Long-term follow up of patients with chronic HCV and F2 or F3 fibrosis after achieving SVR with DAA-based therapy: Results from the Gilead SVR registry.
Zeuzem S, Ferret MB, Gane E, Jacobson I, Gordon SC, Sulkowski M, McNabb B, Chen F, Dvory-Sobol H, Osinusi A, Brainard D, Subramanian M, Ramji A, Agarwal K, Reddy R, and Bourliere M. Long-term follow up of patients with chronic HCV and F2 or F3 fibrosis after achieving SVR with DAA-based therapy: Results from the Gilead SVR registry. J Hepatol 2018; 68:S527-S528.
Background: HCV infected patients with F0-F1 fibrosis experienced minimal liver-related morbidity and mortality following sustained virologic response (SVR) with direct-acting antiviral (DAA) therapy. Less is known about the clinical progression of liver disease among HCV-infected patients with F2 or F3 fibrosis who have achieved SVR with DAA regimens. Methods: Patients enrolled in the Gilead SVR Registry were included in this analysis if they were deemed to have F2 or F3 fibrosis pre-DAA treatment as measured by FibroTest (0.32-0.58 or 0.59-0.72, respectively). Patients could be enrolled upto 60weeks after initiating DAA-treatment that lead to SVR, and study visits occurred every 24 weeks for up to 144weeks. Assessments for signs of jaundice, ascites, hepatic encephalopathy (HE), varices, and hepatocellular carcinoma (HCC) and measurement of alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (Bili), albumin (ALB), prothrombin time (PT), and platelets (PLT), occurred at each visit. Results: A total of 1,489 and 857 patients with F2 and F3 fibrosis were enrolled, with median (range) registry follow up times of 1.9 (0-3.3) and 1.8 (0-3.2) years, respectively. Of these, 57% and 72% were male and the mean (range) ages were 55 (19-80) and 57 (19-82) years for F2 and F3 patients, respectively. There were 2 and 4 cases of HCC reported in 2509 and 1371 person-years of follow-up time for patients with F2 and F3 fibrosis, respectively. Overall, the prevalence of liver-related events was lowat all visits, remaining stable for F2 and numerically decreasing over time for F3 patients (Table). At Week 144, 1 (0.1%) patient with F2 fibrosis had evidence of varices reported and 1 (0.3%) patient with F3 fibrosis had evidence of jaundice reported. Mean week 144 ALT, AST, Bili, ALB, PT, and PLT were within normal limits and comparable to baseline values. Three patients with F2 and 3 patients with F3 fibrosis died, with no causes of death due to liver disease. No liver transplants were reported. There were 4 patients with F2 and 3 patients with F3 fibrosis who experienced virologic failure during follow up; all but one of these patients had clear virologic evidence for reinfection by sequencing. Conclusion: In HCV-infected patients with F2 or F3 fibrosis who achieve SVR with DAA therapy, events including liver-related complications, HCC, death and HCV relapse are rare in the first 144 weeks of follow-up. These data support early treatment of HCV infection and may be useful in guiding monitoring strategies for HCC and other liver-related events following SVR. (Table Presented).