The effect of antiviral therapy on incidence of HCC has not been well established. The aim of this analysis
was to examine HCC incidence using a prediction model. Methods: The incidence of HCC in patients treated with TDF was obtained from the 6-year follow-up data of the registration trials for HBeAg-positive (GS-US-174-0103) and HBeAg-negative (GS-US-174-0102) patients. The predicted risk of HCC in individual patients was estimated using a model validated in cirrhotics and non-cirrhotics (the REACH-B model: Yang et al., Lancet Oncology, 2011). Standardized incidence ratios [SIR] were calculated selleck inhibitor between the observed and predicted numbers of HCC in the study cohort. Results: In the two studies, 641 patients received TDF for 6 years (375 subjects
in study 102 and 266 in 103). During this time, 14 patients with newly diagnosed HCC were reported. Nine were in study 102HBeAg positive; Alectinib nmr among them 3 were cirrhotic. Five were in study 103HBeAg negative; among them 3 were cirrhotic. From the 14 HCC cases, 4 were genotype (gt) C, 5 gt-D, 2 gt-B, 1 gt-E, 1 gt-F and 1 unable to genotype. The 10th HCC case occurred at 3.3 years, at which
time the REACH-B model predicted 11.2 cases. Beyond that time, there was a progressive divergence between the predicted and observed number of HCC cases. In non cirrhotic patients, the effect of TDF became significant (55% reduction) at 6 years of therapy and the SIR was 0.45 (95% confidence interval [CI] = 0.227–0.909) for the last case N-acetylglucosamine-1-phosphate transferase reported near week 336. Conclusion: Based on the REACH-B risk calculator, after long term therapy with TDF, the incidence of HCC decreased compared to the predicted risk. However, despite the small number of patients who developed HCC, continued surveillance is needed for CHB patients receiving long term oral antiviral treatment. AJ WIGG,1 R WUNDKE,1 R MCCORMICK,1 RJ WOODMAN2 1Hepatology and Liver Transplant Medicine Unit, Flinders Medical Centre, Adelaide. 2Division of General Practice, Flinders University, Adelaide.