I-T Wu1, T-H Hu1, C-H Hung1, S-N Lu1, J-H Wang1, C-M Lee1, C-H Chen2. 1. Division of Hepato-Gastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Taiwan. 2. Division of Hepato-Gastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Taiwan. Electronic address: e580306@ms31.hinet.net.
Abstract
OBJECTIVES: The aims of this study are to compare the long-term efficacy and safety of entecavir and tenofovir in nucleos(t)ide analogue (NA)-naive patients with chronic hepatitis B (CHB) with high hepatitis B virus (HBV) DNA (> 6 log10 IU/mL). METHODS: We recruited 419 NA-naive patients for analysis (313 entecavir, 106 tenofovir). We used propensity-score matching to match 106 patients in the tenofovir group with 212 patients in the entecavir group by age, baseline HBV DNA levels and cirrhosis after subgrouping by hepatitis B e antigen (HBeAg) status. RESULTS: There was no significant difference in 3-year cumulative rates of virological response (VR) (96.4% versus 92.1%, p 0.26 in HBeAg-positive or 98.2% versus 98.6%, p 0.64 in HBeAg-negative patients), HBeAg loss (53.8% versus 47.4%, p 0.89) or seroconversion (40.2% versus 41.3%, p 0.77), and hepatocellular carcinoma (HCC) development (4% versus 2.7%, p 0.55) between the tenofovir and entecavir groups in either cohort or propensity-score matching patients. In subgroup analysis of patients with HBV DNA >108 IU/mL, entecavir and tenofovir showed similar effectiveness in achieving VR (90.9% versus 87.7% at 3 years; p 0.13). Tenofovir and diabetes mellitus were independent factors for acute kidney injury during treatment. Multivariate analysis showed that HBeAg-negative status, and lower baseline HBV DNA and HBV surface antigen levels were independent factors for achieving VR. Older age, lower baseline HBV DNA levels, cirrhosis and α-fetoprotein ≥8 ng/mL at 12 months of treatment were independently associated with HCC development. CONCLUSIONS: Tenofovir and entecavir have similar effectiveness in NA-naive CHB patients with high viraemia. Tenofovir might have a higher incidence of acute kidney injury compared with entecavir during treatment.
OBJECTIVES: The aims of this study are to compare the long-term efficacy and safety of entecavir and tenofovir in nucleos(t)ide analogue (NA)-naive patients with chronic hepatitis B (CHB) with high hepatitis B virus (HBV) DNA (> 6 log10 IU/mL). METHODS: We recruited 419 NA-naive patients for analysis (313 entecavir, 106 tenofovir). We used propensity-score matching to match 106 patients in the tenofovir group with 212 patients in the entecavir group by age, baseline HBV DNA levels and cirrhosis after subgrouping by hepatitis B e antigen (HBeAg) status. RESULTS: There was no significant difference in 3-year cumulative rates of virological response (VR) (96.4% versus 92.1%, p 0.26 in HBeAg-positive or 98.2% versus 98.6%, p 0.64 in HBeAg-negative patients), HBeAg loss (53.8% versus 47.4%, p 0.89) or seroconversion (40.2% versus 41.3%, p 0.77), and hepatocellular carcinoma (HCC) development (4% versus 2.7%, p 0.55) between the tenofovir and entecavir groups in either cohort or propensity-score matching patients. In subgroup analysis of patients with HBV DNA >108 IU/mL, entecavir and tenofovir showed similar effectiveness in achieving VR (90.9% versus 87.7% at 3 years; p 0.13). Tenofovir and diabetes mellitus were independent factors for acute kidney injury during treatment. Multivariate analysis showed that HBeAg-negative status, and lower baseline HBV DNA and HBV surface antigen levels were independent factors for achieving VR. Older age, lower baseline HBV DNA levels, cirrhosis and α-fetoprotein ≥8 ng/mL at 12 months of treatment were independently associated with HCC development. CONCLUSIONS:Tenofovir and entecavir have similar effectiveness in NA-naive CHB patients with high viraemia. Tenofovir might have a higher incidence of acute kidney injury compared with entecavir during treatment.
Authors: Eleanor Barnes; Philippa C Matthews; Tingyan Wang; David A Smith; Cori Campbell; Jolynne Mokaya; Oliver Freeman; Hizni Salih; Anna L McNaughton; Sarah Cripps; Kinga A Várnai; Theresa Noble; Kerrie Woods; Jane Collier; Katie Jeffery; Jim Davies Journal: BMC Infect Dis Date: 2021-06-26 Impact factor: 3.090