PAGE-B predicts the risk of developing hepatocellular carcinoma in Caucasians with chronic hepatitis B on 5-year antiviral therapy

• DOI: 10.1016/j.jhep.2015.11.035
• Publication Date: 2015-12-12T13:20:31Z
• Authors: George Papatheodo...; George Dalekos; Vana Sypsa; Cihan Yurdaydin; Maria Buti; John Goulis; Jose Luis Calleja; Heng Chi; Spilios Manolakop...; Giampaolo Mangia; Nikolaos Gatselis; Onur Keskin; Savvoula Savvidou; Juan de la Revilla; Bettina E. Hansen; Ioannis Vlachogia...; Kostantinos Galanis; Ramazan Idilman; Massimo Colombo; Rafael Esteban; Harry L.A. Janssen; Pietro Lampertico
• Keywords: Entecavir; Cumulative incidence; Hepatitis B

Risk scores for hepatocellular carcinoma (HCC) developed in Asians offer poor-moderate predictability in Caucasian patients with chronic hepatitis B (CHB). This nine center cohort study aimed to develop and validate an accurate HCC risk score in Caucasian CHB patients treated with the current oral antivirals, entecavir/tenofovir.We included 1815 adult Caucasians with CHB and no HCC at baseline who received entecavir/tenofovir for ⩾12 months. Using data from eight centers (derivation dataset, n=1325), a HCC risk score was developed based on multivariable Cox models and points system for simplification. Harrell's c-index was used as discrimination, bootstrap for internal validation and the data from the 9(th) and largest center (validation dataset, n=490) for external validation.The 5-year cumulative HCC incidence rates were 5.7% and 8.4% in the derivation and validation dataset, respectively. In the derivation dataset, age, gender, platelets and cirrhosis were independently associated with HCC. The PAGE-B score was developed based on age, gender and platelets (c-index=0.82, 0.81 after bootstrap validation). The addition of cirrhosis did not substantially improve the discrimination (c-index=0.84). The predictability of PAGE-B score was similar (c-index=0.82) in the validation dataset. Patients with PAGE-B ⩽9, 10-17, ⩾18 had 5-year cumulative HCC incidence rates of 0%, 3%, 17% in the derivation and 0%, 4%, 16% in the validation dataset.PAGE-B, which is based only on baseline patients' age, gender and platelets, represents a simple and reliable score for prediction of the 5-year HCC risk in Caucasian CHB patients under entecavir/tenofovir.