Prospective Observational Study on Predictors of Early On-treatment Response and Sustained Virological Response in a Cohort of Treatment naïve HCV-infected Patients Treated With Pegylated Interferons.
Overview
- Phase
- Not Applicable
- Intervention
- Peginterferon alfa-2a [Pegasys]
- Conditions
- Hepatitis C, Chronic
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 2343
- Primary Endpoint
- Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This observational study will assess predictors of early on-treatment and sustained virological response in treatment-naïve patients with chronic hepatitis C initiated on treatment with Pegasys (peginterferon alfa-2a) or peginterferon alfa-2b and ribavirin. Data will be collected during the treatment period (24 or 48 weeks) and 12 and 24 weeks after the end of treatment. Target sample size is <2000.
Investigators
Eligibility Criteria
Inclusion Criteria
- •adult patients, \>/= 18 years of age
- •chronic hepatitis C
- •informed consent to data collection
Exclusion Criteria
- •co-infection with HIV or HBV
- •previous treatment with peginterferon and/or ribavirin
Arms & Interventions
Cohort
Participants chronically infected with the hepatitis C virus including genotypes 1 to 6
Intervention: Peginterferon alfa-2a [Pegasys]
Cohort
Participants chronically infected with the hepatitis C virus including genotypes 1 to 6
Intervention: Peginterferon alfa-2b [PegIntron®]
Outcomes
Primary Outcomes
Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population
Time Frame: At 24 weeks after EOT
Modified sustained virological response (mSVR) was defined as modified virological response (mVR) of HCV RNA \<50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population
Time Frame: At 24 weeks after EOT
Sustained virological response was defined as VR at 24 weeks after EOT. Virological response was defined as HCV RNA of \<15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive HCV mono-infected per protocol (PP) population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population
Time Frame: At 24 weeks after EOT
The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population
Time Frame: At 24 weeks after EOT
Sustained virological response (SVR) was defined as virological response (VR) at 24 weeks after end of treatment (EOT). Virological response was defined as hepatitis C virus ribonucleic acid (HCV RNA) of \<15 international units per milliliter (IU/mL) as assessed by COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (lower limit of detection \[LLOD\] 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive HCV mono-infected modified all-treated (mTRT) population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population
Time Frame: At 24 weeks after EOT
Modified sustained virological response is defined as mVR of HCV RNA \<50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population
Time Frame: At 24 weeks after EOT
The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the positive predictive value (PPV) of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the negative predictive value (NPV) of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Secondary Outcomes
- Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time(At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT)
- Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time(At Week 2, Week 4, Week 12, EOT, and 12 Weeks after EOT)
- Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time(At Week 2, Week 4, Week 12, EOT, and 12 Weeks after EOT)
- Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time(At Week 2, Week 4, Week 12, EOT, and 12 Weeks after EOT)
- Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12(At Week 2, Week 4 and Week 12)
- Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population(24 weeks after EOT)
- Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 24 Weeks After End of Treatment(At 24 weeks after EOT)
- Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12(At Week 2, Week 4 and Week 12)
- Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population(24 weeks after EOT)
- Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment(At 24 weeks after EOT)
- Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12(At Week 4 and Week 12)
- Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 12 Weeks After End of Treatment(At 12 weeks after EOT)
- Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12(At Week 2, Week 4 and Week 12)
- Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12(At Week 2, Week 4 and Week 12)
- Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12(At Week 4 and Week 12)
- Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment(At 12 weeks after EOT)