Durability of the response to peginterferon-α2b and ribavirin in patients with chronic hepatitis C: a cohort study in the routine clinical setting.

OBJECTIVES: To evaluate whether, in chronic hepatitis C-positive naive patients recruited in the routine clinical setting and treated with pegylated-interferon-α2b (Peg-IFN) and ribavirin (RBV), the sustained virologic response (SVR) is durable over the long term and whether it is associated with a decrease in liver complications and incidence of glucose abnormalities. PATIENTS AND METHODS: This was a prospective long-term follow-up study of 182 naive patients enrolled in 2001-2002 and treated with Peg-IFN and RBV and followed up to December 2010, with clinical, biochemical, and virological evaluations every 6-12 months. RESULTS: None of the 115 (63.2%) sustained responders showed late viremic relapse during the follow-up. SVR was better defined at 24 weeks (16/16 relapsers, 100%) than at 12 weeks after the end of therapy (14/16 relapsers, 87.5%). On multivariable analysis, viral genotype (odds ratio 0.16, 95% confidence interval 0.07-0.36, P=0.0001) and a greater than 20% RBV reduction (odds ratio 5.21, 95% confidence interval 1.54-17.67, P=0.008) predicted long-term response (LTR) independently. The incidence of cirrhosis was significantly higher among nonresponders (21.3%) compared with long-term responders (0.9%, P≤0.0001), but the risk of developing glucose abnormalities was not significantly reduced in long-term responders (hazard ratio 1.36, P=0.363). Hepatocellular carcinoma occurred only in three cases. CONCLUSION: SVR achieved in patients treated in the routine clinical setting with Peg-IFN and RBV is durable over the long term and LTR significantly reduces the risk of progression to cirrhosis; however, in a population with mild liver fibrosis, the clinical impact of LTR on the risk of glucose abnormalities seems negligible.

Type 2 diabetes mellitus and chronic hepatitis C: which is worse? Results of a long-term retrospective cohort study.

BACKGROUND: The long-term outcome in patients with chronic hepatitis C and type 2 diabetes mellitus treated with interferon and ribavirin is unclear. We compared incidence of liver-related events and mortality rates between hepatitis C virus-positive patients with or without diabetes mellitus, and the incidence of diabetes-related events between diabetic patients with and without hepatitis C. METHODS: Retrospective study of 309 patients with chronic hepatitis C. Incidence of liver-related events, diabetes-related events and mortality rates were assessed over a mean follow-up of 11.02±4.9 years. RESULTS: 50 (16%) chronic hepatitis C patients had diabetes mellitus. Diabetics showed a higher number of diabetes- and liver-related events than non-diabetics (10% vs 1.5%, p=0.006; 18% vs 5.7%, p=0.007, respectively) with a mortality of 14% vs 1.5% (p=0.0003). Baseline cirrhosis (p=0.002) and non-sustained virological response (p=0.01) were independent risk factors for liver events; diabetes mellitus (p=0.01) and hypertension (p=0.0017) were independent factors for diabetes-related events. CONCLUSIONS: In patients with chronic hepatitis C, comorbidity with diabetes mellitus was associated with a higher mortality rate and incidence of liver/diabetes-related events. Independent risk factors for liver-related events were the non-response to antiviral therapy and cirrhosis at baseline.

Safety of propofol in cirrhotic patients undergoing colonoscopy and endoscopic retrograde cholangiography: results of a prospective controlled study.

BACKGROUND AND AIMS: Safety of propofol sedation in patients with liver cirrhosis undergoing colonoscopy or endoscopic retrograde cholangiopancreatography (ERCP) remains to be studied. The aim of this study was to investigate whether the use of propofol is safe for endoscopic procedures more complex than gastroscopy in patients with liver cirrhosis in a prospective controlled study. METHODS: Two hundred and fourteen consecutive patients, with or without cirrhosis, who underwent colonoscopy or ERCP with propofol sedation were recruited between January and June 2009. Administration of sedation was performed by anesthesiologists and outcome measures were recorded. Main outcomes were complication rates and recovery times. RESULTS: Sixty-one (28.5%) cirrhotic patients and 153 (71.5%) noncirrhotic patients were included. The incidence of sedation-related complications did not significantly differ between the two populations (11.5 vs. 17.0%, respectively, P=0.31). The mean (±SD) dose of propofol administered (213±86 vs. 239±100 mg, P=0.07), the mean time to achieve adequate sedation (3.3±1.1 vs. 3.0±1.2 min, P=0.21), the mean total duration of the endoscopic procedure (24.5±10.6 vs. 27.4±11.8 min, P=0.08), the mean time to reach Observer's Assessment of Alertness and Sedation Scale 5 (17.2±4.4 vs. 18.4±5.6 min, P=0.15), the mean time from completion of the procedure to release (9.0±2.5 vs. 9.1±3.2 min, P=0.86), and the mean time to full recovery (42.2±7.3 vs. 42.3±7.8 min, P=0.88) were very similar between the two groups. The limitation of this study was lack of randomization, and a control group of cirrhotic patients using standard sedation with benzodiazepines and opioids. CONCLUSION: Propofol deep sedation administered by an anesthesiologist with appropriate monitorings seems to be a safe procedure during colonoscopy or ERCP in cirrhotic patients.