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.
Aged ; Genotype* ; Hepacivirus* ; Hepatitis C* ; Hepatitis* ; Humans ; Interferons* ; Multivariate Analysis ; Ribavirin* ; RNA ; Simeprevir ; Transferases

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.
Aged ; Hepacivirus ; Humans ; Interferons ; Japan ; Simeprevir

Background/Aims: Rosemont classification (RC) with en-doscopic ultrasonography (EUS) is important for diagnosing chronic pancreatitis (CP) but is based only on subjective judgement. EUS shear wave measurement (EUS-SWM) is a precise modality based on objective judgment, but its usefulness has not been extensively studied yet. This study evaluated the utility of EUS-SWM for diagnosing CP and esti-mating CP severity by determining the presence of endocrine dysfunction along with diabetes mellitus (DM). Methods: Between June 2018 and December 2018, 52 patients who underwent EUS and EUS-SWM were classified into two groups according to RC: non-CP (indeterminate CP and normal) and CP (consistent and suggestive of CP). The EUSSWM value by shear wave velocity was evaluated with a me-dian value. The EUS-SWM value was compared with RC and the number of EUS features. The diagnostic accuracy and cutoff value of EUS-SWM for CP and DM and its sensitivity and specificity were calculated. Results: The EUS-SWM value significantly positively correlated with the RC and the number of EUS features. The EUS-SWM values that were consistent and suggestive of CP were significantly higher than that of normal. The area under the receiver operating characteristic (AUROC) curve for the diagnostic accuracy of EUS-SWM for CP was 0.97. The cutoff value of 2.19 had 100% sensitivity and 94% specificity. For endocrine dysfunction in CP, the AUROC was 0.75. The cutoff value of 2.78 had 70% sensitiv-ity and 56% specificity. Conclusions EUS-SWM provides an objective assessment and can be an alternative diagnostic tool for diagnosing CP. EUS-SWM may also be useful for pre-dicting the presence of endocrine dysfunction.

Training system of palliative care in Japan has not been fully established, and young physicians’ needs for palliative care training are not nearly satisfied. We have recently conducted a nationwide survey to clarify unmet learning needs among Japanese physicians in specialty training in palliative care and the potential solutions they favored to meet those needs. Here we report findings of content analyses of free comments in the survey. Of 284 physicians, 253 (89%) responded, and 229 were eligible after we had excluded resident physicians with less than 2 years of clinical experience and board-certified palliative care physicians. The content analyses from 80 physicians (35%) identified 162 codes with respect to needs for improvement which were further classified into 24 subcategories and 9 categories (e.g., contents of subspecialty training, certified facilities, research capabilities, learning environment and methods, system of board certification, and networking). These findings may help improve specialty training in palliative care in Japan.

Objectives: To explore background factors contributing to learning needs among physicians in palliative care specialty training. Methods: We conducted a questionnaire survey of physicians in specialty training in palliative care who were within 15 years after medical school graduation. The unmet learning needs (referred to as “needs”) were evaluated on a 5-point scale. Factor analysis was performed to identify underlying subscales of needs. Univariate analysis was performed using an average score of each subscale as a dependent variable and background factors as independent variables. Results: Of 284 physicians, 253 (89%) responded, and 229 were eligible after we had excluded resident physicians with less than 2 years of clinical experience and board-certified palliative care physicians. Factor analysis identified six subscales of the unmet learning needs: research, time, specialist, network, quality, and comprehensiveness. Background factors with significant between-group differences with the effect size of 0.4 or more included: 1) not working at a certified training facility, 2) not working or training at a big hospital, and 3) the number of palliative care physicians being 2 or less in the facility. Conclusion: Improvement of the training system is urgently needed for young physicians who are working at small or non-certified facilities for specialty training, or who have few palliative care colleagues.