Due to difficult side-effects, some experts have
traditionally recommended that hepatitis C patients
with liver cirrhosis should not
be treated with interferon-based therapy.
However, since this is the patient group in greatest need of treatment, researchers
have explored such regimens in clinical trials.
As reported in the February
15, 2008 advance online edition of the Journal of Clinical Gastroenterology,
Italian researchers conducted a study to evaluate the safety and efficacy of interferon-based
combination therapy in previously untreated patients with compensated HCV-related
cirrhosis. They also assessed factors that influence the likelihood of sustained
virological response (SVR) in cirrhotic patients and analyzed clinical outcomes
in sustained responders and non-responders.
The investigators enrolled
365 consecutive patients with biopsy-proven chronic hepatitis C meeting the inclusion
criteria for use of pegylated
interferon alfa-2b (PegIntron) plus ribavirin; 87 of the participants had
compensated liver cirrhosis, while 278 had histological stages between F1 and
F4 on the Ishak scale.
Results
•
At baseline, the cirrhotic and non-cirrhotic patients were comparable with regard
to HCV genotype, HCV viral load, and alanine aminotransferase (ALT) levels at
presentation.
•
The cirrhotic patients were significantly older and had higher body mass index,
serum ferritin, and gamma-glutamyl transpeptidase (GGT) levels.
•
The SVR rate was significantly lower for the cirrhotic patients (45.9%) compared
with the non-cirrhotic subjects (65.8%).
•
The frequency of treatment-related side effects was similar in the 2 groups.
•
Logistic regression analysis showed that, overall, HCV genotypes 1 or 4 and high
HCV viral load were independent variables correlating with non-response.
•
5 of 38 cirrhotic patients (13.2%) who did not respond or who relapsed after treatment
developed hepatocellular carcinoma (HCC) during follow-up.
•
However, no cases of HCC were seen among cirrhotic or non-cirrhotic patients who
achieved SVR.
Conclusion
In
conclusion, the authors wrote, "Cirrhotic patients with compensated disease
have a reasonably good chance of virologic response and should be offered treatment,
carefully monitoring any side effects."
3/11/08
Reference A
Floreani, V Baldo, ER Rizzotto, and others. Pegylated Interferon Alpha-2b Plus
Ribavirin for Naive Patients With HCV-related Cirrhosis. Journal of Clinical
Gastroenterology. February 15, 2008 [Epub ahead of print].
Results
