TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFα-2a and Ribavirin in Chronic Hepatitis C Patients Who Were Null or Partial Responders to Prior PegINFα-2a and Ribavirin Therapy (ATTAIN)

This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis C, TMC435HPC3001, TMC435, Hepatitis C Virus (HCV), HEP C, Genotype 1, Treatment experienced, Null responders, Partial responders Read More

Inclusion Criteria:

• Patient must have had a liver biopsy before screening (or between the screening and baseline visit), unless patient cannot undergo such a procedure or has evidence of portal hypertension not associated with cirrhosis. For patients who had a liver biopsy performed more than 2 years prior to screening or without a biopsy (because of a contraindication or portal hypertension), a non-invasive staging assessment needs to be available. Non-invasive staging assessments include FibroScan, MR-Elastography, or FibroTest/FibroSure and must not be older than 6 months prior to screening
• Chronicity of hepatitis C virus (HCV) infection, as confirmed by one or both of the following: presence of anti-HCV antibody and/or HCV ribonucleic acid (RNA) at least 6 months prior to the screening visit and/or presence of fibrosis on biopsy
• Genotype 1 HCV infection with plasma HCV RNA of >10,000 IU/mL (both confirmed at screening)
• Patient must have had at least 1 documented previous course of treatment with PegINFα-2a or PegINFα-2b in combination with ribavirin (RBV) (at least 12 weeks for null responder and 20 weeks for partial responder)

Exclusion Criteria:

• Hepatic decompensation (impaired functioning of the liver), as indicated by significant laboratory abnormalities or other active diseases
• Infection with Human Immunodeficiency Virus (HIV) or non genotype 1 hepatitis C
• Liver disease not related to hepatitis C infection
• Previous chronic hepatitis C treatment, other than PegIFN and RBV