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Higashimurayama-shi, Japan

Ogawa E.,Kyushu University | Furusyo N.,Kyushu University | Kajiwara E.,Steel Memorial Yawata Hospital | Nomura H.,The Center for Liver Disease | And 10 more authors.
Journal of Gastroenterology and Hepatology (Australia) | Year: 2015

Background and Aim: The addition of hepatitis C virus (HCV) NS3/4A protease inhibitors to the pegylated interferon (PEG-IFN) α and ribavirin combination regimen (triple therapy) has dramatically improved treatment outcome. Unfortunately, anemia remains a common adverse effect. This study was done to compare the development of severe anemia during simeprevir- or telaprevir-based triple therapy. Methods: This retrospective multicenter study consisted of 837 consecutive Japanese HCV genotype 1 patients treated in a real-world clinical setting, 811 of whom were enrolled (simeprevir 281, telaprevir 530). The inosine triphosphate pyrophosphatase (ITPA) genotype at rs1127354 was determined for all studied patients. Logistic regression was done after propensity score matching to assess the risk of development of severe anemia. Results: Propensity score matching of the entire study population yielded 266 matched pairs. Severe anemia (nadir hemoglobin <9.0g/dL) was developed during the treatment period by 81 (30.5%) and 144 (54.1%) patients treated with simeprevir and telaprevir, respectively. Treatment with simeprevir was independently associated with a lower risk of severe anemia (odds ratio 0.25, 95% confidence interval 0.16-0.38, P<0.0001). Moreover, ITPA genotype, age, hemoglobin level, and estimated glomerular filtration rate at baseline were also independent factors associated with the development of severe anemia. Conclusions: Patients treated with simeprevir-based triple therapy have a lower risk of the development of severe anemia than those treated with telaprevir. Moreover, ITPA genotype and age may be useful for individualizing treatment to reduce the risk of anemia-related adverse effects. © 2015 Journal of Gastroenterology and Hepatology Foundation and Wiley Publishing Asia Pty Ltd.


Ogawa E.,Kyushu University | Furusyo N.,Kyushu University | Kajiwara E.,Steel Memorial Yawata Hospital | Takahashi K.,Hamanomachi Hospital | And 10 more authors.
Journal of Hepatology | Year: 2013

Background & Aims: The effects of pegylated interferon (PegIFN) α and ribavirin (RBV) treatment of chronic hepatitis C on the incidence of hepatocellular carcinoma (HCC) have not been well established. This study investigated the impact of treatment outcome on the development of HCC by chronic hepatitis C patients treated with PegIFNα2b and RBV. Methods: This large-scale, prospective, multicenter study consisted of 1013 Japanese chronic hepatitis C patients with no history of HCC (non-cirrhosis, n = 863 and cirrhosis, n = 150). All patients were treated with PegIFNα2b and RBV and the follow-up period started at the end of the antiviral treatment (median observation period of 3.6 years). The cumulative incidence rate of HCC was estimated using the Kaplan-Meier method, according to treatment outcome. Results: Forty-seven patients (4.6%) developed HCC during the observation period. In the non-cirrhosis group, the 5-year cumulative incidence rates of HCC for the sustained virological response (SVR) (1.7%) and transient virological response (3.2%) (TVR: defined as relapse or breakthrough) groups were significantly lower than those of the non-virological response (NVR) group (7.6%) (p = 0.003 and p = 0.03, respectively). A significantly low rate of incidence of HCC by TVR patients in comparison with NVR patients was found for patients aged 60 years and over, but not for those under 60 years of age. In the cirrhosis group, the 5-year cumulative incidence rates of HCC for the SVR (18.9%) and TVR groups (20.8%) were also significantly lower than those of the NVR group (39.4%) (p = 0.03 and p = 0.04, respectively). Conclusions: SVR and complete viral suppression during treatment with relapse (TVR) were associated with a lower risk of HCC development when compared with NVR.


Ogawa E.,Kyushu University | Furusyo N.,Kyushu University | Kajiwara E.,Steel Memorial Yawata Hospital | Takahashi K.,Hamanomachi Hospital | And 10 more authors.
Journal of Gastroenterology and Hepatology (Australia) | Year: 2012

Background and Aims: Pegylated interferon (PEG-IFN) α-2b and ribavirin (RBV) treatment of chronic hepatitis C virus (HCV) infection is associated with a substantially elevated risk of discontinuation. The aim of this study is to evaluate the reason for premature discontinuation during PEG-IFN α-2b and RBV treatment due to adverse effects in patients with chronic HCV infection. Methods: A total of 2871 Japanese patients who had chronic HCV infection treated with PEG-IFN α-2b and RBV were screened. We prospectively investigated the reasons for premature discontinuation of treatment classified by sex and age, and analyzed the timing of discontinuation. Results: Of the 2871 patients, 250 (8.7%) discontinued treatment because of adverse effects. The main reasons for premature discontinuation were neurovegetative symptoms (n=77, 30.8%), depression-related syndrome (n=46, 18.4%), hematologic effects (n=41, 16.4%) and dermatologic effects (n=27, 10.8%). The rate of discontinuation of treatment for patients aged ≥65years was significantly higher than for patients aged <65years, for both men (P<0.0001) and women (P=0.0121). Moreover, the frequency of discontinuation due to neurovegetative symptoms, depression-related syndrome, and hematologic effects for men aged ≥65years was significantly higher than for those aged <65years (P=0.0001, P=0.0016, and P=0.0170, respectively), but not for women. Conclusion: Premature discontinuation due to the adverse effects of PEG-IFN α-2b and RBV treatment by patients with chronic HCV infection is mainly due to neuropsychiatric symptoms and is more common for older than for younger patients. © 2011 Journal of Gastroenterology and Hepatology Foundation and Blackwell Publishing Asia Pty Ltd.


Matsukage T.,Tokai University | Masutani M.,Hyogo College of Medicine | Yoshimachi F.,Aomori Prefectural Central Hospital | Takahashi A.,Takahashi Hospital | And 17 more authors.
Catheterization and Cardiovascular Interventions | Year: 2010

Objectives: The aim of this study was to evaluate the safety and effectiveness of a 0.010-inch guidewire and a balloon catheter for treatment of chronic total occlusion (CTO). Background: Pathological studies have shown that 60-70% of CTO lesions have microchannels of sizes equal to or less than 0.010 inch. Methods: The PIKACHU registry is a prospective, multicenter registry study. A 0.010-inch guidewire had to be used as the first guidewire to attempt to pass the CTO lesion. The primary endpoint was device success using a 0.010 system. Results: A total of 141 patients with 141 lesions were enrolled. The median duration of occlusion was 9 months (range 3-156). Average guiding catheter size was 5.8 ± 0.7 Fr. and TRI was 76.6%. CTOs were mostly between 10-20 mm long, observed in 53 occlusions. There were 107 lesions (75.9%) with bending of more than 45 degrees. Calcification was seen in 91 lesions (64.5%). A 0.010-inch guidewire was successfully passed through in 97 of 141 lesions (68.8%). A 0.010-inch guidewire compatible balloon catheter was passed in 87 of the 97 lesions (88.7%) and final PCI success was achieved in all the cases. The overall clinical success rate was 87.9% (124/141). No MACE or bleeding complications were observed. Conclusion: The PIKACHU registry data suggest that the 0.010-inch system is safe and practicable for treatment of CTO lesions. © 2010 Wiley-Liss, Inc.


Ogawa E.,Kyushu University | Furusyo N.,Kyushu University | Nakamuta M.,Kyushu Medical Center | Kajiwara E.,Steel Memorial Yawata Hospital | And 10 more authors.
Journal of Hepatology | Year: 2013

Background & Aims Anemia is a common adverse effect of telaprevir (TVR) in combination with pegylated interferon (PegIFN)α and ribavirin (RBV) therapy. It occurs at a higher incidence with the TVR relative to PegIFNα and RBV alone. We herein evaluate the baseline and on-treatment predictors of the development of severe anemia by chronic hepatitis C virus (HCV) patients receiving TVR-based triple therapy. Methods This prospective, multicenter study consisted of 292 patients (median age: 62 years) infected with HCV genotype 1. All received 12 weeks of TVR in combination with 24 weeks of PegIFNα2b and RBV. The definition of severe anemia during antiviral treatment is hemoglobin (Hb) <85 g/L. Results 101 (34.6%) patients developed severe anemia during the treatment period. Multivariable logistic regression analysis of possible pretreatment predictors of the development of severe anemia extracted baseline Hb <135 g/L (Hazard ratio [HR], 2.53; p = 0.0013), estimated glomerular filtration rate <80 ml/min/1.73 m2 (HR, 1.83; p = 0.0265), and inosine triphosphatase (ITPA) CC genotype (rs1127354) (HR, 2.91; p = 0.0024). For patients with ITPA CC (n = 227), multivariable logistic regression analysis of possible pretreatment and on-treatment predictors of the development of severe anemia extracted Hb level at week 2 (HR, 0.96; p = 0.0085) and the initial four weeks of weight-adjusted TVR (HR, 1.05; p = 0.0281). Conclusions Anemia remains a risk for all patients treated with TVR-based triple therapy. However, ITPA polymorphism (rs1127354) is useful for predicting the development of severe anemia and will be helpful in the management of treatment. © 2013 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

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