Due
to the risk of complications, interferon-based therapy has traditionally been
considered contraindicated in cirrhotic patients, but some may benefit from treatment.
At
the 57th annual meeting of the American Association for Liver Diseases (AASLD)
last month in Boston, researchers from the University of Palermo in Italy reported
on a study to assess outcomes in a prospective cohort of HCV positive patients
with cirrhosis after antiviral therapy.
The study included 174 consecutive
patients with Child-Pugh A5-A6 cirrhosis. The mean age was 57 years, 62.1% were
men, and 56.3% had esophageal varices. Most (88.5%) had genotype 1 HCV. About
two-thirds (67.2%) were treatment-naive and 32.8% were previously treated with
conventional interferon monotherapy.
Participants were treated with pegylated
interferon alone (27%) or pegylated interferon plus ribavirin (73%), and were
followed for at least 6 months after therapy (median 24 months, range 6-53 months).
Results
•
59
patients (34%) discontinued therapy due to side effects, and 115 received the
full scheduled treatment.
•
32
out of 174 patients (18.3%) achieved sustained virological response (SVR) in an
intent-to-treat analysis, and 32 out of 115 (27.8%) in an as-treated analysis.
•
There
were no significant differences in treatment response among patients with and
without esophageal varices (15.5 vs 21.1%; P = 0.3).
•
Patients
with SVR:
- were younger (53.7 vs 57.8 years; P < 0.01); - were more
likely to have genotype 2 or 3 HCV (65% vs 11.8%; P < 0.001); - had higher
baseline ALT levels (4.7 vs 3.6 x upper limit of normal [ULN]; P < 0.05); -
had lower baseline gamma-glutamyl transferase (GGT) levels (1.7 vs 2.7 x ULN;
P < 0.05).
•
Logistic
regression revealed that the following were independent predictors of SVR:
-
age 62 years or younger (RR 5.8; 95% CI 1.1-30.2); - genotype 2 or 3 HCV (RR
18.1; 95% CI 5.1-64); - baseline ALT > 3 ULN (RR 4.1; 95% CI 1.5-11.5); -
baseline GGT ? 1 ULN (RR 4.3;, 95% CI 1.6-11.6).
•
During
follow-up, 34 patients (19.5%) developed at least 1 liver complication.
•
2
patients died due to liver-related causes, and 1 died due to extrahepatic cancer.
•
All
34 patients with complications had genotype 1 HCV and 25 had esophageal varices.
•
31
liver-related events occurred in non-responders, compared with 2 events in patients
achieving SVR (22.5% vs 6.3%; P < 0.05).
•
By
Cox regression analysis, esophageal varices (RR 3.3; 95% CI 1.5-7.1) and SVR (RR
4.9; 95% CI 1.2-20.4) were significantly associated with liver disease progression.
Conclusion
•
Pegylated
interferon and ribavirin obtains a sustained virological response in 1/5 of patients
with compensated cirrhosis," the researchers wrote in conclusion. "The
sustained response was more common for genotypes 2 or 3, in patients with age
less than 60 years, with elevated values of ALT, and low levels of GGT."
•
Treatment
withdrawal due to intolerance and hematological toxicity was common, without life-threatening
events," they continued. "Patients with sustained virological response
had a minor incidence of disease complications during a short-term follow-up."
11/21/06
Reference V
Di Marco, P Almasio, S De Lisi, and others. The effect of antiviral therapy on
clinical outcome of HCV cirrhosis with portal hypertension: a prospective cohort
study. 57th AASLD. Boston, MA. October 27-31, 2006. Abstract 719.
