Long‐term entecavir or tenofovir disoproxil fumarate therapy in treatment‐naïve chronic hepatitis B patients in the real‐world setting

Abstract

The aim of this study was to determine the long-term efficacy of entecavir (ETV) and tenofovir disoproxil fumarate (TDF) on the natural course of disease in chronic hepatitis B patients (CHB) with/without cirrhosis in clinical practice. A total of 355 treatment-naïve CHB patients were enrolled into the study. The primary outcome measure was viral suppression as defined by serum HBV DNA level <20 IU/mL. A secondary outcome measure was to determine the development of Hepatocellular carcinoma (HCC). Virological and biochemical responses were similar between the two treatment groups over time. The presence of cirrhosis and hepatitis B e antigen (HBeAg) positivity did not appear to impact viral suppression. The cumulative probability of HBeAg loss was 41% at 4 years of therapy. Hepatitis B surface antigen (HBsAg) loss occurred in four patients. Model for End-Stage Liver Disease score was significantly improved from baseline to week 48 and 96 under antiviral therapy (P = 0.013, P = 0.01). HCC was diagnosed in 17 patients (4.8%). The cumulative probability of the development of HCC was 3.3% at 1 year and 7.3% at 4 years of therapy. The development of HCC was independently associated with older age (P = 0.031) and the presence of cirrhosis (P = 0.004). Serum creatinine levels and creatinine clearance remained stable over time. ETV and TDF effectively maintained virological and biochemical responses in long-term follow-up of CHB patients with/without cirrhosis. HCC may still develop, although at a lower rate, and is more likely to develop in patients with cirrhosis, especially in older patients.

The suppressive effect of nucleos(t)ide analogue treatment on the incidence of hepatocellular carcinoma in chronic hepatitis B patients

“…As for TDF, it has been indicated that the suppressive effect on HCC seems equivalent to ETV. 21,22 However, further study is necessary because there have only been a small number of reports. Thus, no obvious differences were found between different NA therapies in suppressing HCC among HBV-infected patients with or without cirrhosis.…”

The impact of nucleos(t)ide analog therapy in hepatitis B on the incidence of hepatocellular carcinoma: an update including recent literature findings

“…There was no significant difference found between the NA in the prevention of HCC. In a study of 355 treatment-naïve patients with CHB, 39.2% of whom had cirrhosis, who received entecavir or tenofovir, Idilman et al [33] found that the cumulative incidence of HCC at 1 year was 3.3% and at 4 years was 7.3%. No significant difference was found between the 2 groups.…”

Hepatocellular Carcinoma in a Chronic Hepatitis B Patient With Suppressed Viral Replication

“…Yine bu çalışmada hastalık ciddiyetiyle (dekompanse siroz, kompanse siroz ve non-sirotik KHB) HSK riskinin arttığı gösterilmiştir. Bununla birlikte non-sirotik hastalarda da HSK (12). Sunulan olguda siroz yoktur ancak ileri yaş ve myelodisplastik sendromla ilişkilendirilmiş olsa da trombosit düşüklüğü gibi risk faktörleri bulunmaktaydı.…”