 189, and 189 in the ensitrelvir 125‐mg, ensitrelvir 250‐mg, and placebo groups, respectively) were included in the intention‐to‐treat population. Ensitrelvir 125‐mg group observed a 77% reduction in the risk of developing any of the 14 COVID‐19 symptoms or fever and a 29% reduction in the risk of worsening of such symptoms or fever versus placebo (statistically nonsignificant). The viral RNA, viral titer, and time to infectious viral clearance observed a statistically significant decrease versus placebo. Most treatment‐related adverse events (TEAEs) were mild to moderate in severity, and the most common TEAE observed across groups was a decrease in high‐density lipoprotein. Conclusions: Our exploratory results suggest a potential reduction in the risk of development or worsening of COVID‐19 symptoms with ensitrelvir. Ensitrelvir showed antiviral efficacy and was well tolerated. Trial Registration: Japan Registry of Clinical Trials identifier: jRCT2031210350. [ABSTRACT FROM AUTHOR]

Published
2024
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7. 1133. Investigation of Treatment-Emergent Amino Acid Substitutions in Nonstructural Protein 5 from Ph2a Study of Ensitrelvir, a Novel Oral SARS-CoV-2 3C-Like Protease Inhibitor

Author

Sanaki, Takao, primary, Baba, Keiko, additional, Yamamoto, Atsuko, additional, Nobori, Haruaki, additional, Uehara, Shota, additional, Kajiwara, Yoko, additional, Yoshida, Ryu, additional, Sakaguchi, Hiroki, additional, Hasegawa, Takahiro, additional, Hatanaka, Akifumi, additional, Ichihashi, Genki, additional, Takeda, Yosuke, additional, Shishido, Takao, additional, and Uehara, Takeki, additional

Published
2022
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9. Additional file 5 of Baloxavir safety and clinical and virologic outcomes in influenza virus-infected pediatric patients by age group: age-based pooled analysis of two pediatric studies conducted in Japan

Author

Hirotsu, Nobuo, Sakaguchi, Hiroki, Fukao, Keita, Kojima, Satoshi, Piedra, Pedro A., Tsuchiya, Kenji, and Uehara, Takeki

Abstract

Additional file 5: Table S4. Duration of symptoms and fever by age group and influenza virus type (subtype) (ITTI population N = 137).

Published
2023
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10. Additional file 4 of Baloxavir safety and clinical and virologic outcomes in influenza virus-infected pediatric patients by age group: age-based pooled analysis of two pediatric studies conducted in Japan

Author

Hirotsu, Nobuo, Sakaguchi, Hiroki, Fukao, Keita, Kojima, Satoshi, Piedra, Pedro A., Tsuchiya, Kenji, and Uehara, Takeki

Abstract

Additional file 4: Table S3. Adverse events occurring in ≥2% of patients in any age group (safety population).

Published
2023
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11. Additional file 6 of Baloxavir safety and clinical and virologic outcomes in influenza virus-infected pediatric patients by age group: age-based pooled analysis of two pediatric studies conducted in Japan

Author

Hirotsu, Nobuo, Sakaguchi, Hiroki, Fukao, Keita, Kojima, Satoshi, Piedra, Pedro A., Tsuchiya, Kenji, and Uehara, Takeki

Abstract

Additional file 6: Table S5. List of IRBs that gave ethical approval for the clinical trials JapicCTI-163,417 and JapicCTI-173,811.

Published
2023
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13. Additional file 3 of Baloxavir safety and clinical and virologic outcomes in influenza virus-infected pediatric patients by age group: age-based pooled analysis of two pediatric studies conducted in Japan

Author

Hirotsu, Nobuo, Sakaguchi, Hiroki, Fukao, Keita, Kojima, Satoshi, Piedra, Pedro A., Tsuchiya, Kenji, and Uehara, Takeki

Abstract

Additional file 3: Table S2. Patient demographics and baseline characteristics by age groups < 2 years, ≥2 to < 6 years, and ≥ 6 to < 12 years (ITTI population).

Published
2023
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14. A Randomized Phase 2/3 Study of Ensitrelvir, a Novel Oral SARS-CoV-2 3C-Like Protease Inhibitor, in Japanese Patients with Mild-to-Moderate COVID-19 or Asymptomatic SARS-CoV-2 Infection: Results of the Phase 2a Part

Author

Mukae, Hiroshi, primary, Yotsuyanagi, Hiroshi, additional, Ohmagari, Norio, additional, Doi, Yohei, additional, Imamura, Takumi, additional, Sonoyama, Takuhiro, additional, Fukuhara, Takahiro, additional, Ichihashi, Genki, additional, Sanaki, Takao, additional, Baba, Keiko, additional, Takeda, Yosuke, additional, Tsuge, Yuko, additional, and Uehara, Takeki, additional

Published
2022
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16. Evaluating the fitness of PA/I38T-substituted influenza A viruses with reduced baloxavir susceptibility in a competitive mixtures ferret model

Author

Lee, Leo Y, primary, Zhou, Jie, additional, Koszalka, Paulina, additional, Frise, Rebecca, additional, Farrukee, Rubaiyea, additional, Baba, Keiko, additional, Miah, Shahjahan, additional, Shishido, Takao, additional, Galiano, Monica, additional, Hashimoto, Takashi, additional, Omoto, Shinya, additional, Uehara, Takeki, additional, Mifsud, Edin J., additional, Collinson, Neil, additional, Kuhlbusch, Klaus, additional, Clinch, Barry, additional, Wildum, Steffen, additional, Barclay, Wendy S., additional, and Hurt, Aeron C., additional

Published
2021
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18. Baloxavir treatment of ferrets infected with influenza A(H1N1)pdm09 virus reduces onward transmission

Author

Lee, Leo Yi Yang, primary, Zhou, Jie, additional, Frise, Rebecca, additional, Goldhill, Daniel H., additional, Koszalka, Paulina, additional, Mifsud, Edin J., additional, Baba, Kaoru, additional, Noda, Takahiro, additional, Ando, Yoshinori, additional, Sato, Kenji, additional, Yuki, Aoe-Ishikawa, additional, Shishido, Takao, additional, Uehara, Takeki, additional, Wildum, Steffen, additional, Zwanziger, Elke, additional, Collinson, Neil, additional, Kuhlbusch, Klaus, additional, Clinch, Barry, additional, Hurt, Aeron C., additional, and Barclay, Wendy S., additional

Published
2020
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22. 1645. Exploring Clinical and Antiviral Efficacy of Baloxavir Marboxil in a Phase 3, Randomized, Double-Blind, Placebo- and Active-Controlled Study of Otherwise Healthy Adults/Adolescents in Seasonal Influenza: Impact on Regional Participants, Treatment Time and Influenza Type B Virus Infection (CAPSTONE-1 Study)

Author

Kawaguchi, Keiko, primary, Portsmouth, Simon, additional, Shishido, Takao, additional, Uehara, Takeki, additional, and Hayden, Frederick, additional

Published
2018
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23. Baloxavir Treatment in Adolescents With Acute Influenza: Subgroup Analysis From the CAPSTONE-1 Trial.

Author

Portsmouth, Simon, Hayden, Frederick G, Kawaguchi, Keiko, Ishibashi, Toru, Kinoshita, Masahiro, Shishido, Takao, Tsuchiya, Kenji, and Uehara, Takeki

Subjects
CONFIDENCE intervals, TREATMENT duration, TREATMENT effectiveness, RANDOMIZED controlled trials, PLACEBOS, INFLUENZA, DESCRIPTIVE statistics, DISEASE duration, DRUG side effects, ACUTE diseases, ENZYME inhibitors, ADOLESCENCE
Abstract

Background Baloxavir marboxil has demonstrated safety and efficacy in treating adult and adolescent outpatients with acute influenza (CAPSTONE-1 trial). Here, we report a subgroup analysis of outcomes in adolescents from the trial. Methods CAPSTONE-1 was a randomized, double-blind, placebo-controlled study. Eligible adolescent outpatients (aged 12-17 years of age) were randomized in a ratio of 2:1 to a single dose of baloxavir 40/80 mg if less than/greater than or equal to 80 kg or placebo. The main outcomes were the time to alleviation of symptoms (TTAS), duration of infectious virus detection, and incidence of adverse events (AEs). Results Among 117 adolescent patients, 90 (77%) comprised the intent-to-treat infected population (63 baloxavir and 27 placebo; 88.9% A(H3N2)). The median TTAS was 38.6 hours shorter (95% confidence interval: −2.6, 68.4) in the baloxavir group compared with placebo (median TTAS, 54.1 hours vs 92.7 hours, P =.0055). The median time to sustained cessation of infectious virus detection was 72.0 hours for baloxavir compared with 120.0 hours for placebo recipients (P <.0001). Treatment-emergent PA/I38X-substituted viruses were detected in 5 of the 51 (9.8%) baloxavir recipients. In the safety population (76 baloxavir and 41 placebo), AEs were less common in baloxavir than placebo recipients (17.1% vs 34.1%; P =.0421). In the baloxavir group, no AEs except for diarrhea were reported in 2 or more patients. Conclusions Baloxavir demonstrated clinical and virologic efficacy in the otherwise healthy adolescents with acute influenza compared with placebo. There were no safety concerns identified. These results were similar to the adult population in CAPSTONE-1 and support baloxavir as a treatment option in adolescents. [ABSTRACT FROM AUTHOR]

Published
2021
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24. Mechanistic roles of microRNAs in hepatocarcinogenesis: A study of thioacetamide with multiple doses and time-points of rats

Author

Dweep, Harsh, primary, Morikawa, Yuji, additional, Gong, Binsheng, additional, Yan, Jian, additional, Liu, Zhichao, additional, Chen, Tao, additional, Bisgin, Halil, additional, Zou, Wen, additional, Hong, Huixiao, additional, Shi, Tieliu, additional, Gong, Ping, additional, Castro, Christina, additional, Uehara, Takeki, additional, Wang, Yuping, additional, and Tong, Weida, additional

Published
2017
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26. Genetic and epigenetic changes in fibrosis-associated hepatocarcinogenesis in mice

Author

Chappell, Grace, Kutanzi, Kristy, Uehara, Takeki, Tryndyak, Volodymyr, Hong, Hue-Hua, Hoenerhoff, Mark, Beland, Frederick A., Rusyn, Ivan, and Pogribny, Igor P.

Subjects
Liver Cirrhosis, Male, Carcinoma, Hepatocellular, Down-Regulation, Article, Genomic Instability, Epigenesis, Genetic, Histones, Proto-Oncogene Proteins p21(ras), Mice, Animals, Diethylnitrosamine, Hepatocyte Nuclear Factor 1-alpha, Promoter Regions, Genetic, Carbon Tetrachloride, beta Catenin, Short Interspersed Nucleotide Elements, Liver Neoplasms, Histone-Lysine N-Methyltransferase, DNA Methylation, Chromatin, Disease Models, Animal, Cell Transformation, Neoplastic, Long Interspersed Nucleotide Elements, Liver, Transcription Factors
Abstract

Hepatocellular carcinoma (HCC) is one of the most prevalent cancers and is rising in incidence worldwide. The molecular mechanisms leading to the development of HCC are complex and include both genetic and epigenetic events. To determine the relative contribution of these alterations in liver tumorigenesis, we evaluated epigenetic modifications at both global and gene specific levels, as well as the mutational profile of genes commonly altered in liver tumors. A mouse model of fibrosis-associated liver cancer that was designed to emulate cirrhotic liver, a prevailing disease state observed in most humans with HCC, was used. Tumor and non-tumor liver samples from B6C3F1 mice treated with N-nitrosodiethylamine (DEN; a single ip injection of 1 mg/kg at 14 days of age) and carbon tetrachloride (CCl4; 0.2 ml/kg, 2 times/week ip starting at 8 weeks of age for 14 weeks), as well as corresponding vehicle control animals, were analyzed for genetic and epigenetic alterations. H-ras, Ctnnb1, and Hnf1α genes were not mutated in tumors in mice treated with DEN+CCl4. In contrast, the increased tumor incidence in mice treated with DEN+CCl4 was associated with marked epigenetic changes in liver tumors and non-tumor liver tissue, including demethylation of genomic DNA and repetitive elements, a decrease in histone 3 lysine 9 trimethylation (H3K9me3), and promoter hypermethylation and functional down-regulation of Riz1, a histone lysine methyltransferase tumor suppressor gene. Additionally, the reduction in H3K9me3 was accompanied by increased expression of long interspersed nucleotide elements (LINE) 1 and short interspersed nucleotide elements (SINE) B2, which is an indication of genomic instability. In summary, our results suggest that epigenetic events, rather than mutations in known cancer-related genes, play a prominent role in increased incidence of liver tumors in this mouse model of fibrosis-associated liver cancer.

Published
2013

29. miRNA expression atlas in male rat

Author

Minami, Keiichi, primary, Uehara, Takeki, additional, Morikawa, Yuji, additional, Omura, Ko, additional, Kanki, Masayuki, additional, Horinouchi, Akira, additional, Ono, Atsushi, additional, Yamada, Hiroshi, additional, Ohno, Yasuo, additional, and Urushidani, Tetsuro, additional

Published
2014
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39. UTILIZATION OF A ONE-DIMENSIONAL SCORE FOR SURVEYING CHEMICAL-INDUCED CHANGES IN EXPRESSION LEVELS OF MULTIPLE BIOMARKER GENE SETS USING A LARGE-SCALE TOXICOGENOMICS DATABASE

Author

KIYOSAWA, Naoki, primary, SHIWAKU, Kouji, additional, HIRODE, Mitsuhiro, additional, OMURA, Ko, additional, UEHARA, Takeki, additional, SHIMIZU, Toshinobu, additional, MIZUKAWA, Yumiko, additional, MIYAGISHIMA, Toshikazu, additional, ONO, Atsushi, additional, NAGAO, Taku, additional, and URUSHIDANI, Tetsuro, additional

Published
2006
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42. Comparative Nephrotoxicity of Cisplatin and Nedaplatin: Mechanisms and Histopathological Characteristics.

Author

Uehara, Takeki, Yamate, Jyoji, Torii, Mikinori, and Maruyama, Toshiyuki

Subjects
*NEPHROTOXICOLOGY, *CISPLATIN, *ANTINEOPLASTIC agents, *DRUG therapy, *RENAL papilla, *TOXICOGENOMICS
Abstract

The antineoplastic platinum complexes cisplatin and its analogues are widely used in the chemotherapy of a variety of human malignancies, and are especially active against several types of cancers. Nedaplatin is a second-generation platinum complex with reduced nephrotoxicity. However, their use commonly causes nephrotoxicity due to a lack of tumor tissue selectivity. Several recent studies have provided significant insights into the molecular and histopathological events associated with nedaplatin nephrotoxicity. In this review, we summarize findings concerning the renal histopathology and molecular pathogenesis induced by antineoplastic platinum complexes, with a particular focus on the comparative nephrotoxicity of cisplatin and nedaplatin in rats. [ABSTRACT FROM AUTHOR]

Published
2011
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