Controlled clinical trial of acyclovir in chronic hepatitis B virus infection.

A randomised, controlled trial comparing acyclovir, 45 mg/kg/day as a continuous IV infusion for 28 days, with no other therapy, was carried out in 30 stable HBsAg carriers seropositive for HBeAg for more than 6 months. Twenty-eight had hepatitis B virus DNA-polymerase activity and/or hepatitis B virus DNA in serum at entry into the study. There were no significant adverse effects of therapy. At 12 months, seroconversion from HBeAg to anti-HBe had occurred in four of 15 treated patients, one of whom had also developed anti-HBs, compared with only one of 15 in the untreated group (95% confidence limits 12% and 51%). Seroconversion from HBeAg to anti-HBe was accompanied by return of serum liver function tests to normal and improved liver histology. The results of this study indicate that acyclovir is of no significant benefit in chronic HBeAg carriers with stable disease.