A Retrospective Study to Assess the Impact of the Use of Interferon in Patients With Chronic Hepatitis C (DECISION)

Roche

Status: Completed

Conditions: Hepatitis C, Chronic

Treatments: Drug: Peginterferon Alfa-2a; Drug: Conventional Interferon; Drug: Ribavirin; Drug: Peginterferon Alfa-2b

Study type: Observational

Funder types: Industry

Identifiers

NCT01280656

ML22995

Details and patient eligibility

About

This retrospective study will assess the sustained virologic response and the safety of two different interferons (pegylated or conventional) in patients with chronic hepatitis C. Data will be collected for 24 weeks.

Enrollment: 660 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, >/=18 years and <70 years of age
• Diagnosis of hepatitis C
• Assessment of viral load prior to treatment (mandatory for genotype 1 only)
• Liver biopsy
• Co-morbidities data
• Use of interferon (pegylated or conventional) and ribavirin to treat hepatitis C infection genotype 2 and 3 and pegylated interferon plus ribavirin to treat hepatitis C infection genotype 1
• Above mentioned treatment started between 01-Sep-2007 and 31-Aug-2008

Exclusion criteria

• Co-infection with human immunodeficiency virus
• Co-infection with hepatitis B virus
• Presence of hepatocarcinoma
• Patients submitted to hemodialysis
• Organ transplant patients

Trial design

660 participants in 3 patient groups

Conventional Interferon Plus Ribavirin

Description:

Eligible participants who will receive conventional interferon plus ribavirin for Chronic Hepatitis C (CHC) according to the standard of care and aligned with the local prescription instructions will be observed during treatment period (48 weeks) and follow up period (24 weeks).

Treatment:

Drug: Conventional Interferon

Drug: Ribavirin

Peginterferon Alfa-2a Plus Ribavirin

Description:

Eligible participants who will receive peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions will be observed during treatment period (48 weeks) and follow up period (24 weeks).

Treatment:

Drug: Peginterferon Alfa-2a

Drug: Ribavirin

Peginterferon Alfa-2b Plus Ribavirin

Description:

Eligible participants who will receive peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions will be observed during treatment period (48 weeks) and follow up period (24 weeks).

Treatment:

Drug: Peginterferon Alfa-2b

Drug: Ribavirin