A Study of Predictors of the Effectiveness of Pegylated Interferon in a Cohort of Participants With Hepatitis C
- Conditions
- Hepatitis C, Chronic
- Interventions
- Registration Number
- NCT01659567
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 516
- Diagnosis of chronic hepatitis C infection
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Chronic Hepatitis C Pegylated Interferon Alfa-2a 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. Chronic Hepatitis C Ribavirin 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Sustained Virological Response (SVR) 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 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 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 Outcome Measures
Name Time Method 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) The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of age (greater than \[\>\] 42 years versus \<=42 years) 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).
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) The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of gender (male versus female) 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).
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) The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline ALT level (\>40 international units per liter \[IU/L\] versus \<=40 IU/L) 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).
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) The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline level of fibrosis on SVR. Level of fibrosis was measured in terms of kilopascals (kPa) using elastography. kPa score was categorized in 4 groups: 0 to 6.0; 6.1 to 9.9; 10.0 to 14.5; and 14.6 and above. 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).
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) The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline viral load count (\>800000 IU/mL versus \<=800000 IU/mL) 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).
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) The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of overall duration of treatment 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).
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) The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of body weight 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).
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) The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of duration of treatment after achieving RVR (\>18 weeks versus \<=18 weeks) on SVR. RVR was defined as HCV RNA \<=25 IU/mL at Week 4 using CAP/CTM test. 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).
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) The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of duration of treatment after achieving cEVR (\>11 weeks versus \<=11 weeks) on SVR. cEVR was defined as HCV RNA \<=25 IU/mL at Week 12, but not at Week 4 using CAP/CTM test. 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).
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 The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of cumulative doses of ribavirin 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).
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 The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of cumulative doses of pegylated interferon alfa-2a 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).
Trial Locations
- Locations (3)
Hepatology Clinic Hepa
🇬🇪Tbilisi, Georgia
Ltd Mrcheveli
🇬🇪Tbilisi, Georgia
Infectious Diseases, AIDS and Clinical Immunology Research Center
🇬🇪Tbilisi, Georgia