Long-term results with interferon therapy in chronic type B hepatitis: a prospective randomized trial.
OBJECTIVE
The aims of this long-term, prospective randomized study were to evaluate the clinical usefulness of alpha-interferon in treating chronic HBV infection and to establish whether clearance of viral replication markers and normalization of liver function tests induced by alpha-interferon were sustained.


METHODS
Sixty-four patients with chronic wild type (HBeAg-positive) hepatitis B, enrolled between 1983 and 1987, were randomized into two groups. Thirty-three patients received alpha-interferon (5 MU/m2 three times weekly for 6 months; treated group), and 31 were not treated (controls). Treated and control patients were prospectively followed for a mean of 86.4 +/- 6.96 and 79.7 +/- 6.8 (p = NS) months, respectively.


RESULTS
Clearance of the following viral markers was found in treated and control patients as follows: HBV-DNA, 26 (78.9%) and 18 (58.1%) (p = 0.106); HBeAg, 30 (90.9%) and 19 (61.2%) (p < 0.007); and HBsAg, 12 (36.4%) and three (9.8%) (p < 0.017). Persistent abnormal ALT levels were found in 11 (33.3%) treated and in 22 (70.9%) control patients (p < 0.025). Four control and three treated patients developed portal hypertension whereas two control and one treated patient developed hepatocellular carcinoma. Seven patients (five treated and two controls) were retrospectively found to have hepatitis C virus (HCV) coinfection before enrollment. To date, all coinfected patients remain positive for HCV-RNA. Also, all HCV coinfected patients, except one in the treated group, had persistent increased serum ALT levels. One of the coinfected patients developed portal hypertension.


CONCLUSIONS
Chronic HBV hepatitis patients responding to interferon treatment had a faster, more complete, and sustained clearance of viral markers than controls; HCV coinfection does not seem to negatively affect the clearance of HBV replicative markers. However when coinfection occurs, hepatic disease persists despite HBV marker clearance.
Mazzella
G
G
Department of Internal Medicine and Gastroenterology, University of Bologna, Italy.
Saracco
G
G
Festi
D
D
Rosina
F
F
Marchetto
S
S
Jaboli
F
F
Sostegni
R
R
Pezzoli
A
A
Azzaroli
F
F
Cancellieri
C
C
Montagnani
M
M
Roda
E
E
Rizzetto
M
M
D000293:Adolescent; D000328:Adult; D000368:Aged; D005260:Female; D005500:Follow-Up Studies; D019694:Hepatitis B, Chronic / Q000175:diagnosis / Q000628:therapy*; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D008111:Liver Function Tests; D008134:Long-Term Care; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D014779:Virus Replication / Q000187:drug effects
D016898:Interferon-alpha