Prospective Multicentric Observational Study in HCV Chronic Infected Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7,600
- 试验地点
- 1
- 主要终点
- Age distribution at recruitment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All HCV infected patients who will consecutively come to the participating clinical centers in a given time span (enrollment periods)
排除标准
- •Younger than 18 years
- •Patients treated at the moment of the enrollment
结局指标
主要结局
Age distribution at recruitment
时间窗: ten years
Age distribution will be expressed in years and reported as median
Sex distribution at recruitment
时间窗: ten years
The sex distribution (males and females) will be reported as frequencies (percent)
BMI distribution at recruitment
时间窗: ten years
The BMI (kg/m\^2) will be expressed in the following cathegories: Underweight, Normal, Overweight, Obese and will be reported as frequencies (percent)
Genotype distribution at recruitment
时间窗: ten years
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)
Liver disease stage at recruitment
时间窗: ten years
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)
Incidence and recurrence of decompensated cirrhosis
时间窗: ten years
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)
Sustained virological response (SVR) in treated patients
时间窗: ten years
Rates of SVR for each expected combination of DAAs used; identification of factors influencing HCV treatment response in the real life.
Changes in the severity of liver disease
时间窗: ten years
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)
Incidence of Hepatocellular carcinoma (HCC)
时间窗: ten years
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)
次要结局
未报告次要终点
研究者
Stefano Vella
Director of the Department of Therapeutic Research and Medicines Evaluation
Istituto Superiore di Sanità