Safety and Antiviral Study of ACH126, 433 (b-L-Fd4C) in Adults With Lamivudine-resistant Chronic Hepatitis B

Inclusion Criteria

• Adults ≥ 18 years of age
• Chronic HBV infection, known to be HbsAg positive ≥ 6 months
• On lamivudine, either 100 or 150 mg daily for the treatment of chronic hepatitis B infection and

• Exhibit a 2-3 log decrease in HBV DNA levels followed by a rebound of at least 1.5 log HBV DNA or

  • Achieved an HBV DNA level of <10,000 copies/mL HBV DNA on at least 2 occasions and have rebounded to > 100,000 copies/mL HBV DNA, or
  • Have a demonstrable 3TC resistant genotype regardless of treatment history.
• HBeAG positive
• HIV negative
• Serum ALT ≥1.5 and ≤10x times upper limit of normal
• HGB ≥10g/dl or HCT ≥30% (in the absence of blood transfusions or erythropoietin treatment in the preceding two weeks)
• Platelet count >75,000/mm(^3), (in the absence of ongoing G-CSF therapy)
• Serum creatinine <1.1 times upper limit of normal (ULN)
• Negative radiologic screening test (ultrasound, CT scan or MRI) for hepatocellular carcinoma (HCC) within 6 months prior to entry
• PT/INR<2
• Subjects of reproductive capability must utilize an approved forms of birth control
• All women of child-bearing capability must have a negative serum or urine pregnancy test (minimum sensitivity of 24 IU/L of b-HCG) within 72 hours prior to the start of study medication
• Subjects must be able to provide written informed consent
• Subject must be available for follow-up for a period of 20 weeks

Exclusion Criteria

• HIV infection
• Hepatitis C co-infection
• Alcohol abuse
• Pregnancy or breast-feeding
• Inability to tolerate oral medication
• Any clinical condition or prior therapy that, in the Investigator's opinion, would make the subject unsuitable for the study or unable to comply with the dosing requirements
• Use of any investigational drug
• Patients with decompensated liver disease
• Use of any concomitant herbal treatments