Long-term clinical outcome after beta-interferon therapy in cirrhotic patients with chronic hepatitis C. TVVH Study Group.
OBJECTIVE
Few data are available concerning the short and long-term effects of beta-IFN in patients with chronic hepatitis C.


METHODS
We randomized 61 consecutive patients with HCV-related cirrhosis to receive: a) natural beta-IFN with a 6 MU/tiw for 6 months followed by 3 MU/tiw for 6 months schedule or b) no treatment. Biochemical and virological response was defined by normalization of ALT and negativization of serum HCV-RNA. Patients were followed-up for 5 years.


RESULTS
A biochemical end-of-therapy response (ETR) was observed in 5/38 patients (13%) who received beta-IFN compared to 2/23 (9%) of untreated cases, but a virological ETR appeared only in 4/38 (11%) treated cases. At long-term follow-up, 6 cases (16%) who received beta-IFN and 4 untreated (17%) developed a persistent normalization of alanine aminotransferase (ALT) but only 2 (5%) and 1 (4%), respectively, were also HCV-RNA negative. The cumulative probability of liver decompensation (variceal bleeding ascites or hepatic encephalopathy) at 60 months was 24% in treated and 35% in untreated cases. Hepatocellular carcinoma developed in 2 treated and in 1 untreated patients.


CONCLUSIONS
beta-IFN therapy was not associated with a significant improvement either in biochemical or virological response in cirrhotic patients with chronic hepatitis C. No significant reduction of cirrhosis related clinical events was linked to treatment.
Bernardinello
E
E
Department of Clinical and Experimental Medicine, University of Padova, Italy.
Cavalletto
L
L
Chemello
L
L
Mezzocolli
I
I
Donada
C
C
Benvegnú
L
L
Merkel
C
C
Gatta
A
A
Alberti
A
A
D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D016174:Hepacivirus / Q000235:genetics / Q000276:immunology; D018937:Hepatitis C Antibodies / Q000032:analysis; D019698:Hepatitis C, Chronic / Q000097:blood / Q000150:complications / Q000628:therapy* / Q000821:virology; D006801:Humans; D016899:Interferon-beta / Q000627:therapeutic use*; D008103:Liver Cirrhosis / Q000097:blood / Q000150:complications* / Q000628:therapy; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000032:analysis; D012189:Retrospective Studies; D016896:Treatment Outcome
D000998:Antiviral Agents; D018937:Hepatitis C Antibodies; D012367:RNA, Viral; D016899:Interferon-beta; D000410:Alanine Transaminase