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Non-Interventional Cohort Study on the Utilization and Impact of Dual and Triple Therapies Based on Pegylated Interferon for the Treatment of Chronic Hepatitis C
This prospective, multicenter, observational cohort study will evaluate the efficacy and safety of pegylated interferon alfa (peginterferon alfa) (e.g. Pegasys) plus ribavirin and treatment regimens containing direct-acting antivirals in participants with chronic hepatitis C who are treatment-naïve or treatment-experienced and HIV HCV co-infected. Data will be collected from participants receiving treatment according to current Summary of Product Characteristics (SPC) and local labeling for the duration of their treatment and a 24-week follow-up.
Details
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Status | COMPLETED |
| Enrolment | 4442 |
| Start date | 2011-09 |
| Completion | 2015-07 |
Conditions
- Hepatitis C, Chronic
Interventions
- Peg-IFN Alfa-2a
- Peg-IFN Alfa-2b
- Ribavirin
- Boceprevir
- Telaprevir
Primary outcomes
- Percentage of Participants With Sustained Virological Response at 24 Weeks Post Completion of the Treatment Period (SVR24) — 24 weeks after end of treatment (up to 118 weeks)
SVR24 rate for dual therapy participants is defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (\<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to \[\<=\] 50 IU/mL) at 24 weeks post completion of the treatment period. If a quantitative test was used, the lower limit of quantification had to be \<=50 IU/mL. SVR24 for triple therapy participants is defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection \<= 50 IU/mL at 24 weeks post completion of the treatment period. - Percentage of Participants With Sustained Virological Response at 12 Weeks Post Completion of the Treatment Period (SVR12) — 12 weeks after end of treatment (up to 118 weeks)
SVR12 rate for dual therapy participants is defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (\<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to \[\<=\] 50 IU/mL) at 12 weeks post completion of the treatment period. If a quantitative test was used, the lower limit of quantification had to be \<=50 IU/mL. SVR12 for triple therapy participants is defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection \<= 50 IU/mL at 12 weeks post completion of the treatment period.
Countries
Belgium, Egypt, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Kuwait, Lebanon, Morocco, North Macedonia, Oman, Pakistan, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Sweden, Switzerland, Syria, Taiwan, Turkey (Türkiye), United Arab Emirates, United Kingdom