Interferon and Ribavirin Treatment in Patients With Hemoglobinopathies
Interferon and Ribavirin Treatment in Patients With Hemoglobinopathies
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.
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.
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)