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Importance of virological response in the early stage of telaprevir-based triple therapy for hepatitis C

World Journal of Hepatology 2015年第26期7卷 2688-2695页

作者： Satoshi Hiramine Norihiro Furusyo Eiichi Ogawa Makoto Nakamuta eiji kajiwara Hideyuki Nomura Kazufumi Dohmen Kazuhiro Takahashi Takeaki Satoh Koichi Azuma Akira Kawano Toshimasa Koyanagi Kazuhiro Kotoh Shinji Shimoda Jun Hayashi Depart- ment of General Internal Medicine Kyushu University Hospital Department of Gastroenterology Kyushu Medical CenterNational Hospital Organization Department of Hepatology Steel Memorial Yahata Hospital the Center for Liver Disease Shin-Kokura Hospital Department of Internal Medicine Chihaya Hospital Department of Medicine Hamanomachi Hospital Center for Liver Disease National Hospital Organization Kokura Medical Center Department of Medicine Kyushu Central Hospital Department of Medicine Kitakyushu Municipal Medical Center Department of Medicine Fukuoka City Hospital Department of Medicine and Bioregulatory Science Graduate School of Medical Sciences Kyushu University Kyushu General Internal Medicine Center Hara- Doi Hospital

AIM: To investigate the efficacy of virological response(VR) to telaprevir(TVR)-based triple therapy in predicting treatment outcome of hepatitis ***: This prospective, multicenter study consisted of 253 Japanese patients infected with hepatitis C virus(HCV) genotype 1b. All received 12 wk of TVR in combination with 24 wk of pegylatedinterferon-α(IFN-α) and ribavirin. Serum HCV RNA was tested at weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24. VR was defined as undetectable serum HCV RNA. Sustained virological response(SVR) was VR at 24 wk after the end of treatment and was regarded as a successful ***: Of 253 patients, 207(81.8%) achieved SVR. The positive predictive value of VR for SVR was 100% at week 2, after which it gradually decreased, and was over 85% to week 12. The negative predictive value(NPV) gradually increased, reaching 100% at week 12. The upslope of the NPV showed a large increase from week 4(40.6%) to week 6(82.4%). There was a moderate concordance between the SVR and VR at week 6(kappa coefficient = 0.44), although other VRs had poor concordance to SVR. Multiple logistic regression analysis extracted VR at week 6(P < 0.0001, OR = 63.8) as an independent factor contributing to SVR. In addition, the interleukin-28 B single nucleotide polymorphism and response to previous pegylated-IFN-α and ribavirin therapy were identified as independent factors for ***: VR at week 6, but not at week 4, is an efficient predictor of both SVR and non-SVR to TVRbased triple therapy.

关键词： Chronic hepatitis C Direct-acting antiviral agent

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Pegylated interferon α-2b plus ribavirin for older patients with chronic hepatitis C

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World Journal of Gastroenterology 2010年第35期16卷 4400-4409页

作者： Mosaburo Kainuma Norihiro Furusyo eiji kajiwara Kazuhiro Takahashi Hideyuki Nomura Yuichi Tanabe Takeaki Satoh Toshihiro Maruyama Makoto Nakamuta Kazuhiro Kotoh Koichi Azuma Junya Shimono Shinji Shimoda Jun Hayashi Department of General Internal Medicine Kyushu University Hospital Department of Internal Medicine Nippon Steel Yawata Memorial Hospital Department of Medicine Hamanomachi Hospital The Center for Liver Disease Shin-Kokura Hospital Department of Medicine Fukuoka City HospitalYoshiduka-honmachi Center for Liver Disease National Hospital Organization Kokura Medical Center Department of Medicine Kitakyushu Municipal Medical Center Department of Gastroenterology Kyushu Medical CenterNational Hospital Organization Department of Medicine and Bioregulatory Science Graduate School of Medical ScienceKyushu University Department of Medicine and Clinical Science Graduate School of Medical SciencesKyushu University Saiseikai Yahata General Hospital Harunomachi Department of Medicine and Biosystemic Science Graduate School of Medical ScienceKyushu University

AIM:To analyze the efficacy and safety of a combination therapy of pegylated interferon(PEG-IFN) α-2b plus ribavirin(RBV) in older Japanese patients(65 years or older) infected with hepatitis C virus(HCV).METHODS:This multicenter study included 938 patients with HCV genotype 1 who received 1.5 μg/kg per week PEG-IFN α-2b plus RBV 600-1000 mg/d for 48 wk and 313 HCV genotype 2 patients who received this treatment for 24 ***:At 24 wk after the end of combination therapy,the overall sustained virological response(SVR) for genotypes 1 and 2 were 40.7% and 79.6%,*** SVR rate decreased signif icantly with age in each genotype,and was markedly reduced in genotype 1(P<0.001).Moreover,the SVR was significantly higher in patients with genotype 1 who were less than 65 years(47.3% of 685) than in those 65 years or older(22.9% of 253)(P<0.001) and was higher in patients with genotype 2 who were less than 65 years(82.9% of 252) than in those 65 years or older(65.6% of 61)(P=0.004).When patients received a dosage at least 80% or more of the target dosage of PEG-IFN α-2b and 60% or more of the target dosage of RBV,the SVR rate significantly increased to 66.5% in patients less than 65 years and to 45.2% in those 65 years or older(P<0.001).Adverse effects resulted in treatment discontinuation more often in patients with genotype 1(14.4%) than in patients with genotype 2(7.3%),especially by patients 65 years or older(24.1%).CONCLUSION:PEG-IFN α-2b plus RBV treatment was effective in chronic hepatitis C patients 65 years or older who completed treatment with at least the minimum acceptable treatment dosage.

关键词： Hepatitis C virus Gerontology Pegylated interferon Ribavirin

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Long-term lamivudine treatment for chronic,hepatitis B in Japanese patients:A project of Kyushu University Liver Disease Study

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World Journal of Gastroenterology 2006年第4期12卷 561-567页

作者： Norihiro Furusyo Hiroaki Takeoka Kazuhiro Toyoda Masayuki Murata Yuichi Tanabe eiji kajiwara Junya Shimono Akihide Masumoto Toshihiro Maruyama Hideyuki Nomura Makoto Nakamuta Kazuhiro Takahashi Shinji Shimoda Koichi Azuma Hironori Sakai Jun Hayashi Department of General Medicine Kyushu University Hospital Department of Environmental Medicine and Infectious Diseases Graduate School of Medical Sciences. Kyushu University Fukuoka Japan Department of Medicine Fukuoka City HospitalFukuoka Japan Department of Internal Medicine Nippon SteelYawata Memorial Hospital Kitakyushu Japan Department of Medicine Yahata SaiseikaiHospital Kitakyushu Japan Department of Clinical Research NationalHospital Organization Kokura Hospital Kitakyushu Japan Department of Medicine KitakyushuMunicipal Medical Center Kitakyushu Japan Department of Internal Medicine ShinKokura Hospital Kitakyushu Japan Department of Medicine and Bioregulatory Science Graduate School of Medical Sciences Kyushu University Fukuoka Japan Department of Medicine HamanomachiHospital Fukuoka Japan Department of Medicine and Biosystemic Science Graduate School of Medical Sciences Kyushu University Fukuoka Japan Department of Medicine and Clinical Science Graduate School of Medical Sciences Kyushu University Fukuoka Japan Department of Gastroenterology National Hospital Organization Kyushu Medical Center Fukuoka Japan

AIM： To determine the efficacy of long-term lamivudine treatment of a large number of Japanese patients with chronic hepatitis B. METHODS： In this retrospective, multi-center trial, 318 Japanese patients with chronic hepatitis B received 100 mg of lamivudine daily for up to 36 （median 21） mo. Virological response was a decline to a serum HBV DNA level less than 3.7 log copies/mL. Virological breakthrough was defined as the reappearance of a serum HBV DNA level to more than 10-fold the minimum during treatment. RESULTS： Lamivudine produced virological response in 86.8% of the 318 patients at 6 mo, in 80.2% of 252 patients at 12 mo, in 69.2% of 133 patients at 24 mo, and in 53.6% of 28 patients at 36 mo. Forward stepwise logistic regression analysis showed an HBV DNA level less than 6.8 log copies/mL （P〈 0.0001）, HBeAg negativity （P〈 0.0001）, a platelet count of 100×10^9/L or more （P= 0.0162） at baseline, and a decline of the HBV DNA level of more than 3.2 log copies/mL as compared with the baseline level at 3 mo after the start of treatment （P= 0.0003） to be significantly associated with virological response. Among patients with a virological response, virological breakthrough was seen in 5.3% of 19 patients who responded virologically at 1 mo, in 20.7% of 203 patients at 3 mo, in 27.5% of 51 patients at 6 mo, in 33.3% of 12 patients at 9 mo, and in 100% of 3 patients at ≥15 mo. A virological breakthrough was found significantly more often in patients with delayed virological response. CONCLUSION： Lamivudine treatment could suppress serum HBV DNA in most of the tested Japanese patients. Long-term efficacy might be seen in patients without HBeAg at baseline, in the absence of cirrhosis, and in patients with a decline in HBV DNA level soon after the start of treatment.

关键词： Hepatitis B virus Lamivudine HBeAg Cirrhosis

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Interferon alpha plus ribavirin combination treatment of Japanese chronic hepatitis C patients with HCV genotype 2:A project of the Kyushu University Liver Disease Study Group

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World Journal of Gastroenterology 2006年第5期12卷 784-790页

作者： Norihiro Furusyo Masaki Katoh Yuichi Tanabe eiji kajiwara Toshihiro Maruyama Junya Shimono Hironori Sakai Makoto Nakamuta Hideyuki Nomura Akihide Masumoto Shinji Shimoda Kazuhiro Takahashi Koichi Azuma Jun Hayashi Kyushu University Liver Disease Study Group Department of General Medicine Kyushu University HospitalFukuokaJapan Department of Medicine Fukuoka City HospitalFukuokaJapan Department of Internal Medicine Nippon Steel Yawata Memorial HospitalKitakyushuJapan Department of Medicine Kitakyushu Municipal Medical CenterKitakyushuJapan Department of Medicine Yahata Saiseikai HospitalKitakyushuJapan Department of Gastroenterology National Hospital Organization Kyushu Medical CenterFukuokaJapan Department of Medicine and Bioregulatory Science Graduate School of Medical SciencesKyushu UniversityFukuokaJapan Department of Internal Medicine ShinKokura HospitalKitakyushuJapan Department of Clinical Research National Hospital OrganizationKokura HospitalKitakyushuJapan Department of Medicine and Biosystemic Science Graduate School of Medical SciencesKyushu UniversityFukuokaJapan Department of Medicine Hamanomachi HospitalFukuokaJapan Department of Medicine and Clinical Science Graduate School of Medical SciencesKyushu UniversityFukuokaJapan

AIM： To determine the efficacy of an interferon alpha and ribavirin combination treatment for Japanese patients infected with hepatitis C virus （HCV） of genotype 2, a multi-center study was retrospectively analyzed. METHODS： In total, 173 patients with HCV genotype 2 started to receive interferon-alpha subcutaneously thrice a week and 600-800 mg of ribavirin daily for 24 wk. RESULTS： The overall sustained virological response （SVR）, defined as undetectable HCV RNA in serum, 24 wk after the end of treatment, was remarkably high by 84.4%, （146/173） by an intention-to-treat analysis. A significant difference in SVR was found between patients with and without the discontinuation of ribavirin （46.9% vs 92.9 %）, but no difference was found between those with and without a dose reduction of ribavirin. A significant difference in SVR was also found between patients with less than 16 wk and patients with 16 or more weeks of ribavirin treatment （34.8 % vs 92.0 %）. CONCLUSION： The 24-wk interferon and ribavirin treatment is highly effective for Japanese patients with HCV genotype 2. The significant predictor of SVR is continuation of the ribavirin treatment for up to 16

关键词： Hepatitis C virus Interferon Ribavirin Genotype 2

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Relationship between body surface area and ALT normalization after long-term lamivudine treatment

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World Journal of Gastroenterology 2005年第44期11卷 6948-6953页

作者： Makoto Nakamuta Shusuke Morizono Yuichi Tanabe eiji kajiwara Junya Shimono Akihide Masumoto Toshihiro Maruyama Norihiro Furusyo Hideyuki Nomura Hironori Sakai Kazuhiro Takahashi Koichi Azuma Shinji Shimoda Kazuhiro Kotoh Munechika Enjoji Jun Hayashi Kyushu University liver Disease Study Group Department of Medicine and Bioregulatory Science Department of Medicine Department of Internal Medicine Department of Clinical Research Department of Environmental Medicine and Infectious Diseases Department of Gastroenterology Department of Medicine and Clinical Science Department of Medicine and Biosystemic Science

AIM： To further evaluate the relationship between BSA and the effects of lamivudine in a greater number of cases and over a longer period of observation than in our previous evaluation. METHODS： We evaluated 249 patients with chronic hepatitis B. The effects of treatment for one year （n = 249）, two years （n = 147）, and three years （n = 72） were evaluated from the levels of serum ALT and HBVoDNA, as biological and virological effects （undetectable levels by PCR）, respectively. Moreover, several variables that could influence the response to treatment, including ALT, albumin, bilirubin, platelet counts, BSA, HBVoDNA, and HBeAg were analyzed. RESULTS： For 1-year treatment, multivariate analysis revealed that BSA （P = 0.0002） was the only factor for the biological effect, and that ALT （P = 0.0017）, HBV- DNA （P = 0.0004）, and HBeAg （P = 0.0021） were independent factors for the virological effect. For 2-year treatment, multivariate analysis again showed that BSA （P = 0.0147） was the only factor for the biological effect, and that ALT （P = 0.0192） and HBeAg （P = 0.0428） were independent factors for the virological effect. For 3-year treatment, multivariate analysis, however, could not reveal BSA （P = 0.0730） as a factor for the normalization of ALT levels. CONCLUSION： BSA is a significant predictor for the normalizing the effect of lamivudine therapy on ALT for an initial 2-year period, suggesting that lamivudine dosage should be based on the individual BSA.

关键词： Lamivudine Hepatitis B virus Body surface area Dose Long-term treatment

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Real-world Effectiveness and Tolerability of Interferonfree Direct-acting Antiviral for 15,849 Patients with Chronic Hepatitis C:A Multinational Cohort Study

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Journal of Clinical and Translational Hepatology 2024年第7期12卷 646-658页

作者： Fanpu Ji Sally Tran Eiichi Ogawa Chung-Feng Huang Takanori Suzuki Yu Jun Wong Hidenori Toyoda Dae Won Jun Liu Li Haruki Uojima Akito Nozaki Makoto Chuma Cheng-Hao Tseng Yao-Chun Hsu Masatoshi Ishigami Takashi Honda Masanori Atsukawa Hiroaki Haga Masaru Enomoto Huy Trinh Carmen Monica Preda Phillip Vutien Charles Landis Dong Hyun Lee Tsunamasa Watanabe Hirokazu Takahashi Hiroshi Abe Akira Asai Yuichiro Eguchi Jie Li Xiaozhong Wang Jia Li Junping Liu Jing Liang Carla Pui-Mei Lam Rui Huang Qing Ye Hongying Pan Jiajie Zhang Dachuan Cai Qi Wang Daniel Q.Huang Grace Wong Vincent Wai-Sun Wong Junyi Li Son Do Norihiro Furusyo Makoto Nakamuta Hideyuki Nomura eiji kajiwara Eileen L.Yoon Sang Bong Ahn Koichi Azuma Kazufumi Dohmen Jihyun An Do Seon Song Hyun Chin Cho Akira Kawano Toshimasa Koyanagi Aritsune Ooho Takeaki Satoh Kazuhiro Takahashi Ming-Lun Yeh Pei-Chien Tsai Satoshi Yasuda Yunyu Zhao Yishan Liu Tomomi Okubo Norio Itokawa Mi Jung Jun Toru Ishikawa Koichi Takaguchi Tomonori Senoh Mingyuan Zhang Changqing Zhao Raluca Ioana Alecu Wei Xuan Tay Pooja Devan Joanne Kimiko Liu Ritsuzo Kozuka Elena Vargas-Accarino Ai-Thien Do Mayumi Maeda Wan-Long Chuang Jee-Fu Huang Chia-Yen Dai Ramsey Cheung Maria Buti Junqi Niu Wen Xie Hong Ren Seng Gee Lim Chao Wu Man-Fung Yuen Jia Shang Qiang Zhu Yoshiyuki Ueno Yasuhito Tanaka Jun Hayashi Ming-Lung Yu Mindie H.Nguyen Department of Infectious Diseases The Second Affiliated Hospital of Xi’an Jiaotong UniversityXi’anShaanxiChina Division of Gastroenterology and Hepatology Department of MedicineStanford University Medical CenterPalo AltoCAUSA Department of General Internal Medicine Kyushu University HospitalFukuokaJapan Hepatobiliary Division Department of Internal MedicineKaohsiung Medical University HospitalKaohsiung Hepatitis Research Center College of Medicine and Center for Liquid Biopsy and Cohort ResearchKaohsiung Medical UniversityKaohsiung Department of Gastroenterology and Metabolism Nagoya City University Graduate School of Medical SciencesNagoyaJapan Gastroenterology&Hepatology Changi General HospitalSinghealthSingapore Singhealth Duke-NUS Medicine Academic Clinical Program Singapore Department of Gastroenterology Ogaki Municipal HospitalOgakiJapan Department of Internal Medicine Hanyang UniversityCollege of MedicineSeoulKorea Hanyang Institute of Bioscience and Biotechnology Hanyang UniversitySeoulKorea Department of Hepatology The Third People's Hospital of Kunming CityKunmingYunnanChina Department of Gastroenterology Internal MedicineKitasato University School of MedicineSagamiharaJapan Gastroenterological Center Yokohama City University Medical CenterYokohamaJapan Division of Gastroenterology and Hepatology Department of Internal MedicineE-Da Cancer HospitalKaohsiung Department of Gastroenterology and Hepatology Nagoya University Graduate School of MedicineNagoyaJapan Division of Gastroenterology and Hepatology Nippon Medical SchoolTokyoJapan Department of Gastroenterology Yamagata University Faculty of MedicineYamagataJapan Department of Transfusion Medicine and Department of Hepatology Osaka Metropolitan University Graduate School of MedicineOsakaJapan San Jose Gastroenterology San JoseCAUSA Gastroenterology&Hepatology Department Clinic Fundeni InstituteBucharestRomania Division of Gastroenterology and Hepatology University of WashingtonSeattleWAUSA Department of

Background and Aims:As practice patterns and hepatitis C virus(HCV)genotypes(GT)vary geographically,a global real-world study from both East and West covering all GTs can help inform practice policy toward the 2030 HCV elimination *** study aimed to assess the effectiveness and tolerability of DAA treatment in routine clinical practice in a multinational cohort for patients infected with all HCV GTs,focusing on GT3 and ***:We analyzed the sustained virological response(SVR12)of 15,849 chronic hepatitis C patients from 39 Real-World Evidence from the Asia Liver Consortium for HCV clinical sites in Asia Pacific,North America,and Europe between 07/01/2014–07/01/***:The mean age was 62±13 years,with 49.6%*** demographic breakdown was 91.1%Asian(52.9%Japanese,25.7%Chinese/Taiwan residents,5.4%Korean,3.3%Malaysian,and 2.9%Vietnamese),6.4%White,1.3%Hispanic/Latino,and 1%Black/***,34.8%had cirrhosis,8.6%had hepatocellular carcinoma(HCC),and 24.9%were treatment-experienced(20.7%with interferon,4.3%with direct-acting antivirals).The largest group was GT1(10,246[64.6%]),followed by GT2(3,686[23.2%]),GT3(1,151[7.2%]),GT6(457[2.8%]),GT4(47[0.3%]),GT5(1[0.006%]),and untyped GTs(261[1.6%]).The overall SVR12 was 96.9%,with rates over 95%for GT1/2/3/6 but 91.5%for ***12 for GT3 was 95.1%overall,98.2%for GT3a,and 94.0%for ***12 was 98.3%overall for GT6,lower for patients with cirrhosis and treatment-experienced(TE)(93.8%)but≥97.5%for tretment-naive patients regardless of cirrhosis *** multivariable analysis,advanced age,prior treatment failure,cirrhosis,active HCC,and GT3/4 were independent predictors of lower SVR12,while being Asian was a significant predictor of achieving ***:In this diverse multinational realworld cohort of patients with various GTs,the overall cure rate was 96.9%,despite large numbers of patients with cirrhosis,HCC,TE,and GT3/***12 for GT3/6 with cirrhosis and TE was lower but st

关键词： Hepatitis C virus Liver cirrhosis Hepatocellular carcinoma Genotype DAA REAL-C

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