Efficacy of Telbivudine With or Without add-on Tenofovir According to Roadmap Strategy Compare With Entecavir
Status:
Unknown status
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
Oral antiviral drugs which can be given to patients with HBeAg-positive chronic hepatitis B
include Lamivudine, Clevudine, Adefovir, Telbivudine, Entecavir and Tenofovir. 2009 American
Association for the Study of Liver Disease (AASLD) Treatment Guidelines and 2009 European
association for the Study of the Liver (EASL) Treatment Guidelines recommend the
administration of Entecavir or Tenofovir with high potency and low resistance. Lamivudine has
low antiviral potency and high incidence of mutation in long-term administration compared to
Entecavir or Tenofovir. Clevudine causes the elevated creatinine kinase (CK), side effects
including myositis/myopathy and much mutation in the long-term administration. Globe study
demonstrated Telbivudine had more excellent antiviral potency than Lamivudine, which was also
comparable to or higher than Entecavir or Tenofovir. Nevertheless, the choice of treatment
drugs can be limited due to the mutation rate of 25% for 2 years. However, the analysis of
Globe study results showed that 2-year treatment progress was very good in patient who showed
virologic response at 24 weeks after the initiation of treatment and that high antiviral
potency and low mutation rate were observed when the Telbivudine roadmap strategy (in the
event that virologic response is shown at 24 weeks, telbivudine monotherapy is maintained and
in the event that virologic response is not shown, tenofovir add-on therapy is done) recently
implemented and announced in 2011 Asian Pacific Association for the Study of the Liver
(APASL) was applied. However, the study was single arm study, which restricted the comparison
between Entecavir and Tenofovir monotherapy groups. Therefore, this study intends to compare
the anti-viral effect and mutation rate between Entecavir 0.5mg monotherapy group and
Telbivudine roadmap strategy group in patients with HBeAg-positive chronic hepatitis B
through a randomized study.