Prednisone withdrawal followed by recombinant alpha interferon in the treatment of chronic type B hepatitis. A randomized, controlled trial.
OBJECTIVE
To determine the efficacy of a short course of prednisone followed by recombinant interferon treatment in patients with chronic type B hepatitis.


METHODS
Randomized, controlled trial with a 5-month treatment phase and a 9-month observation period after treatment.


METHODS
Two referral-based university-affiliated medical centers.


METHODS
Thirty-nine clinically stable patients with chronic type B hepatitis, all of whom were positive for hepatitis B antigen, hepatitis B virus-associated-DNA (HBV-DNA), and DNA polymerase for at least 6 months before entry. Patients included 20 heterosexuals and 19 male homosexuals.


METHODS
Eighteen patients were treated with a 6-week tapered regimen of prednisone, followed by 90 days treatment with recombinant interferon alpha-2b; 21 patients were untreated controls. Paired liver biopsy specimens of 27 patients (pretreatment and 9 months after treatment) were blindly evaluated.


RESULTS
Nine treated patients had a sustained loss of HBV-DNA. In addition, eight treated patients lost hepatitis B e antigen and four became negative for hepatitis B surface antigen (HBsAg). When compared with controls the differences were statistically significant for clearance of HBV-DNA and HBsAg (P = 0.035 and 0.037, respectively). Treated patients who had a sustained loss of HBV-DNA had higher initial alanine aminotransferase lower initial DNA and DNA polymerase levels, and were more frequently heterosexual. Patients who responded to treatment with the disappearance of hepatitis B e antigen and HBV-DNA had normal liver function tests and markedly improved liver histology during follow-up.


CONCLUSIONS
The immunologic priming provided by a short course of prednisone used with alpha interferon may be an effective treatment for selected patients with chronic type B hepatitis.
Perrillo
R P
RP
Veterans Administration Medical Center, St. Louis, Missouri.
Regenstein
F G
FG
Peters
M G
MG
DeSchryver-Kecskemeti
K
K
Bodicky
C J
CJ
Campbell
C R
CR
Kuhns
M C
MC
D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D002908:Chronic Disease; D002986:Clinical Trials as Topic; D003131:Combined Modality Therapy; D004259:DNA-Directed DNA Polymerase / Q000097:blood; D004334:Drug Administration Schedule; D005260:Female; D006509:Hepatitis B / Q000382:microbiology / Q000473:pathology / Q000628:therapy*; D006515:Hepatitis B virus / Q000302:isolation & purification; D006801:Humans; D007370:Interferon Type I / Q000009:adverse effects / Q000627:therapeutic use*; D008099:Liver / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000008:administration & dosage* / Q000009:adverse effects; D011897:Random Allocation; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use
D007370:Interferon Type I; D011994:Recombinant Proteins; D000410:Alanine Transaminase; D004259:DNA-Directed DNA Polymerase; D011241:Prednisone