Hepatocellular carcinoma (HCC) may still develop in chronic hepatitis B (CHB) patients treated with lamivudine. Whether HCC rates are comparable in patients treated with the current first-line antivirals remains uncertain. We estimated the incidence and evaluated predictors of HCC in a large nationwide prospective cohort (HepNet.Greece) of HBeAg-negative CHB patients treated with entecavir. HBeAg-negative CHB patients from the same cohort who were initially treated with lamivudine were used as controls. We included 321 patients treated with entecavir for a median of 40 months and 818 patients treated initially with lamivudine for a median of 60 months. In the entecavir group, HCC developed in 4 of 321 (1.2%) patients at a median of 1.5 (range: 1.0-4.5) years, while the cumulative HCC incidence was significantly higher in cirrhotics than noncirrhotics (1, 3, 5 years: 0%, 3%, 9% vs 1%, 1%, 1%; P = 0.024) and in older patients (P = 0.026). Entecavir compared with lamivudine group patients had lower HCC incidence (1, 3, 5 years: 0.3%, 1.2%, 2.8% vs 0.7%, 3.8%, 5.6%; P = 0.024). However, in multivariable Cox regression analysis, the HCC risk was independently associated with older age (P < 0.001), male gender (P = 0.011) and cirrhosis (P = 0.025), but not with the initial agent. In conclusion, our large nationwide study indicates that the HCC risk remains increased in entecavir-treated HBeAg-negative CHB patients with cirrhosis, particularly of older age, at least for the first 5 years. The HCC risk does not seem to be significantly reduced with entecavir compared with antiviral therapy starting with lamivudine.

Tamoxifen induced hepatotoxicity is observed in a great proportion of breast cancer patients with pre-existing liver steatosis, especially those with higher BMI and higher glucose and lipid levels at baseline control. Glucose intolerance before the beginning of tamoxifen treatment seems to be a predictor of the hepatotoxicity, unrelated to baseline BMI.

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Background Data on the effectiveness of anti–tumour necrosis factor medications in patients with Crohn’s disease with poor prognostic factors are scarce. This study aimed to generate real-world evidence on the effect of early (≤24 months after diagnosis) versus delayed (&gt;24 months) initiation of adalimumab on the 26-week remission rate (Harvey-Bradshaw Index ≤4) in these patients. Methods This multicentre, retrospective, chart-review study performed in 10 Greek hospitals enrolled adult patients with moderate to severe Crohn’s disease (Harvey-Bradshaw Index ≥8) with ≥3 poor prognosis factors who were initiated on adalimumab ≥12 months before enrolment. A sample size of 164 patients (early:delayed cohort allocation ratio, 30:70) was required to address the primary endpoint. Results Eligible patients (n=171) were consecutively enrolled. In the early versus delayed cohorts, the 26-week remission rates (off steroids) using the last-observation-carried-forward imputation method were 60.7% (37/61) versus 47.2% (50/106), respectively (Δ=13.5%, p=0.044). The respective remission rates were 61.2% versus 42.4% among anti–tumour necrosis factor–naive patients (p=0.023) and 58.3% versus 53.2% among anti–tumour necrosis factor–experienced patients (p=0.374). The 52-week remission rates using as-observed data were 78.8% and 60.3%, and the intestinal resection rates were 6.5% and 11.9% in the early versus delayed ADL cohorts, respectively. Conclusions Patients with Crohn’s disease with poor prognostic factors who received early versus delayed treatment with adalimumab achieved higher clinical response and remission rates. This effect was more pronounced in those patients who were bio-naive and steroid-dependent/refractory with concurrent extraintestinal manifestations than those who were not.

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