Combination therapies using nucleos(t)ide analogues lead to higher viral suppression although it may not be sustained for long. Also it remains unknown if combination of more potent analogues is more beneficial than individual drugs. Thus this study is carried out to determine the efficacy and safety of combination of tenofovir plus telbivudine (two most potent nucleos(t)ide analogues)versus monotherapy with either drug alone. This is a 104 week open labelled, prospective, randomized, multicentric study. The patient will receive either tenofovir, telbivudine or the combination of two drugs. After completion of 24 weeks, the non-responders (ie HBV-DNA \> 300 copies/ ml) will be switched to combination arm and will continue receiving tenofovir plus telbivudine for 104 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
300 mg of Tenofovir daily
600 mg of Telbivudine daily
Tenofovir (300 mg daily) plus Telbivudine (600 mg daily)
Institute of Liver & Biliary Sciences
New Delhi, India
Efficacy of combination of telbivudine plus tenofovir vs monotherapy with either drug alone
Time frame: 6 Months and 2 Years
Percentage change in serum HBV DNA levels
Time frame: Baseline and 2 Years
Percentage of patients with ALT normalization
Time frame: Baseline and 2 Years
Percentage of patients with reduction in HBsAg concentration by >50%
Time frame: Baseline and 2 Years
Percentage of patients with virological breakthrough
Time frame: 24 weeks
Percentage of patients with primary treatment failure
Time frame: 12 weeks
Occurrence of adverse events
Time frame: 2 Years
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