Triple antiviral therapy as a new option for patients with interferon nonresponsive chronic hepatitis C

The aim of the study was to evaluate the efficacy of triple, antiviral ther apy with interferon, ribavirin, and amantadine in comparison with interfero n and ribavirin combination treatment in patients with interferon-nonrespon sive chronic hepatitis C. We performed an open-label, prospective randomize d controlled trial at a secondary referral center. We used a 2:1 ratio, pat ients received interferon, ribavirin, and amantadine, or interferon and rib avirin for 12 months, and were followed up for an additional 6 months. Nine ty-four consecutive adult interferon nonresponders with chronic hepatitis C were screened. Sixty consecutive elected patients entered the study. No pa tients withdrew because of adverse effects. Forty patients received interfe ron alfa (5 megaunits on alternate days), ribavirin (800-1,000 mg daily), a nd amantadine (200 mg daily) for 12 months, and 20 patients received the sa me treatment without amantadine. At the end of follow-up, alanine transamin ase (ALT) level normalization was maintained in 23 of 40 patients (57%) aft er triple therapy, but in 2 of 20 patients (10%) after double therapy (P < .001, RR = 2.11, 95% CI, 1.43-3.12), whereas disappearance of serum HCV RNA persisted in 19 of 40 patients (48%) and in 1 of 20 patients (5%), respect ively (P < .001, RR = 1.81, 95% CI, 1.32-2.47). The safety profile was simi lar in the 2 groups. In conclusion, in patients; with interferon-nonrespons ive chronic hepatitis C, triple antiviral therapy for 1 year results in a h igh rate of sustained biochemical and virologic responses.