Prospective, Observational Study of Predictors of the Effectiveness of Pegylated Interferon in a Cohort of Patients With Hepatitis C in Georgia
Overview
- Phase
- Not Applicable
- Intervention
- Pegylated Interferon Alfa-2a
- Conditions
- Hepatitis C, Chronic
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 516
- Locations
- 3
- Primary Endpoint
- Percentage of Participants Achieving Sustained Virological Response (SVR)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This prospective observational study will investigate predictive values of virological response in pegylated interferon alfa-2a (Pegasys)/ribavirin (Copegus) treatment-naive participants with chronic hepatitis C. Participants will be treated with pegylated interferon alfa-2a and ribavirin as prescribed by the physician. Data will be collected for a maximum of 96 weeks.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of chronic hepatitis C infection
Exclusion Criteria
- •Co-infection with human immunodeficiency virus (HIV) and/or hepatitis B
- •Participants previously treated with pegylated interferon alfa-2a/ribavirin
- •Participation in another clinical study within 30 days prior to study start of ML25544
Arms & Interventions
Chronic Hepatitis C
Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (Copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, will be observed for up to 96 weeks.
Intervention: Pegylated Interferon Alfa-2a
Chronic Hepatitis C
Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (Copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, will be observed for up to 96 weeks.
Intervention: Ribavirin
Outcomes
Primary Outcomes
Percentage of Participants Achieving Sustained Virological Response (SVR)
Time Frame: At 24 weeks after end of treatment (EOT) (up to 96 weeks), where EOT = up to 72 weeks
SVR was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) level undetectable (less than \[\<\] 15 international units per milliliter \[IU/mL\]) 24 weeks after completion of the actual treatment period (measured using the COBAS AmpliPrep \[CAP\]/ COBAS TaqMan \[CTM\] test). Percentage of participants achieving SVR was reported.
PPV of Complete Early Viral Response (cEVR) on SVR
Time Frame: At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks
cEVR was defined as HCV RNA \<=25 IU/mL at Week 12, but not at Week 4 using CAP/CTM test. The percentage of participants with probability that the participant who develops cEVR would achieve SVR was termed as PPV of cEVR on SVR. SVR was defined as HCV RNA level undetectable (\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Positive Predictive Value (PPV) of Rapid Viral Response (RVR) on SVR
Time Frame: At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks
RVR was defined as HCV RNA less than or equal to (\<=) 25 IU/mL at Week 4 using CAP/CTM test. The percentage of participants with probability that the participant who develops RVR would achieve SVR was termed as PPV of RVR on SVR. SVR was defined as HCV RNA level undetectable (\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).
Secondary Outcomes
- Odds Ratio (OR) for Impact of Age on SVR(Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks))
- OR for Impact of Gender on SVR(Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks))
- OR for Impact of Baseline Alanine Transaminase (ALT) Level on SVR(Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks))
- OR for Impact of Baseline Level of Fibrosis (kPa) on SVR(Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks))
- OR for Impact of Baseline Viral Load Count on SVR(Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks))
- OR for Impact of Overall Duration of Treatment on SVR(Baseline up to 96 weeks (assessed at Baseline, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks))
- OR for Impact of Body Weight on SVR(Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks))
- OR for Impact of Duration of Treatment After Achieving RVR on SVR(Baseline up to 96 weeks (assessed at Baseline, Week 4, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks))
- OR for Impact of Duration of Treatment After Achieving cEVR on SVR(Baseline up to 96 weeks (assessed at Baseline, Weeks 4, 12, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks))
- OR for Impact of Cumulative Doses of Ribavirin on SVR(At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks)
- OR for Impact of Cumulative Doses of Pegylated Interferon Alfa-2a on SVR(At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks)