Clinical effect of tenofovir disoproxil fumarate versus entecavir in treatment of treatment-naïve patients with chronic HBV infection

Objective To investigate the antiviral effect of tenofovir disoproxil fumarate (TDF) versus entecavir (ETV) in the treatment of treatment-nave patients with chronic HBV infection.Methods A total of 420 treatment-nave patients with chronic HBV infection or liver cirrhosis who received antiviral therapy with TDF or ETV and were regularly followed up in Zhoukou Central Hospital or Bayi Hospital Affiliated to Nanjing University of Chinese Medicine from July 2014 to July 2015 were enrolled, and among these patients, 184 received TDF (TDF group) and 236 received ETV (ETV group) .Laboratory markers were measured at baseline and at weeks 4, 8, 12, 24, and 48 of treatment, including liver and renal function parameters, blood calcium, serum phosphate, creatine kinase, HBV DNA level, hepatitis markers (HBs Ag, HBeAg, and anti-HBe) .Adverse drug reactions were also monitored.The t-test was used for comparison of continuous data between groups, and the chi-square test or Fisher's exact test was used for comparison of categorical data between groups.Results At week 48 of treatment, there were no significant differences between the two groups in HBeAg clearance rate among both HBeAg-positive patients and HBeAg-positive patients with HBV DNA > 6 lg IU/ml (P > 0.05) .There were also no significant differences between the two groups in alanine aminotransferase normalization rate among HBeAg-negative patients, HBeAg-positive patients, and HBeAg-positive patients with HBV DNA > 6 lg IU/ml (P > 0.05) .Both groups had a gradual reduction in HBV DNA level after the antiviral therapy.At week 48 of treatment, there were significant differences between the TDF group and the ETV group in the proportion of patients with a HBV DNA level below the lower limit of detection among HBeAg-positive patients (75.5% vs 60.8%, χ2= 5.857, P = 0.016) and HBeAg-positive patients with HBV DNA > 6 lg IU/ml (75.7% vs 60.5%, χ2= 5.722, P = 0.017) .At week 96 of treatment, the TDF group had a significantly higher rate of HBV DNA below the lower limit of detection than the ETV group among all patients (93.5% vs 86.9%, χ2=4.921, P = 0.027) , HBeAg-positive patients (89.1% vs 76.2%, χ2= 6.781, P = 0.009) , and HBeAg-positive patients with HBV DNA > 6 lg IU/ml (88.3% vs 73.7%, χ2= 7.456, P = 0.006) .Conclusion In HBeAg-positive patients with chronic HBV infection, TDF has a better inhibitory effect on HBV DNA than ETV, especially in those with HBV DNA > 6 lg IU/ml.