Hepatitis C, Chronic
Conditions
Brief summary
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.
Interventions
DRUGPegylated Interferon alfa-2a
Dosing was at the discretion of the investigator in accordance with local clinical practice and local labelling.
DRUGRibavirin
Dosing was at the discretion of the investigator in accordance with local clinical practice and local labelling.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | approximately 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with non-response/relapse/virological breakthrough/virological rebound | approximately 3 years |
| Percentage of patients with rapid virological response (RVR), defined as HCV RNA <50 IU/mL at Week 4 (overall and stratified by prior treatment outcome: non-response and relapse) | approximately 3 years |
| Percentage of patients with early virological response (EVR), defined as HCV RNA <50 IU/mL or an at least 2-log drop from baseline in HCV RNA at Week 12, but with no RVR (overall and stratified by prior treatment outcome: non-response and relapse) | approximately 3 years |
| Time to safety-related dose reduction/treatment discontinuation of any of the treatment compounds | approximately 3 years |
| Safety: Incidence of adverse events | approximately 3 years |
| Duration of treatment | approximately 3 years |
Countries
Romania
Outcome results
None listed