Clinical observation of a 144-week entecavir therapy for HBeAg-positive chronic HBV carriers with high viral load

Objective To assess the safety and clinical efficacy of a 144 weeks Entecavir therapy for chronic HBV carriers who were HbeAg positive with high viral load, and to indicate the clinical significance of antiviral therapy for chronic HBV carriers. Methods In this study, we randomly recruited 64 HBeAg-positive chronic HBV carriers with high viral load. The patients were divided into two groups: treatment group and control group. The treatment group received 0.5 mg entecavir once daily for 144 weeks. Liver function, HBV DNA, HBV testing, hepatic fibrosis testing and abdominal ultrasound were performed at 0, 24, 48, 72, 96, 120 and 144 weeks to observe rates of serological responding, ALT (Alanine transaminase) improvement, HBV-DNA below detection limit, and fibrosis value in observation group. Status of disease and changes in the criteria was also observed for both groups. Safety data of the therapy were recorded. Chi-square test and t-test were used for categorical data and measurement data, respectively. Results There was no statistically signicant change of ALT response rates between treatment group and control group at different time points (P>0.05). The rates of serum HBV-DNA below detection limit had significant difference between the two groups (P<0.05). Both groups showed no serological response (HBeAg-negative) and HBeAg seroconversion. The level of PC, HA, C-IV were significantly lower in the treatment group than control group (P<0.05) at 144 weeks. Comparing the results at 0 week and 144 weeks in the treatment group, the above three criteria showed significant difference (P<0.05) while LN was not (t=0.219). Abdominal ultrasound at 96 weeks indicated that 1 case in treatment group and 2 cases in control group had incrassation on protal vein and splenic vein as well as enlargement of spleen. At 144 weeks, liver cirrhosis occured in 1 case in treatment group and 2 cases in control group. No hepatocellalar carcinoma was observed in either group. Conclusions Antiviral therapy with Entecavir for HbeAg positive chronic HBV carriers with high viral load showed better virological and hepatic fibrosis testing results, indicating that antiviral treatment feasible for these patients to reduce liver cell damage from the virus, liver fibrosis as well as incidence of liver cirrhosis. Key words: HBeAg-positive hronic HBV carriers with high viral load; HBV-DNA; Entecavir; Hepatic fibrosis; Liver cirrhosis