The purpose of this study is to compare the safety, tolerability and effectiveness of 12
weeks of treatment with telbivudine 600 mg daily plus tenofovir DF 300 mg one daily (OD)
taken together vs. tenofovir DF 300 mg once daily (QD) or vs telbivudine 600 mg monotherapy
daily (QD). This is an open labeled, active controlled, viral kinetics study which means the
subjects and study doctor will know what study drug subjects have been assigned. This study
is open to male and female subjects, <40 years of age, who have been infected with HBV for
at least 6 months and have not received oral treatment for HBV.
Change in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Level From Baseline to Weeks 2, 4 and 8.Percentage of Patients Who Are Polymerase Chain Reaction(PCR)Negative at Week 12
Percentage of Patients Who Achieve Hepatitis B "e" Antigen (HBeAg) Loss and HBeAg Seroconversion at Week 12
Characterization of Very Early Viral Kinetics Through Estimated Viral Load
Characterization of Very Early Viral Kinetics Through Viral Clearance
Characterization of Very Early Viral Kinetics Through Rate of Infected Cell Loss
Characterization of Very Early Viral Kinetics Through Efficiency Factor of Blocking Virus Production.
Characterization of Very Early Viral Kinetics Through Half-live of Free Virus
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Both.
Inclusion Criteria:
- Chronic HBV infection, defined as positive serum HBsAg for at least 6 months, or
HBsAg positive > 3 months and negative for IgM anti-HBc and positive for IgG anti-HBc
- Age < 40 years old
- HBeAg positive
- HBV DNA > or = to 10^7 copies/mL by Abbott real-time PCR
- ALT < or = to 1 ULN
- Willing and able to provide written informed consent
- No prior oral HBV therapy (e. g., nucleotide and/or nucleoside therapy or other
investigational agents for HBV infection)
- Is willing and able to comply with the study drug regimen and all other study
procedures and requirements
- Is willing and able to provide written informed consent before any study assessment
is perform
Exclusion Criteria:
- Decompensated liver disease defined as direct (conjugated) bilirubin > 1. 2 × ULN, PT
> 1. 2 × ULN, platelets < 150,000/mm3, serum albumin < 3. 5 g/dL, or prior history of
clinical hepatic decompensation (e. g. ascites, jaundice, encephalopathy, variceal
hemorrhage).
- Received interferon (pegylated or not) therapy within 6 months of the screening visit
- α-fetoprotein > 50 ng/mL
- Evidence of hepatocellular carcinoma (HCC)
- Co-infection with HCV (by serology), or HIV,
- Significant renal, cardiovascular, pulmonary, or neurological disease.
- Received solid organ or bone marrow transplantation.
- Is currently receiving therapy with immunomodulators (e. g., corticosteroids, etc.),
investigational agents, nephrotoxic agents, or agents susceptible of modifying renal
excretion.
- Has proximal tubulopathy.
- Use of other investigational drugs at the time of enrollment, or within 30 days
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical
classes
- Is pregnant or breastfeeding.
- Is a women of child-bearing potential (WOCBP)unless post-menopausal or using one or
more acceptable method of contraception.
- Patient has any other concurrent medical or social condition likely to preclude
compliance with the schedule of evaluations in the protocol, or likely to confound
the efficacy or safety observations of the study.
- Patient is currently abusing alcohol or illicit drugs, or has a history of alcohol
abuse or illicit substance abuse within the preceding two years.
- Patient has a medical condition that requires prolonged or frequent use of systemic
acyclovir or famciclovir.
Other protocol-defined inclusion/exclusion criteria may apply