Lamivudine and Adefovir to Treat Chronic Hepatitis B

You may not qualify if:

• Previous or current treatment with adefovir or tenofovir.
• Co-infection with HDV (Hepatitis D Virus) as defined by the presence of both anti-HDV in serum and HDV antigen in liver
• Co-infection with HCV (Hepatitis C Virus) as defined by the presence of both anti-HCV and HCV RNA in serum.
• Co-infection with HIV (Human immunodeficiency virus) as defined by the presence of anti-HIV in serum.
• Decompensated liver disease as defined by serum bilirubin greater than 2.5 mg%, prothrombin time of greater than 2 seconds prolonged, a serum albumin of less than 3.0 gm%, or a history of ascites, variceal bleeding, or hepatic encephalopathy.
• Presence of other causes of liver disease (i.e., hemochromatosis, Wilson's disease, alcoholic liver disease, non-alcoholic steatohepatitis, alpha-1 antitrypsin deficiency)
• A history of organ transplantation or in the absence of organ transplantation, any immunosuppressive therapy requiring the use of more than 5 mg of prednisone (or its equivalent) daily.
• Significant systemic illnesses other than liver diseases including congestive heart failure, renal failure, chronic pancreatitis, diabetes mellitus with poor control that in the opinion of the investigators might interfere with therapy.
• Pregnancy or inability to practice contraception in patients capable of bearing or fathering children
• Pre-existing bone marrow suppression: White Blood Cells (WBC) less than 2,000 cells/mm(3), hematocrit less than 30%, or platelets less than 50,000 cells/mm(3).
• History of clinically apparent pancreatitis or evidence of subclinical pancreatitis as shown by serum amylase values twice the upper limits of the normal range and abnormalities of the pancreas on CT or other imaging studies of the abdomen
• Prior interferon treatment within 6 months of entry
• Sensory or motor neuropathy apparent from medical history and physical examination
• Creatinine clearance less than 50 ml/min or serum creatinine greater than 1.5 mg/dl; creatinine clearance will be determined on a 24 hour urine specimen. Accuracy of collection will be ensured by documenting appropriate total creatinine excretion in the 24 hour urine specimen (15 mg/kg) and correcting for the patient's age and gender.
• Concurrent use of nephrotoxic agents (e.g., aminoglycosides, amphotericin B, vancomycin, foscarnet, cis-platinum, pentamidine, nonsteroidal anti-inflammatory agents) or competitors of renal tubular excretion (e.g., probenecid) within 2 months prior to study screening or the expectation that the subject will receive these during the course of the study
• +5 more criteria