Clinical trial NCT01945008: Observational Study in HCV Chronic Infection
Official title: Prospective Multicentric Observational Study in HCV Chronic Infected Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Keywords: HCV
observational study
HCV direct-acting antiviral agents
Lead sponsor: Istituto Superiore di Sanità
Sponsor class: OTHER
First posted: 2013-09-18
Enrollment: 7600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient characteristics: :

* any clinical and histopathologic stage of HCV infection
* infected by any HCV genotypes
* Untreated at the time of the enrolment (previously treated subjects are eligible)
* With/without HBV co-infection
* With/without HIV co-infection (in any clinical stage of HIV infection, with or without antiretroviral treatment)

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Age distribution at recruitment
timeFrame: ten years
measure: Sex distribution at recruitment
timeFrame: ten years
measure: BMI distribution at recruitment
timeFrame: ten years
measure: Genotype distribution at recruitment
timeFrame: ten years
measure: Liver disease stage at recruitment
timeFrame: ten years
measure: Sustained virological response (SVR) in treated patients
timeFrame: ten years
measure: Changes in the severity of liver disease
timeFrame: ten years
measure: Incidence of Hepatocellular carcinoma (HCC)
timeFrame: ten years
measure: Incidence and recurrence of decompensated cirrhosis
timeFrame: ten years
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Istituto Superiore di Sanità
Study officials:
affiliation: Istituto Superiore di Sanità
name: Loreta Kondili, MD
role: PRINCIPAL_INVESTIGATOR
References: