Objectives: The applicability of the results of controlled, randomised, therapeutic trials in the general population is not well known. The aim of this prospective study was to assess the results of the treatment of chronic hepatitis C with interferon alpha and ribavirin in "real life."
Methods: In an independent observatory, clinicians from 31 hepatogastroenterology units in French general hospitals registered patients treated with interferon alpha and ribavirin outside clinical trials. Results were compared with those of the best arm (twelve months of bitherapy) of the European-Canadian trial published in 1998 by Poynard et al.
Results: 262 naïve patients were included. Patients were significantly older, had more severe liver fibrosis, with cirrhosis in 17 percent, but were comparable for sex, contamination mode and viral genotype with those of the Poynard et al. trial. Sustained virological response rate (37%, IC 95%: 31-43%) was not significantly lower (difference 6%, IC 95%: - 18% to + 6%) than in the Poynard et al. trial. Results for response factors were similar. Comorbid conditions which would have prevented our inclusion of patients in the Poynard et al. trial were present in 46% and had an independent negative effect on sustained virological response rate. Side-effects were similar.
Conclusions: The efficacy of the combination of interferon alpha and ribavirin remains good in real life, but depends on the characteristics of the treated population. The results of trials should be presented more cautiously to general population.