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Risk of Hepatocellular Cancer in HCV Patients Treated With Direct-Acting Antiviral Agents

Phase observationalN = 22,500

Population
Hepatitis C patients treated with direct-acting antivirals in the Veterans Health Administration in 2015 (mean age 61.6 years; 39.0% with cirrhosis).
Design
Retrospective cohort study in 129 Veterans Health Administration hospitals of hepatitis C patients treated with DAA between 1 January and 31 December 2015, comparing HCC risk by SVR status with Cox regression. Observational: arm roles label the SVR comparison, not randomised assignment.
Arms
  • SVR achieved (experimental, n = 19,518): Treated with DAA, sustained virological response achieved
  • No SVR (control, n = 2,982): Treated with DAA, no sustained virological response
People
Kanwal F
Incidence of hepatocellular carcinomaHR 0.28 (95% CI 0.22–0.36)
Show the numbers
Results reported for Risk of Hepatocellular Cancer in HCV Patients Treated With Direct-Acting Antiviral Agents
EndpointAnalysisSVR achievedNo SVREffect
Incidence of hepatocellular carcinoma22,500 patients treated with DAA (19,518 with SVR; 2982 without)Risk of new hepatocellular carcinoma in patients with versus without SVR, adjusted hazard ratio from Cox regression.primaryKanwal 2017——HR 0.28 (95% CI 0.22–0.36)271 new HCC cases, 183 of them in patients with SVR. Incidence 0.90 vs 3.45 HCC per 100 person-years (SVR vs no SVR). In patients with SVR, cirrhosis carried the highest annual incidence: 1.82 vs 0.34 per 100 person-years without cirrhosis, adjusted hazard ratio 4.73 (95% CI 3.34-6.68). Authors state they found no evidence that DAAs promote HCC.
Results reported for Risk of Hepatocellular Cancer in HCV Patients Treated With Direct-Acting Antiviral Agents
EndpointAnalysisSVR achievedNo SVREffect
Incidence of hepatocellular carcinoma22,500 patients treated with DAA (19,518 with SVR; 2982 without)Risk of new hepatocellular carcinoma in patients with versus without SVR, adjusted hazard ratio from Cox regression.primaryKanwal 2017——HR 0.28 (95% CI 0.22–0.36)271 new HCC cases, 183 of them in patients with SVR. Incidence 0.90 vs 3.45 HCC per 100 person-years (SVR vs no SVR). In patients with SVR, cirrhosis carried the highest annual incidence: 1.82 vs 0.34 per 100 person-years without cirrhosis, adjusted hazard ratio 4.73 (95% CI 3.34-6.68). Authors state they found no evidence that DAAs promote HCC.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
Incidence of hepatocellular carcinoma0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
Incidence of hepatocellular carcinoma0.280.22–0.36
Primary publication: Kanwal F, Kramer J, Asch SM, Chayanupatkul M, Cao Y, El-Serag HB. Risk of Hepatocellular Cancer in HCV Patients Treated With Direct-Acting Antiviral Agents. Gastroenterology. 2017;153(4):996-1005.e1. PubMedDOI

Appears in

Sources

  1. Kanwal F, Kramer J, Asch SM, Chayanupatkul M, Cao Y, El-Serag HB. Risk of Hepatocellular Cancer in HCV Patients Treated With Direct-Acting Antiviral Agents. Gastroenterology. 2017;153(4):996-1005.e1.

    PubMedDOI