Abstract
Aims
Previous studies have shown that baseline high viral load is closely related to treatment response in chronic hepatitis B (CHB). This study was designed to evaluate the differences of treatment responses between de novo lamivudine (LAM) plus adefovir (ADV) combination therapy compared with entecavir monotherapy (ETV).
Methods
A total of 185 HBeAg-positive CHB patients with high viral load were enrolled and assigned to the LAM+ADV group (n=90) or ETV group (n=95). Clinical variables are extracted from medical records.
Results
No significant differences in baseline variables were found between the two groups before antiviral treatment. After 104 weeks of antiviral therapy, the mean HBV DNA viral load in the LAM+ADV group decreased from 8.01±0.65 log10 copies/mL to 0.41±1.04 log10 copies/mL, compared with 8.04±0.57 log10 copies/mL to 0.57±1.28 log10 copies/mL in the ETV group (P=0.35). The virological response rate of LAM+ADV group was 82.2% (74/90) at 104 weeks of treatment, and 80.0% (76/95) in the ETV group (P=0.70). For HBeAg serological responses, HBeAg loss occurred in 23.3% (21/90) and 17.9% (17/95) in the LAM+ADV group and the ETV group, respectively (P=0.36). HBeAg seroconversion was observed in 15.6% (14/90) and 15.8% (15/95) in the LAM+ADV group and ETV group, respectively (P=0.96). However, after 104 weeks of treatment, genotypic resistance was confirmed in 8 cases in the LAM+ADV group, a proportion of 8.8% (8/90), compared with an absence of genotypic resistance in the ETV group (P=0.003).
Conclusion
Both de novo combination therapy of LAM+ADV and ETV monotherapy could effectively inhibit HBV replication in patients with high viral load. However, the rate of genotypic resistance in LAM+ADV treatment remains a concern. For CHB patients with high viral load, ETV treatment may be superior.
Acknowledgments
We thank the nurses of the Department of Infectious Diseases for their help with our study.
Abbreviations
ADV, adefovir dipivoxil; ALT, alanine aminotransferase; CHB, chronic hepatitis B; ETV, entecavir; HBeAb, hepatitis B e antibody; HBeAg, hepatitis B e antigen; HBsAb, hepatitis B surface antibody; HBsAg, hepatitis B surface antigen; HBV, hepatitis B virus; LAM, lamivudine; NUC, nucleos(t)ide analog.
Ethics And Consent
The Institutional Review Board of the Affiliated Hospital of Youjiang Nationalities Medical College approved the study. All procedures followed were in accordance with the ethical standards of the Responsible Committee on Human Experimentation and with the Helsinki Declaration of 1975, as revised in 2008. Informed consent was obtained from all patients for inclusion in the study.
Disclosure
The authors report no conflicts of interest in this work.