The immunogenicity of hepatitis B vaccine is unknown for patients with chro
nic hepatitis C, although hepatitis B vaccination is highly recommended in
these patients. We therefore studied in a prospective open trial of 59 pati
ents with chronic hepatitis C (mean age 42 years, hepatitis C for >10 years
, Child-Pugh score less than or equal to 5) and 58 healthy hospital staff p
ersons the rate of nonresponse (anti-HBs <10 mIU/mL at 9 months) to recombi
nant hepatitis B vaccine (Gen H-B-Vax(R),10 mu g intradeltoidal at month 0,
1, and 6), Nonresponse was observed in 18/59 (31%) patients with chronic h
epatitis C and 5/58 (9%) healthy staff persons (P <.005) (vs, 7% in histori
cal controls; P <.005), low response (anti-HBs 10-99 mIU/mL) in 19% of pati
ents with chronic hepatitis C and 17% of staff persons. High-dose booster v
accination led to seroconversion in 12/15 (80%) of primary nonresponders. P
rimary nonresponse to HE vaccine was related neither to presence of early-s
tage liver cirrhosis nor magnitude of serum hepatitis C virus (HCV) RNA con
centration, nor explained by the presence of human leukocyte antigen (HLA)
types (B8 DR3, B44, DR7, DQ2) predisposing to low antibody response to hepa
titis B surface antigen. The rate of primary nonresponse to the standard re
gimen of recombinant hepatitis B vaccine is surprisingly high in patients w
ith longstanding chronic hepatitis C. Therefore, the antibody to HBV surfac
e antigen (anti-HBs) titer response should be determined in these patients.
Depending on the response titer, higher booster doses may be required to a
chieve and maintain seroprotection in these patients.