Observational Study in HCV Chronic Infection

NCT01945008 | Completed

• 1 other identifier: PITER 01
• Study Type: observational
• Target: 7,600
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C, Chronic

Keywords

HCV; observational study; HCV direct-acting antiviral agents

Outcome Measures

Primary Outcomes (9)

• Age distribution at recruitment

  Age distribution will be expressed in years and reported as median

  ten years

• Sex distribution at recruitment

  The sex distribution (males and females) will be reported as frequencies (percent)

  ten years

• BMI distribution at recruitment

  The BMI (kg/m\^2) will be expressed in the following cathegories: Underweight, Normal, Overweight, Obese and will be reported as frequencies (percent)

  ten years

• Genotype distribution at recruitment

  Genotype distribution will be expressed in the following categories: 1 non subtyped, 1a, 1b, 2, 3, 4-5, and will be reported as frequencies (percent)

  ten years

• Liver disease stage at recruitment

  The liver disease stage distribution will be expressed in the following chategories: F0-F3, F4-cirrhosis, decompensated cirrhosis, HCC, liver transplant, and will be reported as frequencies (percent)

  ten years

• Sustained virological response (SVR) in treated patients

  Rates of SVR for each expected combination of DAAs used; identification of factors influencing HCV treatment response in the real life.

  ten years

• Changes in the severity of liver disease

  Changes in liver function will be evaluated in terms of Child Pugh (C-P) score increase or decrease by 1 or more points, whatever occurred first after the end of treatment. This outcome will be expressed as proportions (percent)

  ten years

• Incidence of Hepatocellular carcinoma (HCC)

  Incidence of HCC will be evaluated on the basis of the first diagnosis reported after the end of treatment, excluding prevalent HCC cases occurred before treatment. Cumulative incidence will be expressed as proportions (percent)

  ten years

• Incidence and recurrence of decompensated cirrhosis

  Liver decompensating event is defined as the presence or appearance of ascites and/or portal hypertensive gastrointestinal bleeding and/or hepatic encephalopathy. Incidence of a decompensating event will be evaluated on the basis of the first occurrence after the end of treatment, excluding cases occurred before treatment. Recurrence of decompensation will be evaluated on the basis of the first events in patients with previous history of decompensated cirrhosis. Cumulative incidence or recurrence will be expressed as proportions (percent)

  ten years

Study Arms (1)

Hepatitis-C infected patients

Patients with Hepatitis-C infection untreated at the enrolment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

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

You may not qualify if:

• Younger than 18 years
• Patients treated at the moment of the enrollment

Sponsors & Collaborators

• Istituto Superiore di Sanità: lead

Study Sites (1)

Istituto Superiore di Sanità

Rome, 00161, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Loreta Kondili, MD

  Istituto Superiore di Sanità

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Therapeutic Research and Medicines Evaluation

Study Record Dates

• First Submitted: September 13, 2013
• First Posted: September 18, 2013
• Study Start: April 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: April 15, 2020

Record last verified: 2020-04

Locations

IT (1)