Conditions: Hepatitis C
Keywords: Hepatitis C Hepatitis TMC435 Liver disease Virus Infection
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 249
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Patients with sustained virologic response (SVR) who completed last post-therapy follow-up visit of the previous study (LPVPS) \[Phase IIb or Phase III\] in which they received a TMC435-containing regimen for the treatment of HCV infection. arm 2: Patients with no sustained virologic response (SVR) who completed last post-therapy follow-up visit of the previous study (LPVPS) \[Phase IIb or Phase III\] in which they received a TMC435-containing regimen for the treatment of HCV infection.

Interventions: intervention 1: No treatment
Intervention descriptions: intervention 1: 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.

Protocol document: