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Your search keyword '"Shigetoshi Fujiyama"' showing total 2 results
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2 results on '"Shigetoshi Fujiyama"'

1. Switching from entecavir to tenofovir disoproxil fumarate for HBeAg-positive chronic hepatitis B patients: a phase 4, prospective study

Author

Fumitaka Suzuki, Yoshiyuki Suzuki, Yoshiyasu Karino, Yasuhito Tanaka, Masayuki Kurosaki, Hiroshi Yatsuhashi, Tomofumi Atarashi, Masanori Atsukawa, Tsunamasa Watanabe, Masaru Enomoto, Masatoshi Kudo, Naoto Maeda, Hiroshi Kohno, Kouji Joko, Kojiro Michitaka, Koichiro Miki, Kazuhiro Takahashi, Tatsuya Ide, Shigetoshi Fujiyama, Tomoko Kohno, Hiroshi Itoh, Sakiyo Tsukamoto, Yuko Suzuki, Yoshiaki Kawano, Wataru Sugiura, and Hiromitsu Kumada

Subjects
Tenofovir disoproxil fumarate, Chronic hepatitis B, HBsAg, HBeAg-positive, Entecavir, Diseases of the digestive system. Gastroenterology, RC799-869
Abstract

Abstract Background Tenofovir disoproxil fumarate (TDF) is widely used and recommended as first-line treatment for patients infected with the hepatitis B virus (HBV). However, current data are limited regarding the efficacy and safety of switching to TDF for the treatment of chronic hepatitis B in hepatitis B e-antigen (HBeAg)-positive patients who are virologically suppressed with another nucleos(t)ide analogue. The primary objective of this study was to evaluate the hepatitis B surface antigen (HBsAg) reduction potential of switching from entecavir (ETV) to TDF at week 48 in HBeAg-positive chronic hepatitis B patients with undetectable serum HBV-DNA. Methods In this multicenter, single-arm, open-label, phase 4 clinical study, 75 participants currently treated with ETV 0.5 mg once daily were switched to TDF 300 mg once daily for 96 weeks. Results At week 48, 3/74 participants (4%) achieved 0.25 log10 reduction of HBsAg levels from baseline (the primary endpoint). Mean HBsAg reduction was −0.14 log10 IU/mL and 12% (9/74) achieved 0.25 log10 reduction by 96 weeks. No participants achieved HBsAg seroclearance. HBsAg reduction at weeks 48 and 96 was numerically greater in participants with higher alanine aminotransferase levels (≥ 60 U/L). Seventeen participants (25%) achieved HBeAg seroclearance up to week 96. No participants experienced viral breakthrough. All drug-related adverse events (18 participants [24%]) were mild in intensity, including an increase in urine beta-2-microglobulin (15 participants [20%]). Conclusions In conclusion, HBsAg reduction was limited after switching from ETV to TDF in this study population. Further investigation is warranted to better understand the clinical impact of switching from ETV to TDF. ClinicalTrials.gov: NCT03258710 registered August 21, 2017. https://clinicaltrials.gov/ct2/show/NCT03258710?term=NCT03258710&draw=2&rank=1

Published
2021
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2. Sofosbuvir–velpatasvir in adults with hepatitis C virus infection and compensated cirrhosis in Japan

Author

Tetsuo Takehara, Namiki Izumi, Satoshi Mochida, Takuya Genda, Shigetoshi Fujiyama, Kazuo Notsumata, Akihiro Tamori, Fumitaka Suzuki, Vithika Suri, Renee‐Claude Mercier, Takuma Matsuda, Kana Matsuda, Naoya Kato, Kazuaki Chayama, and Hiromitsu Kumada

Subjects
Infectious Diseases, Hepatology
Abstract

Protease-free regimens for chronic hepatitis C virus (HCV) infection are safe and effective for persons with either compensated or decompensated cirrhosis. We examined the efficacy and safety of sofosbuvir-velpatasvir in participants with HCV and compensated cirrhosis in Japan.This was a Phase 3, multi-center, open-label study. At 20 sites, 37 individuals with chronic HCV infection of any genotype and compensated cirrhosis received sofosbuvir-velpatasvir (400 mg/100 mg) daily for 12 weeks. Participants were treatment-naïve or treatment-experienced with interferon-based treatments with or without HCV NS3/4A protease inhibitors. Prior exposure with HCV NS5A or NS5B inhibitors was prohibited. The primary study endpoint was sustained virologic response 12 weeks after treatment (SVR12).Among participants, 62% had HCV genotype 1 infection, and 38% had HCV genotype 2. More than three quarters (29/37, 78%) were HCV treatment naïve. All participants (37/37, 100%) achieved SVR12. Seventeen participants (46%) and three participants (8%) had pretreatment resistance-associated substitutions to HCV NS5A and NS5B nucleoside inhibitors respectively, yet no on-treatment breakthrough or relapse occurred. Sofosbuvir-velpatasvir for 12 weeks treatment was safe and well tolerated. The most commonly reported adverse events were headache (8%, 3/37) and diarrhea (5%, 2/37). One serious adverse event, patella fracture, occurred and was considered not treatment related. No participants discontinued study treatment due to an adverse event. Three participants (8%) had a Grade 3 laboratory abnormality; all were hyperglycemia.Sofosbuvir-velpatasvir resulted in high SVR rates and was well tolerated among Japanese patients with HCV and compensated cirrhosis. This single-tablet regimen offers a highly effective, protease-inhibitor free regimen for treating HCV.gov Identifier: NCT04112303.

Published
2022
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