An Observational Study of Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) on Predictive Values of RVR on Sustained Virological Response in Different Stages of Liver Fibrosis in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1
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This observational study will evaluate the predictive value of rapid virological response (RVR) and early virological response (EVR) on sustained virological response (SVR) by stage of liver fibrosis in treatment-naïve patients with chronic hepatitis C genotype 1 initiated on treatment with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). Patients will be followed for 48 weeks of treatment and up to 24 weeks of follow-up.
An Observational Study of Peginterferon-alfa-2a (Pegasys) and Ribavirin (Copegus) on Predictive Values of RVR on Sustained Virological Response (SVR) in Different Stage of Liver Fibrosis in Treatment-naïve Patients With Genotype 1 Chronic Hepatitis C
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Sustained virological response (SVR) rate, in relation to rapid virological response (RVR) in different stages of liver fibrosis in treatment-naïve patients with chronic hepatitis C genotype 1 [ Time Frame: approximately 3 years ]
Secondary Outcome Measures :
Safety: Incidence of adverse events [ Time Frame: approximately 3 years ]
Sustained virological response (SVR) rate, in relation to early virological response (EVR) in different stages of liver fibrosis in treatment naïve patients with chronic hepatitis C genotype 1 [ Time Frame: approximately 3 years ]
Response rates (RVR, EVR, SVR) according to host/virus/treatment-related factors in different stages of liver fibrosis (F>/=3 and </=3) [ Time Frame: approximately 3 years ]
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Treatment-naïve patients with chronic hepatitis C genotype 1 initiated on treatment with Pegasys and Copegus
Adult patients, >/= 18 years of age
Chronic hepatitis C genotype 1
Treatment-naïve, i.e. have not been previously treated with pegylated interferon, standard interferon and ribavirin
Confirmed serum positive HCV RNA
Liver fibrosis confirmed histologically or by fibroscan up to 24 months before treatment
Any contraindications according to the Summary of Product Characteristics for Pegasys or Copegus
Co-infection with hepatitis B or HIV
End stage renal disease (creatinine clearance < 15 ml/min)
Patients treated with immunotherapy
Pregnant women and male partners of women who are pregnant
Female patients of childbearing potential and male patients with female partners of childbearing potential who are unable or unwilling to use effective and continuous contraception during the treatment and for 4 months (females) and 7 months (males) thereafter