Abstract:
BACKGROUND:Once-daily, orally administered, co-formulated glecaprevir (NS3/4A protease inhibitor) and pibrentasvir (NS5A inhibitor) (G/P) demonstrated pangenotypic activity and high sustained virologic response (SVR) rates in studies outside Japan. Here we report safety and efficacy in a subset of Japanese patients with chronic HCV infection who received G/P 300/120 mg in a phase 3, open-label, multicenter study (CERTAIN-1). METHODS:This analysis focuses on three difficult-to-treat subgroups: HCV GT1/2-infected patients who failed to achieve SVR after treatment with a direct acting antiviral (DAA)-containing regimen; GT1/2-infected patients with severe renal impairment (estimated glomerular filtration rate < 30 mL/min/1.73 m2); and GT3-infected patients. Patients in the renal impairment and GT3 cohorts were treatment-naive or interferon treatment-experienced. Noncirrhotic GT1/2-infected, DAA-naïve patients in the renal impairment cohort received G/P for 8 weeks; all other patients were treated for 12 weeks. Primary outcome was SVR (HCV RNA < 15 IU/mL) 12 weeks post-treatment (SVR12). RESULTS:The study enrolled 33 GT1/2-infected patients who failed previous DAA treatment (four with cirrhosis); 12 GT1/2-infected patients with severe renal impairment (two with cirrhosis); and 12 GT3-infected patients (two with cirrhosis). SVR12 was achieved by 31/33 (93.9%), 12/12 (100%), and 10/12 (83.3%) patients, respectively. One serious adverse event (fluid overload, not related to G/P) occurred in a patient on chronic intermittent hemodialysis. CONCLUSIONS:G/P achieved high SVR12 rates and was well tolerated in three difficult-to-treat patient subgroups with limited treatment options in Japan (DAA-experienced patients, patients with severe renal impairment, and GT3-infected patients). These results support the potential suitability of this regimen for these special populations in Japan.
journal_name
J Gastroenteroljournal_title
Journal of gastroenterologyauthors
Kumada H,Watanabe T,Suzuki F,Ikeda K,Sato K,Toyoda H,Atsukawa M,Ido A,Takaki A,Enomoto N,Kato K,Alves K,Burroughs M,Redman R,Pugatch D,Pilot-Matias TJ,Krishnan P,Oberoi RK,Xie W,Chayama Kdoi
10.1007/s00535-017-1396-0subject
Has Abstractpub_date
2018-04-01 00:00:00pages
566-575issue
4eissn
0944-1174issn
1435-5922pii
10.1007/s00535-017-1396-0journal_volume
53pub_type
杂志文章,多中心研究abstract::IL-22 is a relatively new cytokine that is characterized by several unique biological properties. In the intestines, the effect of IL-22 is restricted mainly to non-lymphoid cells such as epithelial cells. Interestingly, the expression pattern and major cellular source of IL-22 have distinct difference between large a...
journal_title:Journal of gastroenterology
pub_type: 杂志文章,评审
doi:10.1007/s00535-017-1401-7
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abstract::To investigate the role played by cytokines in chronic pancreatitis, we examined serum levels of interleukin-1 beta (IL-1 beta) and interleukin-6 (IL-6) by radioimmunoassay (RIA) and enzyme-linked immunosorbent assay (ELISA) in 33 patients with definitively diagnosed chronic pancreatitis. All the patients, who had rec...
journal_title:Journal of gastroenterology
pub_type: 杂志文章
doi:10.1007/BF02358371
更新日期:1994-06-01 00:00:00
abstract::We present a patient with complication of huge hepatic subcapsular hematoma after extracorporeal shock wave lithotripsy (ESWL) for pancreatic lithotripsy. The hematoma measured 78-110mm. Angiography showed a subcapsular hematoma, rather than a hematoma in the liver. In the arterial phase, the distal end of the small v...
journal_title:Journal of gastroenterology
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doi:10.1007/s005350050325
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abstract:BACKGROUND:We recently reported the real-world changes in the etiologies of liver cirrhosis (LC) based on nationwide survey data and assessed the etiologies of LC with hepatocellular carcinoma (HCC). METHODS:Fifty-five participants from 68 institutions provided data on 23,637 patients with HCC-complicated LC. The chan...
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abstract:BACKGROUND:The levels of serum HER2 extracellular domain (ECD) are highly correlated with tissue HER2 status in metastatic gastric cancer (AGC). We sought to explore whether serum HER2 ECD could predict the efficacy of trastuzumab-treated HER2-positive AGC. MATERIALS AND METHODS:From 2011 to 2013, trastuzumab-treated ...
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abstract:BACKGROUND:Gastric complications of indomethacin involve generation of reactive oxygen species, which induce gastric mucosal injury via lipid peroxidation of cell membranes. Peroxidation by reactive oxygen species alters the amounts of unsaturated fatty acids in the cell membrane and thus affects membrane fluidity. Ind...
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doi:10.1007/s00535-007-2116-y
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abstract:BACKGROUND:This study examined the association of cholelithiasis post-cholecystectomy with subsequent cancers and evaluated the risk of cancer in patients with both cholelithiasis and cholecystectomy. METHODS:The Taiwanese National Health Insurance Research Database was used to identify 15545 newly diagnosed cholelith...
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doi:10.1007/s00535-013-0846-6
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abstract::This paper describes a program of research undertaken by the Inflammatory Bowel Disease Study Group at the Royal Free Hospital School of Medicine. The Group has tested the hypothesis that the primary pathological abnormality in Crohn's disease is in the mesenteric blood supply. The first experiments involved microcorr...
journal_title:Journal of gastroenterology
pub_type: 杂志文章,评审
doi:
更新日期:1994-07-01 00:00:00
abstract:BACKGROUND:Better diagnosis of metastatic disease has been pursued by oncologists: however, many of the tumor markers have been still controversial. Our purpose was to estimate the usefulness of soluble E-selectin and its ligand sialyl Lewis A for more accurate diagnosis as a combined tumor marker for metastases in col...
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abstract:BACKGROUND:Most studies evaluating visceral sensation measure visceromotor response (VMR) to colorectal distention (CRD). However, CRD itself induces visceral sensitization, and little is known about the detailed characteristics of this response. The present study tried to clarify this question. METHODS:VMR was determ...
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journal_title:Journal of gastroenterology
pub_type: 杂志文章
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abstract::Diagnosis of chronic pancreatitis in its early stage is an extremely difficult task. If the genetic predispositions are identified, it may help make possible the earlier diagnosis of chronic pancreatitis or the detection of patients at risk. There are two major hypotheses about the pathogenesis of chronic pancreatitis...
journal_title:Journal of gastroenterology
pub_type: 杂志文章,评审
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abstract:BACKGROUND:Liver cirrhosis affects the results of many of the traditional techniques currently used to evaluate nutritional status. Our aim was to compare the traditional two-compartment model (subjective global assessment and anthropometry and blood tests) of nutritional assessment with a multicompartmental model (bod...
journal_title:Journal of gastroenterology
pub_type: 评论,杂志文章
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abstract:BACKGROUND:Obliterative phlebitis is a useful pathological finding for the diagnosis of lymphoplasmacytic sclerosing pancreatitis (LPSP), or type 1 autoimmune pancreatitis. The present study evaluated histological findings of obliterative phlebitis, including the significance of adding Elastica van Gieson stain (EVG) i...
journal_title:Journal of gastroenterology
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更新日期:2014-04-01 00:00:00
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journal_title:Journal of gastroenterology
pub_type: 杂志文章,评审
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journal_title:Journal of gastroenterology
pub_type: 杂志文章
doi:
更新日期:2000-01-01 00:00:00
abstract:BACKGROUND:The precise pathogenic mechanism of nonsteroidal antiinflammatory drug-induced small intestinal injury is still unknown. In the present study, we investigated the mechanism by which indomethacin induced mucosal injury by using an in vitro model of small intestine. METHODS:The colon cancer cell line Caco-2, ...
journal_title:Journal of gastroenterology
pub_type: 杂志文章
doi:10.1007/s00535-008-2293-3
更新日期:2009-01-01 00:00:00
abstract::Although esophageal candidiasis is the most common form of Candida infection in the gastro-intestinal tract, little attention has been directed toward determining the mechanism of its infection. We have already clarified the existence of four modes of adherence of Candida albicans to the esophagus; attachment, subepit...
journal_title:Journal of gastroenterology
pub_type: 杂志文章
doi:10.1007/BF01229065
更新日期:1994-02-01 00:00:00
abstract::Anomalous arrangement of the pancreaticobiliary ductal system (AAPB), a congenital anomaly defined as a union of the pancreatic and biliary ducts located outside the duodenal wall, is a newly designated disease entity, and is frequently found in adult patients with gallbladder carcinoma (GBX). In the present study, th...
journal_title:Journal of gastroenterology
pub_type: 杂志文章
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abstract:BACKGROUND:Infection with Helicobacter pylori is the main risk factor for development of gastric cancer. CD44 overexpression, especially that of variant 9 (CD44v9), has also been implicated in the local inflammatory response and metaplasia-carcinoma sequence in human stomach. We recently identified miR-328 as one of th...
journal_title:Journal of gastroenterology
pub_type: 杂志文章
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abstract::Preoperative biliary drainage (PBD) has been thought to be preferable regardless of the site of biliary strictures, e.g., distal or proximal strictures because PBD by endoscopy or interventional radiology decreases postoperative mortality and morbidity rates. However, recently, several studies have revealed that PBD s...
journal_title:Journal of gastroenterology
pub_type: 杂志文章,评审
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journal_title:Journal of gastroenterology
pub_type: 杂志文章,评审
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abstract:BACKGROUND:Hepatitis C virus (HCV) core protein is known to cause oxidative stress and alter apoptosis pathways. However, the apoptosis results are inconsistent, and the real significance of oxidative stress is not well known. The aim of this study was twofold. First, we wanted to confirm whether core-induced oxidative...
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abstract:BACKGROUND:Evidence suggests that rates of gastroesophageal reflux disease are increasing in the Asia-Pacific region, where patients tend to have predominantly non-erosive reflux disease as opposed to erosive (reflux) esophagitis. At present, data for the responsiveness of non-erosive reflux disease to proton pump inhi...
journal_title:Journal of gastroenterology
pub_type: 杂志文章,随机对照试验
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更新日期:2011-07-01 00:00:00
abstract::A case of heterotopic gastric mucosa in the fundus of the gallbladder is reported. A 23-year-old man, who had been healthy and asymptomatic, visited our hospital because of abnormal findings in a liver enzyme test given during a routine health screening. Ultrasonography demonstrated a highly echogenic polypoid mass in...
journal_title:Journal of gastroenterology
pub_type: 杂志文章
doi:10.1007/BF02347576
更新日期:1995-08-01 00:00:00
abstract::In our hospital, 83 patients with colorectal cancer underwent the immunologic fecal occult blood test (IFOBT). The positive rate for IFOBT in all patients was 87%. Colon cancers more proximal than the transverse colon were 100% positive. Carcinomas of the ulcerative type showed a significantly higher positive rate tha...
journal_title:Journal of gastroenterology
pub_type: 杂志文章
doi:10.1007/BF02348665
更新日期:1995-04-01 00:00:00
abstract::Duodenal gastrinoma is recognized as a relatively common cause of Zollinger-Ellison syndrome, but its clinical and biological features are not well known. Here we report a case of duodenal gastrinoma with lymph node metastasis which was confirmed by pathology examinations. Hypergastrinemia and gastric acid hypersecret...
journal_title:Journal of gastroenterology
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abstract:BACKGROUND:Neovascularization was shown to be critically involved in the progression of multiple cancers, and treatment approaches targeting tumor-associated neovascularization provide convincing results in recent years in some tumor entities. However, little is known about the tumor-associated neovascularization in hi...
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更新日期:2008-01-01 00:00:00
abstract:BACKGROUND:The Japan Society of Diabetes Mellitus reported that the leading cause of death in patients with diabetes mellitus (DM) was chronic liver disease; however, there are limited studies investigating the cause of liver injury in these patients. Our study aimed to clarify the clinicopathological features of liver...
journal_title:Journal of gastroenterology
pub_type: 杂志文章,多中心研究
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