Antiviral Therapy in Decompensated Hepatitis C Virus (HCV) Cirrhosis

Casa Sollievo della Sofferenza IRCCS

Status and phase: Completed; Phase 3; Phase 2

Conditions: Liver Cirrhosis, Experimental

Treatments: Drug: peginterferon and ribavirin

Study type: Interventional

Funder types: Other

Identifiers

NCT00301509

630/DS

Details and patient eligibility

About

To evaluate:

1. the impact of combined antiviral therapy (Peginterferon plus ribavirin) on natural history of patients affected with HCV decompensated cirrhosis, after sustained virological response. A controlled study.
2. safety and efficacy of antiviral therapy in this population by using a statistically significally number of patients as controls.

Full description

Decompensated HCV cirrhosis is a relevant problem as its clinical evidences predisposes to an high mortality risk, with a survival rate of 50% at 5 years (1,2). Davis et. al processed a mathematical model of the natural history of chronic hepatitis C and projected the total number of cases with cirrhosis increased by more than 50% by 2010 and then plateaued (3). As a result, there will be a dramatic increase in the number of cases with complications of liver failure and decompensated events of cirrhosis will increase to 25% in 2010, 32% in 2020, 36% in 2030, and 38% in 2040 (3, table 1).Liver transplantation is the treatment of choice but the limited number of organ donor makes not realizable for the major of patients. Furthermore, age over 65 years correlated disease is not accepted to enter into the list of liver transplant. To prevent these patients from worsening their liver disease has positive economic implications in terms of health care resources used as diagnostic tests, clinic visits, drug therapy, hospitalization for management of complications, and later on, liver transplantation, and indirect costs related to lost work time and impaired quality of life. our controlled study on antiviral treatment of decompensated cirrhotics has shown that HCV clearance by therapy can be life-saving, improves hepatic function, and reduces disease progression. Treatment should be encouraged in CTP classes A and B, and especially in patients infected by genotype 2. The benefit of treating patients with genotype 1 remains unproven.

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: HCV cirrhotics admitted to hospital for a decompensated event, such as ascites, variceal bleeding, and hepatic encephalopathy -

Exclusion Criteria: rapid deterioration of liver and/or renal function, detection of hepatocarcinoma, infection with HIV or HBV viruses, current alcohol or drug abuse, chronic invalidating disease, bacterial infections, platelets <35,000 cells/μL, neutrophils <1,000 cells/μL, haemoglobin level <10 g/dL, total bilirubin >3 mg/dL, and serum creatinine >2.0 mg/dL.