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Risk of hepatocellular carcinoma in patients with chronic hepatitis C and stage-3 liver fibrosis after sustained virological response (SVR) with direct-acting antivirals
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Liver Cancer Rate 0.5 per 100 Yearly After SVR in People With F3 Fibrosis
AASLD The Liver Meeting Digital Experience, November 13-16, 2020
Mark Mascolini
Among people with chronic HCV infection and F3 fibrosis, only 1 of every 200 individuals yearly had a newly detected primary liver tumor (usually hepatocellular carcinoma, HCC) after sustained virologic response (SVR) to direct-acting antivirals (DAA) [1]. Researchers from Madrid's Hospital Universitario La Paz and collaborators across Spain noted that this liver cancer incidence lies below an established cutoff for cost-effectiveness.
This observational study involved people with chronic HCV infection seen at 12 hospitals in Spain. All had stage 3 fibrosis when first seen and SVR with DAAs between January and December 2015. The analysis excluded people with HCC diagnosed before SVR, another liver disease (except fatty liver), and indirect findings of cirrhosis or portal hypertension. The researchers established F3 fibrosis in two steps: (1) transient elastography between 9.5 and 14.5 kPa, and (2) exclusion of indirect findings of cirrhosis or portal hypertension.*
The analysis focused on 506 people, 303 of them (60%) men, with a median age of 57.2 years. Eighty-seven people (17%) had diabetes, 93 (18%) had HIV, and 119 (23%) had a body mass index above 25 kg/m2 (overweight or obese).
Through a median follow-up of 33.3 months, 6 people had a new primary liver tumor (5 HCC and 1 intrahepatic cholangiocarcinoma). That number yielded a primary liver tumor incidence of 0.49 per 100 person-years, which works out to 1 case yearly in every 200 people. Cumulative incidence at 36 months stood at 1.1% (95% confidence interval 0 to 2.1). Median time from SVR to cancer diagnosis was 20.4 months.
Five of 6 people with newly diagnosed liver cancer were men, and ages ranged from 55 to 76. Baseline fibrosis scores by transient elastography ranged from 10 to 12. No one had HIV infection or metabolic syndrome.
Multivariate analysis determined that men older than 55 had a 7-fold higher risk of liver cancer (hazard ratio 7.16, 95% confidence interval 1.23 to 41.75, P = 0.029; reference group not stated). Liver cancer incidence in men over 55 was 1.1 per 100 person-years, about twice higher than in the whole study group. Factors not associated with liver cancer in the multivariate analysis included arterial hypertension, hyperlipidemia, diabetes, smoking, alcohol intake, and HIV infection.
The researchers believe this is the first study to assess HCC risk in a well-defined F3 fibrosis population with DAA-induced SVR. They noted that the primary liver tumor incidence of 0.49 per 100 person-years lies below the 1.5% cutoff considered cost-effective.
*Excluded factors were nodular liver surface, splenomegaly (spleen long axis >13 cm), ascites or portosystemic collaterals detected on imaging, thrombocytopenia, and endoscopic evidence of esophago-gastric varices.
Reference
1. Sanchez-Azofra M, Fernandez I, Garcia-Buey ML, et al. Risk of hepatocellular carcinoma in patients with chronic hepatitis C and stage-3 liver fibrosis after sustained virological response (SVR) with direct-acting antivirals. AASLD The Liver Meeting Digital Experience, November 13-16, 2020. Abstract 135.
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