Abstract:
BACKGROUND:Little is known about the efficacy, safety and tolerability of pegylated interferon plus ribavirin treatment in patients with chronic hepatitis Cvirus (HCV) infection and histologically proven fully established cirrhosis. We aimed here to evaluate the safety of this regimen in such patients and to identify baseline and on-treatment predictors of a sustained virological response (SVR). METHODS:Patients with histologically proven, HCV-induced cirrhosis were randomized to receive pegylated interferon-alpha2b (PEG-IFN-alpha2b; 1.0 microg/kg/week, n=56; group A) or recombinant interferon-alpha2b (IFN-alpha2b; 3 million IU three times/week, n=36; group B), each in combination with a weight-based dose of ribavirin (800-1,200 mg/day) for up to 48 weeks. The primary endpoint of the study was the assessment of SVR, defined as undetectable HCV RNA 24 weeks after treatment cessation. RESULTS:Overall, 40% (37/93) of patients attained SVR: 44% (25/57) in group A and 33% (12/36) in group B (P=0.31). SVR rates were significantly higher in genotype 2/3 patients than in genotype 1 patients (69% versus 25%; P<0.0001). Platelet count at baseline, rapid virological response, and early virological response were predictors of SVR. Twelve patients discontinued treatment because of an adverse event and 20 patients required ribavirin dose reduction for the management of anaemia. CONCLUSIONS:PEG-IFN-alpha2b plus ribavirin for 48 weeks is an efficacious and well-tolerated treatment regimen for patients with HCV-induced cirrhosis. Although SVR rates were more satisfactory in genotype 2/3 than in genotype 1 patients, our study identified additional predictors of response that could allow physicians to better manage treatment in this 'difficult-to-cure' subset of patients.
journal_name
Antivir Therjournal_title
Antiviral therapyauthors
Roffi L,Colloredo G,Pioltelli P,Bellati G,Pozzpi M,Parravicini P,Bellia V,Del Poggio P,Fornaciari G,Ceriani R,Ramella G,Corradi C,Rossini A,Bruno S,Gruppo Epatologico Lombardo.subject
Has Abstractpub_date
2008-01-01 00:00:00pages
663-73issue
5eissn
1359-6535issn
2040-2058journal_volume
13pub_type
杂志文章,多中心研究,随机对照试验abstract:BACKGROUND:HBV antiviral therapy has the potential to reduce the burden of HBV-related liver disease by suppressing HBV DNA replication to undetectable levels, reducing the progression of liver fibrosis and reducing the risk of hepatocellular carcinoma (HCC) development. Treatment outcomes and long-term benefits requir...
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journal_title:Antiviral therapy
pub_type: 临床试验,杂志文章,随机对照试验
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更新日期:2003-10-01 00:00:00
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pub_type: 临床试验,杂志文章,随机对照试验
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pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
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journal_title:Antiviral therapy
pub_type: 杂志文章
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更新日期:2008-01-01 00:00:00