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Hideyuki Tamai,Naoki Shingaki,Yoshiyuki Mori,Kosaku Moribata,Akira Kawashima,Yoshimasa Maeda,Toru Niwa,Hisanobu Deguchi,Izumi Inoue,Takao Maekita,Mikitaka Iguchi,Jun Kato,Masao Ichinose 거트앤리버 소화기연관학회협의회 2016 Gut and Liver Vol.10 No.4
Background/Aims: This study aimed to predict sustained viral response (SVR) to low-dose pegylated interferon (PEGIFN) plus ribavirin of elderly and/or cirrhotic patients with genotype 2 hepatitis C virus (HCV) using viral response within 2 weeks. Methods: Low-dose PEG-IFN-α-2b plus ribavirin was administered to 50 elderly and/or cirrhotic patients with genotype 2 HCV for 24 weeks. The dynamics of HCV RNA and HCV core antigen levels within 2 weeks were measured. Results: The patients’ median age was 66 years. There were 21 male and 29 female patients. The median baseline HCV RNA level was 5.7 log IU/mL. Rapid viral response was achieved in 17 patients (34%), SVR in 28 (56%), and two (4%) discontinued treatment. Univariate analysis of factors contributing to SVR showed significant differences for sex, baseline virus level, and response within 4 weeks. When 40 fmol/L was set as the cutoff value for the core antigen level at 1 week, the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy for predicting SVR were 93%, 75%, 84%, 88%, and 85%, respectively. Conclusions: Low-dose PEG-IFN plus ribavirin was a safe and costeffective treatment for elderly and/or cirrhotic patients with genotype 2 HCV, and the viral response within 2 weeks was a useful predictor of SVR.
( Hideyuki Tamai ),( Yoshiyuki Ida ),( Akira Kawashima ),( Naoki Shingaki ),( Ryo Shimizu ),( Kosaku Moribata ),( Tetsushi Nasu ),( Takao Maekita ),( Mikitaka Iguchi ),( Jun Kato ),( Taisei Nakao ),( 대한간학회 2017 Gut and Liver Vol.11 No.4
Background/Aims: The present study aimed to evaluate the safety and efficacy of simeprevir-based triple therapy with reduced doses of pegylated interferon (PEG-IFN) and ribavirin for interferon (IFN) ineligible patients, such as elderly and/or cirrhotic patients, and to elucidate the factors contributing to a sustained virologic response (SVR). Methods: One hundred IFN ineligible patients infected with genotype 1b hepatitis C virus (HCV) were treated. Simeprevir (100 mg) was given orally together with reduced doses of PEG-IFN-α 2a (90 μg), and ribavirin (200 mg less than the recommended dose). Results: The patients` median age was 70 years, and 70 patients were cirrhotic. Three patients (3%) discontinued treatment due to adverse events. The SVR rate was 64%. Factors that significantly contributed to the SVR included the γ-glutamyl transferase and α-fetoprotein levels, interleukin- 28B (IL28B) polymorphism status, and the level and reduction of HCV RNA at weeks 2 and 4. The multivariate analysis showed that the IL28B polymorphism status was the only independent factor that predicted the SVR, with a positive predictive value of 77%. Conclusions: Simeprevir-based triple therapy with reduced doses of PEG-IFN and ribavirin was safe and effective for IFN ineligible patients infected with genotype 1b HCV. IL28B polymorphism status was a useful predictor of the SVR. (Gut Liver 2017;11:551-558)
( Yuki Wada ),( Hideyuki Tamai ),( Akira Kawashima ),( Naoki Shingaki ),( Yoshiyuki Mori ),( Masanori Kawaguchi ),( Kosaku Moribata ),( Hisanobu Deguchi ),( Kazuki Ueda ),( Izumi Inoue ),( Takao Maeki 대한소화기학회 2014 Gut and Liver Vol.8 No.4
Background/Aims: The present study aimed to clarify whether virological response within 2 weeks after therapy initiation can predict a null response to pegylated interferon α-2b plus ribavirin therapy in patients with high viral load genotype 1b hepatitis C. Methods: The participants consisted of 72 patients with high viral load genotype 1b. The dynamics of viral load within 2 weeks were measured. Results: Significant differences between null responders and nonnull responders were noted for interleukin (IL)-28B genotype, amino acid 70 substitution, α-fetoprotein, low-density lipoprotein cholesterol, hyaluronic acid, and viral response. The area under the curve (AUC) for the receiver operating characteristic curve of the hepatitis C virus (HCV) RNA level decline at 2 weeks (AUC=0.993) was the highest among the factors predicting the null response. When the cutoff value for the HCV RNA level decline at 2 weeks was set at 0.80 log, the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy in predicting a null response were 82%, 96%, 82%, 96%, and 94%, respectively. In comparison, values for the non-TT and mutant type of amino acid 70 substitution were similar to those for HCV RNA level decline at 2 weeks. Conclusions: Virological response at 2 weeks or the combination of IL-28B and amino acid 70 substitution are accurate predictors of a null response. (Gut Liver 2014;8:421-427)
The Real-World Safety and Efficacy of Daclatasvir and Asunaprevir for Elderly Patients
( Shinya Taki ),( Hideyuki Tamai ),( Yoshiyuki Ida ),( Naoki Shingaki ),( Akira Kawashima ),( Ryo Shimizu ),( Kosaku Moribata ),( Takao Maekita ),( Mikitaka Iguchi ),( Jun Kato ),( Taisei Nakao ),( Ma 대한간학회 2018 Gut and Liver Vol.12 No.1
Background/Aims: Although daclatasvir with asunaprevir was approved in Japan for interferon ineligible or intolerant patients, patients aged ≥75 years were excluded in the phase III trial. The present study aimed to evaluate the safety and efficacy of this therapy for elderly patients aged ≥75 years and to clarify whether an extremely high sustained virological response (SVR) rate can be achieved, even in a real-world setting when patients with resistance-associated substitutions (RASs) to nonstructural protein 5A (NS5A) inhibitors or prior simeprevir failure are excluded. Methods: Daclatasvir (60 mg) and asunaprevir (100 mg) were orally administered daily for 24 weeks. Patients without pre-existing NS5A RASs and simeprevir failure were enrolled in this study. Results: Overall, 110 patients were treated. The median age was 73 years old. The SVR rates of total patients, those aged ≥75 years, and those aged <75 years were 97% (107/110), 98% (46/47), and 97% (61/63), respectively. The treatment of two patients (2%) was discontinued because of adverse events. Conclusions: Daclatasvir with asunaprevir was a safe treatment, even in patients aged ≥75 years. When patients without pre-existing NS5A RASs and prior simeprevir failure were selected, an extremely high SVR rate could be achieved irrespective of age. (Gut Liver 2018;12:86-93)