Hepatitis C, Chronic
Conditions
Brief summary
This prospective observational study will evaluate the efficacy and safety of peginterferon alfa-2a in combination with ribavirin in participants with chronic hepatitis C, including participants with compensated liver cirrhosis, in clinical practice.
Interventions
DRUGPeginterferon alfa-2a
Administration of treatment will be according to local recommendation under local labeling.
DRUGRibavirin
Ribavirin tablets twice daily orally will be administered depending on body weight, according summary product characteristics and prescribing of ribavirin in real clinical practice.
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
* Serologically confirmed chronic hepatitis C (CHC), hepatitis C virus (HCV) RNA detectable * Compensated liver cirrhosis (Child-Pugh Class A) included * Initiating combined therapy with peginterferon alfa-2a and ribavirin
Exclusion criteria
* Human immunodeficiency virus (HIV) co-infection * Contraindications for combined therapy according to actual prescribing information
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) (less than [<] 50 International Units per Milliliter [IU/mL]) 24 Weeks Post Therapy Completion | Baseline up to 24 Weeks Post Therapy Completion (approximately 3.5 years) |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Previously Treated Participants With SVR and Negative HCV RNA (< 50 IU/mL) at Week 12 | Week 12 |
| Percentage of Previously Treated Participants With SVR and Decrease in HCV RNA by Greater Than or Equal to (>/=) 2 Logarithm 10 From Baseline at Week 12 | Baseline, Week 12 |
| Percentage of Naive Participants With SVR and Decrease in HCV RNA by >/= 2 Logarithm 10 From Baseline at Week 12 | Baseline, Week 12 |
| Percentage of Naive Participants With Sustained Virological Response (SVR)) and Negative HCV RNA (< 50 IU/mL) at Week 4 and 12 | Week 4, 12 |
| Percentage of Naive Participants With SVR, Decrease in HCV RNA by Negative HCV RNA (<50 IU/mL) at Week 24 | Week 24 |
| Percentage of Participants With SVR and Dose Reduction of Ribavirin or Peginterferon alfa-2a due to Adverse Event | Baseline up to approximately 3.5 years |
| Percentage of Participants With Adverse Events | Baseline up to approximately 3.5 years |
| Percentage of Previously Treated Participants With SVR, Decrease in HCV RNA by Negative HCV RNA (<50 IU/mL) at Week 24 | Week 24 |
Countries
Russia, South Korea
Outcome results
None listed