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
- 4680
- Primary Endpoint
- Percentage of Participants With Sustained Virological Response by Genotype in Per-Protocol 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) 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 <5000.
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 Hepatitis B Virus (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®)
Outcomes
Primary Outcomes
Percentage of Participants With Sustained Virological Response by 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. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Percentage of Participants With Modified Sustained Virological Response by 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 who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Percentage of Participants With Modified Sustained Virological Response by 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. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response by Genotype 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. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Percentage of Participants With Sustained Virological Response by 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 hepatitis C virus (HCV) mono-infected modified all-treated (mTRT) who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Percentage of Participants With Predictive Values of Virological Response by Week 4 and Week 12 on Modified Sustained Virological Response by Genotype 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. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
Secondary Outcomes
- Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time(At Week 2, Week 4, and Week 12, EOT, and 12 weeks after EOT)
- Percentage of Participants With Virological Response by Genotype in Per-Protocol 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 Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12(Week 2, Week 4, and Week 12)
- Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12(Week 4 and Week 12)
- Percentage of Participants With At Least 1 Log Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12(Week 2, Week 4, and Week 12)
- Percentage of Participants With Modified Virological Response by 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 1-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12(Week 2, Week 4, and Week 12)
- Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time(At Week 2, Week 4, Week 12, EOT, and 12 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)
- Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population(At 24 weeks after EOT)
- Percentage of Participants With At Least 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype 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 by Genotype 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 Per Protocol Population at 24 Weeks After End of Treatment(At 24 weeks after EOT)
- Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population(At 24 weeks after EOT)
- 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)
- 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)