Interferon and Ribavirin Treatment in Patients With Hemoglobinopathies (IFNRIBAHE)

Azienda Ospedaliera V. Cervello

Status and phase

Unknown

Phase 4

Conditions

Hemoglobinopathies

Treatments

Drug: PEG-IFN alpha2a or PEG-IFN alpha2b and Ribavirin

Study type

Interventional

Funder types

Other

Identifiers

NCT00887081

AOVCervello1

Details and patient eligibility

About

Worldwide, several studies report that 4.4% to 85.4% of thalassemia patients were positive for anti hepatitis C antibodies. Recently, three different studies reported the efficacy and the safety of combination therapy with pegylated interferon and ribavirin in thalassemic patients. This study is carried ahead to assess the impact of combination therapy with pegylated-interferon and ribavirin in a large cohort of italian patients with beta thalassemia major - transfused and not transfused, sickle cell disease and sickle/beta-thalassemia.

Full description

Infection is more common in patients who received a high number of blood transfusions before 1990. The prevalence of HCV infection is higher in Italy, where more than 70% of thalassemia major patients are HCV-RNA positive. In Italy and worldwide, genotype 1 is the most frequent. Regarding the prevalence of cirrhosis, the clinical data of different cohorts of thalassemia patients showed a rate of cirrhosis ranging from 10% to 20%. Male sex, high serum ALT values, and a positive serum test for qualitative HCV-RNA are significantly associated with severe fibrosis or cirrhosis. Cirrhosis related to hepatitis C virus infection is the major risk factor for development of hepatocellular carcinoma and is a major cause of liver failure. An Italian study that reported clinical data of 22 thalassemia patients with hepatocellular carcinoma concluded that the development of hepatocellular carcinoma is associated with the presence of cirrhosis, male gender, age over 35 years, and active HCV infection. Another prospective study reported a 2% incidence of new HCC during the follow-up of 105 adult thalassemia patients cohort. Yet before 2000, several controlled trials reported that combination therapy with alpha-interferon, given three times a week, and ribavirin, given every day, was more effective than interferon alone.Recently, three different studies reported the efficacy and the safety of combination therapy with pegylated interferon and ribavirin in thalassemic patients. Less extensive data are present actually in literature about efficacy of combination therapy with pegylated interferon and ribavirin in HCV infected patients with sickle cell disease or sickle/beta-thalassemia.

Enrollment

150 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Thalassemia Major or Sickle Cell Disease or Sickle/Beta Thalassemia patients
Regularly transfused (hemoglobin ≥ 9.5 gr/dl) or not transfused, under or not iron chelation regimen
With positivity to HCV-RNA and chronic liver disease with or without cirrhosis, naïve or non-responder or relapser after interferon mono-therapy

Exclusion criteria

Thalassemia Major or Sickle Cell Disease or Sickle/Beta Thalassemia patients with not compensated liver failure or heart failure
Low white blood cells (neutrophils < 1.500/mmc and/or white blood cells < 3.000/mmc)
Low platelets count (< 100.000/mmc)
Significant positivity to Coombs test with clinical and serologic evidence of immune hemolytic anemia, severe endocrinopathy, detection of high titre autoantibodies, co-infection with HBV (HbsAg positive)