BOSTON — Patients with hepatitis C infection cirrhosis treated with oral direct-acting antiviral agents were not at increased risk for developing hepatocellular carcinoma, according to study findings presented here.
“However, a subset of patients may go on to develop an aggressive tumor during or directly following treatment,” Alfredo Alberti, MD, from the University of Padova in Italy, said during a press briefing. “This suggests that the immunological and molecular changes in the liver microenvironment could support the growth and spread of microscopic, and initially invisible, HCC. Further studies are needed to clarify these issues and identify predictive markers. … Meanwhile, patients treated with direct-acting antiviral agents with advanced liver disease should continue to be closely monitored for HCC.”
Recent conflicting data suggest a possible association between HCC risk and antiviral therapy, with some reports suggesting a significant recurrence of HCC or de novo incidence during or after DAA therapy, according to Alberti.
For this reason, the researchers sought to assess the incidence of HCC in patients with HCV and advanced liver disease who underwent DAA therapy and did not have previous HCC. Patients with fibrosis F3 or cirrhosis (n = 3,381) were prospectively enrolled between January 2015 and June 2016. They were assessed for the timing and pattern of HCC diagnosis and the factors associated with tumor occurrence.
According to study results, patients with fibrosis F3 had an SVR of 97%. This was followed by 92% in those with cirrhosis Child Pugh A and 80% in those with cirrhosis Child Pugh B.
The overall incidence for de novo HCC was 1.64%, with a stable 2.5% increase in cumulative incidence during the 18-month follow-up period.
When the researchers further analyzed HCC incidence during different liver disease stages, incidence was 0.23% PPY in patients with fibrosis F3; 1.64% PPY in those with cirrhosis and cirrhosis Child Pugh A; and 2.92% PPY in those with cirrhosis Child Pugh B.
Results of Kaplan Meier analysis indicated a difference in cumulative incidence during follow-up, however, this did not reach statistical significance at the Mantel test, according to Alberti.
Alberti A, et al. Abstract 19. Presented at: The Liver Meeting; Nov. 11-15, 2016; Boston.
Disclosure: Alberti reports receiving a research grant from Gilead and speaker fees from AbbVie and Bristol Myers Squibb.