Treatment of chronic hepatitis C with alpha-interferon plus ofloxacin in patients not responding to alpha-interferon alone.

BACKGROUND/AIMS: Ofloxacin, a quinolone antibiotic, was recently shown to increase the primary response rate to alpha-interferon treatment of chronic hepatitis C.

METHODS

Fifty-five patients with chronic hepatitis C were scheduled to receive 3 MU of a-interferon, three times a week, for 1 year. After 3 months of therapy, patients who were still HCV RNA-positive in serum started receiving a combined regimen with 3 MU of alpha-interferon, three times a week, plus ofloxacin, 600 mg daily, per os. After 3 months of combined therapy, patients with undetectable serum HCV RNA continued the combined regimen for another 6 months, whereas patients who were still HCV RNA-positive were definitively considered as non-responders and withdrawn from the study. Serum HCV RNA levels were quantitatively evaluated after 3 months of therapy with a-interferon alone and compared with those detected after 3 months of combined regimen.

RESULTS

Among the 54 patients who completed the first 3 months of treatment, 32 (59.3%) still had HCV RNA detectable in serum and started receiving the ofloxacin/alpha-interferon therapy. Among the 26 patients who completed the 3 additional months of combined regimen, only one showed a virological response: this patient maintained a complete response to the end of combined treatment, but relapsed thereafter. The combination therapy had no effect on the serum HCV RNA or alanine aminotransferase levels.

CONCLUSIONS

The combined administration of alpha-interferon and ofloxacin to patients with chronic hepatitis C who have not responded to alpha-interferon alone does not increase the primary virological response rate.