The purpose of this study is to investigate durability of SVR in chronic HCV patients who achieved SVR in the previous study with TMC435-containing regimen and time for resistance associated mutations to return to baseline in chronic HCV patients who did not achieve SVR in the previous study with TMC435-containing regimen.
Name: No treatment
Description: No treatment was given to patients during this study as this is a follow-up study of previous Phase IIb or Phase III in which they received a TMC435-containing regimen.Type: DrugGroup 1: TMC 435 - Patients With SVR at LPVPS Group 2: TMC 435 - Patients With No SVR at LPVPS
Description: The SVR rate is the proportion (%) of participants with HCV RNA less than (<) 25 International Units/milliliter (IU/mL).
Measure: Percentage of Participants Maintaining SVR at the Last Available Visit Time: Last Available Visit (Month 36 for subjects completing the study)Description: Sequencing was performed to assess changes in the sequence of the HCV NS3/4A protein region over time in participants with no SVR at LPVPS (ie confirmed detectable HCV RNA at the last visit of the previous study). EOS defined as last available sequencing sample. AEM and NEM represents any emerging mutation and no emerging mutation at time of failure of the previous study.
Measure: Overall Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA at the Last Visit of the Previous Study Time: Baseline and Month 36Description: Sequencing was performed to assess changes in the sequence of the HCV NS3/4A protein region over time in participants with no SVR at LPVPS (ie confirmed detectable HCV RNA at the last visit of the previous study). EOS defined as last available sequencing sample. AEM and NEM represents any emerging mutation and no emerging mutation at time of failure of the previous study.
Measure: Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA (With Q80K at Baseline) at the Last Visit of the Previous Study Time: Baseline and Month 36Description: Sequencing was performed to assess changes in the sequence of the HCV NS3/4A protein region over time in participants with no SVR at LPVPS (ie confirmed detectable HCV RNA at the last visit of the previous study). EOS defined as last available sequencing sample. AEM and NEM represents any emerging mutation and no emerging mutation at time of failure of the previous study.
Measure: Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA (Without Q80K at Baseline) at the Last Visit of the Previous Study Time: Baseline and Month 36Description: Relapse at any time after the LPVPS until the last individual visit of this study. All participants maintained SVR until the last available visit. No late viral relapse was therefore observed.
Measure: Percentage of Participants With Late Viral Relapse Time: End of study (at month 36)Allocation: Non-Randomized
Parallel Assignment
There is one SNP
AEM and NEM represents any emerging mutation and no emerging mutation at time of failure of the previous study.. Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA (With Q80K at Baseline) at the Last Visit of the Previous Study. --- Q80K ---
AEM and NEM represents any emerging mutation and no emerging mutation at time of failure of the previous study.. Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA (Without Q80K at Baseline) at the Last Visit of the Previous Study. --- Q80K ---