Antiviral Efficacy of Switching to ETV Plus TDF
Summary
Switching to Entecavir(ETV) plus Tenofovir Disoproxil Fumarate(TDF) combination will result in faster and greater antiviral activity and lower rates of resistance emergence over maintaining Lamivudine(LAM)/Telbivudine(LdT)+Adefovir(ADV) combination in partial responders to LAM/LdT+ADV rescue therapy. Earlier switching to combination with the most potent regimen will be more effective to achieve virologic response(VR) and prevent further resistance emergence. All subjects will orally take assigned drugs once daily for 48 weeks. All subjects will be assessed at baseline and every three months thereafter. Evaluations at each visit will include vital signs, physical examinations, laboratory tests, HBV DNA levels and adverse events. At baseline and every six months thereafter, serum will be assayed for HBV serology. Genotypic analysis will be performed at baseline and 48 weeks.
Timeline
- Start
- 2012-08
- Primary completion
- 2014-05
- Completion
- 2014-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Adefovir | Unknown | 10 mg | Oral |
| Subject | Entecavir | Small molecule | 1 mg | Oral |
| Comparator | Lamivudine | Other / unclassified | 100 mg | Oral |
| Comparator | Telbivudine | Small molecule | 600 mg | Oral |
| Subject | Tenofovir | Small molecule | 300 mg | Oral |