Sofosbuvir/velpatasvir plus ribavirin for Child-Pugh B and Child-Pugh C hepatitis C virus-related cirrhosis

Background/Aims@#Real-world studies assessing the effectiveness and safety of sofosbuvir/velpatasvir (SOF/VEL) plus ribavirin (RBV) for Child-Pugh B/C hepatitis C virus (HCV)-related cirrhosis are limited. @*Methods@#We included 107 patients with Child-Pugh B/C HCV-related cirrhosis receiving SOF/VEL plus RBV for 12 weeks in Taiwan. The sustained virologic response rates at off-treatment week 12 (SVR12) for the evaluable population (EP), modified EP, and per-protocol population (PP) were assessed. Thesafety profiles were reported. @*Results@#The SVR12 rates in the EP, modified EP and PP were 89.7% (95% confidence interval [CI], 82.5–94.2%), 94.1% (95% CI, 87.8–97.3%), and 100% (95% CI, 96.2–100%). Number of patients who failed to achieve SVR12 were attributed to virologic failures. The SVR12 rates were comparable regardless of patient characteristics. One patient discontinued treatment because of adverse events (AEs). Twenty-four patients had serious AEs and six died, but none were related to SOF/VEL or RBV. Among the 96 patients achieving SVR12, 84.4% and 64.6% had improved Child-Pugh and model for endstage liver disease (MELD) scores. Multivariate analysis revealed that a baseline MELD score ≥15 was associated with an improved MELD score of ≥3 (odds ratio, 4.13; 95% CI, 1.16–14.71; P=0.02). Patients with chronic kidney disease (CKD) stage 1 had more significant estimated glomerular filtration rate declines than patients with CKD stage 2 (-0.42 mL/min/1.73 m2/month; P=0.01) or stage 3 (-0.56 mL/min/1.73 m2/month; P<0.001). @*Conclusions@#SOF/VEL plus RBV for 12 weeks is efficacious and well-tolerated for Child-Pugh B/C HCV-related cirrhosis.

Sofosbuvir/velpatasvir plus ribavirin for Child-Pugh B and Child-Pugh C hepatitis C virus-related cirrhosis

Background/Aims@#Real-world studies assessing the effectiveness and safety of sofosbuvir/velpatasvir (SOF/VEL) plus ribavirin (RBV) for Child-Pugh B/C hepatitis C virus (HCV)-related cirrhosis are limited. @*Methods@#We included 107 patients with Child-Pugh B/C HCV-related cirrhosis receiving SOF/VEL plus RBV for 12 weeks in Taiwan. The sustained virologic response rates at off-treatment week 12 (SVR12) for the evaluable population (EP), modified EP, and per-protocol population (PP) were assessed. Thesafety profiles were reported. @*Results@#The SVR12 rates in the EP, modified EP and PP were 89.7% (95% confidence interval [CI], 82.5–94.2%), 94.1% (95% CI, 87.8–97.3%), and 100% (95% CI, 96.2–100%). Number of patients who failed to achieve SVR12 were attributed to virologic failures. The SVR12 rates were comparable regardless of patient characteristics. One patient discontinued treatment because of adverse events (AEs). Twenty-four patients had serious AEs and six died, but none were related to SOF/VEL or RBV. Among the 96 patients achieving SVR12, 84.4% and 64.6% had improved Child-Pugh and model for endstage liver disease (MELD) scores. Multivariate analysis revealed that a baseline MELD score ≥15 was associated with an improved MELD score of ≥3 (odds ratio, 4.13; 95% CI, 1.16–14.71; P=0.02). Patients with chronic kidney disease (CKD) stage 1 had more significant estimated glomerular filtration rate declines than patients with CKD stage 2 (-0.42 mL/min/1.73 m2/month; P=0.01) or stage 3 (-0.56 mL/min/1.73 m2/month; P<0.001). @*Conclusions@#SOF/VEL plus RBV for 12 weeks is efficacious and well-tolerated for Child-Pugh B/C HCV-related cirrhosis.

The Effect of the First Spontaneous Bacterial Peritonitis Event on the Mortality of Cirrhotic Patients with Ascites: A Nationwide Population-Based Study in Taiwan

BACKGROUND/AIMS: Spontaneous bacterial peritonitis (SBP) contributes to poorer short-term mortality in cirrhotic patients with ascites. However, it is unknown how long the effect of the first SBP event persists in these patients. METHODS: The National Health Insurance Database, derived from the Taiwan National Health Insurance Program, was used to identify and enroll 7,892 cirrhotic patients with ascites who were hospitalized between January 1 and December 31, 2007. All patients were free from episodes of SBP from 1996 to 2006. RESULTS: The study included 1,176 patients with SBP. The overall 30-day, 90-day, 1-year, and 3-year mortality rates in this group were 21.8%, 38.9%, 57.5%, and 73.4%, respectively. The overall 30-day, 90-day, 1-year, and 3-year mortality rates in the non-SBP group were 15.7%, 32.5%, 53.3%, and 72.5%, respectively. After adjusting for gender, age, and other medical comorbidities, the adjusted hazard ratios of SBP for 30-day, 30- to 90-day, 90-day to 1-year, and 1- to 3-year mortality were 1.49 (95% confidence interval [CI], 1.30 to 1.71), 1.19 (95% CI, 1.02 to 1.38), 1.04 (95% CI, 0.90 to 1.20), and 0.90 (95% CI, 0.77 to 1.05), respectively, compared with the non-SBP group. CONCLUSIONS: The effect of SBP on the mortality of cirrhotic patients with ascites disappeared in those surviving more than 90 days after the first SBP event.

The effect of bacterial infections in cirrhotic patients with esophageal variceal bleeding.

BACKGROUND: Cirrhotic patients are prone to having bacterial infections due to impaired innate immunity. This nationwide population-based study aimed to identify the effect of bacterial infections on the mortality of the cirrhotic patients with esophageal variceal bleeding (EVB). MATERIAL AND METHODS: The Taiwan National Health Insurance Database was used to collect data about the cirrhotic patients receiving endoscopic procedures for EVB between January 1, 2004 and December 31, 2004. The enrolled patients were followed up individually for one year to identify their 6-week and 1-year mortalities. RESULTS: Of the 2,053 cirrhotic patients with EVB, 318 (15.5 %) were diagnosed with bacterial infections. Compared to non-infection group, the adjusted hazard rations (HRs) of bacterial infection for 6-week and 1-year mortalities were 2.69 (2.06-3.52) and 1.89 (1.56-2.28), respectively. Compared to non-infection group, the HRs of pneumonia, spontaneous bacterial peritonitis, urinary tract infection, and sepsis without specific focus (SWSF) were 3.54, 1.91, 1.04, and 3.95 for 6-week mortality, and 3.18, 1.52, 1.15, and 2.23 for 1-year mortality of cirrhotic patients with EVB. CONCLUSIONS: In cirrhotic patients with EVB, bacterial infections increase 2.7 folds of 6-week mortality and 1.9 folds of 1-year mortality. Of all infections, pneumonia and SWSF contributed higher risks for mortality.

High frequency of unusual gastric/duodenal ulcers in patients with Behçet's disease in Taiwan: a possible correlation of MHC molecules with the development of gastric/duodenal ulcers.

The gastrointestinal (GI) involvement of Behçet's disease (BD) mainly affects the ileocecal region and colon. The gastroduodenal mucosa appears to be the least frequently involved segment of the gastrointestinal tract. The objective of this study was to assess the severity of gastric/duodenal involvement in BD patients in Taiwan. Behçet's disease was diagnosed according to the diagnostic criteria issued by the International Study Group for Behçet's Disease. We obtained and recorded clinical and laboratory data. A routine endoscopic examination with a urease test for Helicobacter pylori infection was arranged. Furthermore, HLA tissue typing was also performed by polymerase chain reaction with sequence-specific primers to evaluate the possible genetic loads associated with ulcer development. A total 28 BD patients, diagnosed at DaLin TzuChi hospital from 1999 to 2002, were enrolled in this study. The prevalence rate of gastric/duodenal ulceration was 43% (six patients had combined gastric and duodenal ulcers, three patients had simple gastric ulcers, and three patients had simple duodenal ulcers). No risk factors of nonsteroidal anti-inflammatory drug (NSAID) or H. pylori infection were found to be associated with gastrointestinal ulcers in our BD patients. All patients with peptic ulcers responded well to systemic steroids and immunosuppressant treatment in this preliminary observation. Furthermore, 7 of 12 gastric/duodenal ulcer patients (58%) carried an A2/B46/Cw1 or A11/B46/Cw1 genotype. Our data indicated that gastric/duodenal ulcers were a common manifestation in Chinese patients with BD in Taiwan in close association with the distinct genotypes of A2/B46/Cw1 or A11/B46/Cw1. A good response to systemic steroids, rather than conventional H2 blockers, might be due to downregulation of the vasculitis.