Non-interventional Study to Observe Triple Combination Therapy With Boceprevir or Simeprevir Plus Peginterferon Alfa-2a Plus Ribavirin for Re-treatment of Chronic Hepatitis C in Hungary (IMPERIAL)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 19
- Primary Endpoint
- Sustained Virological Response 24 (SVR24) Rate
Study Overview
Brief Summary
This prospective, national, multicenter, non-interventional study examined the use of triple combination therapy with boceprevir, pegylated interferon (peginterferon) alfa-2a and ribavirin in re-treating participants with genotype 1 chronic hepatitis C (CHC) infection. Dosing and treatment duration were at the discretion of the investigator in accordance with local clinical practice and local labeling. Participants were to be observed for the duration of their triple combination therapy and for up to 24 weeks thereafter.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years of age or over
- •Genotype 1 CHC infection
- •Prior unsuccessful treatment with peginterferon alfa plus ribavirin (null-response, partial response and relapsed participants)
- •Receiving triple combination therapy with boceprevir, peginterferon alfa-2a and ribavirin according to standard of care and in line with local labeling
- •Enrollment in the study no later than 4 weeks after start of triple combination therapy (including peginterferon alfa-2a and ribavirin lead-in phase)
Exclusion Criteria
- •Naïve participants not responding to peginterferon alfa plus ribavirin at week 4 (HCV RNA drop < 1 log10) or at week 12 (HCV RNA >/= 15 international units/milliliter [IU/mL]) and switching to triple combination therapy with boceprevir
Arms & Interventions
Triple Combination Therapy
Participants who demonstrated genotype 1 chronic hepatitis C infection and had a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa + ribavirin, and who were subjected to receive a triple combination therapy with simeprevir or boceprevir plus peginterferon alfa-2a and ribavirin were observed.
Intervention: Boceprevir (Drug)
Triple Combination Therapy
Participants who demonstrated genotype 1 chronic hepatitis C infection and had a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa + ribavirin, and who were subjected to receive a triple combination therapy with simeprevir or boceprevir plus peginterferon alfa-2a and ribavirin were observed.
Intervention: Simeprevir (Drug)
Triple Combination Therapy
Participants who demonstrated genotype 1 chronic hepatitis C infection and had a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa + ribavirin, and who were subjected to receive a triple combination therapy with simeprevir or boceprevir plus peginterferon alfa-2a and ribavirin were observed.
Intervention: Pegylated Interferon (Peginterferon) Alfa-2a (Drug)
Triple Combination Therapy
Participants who demonstrated genotype 1 chronic hepatitis C infection and had a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa + ribavirin, and who were subjected to receive a triple combination therapy with simeprevir or boceprevir plus peginterferon alfa-2a and ribavirin were observed.
Intervention: Ribavirin (Drug)
Outcomes
Primary Outcomes
Sustained Virological Response 24 (SVR24) Rate
Time Frame: 24 weeks after end of treatment (EOT) at Week 72
The SVR 24 rate is defined as percentage of participants with Hepatitis C virus (HCV) Ribonucleic Acid (RNA) less than 15 international unit/milliliter (IU/mL) after the 24-weeks follow-up.
Secondary Outcomes
- Number of Participants With Treatment Discontinuation Due to Futility(Up to Week 48)
- Number of Participants With Adverse Events(Up to 72 weeks)
- Percentage of Participants With Virological Response(Weeks 4, 8, 12, and 24)
- Percentage of Participants With Positive Predictive Value of Liver Fibrosis(Screening (before Week 1))
- Number of Participants With Virological Breakthrough(Up to Week 48)
- Percentage of Participants With Positive Predictive Value of Participant Demographics for SVR Rate(Screening (before Week 1))
- Predictive Value of HCV Disease Characteristics(Screening (before Week 1))
- Number of Participants With Virological Relapse(Week 49 up to Week 72)
- Number of Participants With Treatment Discontinuation(Up to Week 48)
- Percentage of Participants With Positive Predictive Value of Previous Virological Response (Null-response, Partial Response, or Relapse)(Up to 72 weeks)