Effect of prolonged interferon therapy on the outcome of hepatitis C virus-related cirrhosis: a randomized trial.
OBJECTIVE
The impact of interferon (IFN) treatment on the occurrence of complications related to hepatitis C virus (HCV)-related cirrhosis is debated because the majority of studies are retrospective. We designed a randomized controlled trial comparing the efficacy of prolonged IFN alfa-2a treatment vs nontreatment on complication-free survival in patients with compensated HCV cirrhosis.


METHODS
A total of 102 patients (mean age, 60.5 +/- 9.5 y; male/female ratio, .82) with biopsy examination-proven HCV cirrhosis, Child-Pugh score A, who were hepatocellular carcinoma (HCC) free, and had at least 1 risk factor of complications were randomized to receive IFN or no therapy for 24 months.


RESULTS
During the follow-up evaluation, the complication rate was 24.5%: HCC occurred in 12 and decompensation unrelated to HCC occurred in 13 patients. The number of HCC patients was similar in both groups. The probability of complication-free survival was not significantly different between treated and untreated patients (98% and 72.3% vs 90% and 70.7% at 12 and 24 mo, respectively, P = .59). The median time until complication occurrence was 17.1 months in the treated group vs 13.6 months in the untreated group (P = .2).


CONCLUSIONS
This randomized controlled trial showed that a 2-year course of IFN has little or no impact on complication-free survival in patients with high-risk compensated HCV cirrhosis.
Fartoux
Laetitia
L
AP-HP, Hôpital Saint-Antoine, Paris, France.
Degos
Françoise
F
Trépo
Christian
C
Goria
Odile
O
Calès
Paul
P
Tran
Albert
A
Buffet
Catherine
C
Poynard
Thierry
T
Capron
Dominique
D
Raabe
Jean-Jacques
JJ
Roulot
Dominique
D
Naveau
Sylvie
S
Grange
Jean-Didier
JD
Poupon
Renée E
RE
Poupon
Raoul
R
Serfaty
Lawrence
L
D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use; D016001:Confidence Intervals; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D019698:Hepatitis C, Chronic / Q000175:diagnosis / Q000188:drug therapy / Q000401:mortality*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D008103:Liver Cirrhosis / Q000188:drug therapy* / Q000401:mortality* / Q000821:virology*; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D011336:Probability; D011379:Prognosis; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011994:Recombinant Proteins; D012016:Reference Values; D018570:Risk Assessment; D012720:Severity of Illness Index; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome
D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins