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Background and aims Rapid virologic response is the best predictor of sustained virologic response with dual therapy in genotype-1 chronic hepatitis C, and its evaluation was proposed to tailor triple therapy in F0–F2 patients. Bio-mathematical modelling of viral dynamics during dual therapy has potentially higher accuracy than rapid virologic in the identification of patients who will eventually achieve sustained response. Study's objective was the cost-effectiveness analysis of a personalized therapy in naive F0–F2 patients with chronic hepatitis C based on a bio-mathematical model (model-guided strategy) rather than on rapid virologic response (guideline-guided strategy). Methods A deterministic bio-mathematical model of the infected cell dynamics was validated in a cohort of 135 patients treated with dual therapy. A decision-analytic economic model was then developed to compare model-guided and guideline-guided strategies in the Italian setting. Results The outcomes of the cost-effectiveness analysis with model-guided and guideline-guided strategy were 19.1–19.4 and 18.9–19.3 quality-adjusted-life-years. Total per-patient lifetime costs were €25,200–€26,000 with model-guided strategy and €28,800–€29,900 with guideline-guided strategy. When comparing model-guided with guideline-guided strategy the former resulted more effective and less costly. Conclusions The adoption of the bio-mathematical predictive criterion has the potential to improve the cost-effectiveness of a personalized therapy for chronic hepatitis C, reserving triple therapy for those patients who really need it.

Background: Contrast-induced acute kidney injury (CI-AKI) is defined as a deterioration in renal function after administration of radiologic iodinated contrast media (CM). Iodixanol, showed a lower CI-AKI incidence than low-osmolar contrast media (LOCM). A cost-effectiveness analysis was performed comparing iodixanol and LOCM in intravenous (IV) setting in Italy.Methods: A Markov model was developed. Patients moved across four health states: CI-AKI free, CI-AKI, myocardial infarction, and death. The simulation horizon was lifetime with 1-month cycles. Costs and outcomes were discounted at 3.5 percent rate. CI-AKI incidence was considered from published literature across different definitions. Cost-effectiveness of iodixanol was assessed in terms of incremental cost per life-year gained. Net monetary benefit (NMB) was also calculated. Both deterministic and probabilistic sensitivity analyses were performed.Results: Base-case results showed an average survival increase of 0.51 life-years and a savings of €7.25 for iodixanol versus LOCM. The cost-effectiveness of iodixanol was confirmed when other scenarios were explored, such as varying CI-AKI definition, sub-populations with specified risk factors, CM hospital bids prices, and inclusion of adverse drug reactions of allergic nature. An NMB ranging between €6,007.25 and €30,007.25 was calculated.Conclusion: Base-case results show that IV iodixanol is cost-effective compared with LOCM in the Italian clinical setting of a hospital computed tomography radiology practice. However, some caution is due, mainly linked to inherent limitations of the modeling technique and to the lack of agreement on CI-AKI incidence data in the clinical literature.

• Conclusions To assess the economic and clinical impact of the use of peginterferon α-2a (40KD) versus LAM for the treatment of HBeAg-negative CHB and versus IFN for the treatment of HBeAg-positive CHB disease in Italy. • Objective Chronic Hepatitis B (CHB) is caused by chronic infection with Hepatitis B Virus (HBV) and represents a major global health problem. Traditional CHB treatments are lamivudine (LAM) and interferon α-2a (IFN). Peginterferon α-2a (PEG) has been recently approved for the treatment of CHB disease.

s / Digestive and Liver Disease 45 (2013) e367–e371 e369 accumulation was evaluated by AdipoRed assay, apoptosis by the Caspase-3 activity and annexin V/FITC-PI assays. Reactive oxygen species (ROS) was measured using Dihydrorhodamine123. mRNA and protein expression of p53 and lipid metabolism-related genes were evaluated by qRT-PCR and Western blotting, respectively. Transfection of the wt-p53 in Huh7.5.1 was done using Lipofectamine 2000. Results: FFAs treatment was not cytotoxic and enhanced intracellular lipid content, with a statistically significant difference between HepG2 and Huh7.5.1. FFAs overload induced a similar down-regulation of the de novo lipid synthesis genes in both cell lines. Conversely, FFAs modulated the fatty acid b-oxidation pathway (FAO) in an opposite way between HepG2 and Huh7.5.1. Following the FFAs treatment, p53 and its active forms were up-regulated in HepG2 and down-regulated in Huh7.5.1 cells. Transfection of wt-p53 in Huh7.5.1 cells reverts the different lipid metabolism behavior observed in these cells. Apoptosis and ROS were higher in HepG2 respect to Huh7.5.1 cells. Conclusions: We highlight the important role of the p53domain containing residue 220 in regulating FAO pathway. These results prompt us to consider the Y220C mutation paradoxically protective against steatosis and maybe against its progression. These findings may in part explain the occurrence of neoplastic nodules in steatotic patients who never develop cirrhosis, suggesting theopportunity of sequencingp53 topredict liver transformation in the presence of hepatic steatosis. http://dx.doi.org/10.1016/j.dld.2013.09.010 BUDGET IMPACT ANALYSIS OF A PERSONALIZED HBEAG NEGATIVE CHB ANTIVIRAL THERAPY MODEL S. Iannazzo1,∗, M. De Francesco1, B. Coco2, M.R. Brunetto2, R. Tomic3, D. Paolini3, G. Palmieri3, F. Bonino4 1 IMS RWE Solutions and HEOR, Milan, Italy 2 Hepatology-Unit, University Hospital (AOUP), Pisa, Italy 3 Roche S.p.A. Monza, Italy 4 General Medicine II Digestive and Liver Disease Unit, University Hospital (AOUP), Pisa, Italy Introduction: A finite 48-weeks course of peg-interferon (PEG) can induce off-therapy immune control of chronic hepatitis B (CHB) leading to HBsAg clearance/anti-HBs seroconversion. The alternative option is direct inhibition of viral replication by continuous administration of nucleosides analogues (NUCs) which generally yields higher success rates, but at the price of a life-long treatment. Exploiting the early identification of PEG-non-responders by combined HBV-DNA and HBsAg quantification at week-12 (stopping-rule), a new sequential therapeutic strategy may benefit both patients and payers. Aim: Pharmacoeconomic analysis may help assessing the economic impact of therapeutic alternatives through the development of simulation models. We evaluated the impact of the adoption of PEG-week-12-stopping-rule in the treatment of HBeAg-negative CHB in Italy with this pharmacoeconomic technique. Methods and results: A Markov model was developed over a 5 year horizon to simulate the course of CHB through virologic response, relapse, HBsAg clearance, compensated and decompensated cirrhosis, hepatocarcinoma, liver transplant, post-liver transplant and death. Transition probabilities between states were derived from the literature. The current mix of treatment with NUCs (entecavir, tenofovir, adefovir, lamivudine and telbivudine) and PEG (with no stopping rule) was compared with a mix based on a hypothetical uptake of PEG (with the stopping rule). The percentage of uptake from NUCs started at 25%, increasing over time. The estimated budget impact resulted in a saving of approximately D 74 million, 95% of which accounted for drug cost. The beneficial impact of the stopping-rule became clear from the second year, when a break-even point was reached. Conclusion: The estimated savings in drug costs following the uptake of PEG+ stopping-rule in the treatment of CHB HBeAg negative patients demonstrate a potentially advantageous profile of such a strategy that could allow for more efficient use of health care resources. http://dx.doi.org/10.1016/j.dld.2013.09.011 IDENTIFICATION AND CONSUMPTION OF HEPATOPATHIC PATIENTS IN TUSCANY REGION: LIMITS AND OPPORTUNITIES OF ADMINISTRATIVE DATA M. Vainieri1,∗, B. Bini1, B. Coco2, F. Oliveri2, M.R. Brunetto2, F. Bonino3, S. Nuti1 1 Institute of Management – Laboratorio Management e Sanita, Scuola Superiore Sant’Anna of Pisa, Pisa, Italy 2 Hepatology Unit, University Hospital of Pisa, Pisa, Italy 3 General Medicine Unit 2, Department of Internal Medicine, University Hospital of Pisa, Pisa, Italy Introduction: Most studies concerning prevalence or cost effectiveness are based on the enrolment of patients or people throughout health centers and clinical data. However local, regional and central government have access to a wide number of information using administrative data. What are the limits and opportunities of administrative data? Aim: The objectives of the study were to identify hepatopatic patient and its consumption using administrative data. Methods: This study identified and analysed the hepatopathic patient consumptions throughout the linkage of hospitalization, exemption, outpatient and pharmaceutical records of the Tuscany Region in 2010. The analysis can be divided into two steps: 1. The selection criteria to identify hepatopatic patients throughout hospitalization, outpatient, pharmaceutical and exemption administrative datasets (identification of the key tracing information from each dataset). 2. The analysis of consumption in terms of tariffs was carried out for the four groups: asymptomatic hepatopathy; symptomatic cirrhosis; hepatocellular carcinoma; transplant. Results: With the above selection criteria we identified around 1.37% of the Tuscan population over 14 years old who executed at least one tracing exam or treatment or got the exemption for hepatopatic diseases. The 85% of epatopatic identified belongs to the first group, asymptomatic hepatopathy, which includes viral and non viral ephatitis and colangio hepatopathy. The analysis of the overall healthcare expenditure for the hepatopathy patients, including also expenses for illness not directly connected with hepatopathy, highlighted that the median healthcare expenditure for the four groups is the following: D 1888 for asymptomatic hepatopathy; D 6591 for symptomatic cirrhosis; D 8221 hepatocellular carcinoma; and D 9812 for transplant. Conclusions: There are a number of limits in the usage of the administrative data, however local and regional managersmay use e370 Abstracts / Digestive and Liver Disease 45 (2013) e367–e371 administrative data to activate learning processes that can help a better planning of resources and evaluation purposes based on benchmarking. Indeed administrative data allow to monitor and compare performance across providers over timewith small effort. http://dx.doi.org/10.1016/j.dld.2013.09.012 IDENTIFICATION OF RESPONDERS TO SORAFENIB IN HEPATOCELLULAR CARCINOMA: IS TUMOUR VOLUME MEASUREMENT THE WAY FORWARD? R. Sacco1,∗, I. Bargellini2, A. Scionti2, V. Mismas1, G. Masi3, C. Vivaldi3, C. Caparello3, R. Fiorile1, F. Letterio1, G. Bresci1, C. Bartolozzi1 1 Department of Gastroenterology, Pisa University Hospital, Pisa, Italy 2 Department of Radiology, Pisa University Hospital, Pisa, Italy 3 Department of Oncology, Pisa University Hospital