Volume 73 - 2010 - Fasc.1 - Original articles
Effectiveness and tolerability of pegylated interferon alfa-2b in combination with ribavirin for treatment of chronic hepatitis C : the PegIntrust Study
Background and study aims : Large international clinical trials conducted in the past 5 years rapidly improved the treatment of chronic hepatitis C; however, it is unclear whether the advances seen in clinical trials are being paralleled by similar improvements in routine clinical practice. PegIntrust is a Belgian community- based trial evaluating the sustained virological response.
Patients and Methods : Observational study of 219 patients receiving pegylated interferon alfa-2b (1.5 µg/kg/wk) and weight- based ribavirin (800-1200 mg/day) for 48 weeks. Primary study end point was sustained virological response (SVR), defined as unde- tectable HCV RNA 6 months after the completion of treatment.
Results : In total, 108 patients (49.3 %) had undetectable HCV RNA at the end of therapy, 91 (41.6%) attaining SVR. Of the 111 patients without an end-of-treatment response, 28 were non-responders, and 21 had virological breakthrough. In total, 134 patients attained early virological response (EVR); 88 (65.7%) of those patients attained SVR. In contrast, 82 (96.5 %) of the 85 patients who did not attain EVR also did not attain SVR. Age, fibrosis score and baseline viral load were identified as important predictors of treatment outcome. The most frequently reported serious adverse events resulting in treatment discontinuation were anemia (n = 10), fatigue/asthenia/malaise (n = 6) and fever (n = 3).
Conclusion : Our data indicate that treatment of chronic hepa- titis C with PEG-IFN alfa-2b plus weight-based ribavirin results in favourable treatment outcomes in a Belgian cohort of patients treated in community-based clinical practice. (Acta gastroenterol. belg., 2010, 73, 5-11).
Elevated serum uric acid is an independent risk factor for nonalcoholic fatty liver disease in Japanese undergoing a health checkup
Background and study aims : The question of whether elevated serum uric acid is an independent risk factor for nonalcoholic fatty liver disease evident on ultrasonography was investigated by longi- tudinal approach in Japanese undergoing a health checkup.
Patients and methods : A total of 1,386 male and 3,453 female nondrinkers participating in health checkups in both 2000 and 2005 were included. Multiple logistic regression analyses were per- formed for 1,042 men (51.4 ± 11.2 years old) and 3,076 women (51.8 ± 9.2 years old) to identify independent factors for newly developed nonalcoholic fatty liver disease in 2005. Adjustment was made for age, body mass index, body mass index increase for 5 years, systolic blood pressure, triglyceridemia, fasting blood glu- cose, and smoking.
Results: The prevalence of nonalcoholic fatty liver disease and body mass index, systolic blood pressure, and triglyceride were sig- nificantly higher in the participants with elevated serum uric acid, with a significant increasing trend in relation to serum uric acid quartiles. Nonalcoholic fatty liver disease was newly diagnosed in 17.4% of males and 8.2% of females, respectively, in 2005. Serum uric acid adjusted for other factors was a risk factor for nonalco- holic fatty liver disease in both sexes and quartiles 3 and 4 had sig- nificantly elevated risks. The odds ratio and 95% confidence inter- val for one increment of serum uric acid were 1.31 and 1.11-1.56 in men and 1.30 and 1.10-1.53 in women, respectively.
Conclusions : Elevated serum uric acid is an independent risk factor for nonalcoholic fatty liver disease in Japanese undergoing a health checkup. (Acta gastroenterol. belg., 2010, 73, 12-17).
The first prospective endoscopic experience with the ePTFE-covered Viabil stent in patients with a distal malignant biliary stenosis
Background and study aims. Endoscopic insertion of a biliary stent is standard practice in the palliative treatment of malignant biliary obstructions. Experience with the new ePTFE-covered Viabil stent is mainly limited to the percutaneous approach. We report our experience with its endoscopic application in patients with distal malignant biliary obstructions.
Patients and methods. Eleven patients with an inoperable tumour, without apparent metastatic disease, and with an ECOG score of 0 to 1, were included. All patients received an ePTFE-cov- ered Viabil stent of 10 mm diameter, with transmural side-holes. Primary endpoints were stent patency and patient survival.
Results. Overall median patient survival was 220 days; 10 patients died free of jaundice from non-stent related causes. Due to malfunction of the prototype stents at insertion, the introduction of 2 Viabils was required in 3 patients to acquire complete bile duct drainage. Thus, a total of 14 stents was needed in 11 patients. Stent dysfunction occurred in 3/11 patients. It always resulted from mas- sive stone impaction needing stone removal with additional stent- ing in two out of 3 patients. Stent patency was 80% at 3 and 6 months, and 63% at 9 and 12 months. Lifetime palliation was 73%.
Although the biliary Viabil device has been developed to mini- mize bacterial adherence and sludge formation, stent dysfunctions in this series always resulted from stone impaction. Moreover, mal- function of the prototype stents needed the insertion of a second stent in 3 patients. Overall life time palliation was 73%. Further experience with newer versions of the device as well as comparative studies versus other metallic stents are needed. (Acta gastroenterol. belg., 2010, 73, 18-24).