Combination therapy with interferon-alpha plus N-acetyl cysteine for chronic hepatitis C: A placebo controlled double-blind multicentre study

A small pilot study in patients with chronic hepatitis C (HCV) infection su ggested that antiviral treatment with interferon (IFN) plus N-acetyl cystei ne (NAC) was more effective than treatment with interferon alone [Beloqui e t al. (1993) Journal of Interferon Research 13:279-282]. An attempt was mad e to confirm this by performing a placebo-controlled double-blind study at 8 medical centres in Spain and Italy. One-hundred forty-seven patients with chronic HCV infection were investigated, 73 received 3MU IFN-alpha thrice weekly plus NAC 1800 mg daily and 74 received IFN alone. Treatment was cont inued for 6 months and patients were followed up for a further 6 months. Am ongst patients receiving IFN plus NAC, sustained virological responses were observed in 5.5%, transient responses in 26% and non-response in 68.5%. Th e figures for patients receiving IFN only were 4.1%, 24.3% and 71.6% respec tively. Sustained virological response was significantly associated with no n-type 1 genotypes (P = 0.045) and with low pre-treatment viraemia levels ( P = 0.034). Biochemical response (serum ALT concentrations) correlated with virological outcome in 97% (n = 139) of cases. Patients who experienced a sustained virological response also showed reduction in the Knodell histolo gical activity index. It is concluded that patients with chronic HCV infect ion are very unlikely to benefit from the addition of N-acetyl cysteine to conventional therapy with interferon-alpha. J. Med. Virol. 61: 439-442, 200 0. (C) 2000 Wiley-Liss, Inc.