Abstract

Background and Aims: To introduce the possible role of hydroxyurea (HU), a well-characterized antineoplastic drug with established antiviral effects, in the treatment of chronic hepatitis B. Methods: Four antiretroviral-naive patients with chronic hepatitis B were enrolled in this limited pilot trial, and given 1000 mg/day of hydroxyurea for 4 weeks; then, the administration of the drug was suspended for 4 weeks. A clinical study and laboratory safety assessments and measurements of viral load were made at baseline, after drug therapy, and after one month suspension of the treatment. Results: All 4 patients showed a significant decrease in viral load after 4 weeks of hydroxyurea therapy and the viral load of 2 patients increased again after a 4-week suspension of hydroxyurea. Conclusions: Our data demonstrate that the old low-cost antineoplastic drug, hydroxyurea, efficiently blocks hepatitis B virus (HBV) replication. We suggest that HU will play an important role in the treatment of chronic hepatitis in the foreseeable future. Further studies including those that evaluate optimal dosing in long-term use will continue to define the role of HU in the treatment of HBV infection alone or in combination with other antiviral drugs.