Comparison of treatment with two different doses of leukocyte interferon alpha in patients with chronic hepatitis C.
OBJECTIVE
This study was carried in order to investigate whether human leukocyte interferon-alpha administered for 12 months at two different dosages, improves long-term responses in chronic hepatitis C and to see whether pre-treatment gamma-glutamyl transpeptidase values help to predict the clinical response to Interferon.


METHODS
Forty-five patients were treated for 12 months with natural Interferon-alpha: 3 MU (group A: 31 cases); 6 MU (group B: 14 cases). Biochemical and virological responses were monitored during treatment and follow-up.


RESULTS
Alanine aminotransferase was normalized in 58.1% (Group A) and 54.5% (Group B) of patients by the end of the treatment. Due to side effects 3 patients had to discontinue treatment. During follow-up, remission was maintained in 30.8% and 45.4% of patients respectively (p = 0.046). After 12 months of therapy, respectively 46.7% and 45.4% of patients with complete biochemical response, cleared virus from serum, as did, among long-term responders, 3/8 and 3/4 evaluated patients. Independently of dosage, a complete response was found more often in patients with normal pre-treatment gamma-glutamyl transpeptidase than in those with pre-treatment abnormal values.


CONCLUSIONS
High dosage of IFN alpha was associated with a significantly greater rate of sustained biochemical response and with a better chance of viremia becoming negative. Pre-treatment gamma-glutamyl transpeptidase was able to predict the outcome of the treatment.
Laghi
V
V
Department of Infectious and Tropical Diseases. University La Sapienza Rome, Italy.
Toccaceli
F
F
Rosati
S
S
Monini
A
A
Grimaldi
M
M
Foglianti
G
G
Canova
N
N
Palazzini
E
E
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002908:Chronic Disease; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D016174:Hepacivirus / Q000235:genetics / Q000276:immunology; D006526:Hepatitis C / Q000097:blood / Q000628:therapy*; D018937:Hepatitis C Antibodies / Q000032:analysis; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000032:analysis; D012189:Retrospective Studies; D005723:gamma-Glutamyltransferase / Q000097:blood
D000998:Antiviral Agents; D018937:Hepatitis C Antibodies; D016898:Interferon-alpha; D012367:RNA, Viral; D005723:gamma-Glutamyltransferase; D000410:Alanine Transaminase