Antiviral treatment of HCV in thalassemia has raised concerns of ribavirin-induced hemolysis and increased iron loading. Blood Transfusion in Thalassemic patients are a known high risk for acquiring hepatitis C. The investigators are trying the PEGASYS (Peginterferon alpha-2a(40 KD)) plus Ribavirin in Thalassemic patients with HCV.
Patients with Thalassemia receive chronic blood transfusions and have an increased prevalence of chronic Hepatitis C virus (HCV) infection, particularly if transfused before HCV serological testing became available. The investigators enrolled 300 patients into the study. The patients received PEGASYS (Peginterferon alpha-2a(40 KD)) 180 microgram per week plus COPEGUS (Ribavirin) 1000 milligram for weight less than or equal 75 kg and 1200 milligram for more than 75 kg for 48 weeks. Follow up period is 6 months after treatment. The patients are visited every 4 weeks with biochemistry lab tests. The patients are checked with quantitative HCV RNA (Ribonucleic Acid) on the third months after initiation of the treatment to assess early virologic response and at the end of the study for complete response rate and on the six month after treatment completion for sustained response rate. The patients with undetectable HCV RNA are considered as responders.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
PEGASYS: 180 microgram per week (Injection) Plus Ribavirin: \[=\<75 kg: 1000 mg; \>75 kg: 1200 mg per day (PO)\]
Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Tehran, Tehran Province, Iran
Early Virologic Response
Time frame: After 12 weeks of Treatment
End of Treatment Response
Time frame: 48 Weeks
Sustained Virologic Response
Time frame: 24 weeks after Treatment
Rapid Virologic Response
Time frame: One month after Treatment
Tolerability of drugs for whole therapy period
Time frame: During Treatment
Biochemical response (ALT)
Time frame: End of Treatment AND 24 weeks after Treatment
Laboratory Parameters
Time frame: During Treatment AND End of treatment
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