Tailoring antiviral therapy of chronic hepatitis C to the single patient standard therapy versus treatment guided by a physic-mathematical model of the dynamics of Hepatitis C Virus infection.

INTERVENTION: Pharmaceutical Form: Solution for injection INN or Proposed INN: Interferons Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 180‐ Pharmaceutical Form: Coated tablet INN or Proposed INN: Ribavirin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐ CONDITION: Chronic Hepatitis C with or without cirrhosis ; MedDRA version: 6.1 Level: PT Classification code 10019744 PRIMARY OUTCOME: Main Objective: a. To evaluate and compare the overall costs and the pharmaco‐economical aspects of drug efficacy in the two different therapy strategies standard treatment according to the guidelines of the Italian Association for the Study of the Liver 4 and treatment tailored to the single patient by using the simulations of the HCV infected hepatocytes provided by the mathematical model of HCV dynamics. b. To evaluate and compare the mean therapy durations in weeks needed to achieve a sustained response by the two different therapeutic strategies. Primary end point(s): Number of weeks of therapy required for one sustained virological response Secondary Objective: To analyse the impact of the two different therapeutic strategies in terms of Sustained Virological Response INCLUSION CRITERIA: Patients with chronic hepatitis C with or without cirrhosis and are either therapy na ve or were relapsers after a previous standard therapy course. Their age will range between 18 and 70 years and females have to be willing to be able to take preventive contraceptive measures during treatment and for 6 months after the end of therapy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range