Real-world efficacy and safety of 12-week sofosbuvir/velpatasvir treatment for patients with decompensated liver cirrhosis caused by hepatitis C virus infection.

AIM: This study aimed to evaluate the real-world efficacy and safety of 12-week sofosbuvir/velpatasvir (SOF/VEL) treatment for patients with decompensated liver cirrhosis caused by hepatitis C virus (HCV) infection. METHODS: A total 72 of patients with Child-Pugh (CP) class B or C were enrolled. We evaluated the sustained virologic response at 12 weeks after the end of treatment (SVR12), adverse events (AEs), and changes in the liver function. RESULTS: All participants had genotype 1 or 2 HCV infection. At baseline, the numbers of patients with CP class B and C were 59 and 13, respectively. The overall SVR12 rate was 95.8% (69/72); 94.9% (56/59) in CP class B and 100% (13/13) in CP class C. The serum albumin level, prothrombin time and ascites were significantly improved (P < 0.01); however, the serum bilirubin level and encephalopathy did not improve. Among patients who achieved SVR12, 75.0% showed an improvement in their CP score, while 5.9% showed a worsening. The presence of large portosystemic shunt (diameter ≥6 mm) and hyperbilirubinemia (≥2.0 mg/dL) were independent factors that interfered with the improvement in the CP score (P < 0.05). The most common AEs were encephalopathy (15.3%) and skin symptoms (7.9%). Two patients discontinued SOF/VEL due to AEs. CONCLUSIONS: Treatment with SOF/VEL for 12 weeks was relatively safe and effective for patients with decompensated cirrhosis. An SVR provided an improvement of the liver function in the majority of patients. However, large portosystemic shunt and hyperbilirubinemia were independent factors that interfered with the improvement in the CP score.

Efficacy and safety of glecaprevir and pibrentasvir combination therapy in old-aged patients with chronic hepatitis C virus infection.

Objective: Combination therapy with glecaprevir and pibrentasvir (G/P) has been shown to provide a sustained virologic response (SVR) rate of >97% in patients with chronic hepatitis C virus (HCV) infection in the first published real-world Japanese data. However, a recently published study showed that the treatment was often discontinued in patients ≥75 years old, resulting in low SVR in intention-to-treat (ITT) analysis. Thus, our aim was to evaluate real-world data for G/P therapy in patients ≥75 years of age, the population density of which is high in "rural" regions. Patients and Methods: We conducted a multicenter study to assess the efficacy and safety of G/P therapy for chronic HCV infection, in the North Kanto area in Japan. Results: Of the 308 patients enrolled, 294 (95.5%) completed the treatment according to the protocol. In ITT and per-protocol analyses, the overall SVR12 rate was 97.1% and 99.7%, respectively. The old-aged patients group consisted of 59 participants, 56 of whom (94.9%) completed the scheduled protocol. Although old-aged patients tended to have non-SVR factors such as liver cirrhosis, history of HCC, and prior DAA therapies, the SVR12 rates in old-aged patients were 98.3% and 100% in the ITT and PP analyses, respectively. Of 308 patients enrolled, adverse events were observed in 74 patients (24.0%), with grade ≥3 events in 8 patients (2.6%). There was no significant difference in any grade and grade ≥3 adverse events between the old-aged group and the rest of the study participants. Only one patient discontinued the treatment because of adverse events. Conclusion: G/P therapy is effective and safe for old-aged patients.

No Regional Disparities in Sofosbuvir Plus Ribavirin Therapy for HCV Genotype 2 Infection in Tochigi Prefecture and Its Vicinity.

Objective Regional disparities were observed in the outcomes of interferon (IFN)-based therapy for chronic hepatitis C virus (HCV) infection in a Japanese nationwide study. However, whether or not these regional disparities are observed in the outcomes of direct-acting antiviral drugs, including sofosbuvir (SOF) plus ribavirin (RBV) therapy, remains unclear. Methods We conducted a multicenter study to assess the efficacy of SOF plus RBV therapy for HCV genotype 2 infection in Tochigi Prefecture and its vicinity, in which IFN-based therapy yielded a low sustained virologic response (SVR) rate. In addition, we divided Tochigi Prefecture into six regions to examine regional disparities in the SVR. Patients We enrolled patients with chronic HCV genotype 2 infection. Results Of the 583 patients enrolled, 569 (97.6%) completed the treatment, and 566 (97.1%) also complied with post-treatment follow-up for 12 weeks. The overall SVR12 rate was 96.1% by per protocol and 93.7% by intention-to-treat analyses. No marked differences were observed in the SVR12 between subjects ≥65 and <65 years of age. Although large gaps were observed in the characteristics of patients and accessibility to medical resources, there was no significant difference in the SVR12 rate among the six regions in Tochigi Prefecture. Conclusion SOF plus RBV therapy was effective for HCV genotype 2 infection in an area where IFN-based therapy had previously shown unsatisfactory results. In addition, no regional disparities in the SVR12 were observed in Tochigi Prefecture.

Risk factors for recurrent bile duct stones after endoscopic papillary balloon dilation: long-term follow-up study.

BACKGROUND: Little is known about the long-term results of endoscopic papillary balloon dilation (EPBD) for bile duct stones. METHODS: Between 1995 and 2000, 204 patients with bile duct stones successfully underwent EPBD and stone removal. Complete stone clearance was confirmed using balloon cholangiography and intraductal ultrasonography (IDUS). Long-term outcomes of EPBD were investigated retrospectively in the year 2007, and risk factors for stone recurrence were multivariately analyzed. RESULTS: Long-term information was available in 182 cases (89.2%), with a mean overall follow-up duration of 9.3 years. Late biliary complications occurred in 22 patients (12.1%), stone recurrence in 13 (7.1%), cholangitis in 10 (5.5%), cholecystitis in four, and gallstone pancreatitis in one. In 11 of 13 patients (84.6%), stone recurrence developed within 3 years after EPBD. All recurrent stones were bilirubinate. Multivariate analysis identified three risk factors for stone recurrence: dilated bile duct (>15 mm), previous cholecystectomy, and no confirmation of clean duct using IDUS. CONCLUSION: Approximately 7% of patients develop stone recurrence after EPBD; however, retreatment with endoscopic retrograde cholangiopancreatography is effective. Careful follow up is necessary in patients with dilated bile duct or previous cholecystectomy. IDUS is useful for reducing stone recurrence after EPBD.

[Ultrasonography with liquid type CalorieMate for gallbladder motility].

We usually use yolks to assess gallbladder motility by ultrasonography. In this study, we evaluated liquid type CalorieMate as a simple oral stimulus instead of yolks. The volunteers (n = 27) underwent ultrasonography before, 30 min after, and 60 min after taking liquid type CalorieMate. Gallbladder volume and the ejection fraction were measured by ellipsoid method. The mean fasting gallbladder volume, 30-min ejection fraction, and 60-min one were 13.5 ml, 53%, and 62%, respectively. These results were similar to the previous reports by yolks. If the fasting volume is lower than 4ml, they should take re-examination after longer fast to reduce the influence of the dinner the day before the exam. In conclusion, liquid type CalorieMate is useful stimulus to assess gallbladder motility.