Angelo Iacobellis

Meta-analysis: the outcome of anti-viral therapy in HCV genotype 2 and genotype 3 infected patients with chronic hepatitis.

Background  Anti‐viral therapy seems more successful in HCV genotype 2 than genotype 3‐infected patients.

External Validation of Biochemical Indices for Noninvasive Evaluation of Liver Fibrosis in HCV Chronic Hepatitis

External Validation of Biochemical Indices for Noninvasive Evaluation of Liver Fibrosis in HCV Chronic Hepatitis

Long-Term Outcome After Antiviral Therapy of Patients With Hepatitis C Virus Infection and Decompensated Cirrhosis

BACKGROUND & AIMS We evaluated the long-term outcomes after antiviral therapy of patients with decompensated cirrhosis and hepatitis C virus (HCV) infection. METHODS Seventy-five patients with HCV infection and decompensated cirrhosis received therapy with peginterferon alfa-2b and ribavirin. We compared adverse-event profiles and mortality rates between patients with or without sustained virologic responses (SVRs). The mean follow-up time off therapy was 51 ± 18 months (range, 3-78 months). RESULTS Seven patients with HCV genotypes 1 or 4 (16%) and 17 patients with genotypes 2 or 3 (55%) achieved SVRs. The mean survival times were 53 months among patients who did not achieve SVRs (95% confidence interval [CI], 48-59 months) and 73 months among those who did achieve SVRs (95% CI, 67-80 months) (P = .004). During the study, 25 patients died (2 with and 23 without SVRs). During the follow-up period, 8 of 24 patients with SVRs (33.3%) and 49 of 51 without SVRs (96.1%) experienced further events of decompensation (P < .0001). The hospital readmission rates for patients with and without SVRs were 7.4 and 56 per 1000 person-months, respectively (ratio of 7.5 without/with SVR; 95% CI, 4.0-16.0; P < .0001). At the end of the follow-up period, the incidence of hepatocellular carcinoma was not associated with clearance of HCV. CONCLUSIONS Among patients with cirrhosis that is a result of HCV infection and who have progressed to a stage of liver decompensation, an SVR after antiviral therapy is a positive prognostic factor.

Ultrasonographic and biochemical parameters in the non‐invasive evaluation of liver fibrosis in hepatitis C virus chronic hepatitis

Background : Prior studies suggest that platelet counts of <140 000/μL can discriminate patients with different stages of fibrosis.

Sustained virological responses following standard anti‐viral therapy in decompensated HCV‐infected cirrhotic patients

Background  Little data is available about predictors of sustained virological response (SVR) during anti‐viral therapy of patients with decompensated HCV cirrhosis.

Bleeding after invasive procedures is rare and unpredicted by platelet counts in cirrhotic patients with thrombocytopenia

BACKGROUND In cirrhotics with low circulating platelets (PLT), restoration of normal cell counts has been traditionally recommended before invasive procedures. However, there is neither consensus on the PLT transfusion threshold nor evidence of its clinical efficacy. PATIENTS In order to fill this gap of knowledge, we prospectively collected and analyzed data on circulating PLT counts [and International Normalized Ratio (INR)] values in a case series of 363 cirrhotics scheduled to undergo invasive investigations. PLT and/or fresh-frozen plasma (FFP) units were infused at the discretion of the attending physician, and the occurrence of post-procedural bleeding was related to pre-and post-infusion results. RESULTS 852 Procedures were carried out in 363 cirrhotics sub-grouped according to the Child-Pugh-Turcotte (CPT) classification (class A/B/C: 124/154/85). The infusion of PLT and/or FFP improved only marginally circulating PLT counts and INR values. Ten post-procedural bleeds occurred in the whole case series, i.e. 1 episode every 85 procedures or every 36 patients. Post-procedural bleeding was unrelated to the PLT counts, to the degree of INR abnormalities, nor to the CPT classes, but was more frequent in patients who underwent repeated investigations. In the 10 patients with the most profound alterations in PLT and/or INR values, no post-procedural bleeding occurred. CONCLUSIONS In cirrhotic patients with low PLT and/or abnormal INR values undergoing invasive investigations, post-procedural bleeding was rare and unpredicted by PLT counts or abnormal INR values. In particular, the recommendation to infuse platelets when counts are <50×103/L is not substantiated by this case series of cirrhotic patients.

Detection of abnormal lesions recorded by capsule endoscopy

BACKGROUND AND STUDY AIM Capsule endoscopy is a non-invasive technique for small bowel examination but its evaluation is time consuming. The aim of this study was to assess whether, following adequate training, an endoscopy nurse is capable of picking up all significant images without reducing the diagnostic accuracy of the procedure. PATIENTS AND METHODS Between April 2003 and December 2004, a total of 41 consecutive capsule endoscopy studies were blindly reviewed by both an endoscopy nurse and an endoscopist. The two operators had to select all significant images independently and to complete a structured questionnaire. Thirty-nine capsule endoscopy examinations (two studies discharged for premature battery failure) were evaluated. The agreement between the two operators was calculated by kappa statistics (coefficient of agreement). RESULTS Agreement was excellent for all kind of selected lesions (mean kappa>0.85); the agreement was complete (kappa=1) for site identification, active bleeding, stenosis and negative studies. The greater disagreement (kappa=0.77) was found in cases of subtle mucosal abnormalities (i.e. reduction of villi), which were over-estimated by the nurse. CONCLUSIONS The preview recordings made by the nurse may increase the cost/effectiveness of the study, by considerably reducing the time needed for the endoscopist to make the final report (about 5-10 min), without compromising final diagnosis.

Systematic review: interferon-free regimens for patients with HCV-related Child C cirrhosis

It is unclear whether the efficacy and long‐term outcome of treating patients with hepatitis C virus (HCV)‐positive cirrhosis with the new protease inhibitors will extend to those with Child C cirrhosis.

Antiviral therapy in compensated and decompensated cirrhotic patients with chronic HCV infection

Liver cirrhosis secondary to HCV infection is a chronic disorder that carries high morbidity and mortality. Approved antiviral treatment for this condition at present includes peginterferon in combination with ribavirin. Treatment is only recommended for a well-compensated liver cirrhosis, whereas antiviral therapy is commonly not implemented in cirrhotics with signs of liver decompensation, over the concern that the use of peginterferon and ribavirin might expose patients to severe treatment-related side effects. This review focuses on data available to support both efficacy and safety of antiviral therapy in both compensated and decompensated cirrhotic patients.

Boceprevir or telaprevir in hepatitis C virus chronic infection: The Italian real life experience

AIM To check the safety and efficacy of boceprevir/telaprevir with peginterferon/ribavirin for hepatitis C virus (HCV) genotype 1 in the real-world settings. METHODS This study was a non-randomized, observational, prospective, multicenter. This study involved 47 centers in Italy. A database was prepared for the homogenous collection of the data, was used by all of the centers for data collection, and was updated continuously. All of the patients enrolled in this study were older than 18 years of age and were diagnosed with chronic infection due to HCV genotype 1. The HCV RNA testing was performed using COBAS-TaqMan2.0 (Roche, LLQ 25 IU/mL). RESULTS All consecutively treated patients were included. Forty-seven centers enrolled 834 patients as follows: Male 64%; median age 57 (range 18-78), of whom 18.3% were over 65; mean body mass index 25.6 (range 16-39); genotype 1b (79.4%); diagnosis of cirrhosis (38.2%); and fibrosis F3/4 (71.2%). The following drugs were used: Telaprevir (66.2%) and PEG-IFN-alpha2a (67.6%). Patients were naïve (24.4%), relapsers (30.5%), partial responders (14.8%) and null responders (30.3%). Overall, adverse events (AEs) occurred in 617 patients (73.9%) during the treatment. Anemia was the most frequent AE (52.9% of cases), especially in cirrhotic. The therapy was stopped for 14.6% of the patients because of adverse events or virological failure (15%). Sustained virological response was achieved in 62.7% of the cases, but was 43.8% in cirrhotic patients over 65 years of age. CONCLUSION In everyday practice, triple therapy is safe but has moderate efficacy, especially for patients over 65 years of age, with advanced fibrosis, non-responders to peginterferon + ribavirin.