Pegylated interferon alpha-2b plus ribavirin for naive patients with HCV-related cirrhosis.
BACKGROUND
Data on the efficacy of antiviral therapy in patients with HCV-related compensated cirrhosis are generally drawn from analyzing subgroups in larger trials.


OBJECTIVE
(1) To analyze the safety and efficacy of combination therapy in naive patients with HCV-related cirrhosis; (2) to evaluate the factors influencing the sustained virologic response (SVR) in cirrhotic patients by comparison with a group of noncirrhotic patients; (3) to analyze the outcome of cirrhotic patients either acquiring SVR and nonresponders to the antiviral therapy during the posttreatment follow-up.


METHODS
We consecutively enrolled 365 patients with biopsy-proven HCV-related chronic hepatitis meeting the inclusion criteria for pegylated interferon a-2b plus Ribavirin: 87 patients had compensated liver cirrhosis and 278 had histologic stages between 1 and 4 according to Ishak's classification.


RESULTS
The 2 groups were comparable for genotype, viral load, and alanine transferase at presentation. Cirrhotic patients were significantly older and had significantly higher body mass index, serum ferritin, and gamma-glutamyl transpeptidase. The rate of side effects was similar in the 2 groups, whereas the rate of SVR was significantly lower in cirrhotic (45.9%) than in noncirrhotic patients (65.8%). Logistic regression analysis showed that genotype 1 to 4 and high viral load were independent variables correlating with nonresponse in the sample as a whole. During follow-up, hepatocellular carcinoma developed in 5/38 (13.2%) cirrhotic patients not responding or relapsing after treatment. No cases of hepatocellular carcinoma were seen among cirrhotic or noncirrhotic patients with a SVR.


CONCLUSIONS
Cirrhotic patients with compensated disease have a reasonably good chance of virologic response and should be offered treatment, carefully monitoring any side-effects.
Floreani
Annarosa
A
Department of Surgical and Gastroenterological Sciences, University of Padova , Padova, Italy. annarosa.floreani@unipd.it
Baldo
Vincenzo
V
Rizzotto
Erik Rosa
ER
Carderi
Isabella
I
Baldovin
Tatjana
T
Minola
Eliseo
E
D000328:Adult; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000209:etiology / Q000517:prevention & control*; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005838:Genotype; D019698:Hepatitis C, Chronic / Q000150:complications* / Q000188:drug therapy; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use; D008103:Liver Cirrhosis / Q000188:drug therapy* / Q000209:etiology; D008113:Liver Neoplasms / Q000209:etiology / Q000517:prevention & control; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins; D012008:Recurrence; D012254:Ribavirin / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome; D019562:Viral Load
D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D012254:Ribavirin