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Non-characterized nodules linked to early HCC following DAA therapy

Patients undergoing direct-acting antiviral therapy for hepatitis C who had non-characterized liver nodules had a higher risk for hepatocellular carcinoma within a short follow-up time than other patients, according to a recently published study.

“Our study suggests that there is an increased emergence of HCC early during follow-up in patients with cirrhosis treated with DAA,” Zoe Mariño, MD, from the University of Barcelona, Spain, and colleagues wrote. “The peak of cancer associated in time with DAA therapy is significantly relevant in patients that were shown to have undetermined nodules prior to treatment initiation.”

Mariño and colleagues retrospectively reviewed the data of 1,123 patients with cirrhosis who underwent DAA therapy for HCV. Prior to starting DAA therapy, the researchers found 995 patients without evidence of nodules, 48 cases of benign nodules and 80 cases of non-characterized nodules.

Median clinical follow-up from the start of DAA therapy to end of follow-up was 19.6 months (range, 16.8-23.3 months) and the median radiologic follow-up from baseline imaging to last case of HCC development was 12.33 months (range, 9.04-15.94). During that time, 72 patients developed HCC and 31 patients died.

Incidence of HCC was 3.73% per 100 person-years (95% CI, 2.96-4.7) in the whole cohort. The relative risk for HCC incidence differed according to baseline imaging information, in which patients with non-characterized nodules had a higher risk (RR = 2.83; 95% CI, 1.55-5.16) than those with benign nodules (RR = 0.36; 95% CI, 0.05-2.62) and those with no nodules.

Patients with non-characterized nodules had a higher relative risk compared with other patients in all subgroup analyses including HCC adherence and after adjusting for baseline variables.

“It has been suggested that development of HCC in DAA treated patients would represent the emergence of already existing clones and would have thus appeared irrespective of treatment and its success,” Mariño and colleagues wrote. “This is surely the case, but the key point is to what extent DAA therapy is associated with an increased rate of HCC emergence early during follow-up after therapy. Our data support this possibility and suggest that some clones are primed to grow and become overt cancers in a minority, but clinically relevant proportion of patients.” – by Talitha Bennett

Disclosure: Mariño reports she has received speaker fees from AbbVie, Gilead, Janssen and Merck Sharp & Dohme and has advised for Bristol-Myers Squibb and Gilead. Please see the full study for the other authors’ relevant financial disclosures.