Individualized treatment of genotype 1 Naïve patients : an Italian multicenter field practice experience

Background: Triple therapy including Telaprevir or Boceprevir still represents in many European countries the standard of care for patients with Hepatitis C Virus genotype 1 infection. The number of patients who received this treatment resulted generally lower than expected. We investigated, among na\u131\ua8ve patients, number and characteristics of treatment candidates who were started on triple or dual therapy in comparison to those who were deferred. Patients and Methods: 621 na\u131\ua8ve treatment candidates were prospectively evaluated at each center. Factors associated with decision to defer or treat with dual or triple therapy were investigated by univariate and multivariate analyses. Rates of Sustained Virological Response and safety profile were analysed. Results: Of candidates to treatment, 33% did not received it. It was mostly due to high risk of Interferon-induced decompensation. Of 397 patients who were started on treatment, 266 (67%) received triple, 131 dual. Among patient receiving treatment, unfavorable IL28B, severe liver damage and higher albumin were independently associated with the physician decision to administer triple therapy. Sustained Virological Response after dual therapy was 66.4%, after triple 73.7% (p = 0.14). 142 patients received Telaprevir. The choice of Telaprevir-based therapy was associated with higher Body Mass Index and advanced liver disease. Sustained Virological Response rates were 71.1% after Telaprevir and 76.6% after Boceprevir. Conclusions: Individualizing treatment with available regimens allows to maximize Sustained Virological Response and to reduce the number of patients who remain untreated. High proportion of patients with severe liver damage urgently need Interferon free treatment

Hepatitis C virus clearance after direct-acting antivirals in cirrhotic patients by stages of liver impairment: the ITAL-C network study

Background and Aims: HCV-infected patients with decompensated cirrhosis, and in particular those Child-Pugh-Turcotte (CPT) class C, are usually excluded from studies investigating the sustained virological response (SVR12) to new direct-acting antivirals (DAAs). A more refined classification of cirrhotic patients has been provided by D’Amico et al. In this system stage 1 includes patients without portal hypertension, stage 2 those with esophageal varices, stage 3 patients who bled from varices, stage 4 patients with a single episode of decompensation events, and stage 5 those with multiple decompensation events. To assess the SVR12 after therapy in patients with advanced fibrosis and cirrhosis stratified according to the D’Amico” system. To evaluate the functional outcome during the follow up after treatment. Methods:We investigated a cohort of 2612 patients, from a network of 24 Italian centers, with chronic HCV infection and advanced fibrosis (no. = 575) or cirrhosis (no. = 2037). Different DAAs schedules were administered at the physicians’ choice, in accordance with national and international guidelines. All patients have completed 3 months of follow-up post treatment. Results: At exception of bilirubin levels, numbers of patients with normal albumin and INR values increased significantly in respect to baseline. Circulating platelets and creatinine levels increased significantly in respect to baseline. A remarkable increase in the numbers of CPT class A patients became apparent, whose frequency increased from 35.9% to 80.3% (p < 0.001). During the 3 month post-treatment follow up, no decompensation events were detected in patients with advanced hepatic fibrosis; a single patient developed HCC, and one patient died for acute leukemia. Of the 1739 stage 1 and 2 cirrhotics, 33 patients (1.9%) manifested events of decompensation or a HCC, and 1 of them died for uncontrolled esophageal bleed. Among the 277 decompensated cirrhotics (stage 3 to 5), 25 subjects (9.0%) experienced single or multiple events or a HCC, 4 were transplanted being HCVRNA negative at the time of the OLT,1 died for acute hepatic failure and 1 for diabetic complications. Results are shown in the Table. Conclusions: Our findings support the safety and the efficacy of DAAs treatment even in patients with portal hypertension and decompensated liver disease (stages 3–5 or CPT class C)