After randomization, patients were seen every 3 months for 3.5 years and then every 6 months thereafter for an interval medical history, physical examination, Dasatinib cell line and laboratory testing to assess for clinical outcomes and adverse events. Local laboratory tests included complete blood count, hepatic panel (which included serum albumin, aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase, and total bilirubin), creatinine, prothrombin time/international normalized ratio (INR), and alpha-fetoprotein (AFP). Quantitative HCV RNA was measured in a central laboratory at each visit during

the first 3.5 years. Abdominal ultrasound was performed

6 months BGB324 supplier after randomization and then every 12 months to screen for HCC. According to the initial HALT-C Trial protocol, patients who achieved SVR ceased participation in the trial after Week 72, although many of the patients continued to be followed outside the HALT-C Trial by the investigators at their respective sites. In 2008, the HALT-C Trial protocol was amended to allow HALT-C Trial clinical centers to contact patients who had achieved SVR and invite them to participate in the current study. The HALT-C Trial protocol amendment was approved by the institutional review boards of all the HALT-C Trial sites. Patients provided informed consent for participation in the initial HALT-C Trial as well as the amended protocol. The amended protocol allowed for a single study visit consisting of a standard interview regarding the occurrence of hepatic decompensation or a diagnosis of HCC, and a physical examination to identify clinical signs of hepatic decompensation. Blood was drawn to test for complete blood count, hepatic panel, creatinine, INR, AFP, and HCV RNA, and an abdominal ultrasound was performed. Patients who had a history consistent with

decompensated liver disease, HCC, or liver transplantation were asked to sign a “release of information” form to allow HALT-C Trial investigators to review medical records related nearly to the event. Patients who agreed to participate but were unable to attend an in-person clinic visit answered a structured telephone interview designed to elicit evidence of decompensated liver disease, HCC, or liver transplantation and were asked to mail a signed release of medical records to the clinical site to allow findings from a recent physical examination, blood tests, and abdominal imaging (not performed at a HALT-C clinical site) to be reviewed. In order to assess the relative impact of achieving SVR on morbidity and mortality, we selected two comparison groups from the 1050 patients randomized into the HALT-C Trial (Fig. 1).