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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pegylated interferon alfa-2a | Participants with chronic hepatitis C with previous treatment failure received combination therapy with pegylated interferon alfa-2a plus ribavirin or treatment regimens containing direct-acting anti-viral (DAAs) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegylated Interferon alfa-2a | Drug | Dosing was at the discretion of the investigator in accordance with local clinical practice and local labelling. |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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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:
Exclusion Criteria:
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Treatment-experienced participants with chronic hepatitis C receiving re-treatment with Pegasys plus ribavirin or regimens containing direct-acting antivirals (DAAs)
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brasov | 500326 | Romania |
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|
| Ribavirin | Drug | Dosing was at the discretion of the investigator in accordance with local clinical practice and local labelling. |
|
| approximately 3 years |
| Percentage of patients with non-response/relapse/virological breakthrough/virological rebound | approximately 3 years |
| Duration of treatment | 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 |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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