Observational Study in HCV Chronic Infection
Observational Study in HCV Chronic Infection
HCV infection is the most frequent cause of liver chronic disease, cirrhosis and
 hepatocellular carcinoma in western countries.

 To date, the standard antiviral treatment, including pegylated interferon (PEG-IFN) plus
 ribavirin (RBV), has relatively low effectiveness in patients infected with genotype 1 and 4,
 and is associated with important adverse side effects, that lead to treatment interruption in
 approximately 30% of cases.

 The recent association of first generation HCV- specific direct-acting antiviral agents
 (DAAs) (telaprevir and boceprevir) to standard treatment has resulted in higher SVR rates,
 also in patients infected with genotype-1 HCV and in non responders to PEG-IFN plus RBV.
 While several new DAAs are in development, the ultimate goal is represented by IFN-free
 regimens, that will provide a great advantage in terms of patients adherence to therapy and
 quality of life.

 In this context, prospective observational studies are needed to evaluate the real and
 long-term impact of the new DAAs in the clinical practice, in terms of efficacy, safety,
 costs and impact on patients quality of life.

 Italy is the European country with the greatest number of HCV infected people (average, 3% of
 population), with higher prevalence in the center and in the south of the country, especially
 in older individuals, and the highest mortality caused by hepatocellular carcinoma. Genotype
 1 is the most frequent one (in more than 50% of infected people). DAAs were approved at the
 end of 2012. For these reasons, Italy represents an interesting context for collecting data
 on long-term efficacy, safety and tolerability of new anti-HCV treatments.

 The PITER cohort study, developed in the frame of Italian Platform for the study of the
 therapy of viral hepatitis a prospective observational study, is based on a large cohort of
 HCV infected patients from more than 100 clinical centers distributed on the whole national
 area.

 The main aims of the PITER longitudinal cohort study are: 1) to produce of an ongoing and
 continuously updated picture of the changing epidemiology of HCV infection in the country; 2)
 to evaluate in a real-life setting the expected impact of DAAs on the natural course of
 infection and on long-term morbidity and mortality.
Collected data will include clinical, laboratory and anatomopathological information and will
 be recorded in electronic CRF, at the enrollment and follow-up visits.

 Special attention will be devoted to specific patient categories (with HIV, HBV, HDV and HEV
 coinfections, comorbidities, disease patients who presents signs of liver disease
 progression). Subjects starting an antiviral regimen will be followed according to specific
 guidelines.

 A sub-study on quality of life/adherence to treatment/treatment satisfaction will be also
 conducted on all treated patients of the cohort.
Inclusion Criteria:

 - All HCV infected patients who will consecutively come to the participating clinical
 centers in a given time span (enrollment periods)

 Exclusion Criteria:

 -  Younger than 18 years

 -  Patients treated at the moment of the enrollment