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.
This is a 3-year follow-up study in patients who completed the last post-therapy follow-up visit of the previous Phase IIb \[NCT00882908, NCT00980330\] or Phase III \[NCT01289782, NCT01290679, NCT01281839\] study in which they received TMC435, in combination with pegylated interferon and ribavirin, for the treatment of hepatitis C infection. The entire study duration for each patients will be approximately 36 months. The medical follow-up of the patients will be performed according to the local standard of care. This study will evaluate the levels of hepatitis C virus in the blood circulation, as well as safety and alpha-fetoprotein testing and the change in sequence of HCV NS3/4A region over time in patients with confirmed detectable HCV RNA at last post-therapy follow-up visit of the previous TMC435 study. In this study the development of liver disease progression will also be assessed. No medication will be administered in this study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
249
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.
Percentage of Participants Maintaining SVR at the Last Available Visit
The SVR rate is the proportion (%) of participants with HCV RNA less than (\<) 25 International Units/milliliter (IU/mL).
Time frame: Last Available Visit (Month 36 for subjects completing the study)
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
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.
Time frame: Baseline and Month 36
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
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.
Time frame: Baseline and Month 36
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
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.
Time frame: Baseline and Month 36
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Unnamed facility
Bakersfield, California, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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Jacksonville, Florida, United States
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Orlando, Florida, United States
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Chicago, Illinois, United States
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New Orleans, Louisiana, United States
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Saint Paul, Minnesota, United States
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Tupelo, Mississippi, United States
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Chapel Hill, North Carolina, United States
...and 38 more locations
Percentage of Participants With Late Viral Relapse
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.
Time frame: End of study (at month 36)
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
Time frame: End of study (at month 36)