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

Background/Aims: Ofloxacin, a quinolone antibiotic, was recently shown to increase the primary response rate to α-interferon treatment of chronic hepatitis C. Methods: Fifty-five patients with chronic hepatitis C were scheduled to receive 3 MU of α-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 α-inteferon, 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another 6 months, whereas patients who were still HCV RNA-positive were definitively considered as non-responders and withdrawn from the study.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 α-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/α-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 α-interferon and ofloxacin to patients with chronic hepatitis C who have not responded to α-interferon alone does not increase the primary virological response rate.