Hepatitis C Virus Infection in Patients With Hemoglobinopathies

NCT ID: NCT03149289

Last Updated: 2017-05-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 168 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-01
• Study Completion Date: 2017-02-01

Brief Summary

Progression of liver fibrosis in patients with hemoglobinopathies is strongly related to the severity of iron overload and the presence of chronic hepatitis C virus (HCV) infection. Effective iron chelation therapy and HCV infection eradication are efficacy to prevent liver complications. EASL and AASLD guidelines recommend interferon-free regimens for the treatment of HCV infection in patients with hemoglobinopathies. However, data regarding the use of direct-acting antiviral drugs (DAAs) in this patient population are very few This large, observational study evaluated the safety and efficacy of standard therapy with DAAs in a large Italian cohort of with hemoglobinopathies, chronic HCV infection and advanced liver fibrosis.

Detailed Description

Many patients with hemoglobinopathies have been infected with hepatitis C virus (HCV) through blood transfusion, mostly before screening of blood donors was introduced in 1992. The reported prevalence of anti-HCV-positive thalassemia patients varies between 4.4% in Turkey and 85.4% in Italy. HCV infection is associated with decompensated cirrhosis, hepatocellular carcinoma and other liver complications, especially if left untreated. Prevalence of cirrhosis in thalassemia patients up to 32% have been reported.

Thalassemia patients with cirrhosis have an increased risk of death. Progression of liver fibrosis is strongly related to the presence of chronic HCV infection and extent of iron overload. Thalassemia patients with elevated serum aminotransferase levels for >6 months should be tested for HCV infection and, in the event of HCV infection, HCV genotyping is recommended in order to plan antiviral therapy and the likelihood of response. Noninvasive transient elastography (FibroScan®) can be used to determine the presence of fibrosis in thalassemia patients with HCV infection.

Effective chelation therapy and treatment of HCV infection are needed in order to prevent liver complications and decrease morbidity and mortality. For many years, pegylated interferon (peg-IFN) plus ribavirin was the standard of care for the treatment of chronic HCV infection and decompensated cirrhosis. Studies of peg-IFN plus ribavirin have demonstrated sustained virological response (SVR) rates of 25-64% in patients with thalassemia and HCV infection. However, peg-IFN and ribavirin are both associated with anemia. Ribavirin-associated hemolysis leads to an increased requirement for blood transfusions, which in turn can lead to worsening of iron overload. Therefore, European Association for the Study of the Liver (EASL) 2015 guidelines recommend interferon-free regimens for the treatment of HCV infection in patients with hemoglobinopathies. The aim of this study was to evaluate the safety and efficacy of DAA standard regimens in patients with hemoglobinopathies and chronic HCV liver disease treated in Italy.

Antiviral treatments were administered according to Italian Medicines Agency (AIFA) guidelines.

Conditions

Hepatitis C, Chronic; Hemoglobinopathies

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

HCV RNA positive

hemoglobinopathies with hepatites C treated with antiviral drugs

Antiviral drugs

Intervention Type: DRUG

sofosbuvir, ribavirin, daclatasvir, ledipasvir, simeprevir, paritaprevir, dasabuvir, ombitasvir

Interventions

Antiviral drugs

sofosbuvir, ribavirin, daclatasvir, ledipasvir, simeprevir, paritaprevir, dasabuvir, ombitasvir

Intervention Type: DRUG

Other Intervention Names

Direct-acting antiviral drugs'

Eligibility Criteria

Inclusion Criteria

• Patients with hemoglobinopathies, chronic hepatitis due to HCV and the presence of fibrosis (defined as Fibroscan® stiffness ≥10 kPa) or a bioptic evaluation of cirrhosis (same ISHAK fibrosis score) determined within 6 months previously. Patients with extrahepatic manifestations of chronic hepatitis C virus infection (cryoglobulinemia with organ damage, B-lymphoproliferative disorders) were also included.

Exclusion Criteria

• Patients with active cancer, including hepatocellular carcinoma, and pregnant or lactating females were excluded from the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cagliari

OTHER

Sponsor Role: collaborator

University of Turin, Italy

OTHER

Sponsor Role: collaborator

Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello

OTHER

Sponsor Role: collaborator

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role: collaborator

Ente Ospedaliero Ospedali Galliera

OTHER

Sponsor Role: collaborator

University of Campania Luigi Vanvitelli

OTHER

Sponsor Role: collaborator

Cardarelli Hospital

OTHER

Sponsor Role: collaborator

Reggio Calabria

OTHER

Sponsor Role: collaborator

University of Palermo

OTHER

Sponsor Role: collaborator

Società Italiana Talassemie ed Emoglobinopatie

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vito Di Marco, MD

Role: STUDY_DIRECTOR

University of Palermo, Palermo, Italy

Other Identifiers

HCV-SITE

Identifier Type: -

Identifier Source: org_study_id