Comparison of Pegasys Versus Peg-Intron for Treatment of Chronic Hepatitis C Genotype 4

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Genotype 4 hepatitis C virus is the cause of approximately 20% of the 170 million cases of chronic hepatitis C in the world. Although rare in western nations, genotype 4 is the most common variant of the hepatitis C virus in Egypt and is also found throughout Africa and the Middle East. Early reports on the treatment of patients with genotype 4 chronic hepatitis C with interferon-alfa (IFN)-alfa monotherapy indicate poor rates of sustained viral response (SVR). With the introduction of ribavirin combination therapy and with pegylation of the IFN alfa molecule, however, response rates have improved dramatically, and current clinical trial data indicate that SVR rates between 43 and 79% are attainable in genotype 4 patients who are receiving pegylated IFN alfa plus ribavirin for 48 weeks. Clinical advances to optimize treatment for each patient have also been made, and tailored treatment options are now being developed that are comparable to the treatment approaches for genotype 1, 2, and 3 patients. A treatment duration of between 36 and 48 weeks appears to be optimal for most patients with chronic hepatitis C genotype 4.The aim of this study is to assess the efficacy and safety of pegylated interferon alpha 2a in patients with chronic hepatitis C genotype 4 in comparison to a historical cohort of patients treated with pegylated interferon alpha 2b

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amr Hafez
• Collaborator: Ain Shams University
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2a; Peginterferon alfa-2b; Ribavirin

Criteria

Inclusion Criteria:

1. Adult men and women

2. Age: 25 to 55 years with documented chronic hepatitis

3. Elevated serum alanine aminotransferase at least 2 times the upper limit of normal (40 U/L) on 2 occasions during the preceding 6 months

4. Detectable anti-HCV antibody status assessed by second-generation enzyme-linked immunosorbent assay (Roche Diagnostics, Branchburg, New Jersey); 5. Detectable HCV RNA by polymerase chain reaction (Cobas Amplicor HCV Monitor v2.0 [Roche Diagnostics, Branchburg, New Jersey]; lower limit of quantitation [50 IU/mL])

5. Infection with HCV genotype 4

6. Histologic evidence of chronic hepatitis C in a liver biopsy specimen obtained within the preceding year.

Exclusion Criteria:

1. Hepatitis A, hepatitis B, autoimmune hepatitis, alcoholic liver disease, drug-induced hepatitis.

2. Decompensated liver disease with a history of variceal hemorrhage, ascites, or hepatic encephalopathy.

3. Patients coinfected with schistosomiasis or human immunodeficiency virus

4. leukocyte count lower than 3000 /mm3, neutropenia (<1500 cells/mm3), a hemoglobin level lower than 12 g/dL for women and lower than 13 g/dL for men, thrombocytopenia (<90,000 cells/mm3), creatinine concentration 1.5 times the upper limit of normal

5. Organ transplantation

6. Neoplastic disease

7. Severe cardiac or pulmonary disease

8. Unstable thyroid dysfunction

9. Psychiatric disorder

10. Current pregnancy or breast feeding.

11. Therapy with immunomodulatory agents within the last 6 months