title: Accuracy of risk scores for patients with chronic hepatitis B receiving entecavir treatment.
abstract: OBJECTIVE
  Little is known about the validity of hepatocellular carcinoma (HCC) risk scores derived from treatment-naïve patients with chronic hepatitis B for patients treated with entecavir.
  
  
  METHODS
  We performed a retrospective-prospective cohort study of 1531 patients with chronic hepatitis B (age, 51 ± 12 years; 1099 male; 332 with clinical cirrhosis) who were treated with entecavir 0.5 mg daily for at least 12 months at Prince of Wales Hospital in Hong Kong from December 2005 to August 2012. The patients were assessed once every 3 to 6 months for symptoms, drug history, and adherence; blood samples were collected for biochemical analyses. We validated 3 HCC risk scores (CU-HCC, GAG-HCC, and REACH-B scores) based on data collected when patients began treatment with entecavir and 2 years later.
  
  
  RESULTS
  After 42 ± 13 months of follow-up, 47 patients (2.9%) developed HCC. The 5-year cumulative incidence of HCC was 4.3% (95% confidence interval [CI], 3.6%-5.0%). Older age, presence of cirrhosis, and virologic remission after 24 months or more of therapy were independently associated with HCC in the entire cohort; advanced age and hypoalbuminemia were associated with HCC in patients without cirrhosis. The area under the receiver operating characteristic curves (AUCs) for baseline CU-HCC, GAG-HCC, and REACH-B scores for HCC were 0.80 (95% CI, 0.75-0.86), 0.76 (95% CI, 0.70-0.82), and 0.71 (95% CI, 0.62-0.81), respectively; the time-dependent AUCs 1 to 4 years after patients started treatment were comparable to those at baseline. The cutoff value of the baseline CU-HCC score identified patients who would develop HCC with 93.6% sensitivity and 47.8% specificity, the baseline GAG-HCC score with 55.3% sensitivity and 78.9% specificity, and the baseline REACH-B score with 95.2% sensitivity and 16.5% specificity. Compared with patients with CU-HCC scores <5 at baseline, those with CU-HCC scores that either decreased from ≥5 to <5 or remained ≥5 had a higher risk of HCC (5-year cumulative incidences, 0% vs 3.9% and 7.3%; P = .002 and P < .001, respectively).
  
  
  CONCLUSIONS
  The CU-HCC, GAG-HCC, and REACH-B HCC risk scores accurately predict which patients with chronic hepatitis B treated with entecavir will develop HCC.
authors: Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong SAR, China.
authors: Grace Lai-Hung
authors: GL
authors: Wong
authors: Henry Lik-Yuen
authors: HL
authors: Chan
authors: Hoi-Yun
authors: HY
authors: Chan
authors: Pete Chi-Hang
authors: PC
authors: Tse
authors: Yee-Kit
authors: YK
authors: Tse
authors: Christy Wing-Hin
authors: CW
authors: Mak
authors: Stanley King-Yeung
authors: SK
authors: Lee
authors: Zoe Man-Yi
authors: ZM
authors: Ip
authors: Andrew Ting-Ho
authors: AT
authors: Lam
authors: Henry Wing-Hang
authors: HW
authors: Iu
authors: Joyce May-Sum
authors: JM
authors: Leung
authors: Vincent Wai-Sun
authors: VW
authors: Wong
mesh_terms: D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects; D006528:Carcinoma, Hepatocellular / Q000453:epidemiology* / Q000209:etiology; D016001:Confidence Intervals; D004279:DNA, Viral / Q000032:analysis; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006147:Guanine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D006515:Hepatitis B virus / Q000235:genetics; D019694:Hepatitis B, Chronic / Q000150:complications / Q000188:drug therapy* / Q000821:virology; D006723:Hong Kong / Q000453:epidemiology; D006801:Humans; D008113:Liver Neoplasms / Q000453:epidemiology* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D015203:Reproducibility of Results; D012189:Retrospective Studies; D018570:Risk Assessment / Q000379:methods*; D012307:Risk Factors
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; C413685:entecavir; D006147:Guanine