The immunogenicity of
hepatitis B vaccine is unknown for patients with
chronic hepatitis C, although
hepatitis B vaccination is highly recommended in these patients. We therefore studied in a prospective open trial of 59 patients with
chronic hepatitis C (mean age 42 years,
hepatitis C for >10 years, Child-Pugh score < or = 5) and 58 healthy hospital staff persons the rate of nonresponse (anti-HBs <10 mIU/mL at 9 months) to recombinant
hepatitis B vaccine (
Gen H-B-Vax(R),10 microg intradeltoidal at month 0, 1, and 6). Nonresponse was observed in 18/59 (31%) patients with
chronic hepatitis C and 5/58 (9%) healthy staff persons (P <.005) (vs. 7% in historical controls; P <.005), low response (anti-HBs 10-99 mIU/mL) in 19% of patients with
chronic hepatitis C and 17% of staff persons. High-dose booster vaccination led to seroconversion in 12/15 (80%) of primary nonresponders. Primary nonresponse to HB
vaccine was related neither to presence of early-stage
liver cirrhosis nor magnitude of serum hepatitis C virus (HCV)
RNA concentration, nor explained by the presence of
human leukocyte antigen (HLA) types (B8 DR3, B44, DR7, DQ2) predisposing to low antibody response to
hepatitis B surface antigen. The rate of primary nonresponse to the standard regimen of recombinant
hepatitis B vaccine is surprisingly high in patients with longstanding
chronic hepatitis C. Therefore, the antibody to HBV
surface antigen (anti-HBs) titer response should be determined in these patients. Depending on the response titer, higher booster doses may be required to achieve and maintain seroprotection in these patients.