Triple Therapy With Peg-Interferon Alfa-2b/Ribavirin Plus Amantadine Compared to Standard Peg-Interferon Alfa-2b/Ribavirin for Previous Hepatitis C Virus (HCV) Non Responders

• Status: Terminated
• Trial end date: 2003-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Triple antiviral therapy with peg-interferon-alfa/ribavirin+amantadine was suggested to increase sustained virological response (SVR) rates in HCV non-responders to a standard interferon/ribavirin combination.

Patients with hepatitis C virus infection were eligible if they had failed to respond to a single previous 24 week cycle of interferon/ribavirin combination therapy. Non-response was defined as persistent HCV RNA in the serum during the last month of treatment.

This study tested the efficacy and safety of pegylated interferon alfa-2b with ribavirin and amantadine or a placebo for 48 weeks.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Collaborator: Schering-Plough
• Treatments: Amantadine; Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2b; Ribavirin

Criteria

Inclusion Criteria:

• Positive anti-HCV antibody test

• Patients who did not respond to treatment with standard interferon + ribavirin (HCV RNA+ by PCR in the last month of treatment)

• Compensated liver disease

• Neutrophil count over or equal to1000/mm3

• Platelet count over or equal to 100 giga/L

• Haemoglobin over or equal to 10g/dL

• Patients had to have undergone a post-treatment liver biopsy within a year, showing a METAVIR histological score over or equal to A1F1, without cirrhosis (fibrosis score below F4)

• ALT over N and HCV RNA+ at screening

Exclusion Criteria:

• Co-infection with hepatitis B or human immunodeficiency virus

• Any other cause of liver disease

• Active drug abuse, active alcohol consumption above 40g/day

• Organ grafts

• Presence of hepatocellular carcinoma

• Cardiovascular, metabolic, renal, haematological, neurological or psychiatric disease

• Patients with previous amantadine use

• Systemic immunosuppressive or antiviral treatment during the last 24 weeks and those with a history of interferon and/or ribavirin intolerance