Amantadine in non-responder patients with chronic hepatitis C: a randomized prospective study

The management of non-responders (NR) represents the most challenging of all aspects in the care of patients with chronic hepatitis C (CHC). The purpose of the study was to evaluate the efficacy of amantadine.

Fourty- three patients with CHC who did not respond to prior combination therapy [IFNα-2a plus ribavirin for 48 weeks] were enrolled into the study. The first group (n=21) was administered pegylated IFN-α2a (180 mcg/week) plus ribavirin (1000-1200 mg/day) and amantadine (200mg/day) for 48 weeks. After discontinuation of therapy, patients were followed-up for an additional 24 weeks. The second group (n=22) received only amantadine (200mg/day) daily for at least 24 weeks (mean 96 weeks) and starting from the 24th week, HCV-RNA was assessed every 12 weeks without discontinuation of therapy.

Mean ALT levels before treatment were 115.30 units in the first and 107.73 units in the second group whereas they were 48.38 and 54.76 units, respectively, after the treatment (p<0.001 for both). Sustained viral response rate for the first group at the 72nd week was 52.3% (11/21) (p<0.025). Among patients receiving amantadine, 1 patient became HCV-RNA negative at the 24th and 3 patients at the 48th week (response rate at week 48 was 18.2%), 1 patient at the second year and 1 patient at the fourth year of the treatment (p=0.031).

Amantadine has a potential anti-inflammatory activity that can be a safe alternative for NR-CHC subjects to combination therapy.