An escalating dose regimen of pegylated interferon and ribavirin in HCV cirrhotic patients referred for liver transplant.
BACKGROUND
To lessen the severity of recurrent hepatitis C virus (HCV) postliver transplantation (post-LT) by treating HCV patients with cirrhosis, we assessed the safety and efficacy of an escalating dose pegylated interferon (PEG-IFN)/ribavirin protocol in pre-LT patients.


METHODS
Ninety patients were treated with 90 microg PEG-IFN alpha-2a and 400 mg ribavirin and advanced to 180 microg and 800 to 1200 mg, respectively, over 8 weeks.


RESULTS
Mean age was 55.3 years. Thirty-four percent of patients received prior interferon treatment, 77% had genotype 1 or 4. Mean Child's score was 6.7 and model for end-stage liver disease 11.2; 49% reached full-dose PEG-IFN and 85% ribavirin, 18% required dose reduction, 33% stopped treatment because of adverse effects, 9% had deterioration of liver function, and 7% died. Follow-up of 9.6 months showed sustained virological response in 13% of patients. The rate of serious complications was 16.3% in Child's class A, 48% in B, and 100% in C (P=0.005). Serum albumin was a significant predictor for worsening liver function (P=0.007).


CONCLUSIONS
Using an escalating dose regimen of PEG-IFN alpha-2a and ribavirin, we achieved only a 13% sustained virological response in HCV cirrhotic pre-LT patients with an accompanying 9% risk of worsening liver function and 7% risk of death.
Massoumi
Hatef
H
Division of Gastroenterology and Hepatology, Our Lady of Mercy Medical Center, Bronx, NY, USA.
Elsiesy
Hussein
H
Khaitova
Viktoriya
V
Peterson
Brent
B
Norkus
Edward
E
Grewal
Priya
P
Liu
Lawrence
L
Chang
Charissa
C
Bach
Nancy
N
Schiano
Thomas D
TD
D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000378:metabolism*; D006526:Hepatitis C / Q000188:drug therapy* / Q000821:virology*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D008103:Liver Cirrhosis / Q000188:drug therapy / Q000628:therapy* / Q000821:virology; D016031:Liver Transplantation / Q000379:methods*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011994:Recombinant Proteins; D012254:Ribavirin / Q000627:therapeutic use*; D016896:Treatment Outcome
D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b