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IMPACT OF FIBROSIS AND VIRAL LOAD ON SUSTAINED VIROLOGIC RESPONSE OF G2 AND G3 PATIENTS TREATED WITH PEGINTERFERON alpha-2B PLUS RIBAVIRIN: RESULTS OF THE CANADIAN POWER PROGRAM
PMarotta, R Bailey, F Wong, S Feinman, N Hilzenrat, R Woolstencroft, C Cooper
London Health Sciences Centre; University of Alberta; University of Toronto; Mount Sinai Hospital; Jewish General Hospital; Schering-Plough Canada Inc; University of Ottawa
AIM: This subanalysis of the Canadian POWeR program examines the impact of viral load and fibrosis on SVR rates patients infected with either Genotype (G) 2 or G3 and treated with PEG-IFN alpha 2b and weight-based ribavirin (RBV) in “real-life” clinical settings.
METHODS: Patients received PEG-IFN alpha 2b (1.5µg/kg/wk) + weight-based RBV (800-1200mg/d) in academic and community clinics across Canada between 2002 and 2007. Sustained virologic response (SVR) was defined as undetectable HCV RNA 24 weeks post-treatment.
RESULTS: 276 (113 with liver biopsy) G2 and 389 (137 with liver biopsy) G3 patients, including those who discontinued because of side effects, lack of response, or personal reasons, were analyzed. Patients were excluded if they had undetectable HCV RNA at EOT but no 6-month follow up, had no treatment data, or had HIV/HCV co-infection. SVR rates for each of G2 and G3 patients were consistent across weight categories, although G2 patients achieved significantly higher overall SVR than those with G3 (79% vs 72%; P=0.0458). In patients with F1-F2 fibrosis and LVL, similar rates of SVR were attained for either G2 or G3 (75% vs 80%; P=ns); however, in patients with F1-F2 fibrosis and HVL, significantly higher SVR rates were observed in those with G2 than G3 (91% vs 68%; P=0.0446). Amongst G3 patients, significantly higher SVR was observed in patients without cirrhosis (F1-F3) than those with cirrhosis (F4) (75% vs 47%; P<0.026); and in those with LVL versus those with HVL (76% vs 65%; P=0.0365). The impact of cirrhosis on SVR did not exist in G2 patients.
CONCLUSIONS: These Canadian observational data reinforce the concept that G2 and G3 patients exhibit distinct responses to PEG-IFN plus weight-based RBV therapy. Viral load significantly impacts on SVR in G3 patients with minimal fibrosis. Negative prognostic characteristics of G3 cirrhotic patients require innovative therapeutic approaches including modified dose or duration of treatment.
Supported by Schering-Plough