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

Roche

Status: Completed

Conditions: Hepatitis C, Chronic

Study type: Observational

Funder types: Industry

Identifiers

NCT01750216

ML28344

Details and patient eligibility

About

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.

Enrollment: 196 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Any contraindications according to the Summary of Product Characteristics for Pegasys or Copegus
• Co-infection with hepatitis B or HIV
• Post-transplant patients
• 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

Trial design

196 participants in 1 patient group

Cohort