An Observational Study of Pegasys (Peginterferon Alfa-2a) Plus Ribavirin Based Regimens in Patients With Chronic Hepatitis C With Previous Treatment Failure

Hoffmann-La Roche282 enrolled

Overview

This prospective, national, multicenter, observational study will evaluate in routine clinical practice the efficacy and safety of re-treatment with Pegasys (peginterferon alfa-2a) plus ribavirin or regimens containing direct-acting antivirals in participants with chronic hepatitis C who failed previous treatment. Participants will be followed for the duration of their treatment (24, 48 or 72 weeks) and for 24 weeks of follow-up.

Study Type

OBSERVATIONAL

Enrollment

282

Conditions

Hepatitis C, Chronic

Interventions

Pegylated Interferon alfa-2aDRUG

Dosing was at the discretion of the investigator in accordance with local clinical practice and local labelling.

RibavirinDRUG

Dosing was at the discretion of the investigator in accordance with local clinical practice and local labelling.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult participants, \>/= 18 years of age * Participants with chronic hepatitis C who have been previously treated with pegylated interferon, standard interferon, ribavirin * No contra-indications to pegylated interferon and ribavirin therapy or to the treatment regimen containing DAAs as detailed in the local label * Treatment in line with summary of Product Characteristics/local labeling for Pegasys/ribavirin and DAAs, in particular: * Positive serum hepatitis C virus (HCV) ribonucleic acid (RNA) * Fertile males and females receiving ribavirin must use two forms of contraception during treatment with Pegasys/ribavirin and until 6 months post-treatment * No co-infection with hepatitis B or human immunodeficiency virus (HIV) Exclusion Criteria: * History or other evidence of a medical condition associated with chronic liver disease other than chronic hepatitis C * History of neurological disease * History of severe psychiatric disease * Decompensated diabetes * History of immunologically mediated disease * History of severe cardiac disease * History or evidence of severe chronic pulmonary disease * Inadequate hematologic function * Pregnant or breastfeeding women * Male partners of pregnant women

Locations (1)

Unnamed facility

Brasov, Romania

Outcomes

Primary Outcomes

Sustained virological response (SVR) rate, defined as percentage of patients with HCV RNA <50 IU/mL at 24 weeks post completion of treatment (overall and stratified by prior treatment outcome: non-response and relapse)