Direct Acting Antiviral-Post Authorization Safety Study

Screening Inclusion Criteria:

• Current participant in TARGET-HCC
• Adults, age ≥18 years
• First diagnosis of HCC (mixed HCC/cholangiocarcinoma may be included). Diagnosis may be histological/cytological and/or radiological.
• BCLC Stage A
• Underwent, undergoing, or planned to undergo therapy for HCC, with exception that transplant as prior or planned treatment for HCC is excluded.
• HCV RNA positive

Screening Exclusion Criteria:

• Inability to provide informed consent
• HCC-free imaging (as defined in Section 9.1.1) after treatment of initial HCC prior to Screening (see Section 9.2.9 for imaging details)
• Prior liver transplantation
• Hepatitis B Virus (HBV) surface antigen positive (HBsAg)
• Previously treated with direct-acting antiviral agents (not DAA-naïve); Note that prior (peg)IFN and/or ribavirin therapy is allowed

Enrollment Inclusion Criteria:

• Continued participation in TARGET-HCC
• No recurrence or progression of initial HCC beyond BCLC Stage A prior to Enrollment/Baseline
• HCC-free imaging (as defined in Section 9.1.1) at Enrollment/Baseline (see Section 9.2.9 for imaging details; participants may remain in Screening until an HCC-free image is obtained)
• Remains DAA-naïve (prior therapy with (peg)IFN and/or ribavirin is allowed)

Enrollment Exclusion Criteria:

• Liver transplantation since Screening