Study of Combivir for Patients With Primary Biliary Cirrhosis

Exclusion Criteria

• •Patients treated with immunosuppressive or anti-inflammatory agents such as colchicine, methotrexate, D-penicillamine, cyclosporine, tacrolimus, mycophenolate mofetil, corticosteroid therapy will be excluded but may enter the study after a 3 month period off immunosuppressive and anti-inflammatory therapy.
• •Advanced liver disease: Childs Pugh class B or C cirrhosis, recurrent variceal hemorrhage, spontaneous encephalopathy, diuretic resistant ascites, need for liver transplantation within the year.
• •Patients with a secondary hepatic diagnosis such as viral hepatitis, drug induced liver injury, extrahepatic biliary obstruction, primary sclerosing cholangitis, metabolic liver diseases or alcoholic liver disease.
• •Regular use of more than 30 g of alcohol per day in the last year.
• •Patients with a predicted survival of less than 3 years from malignant or other potentially life threatening disease.
• •Creatinine clearance less than \< 70 mL/min using the Cockcroft Gault equation:
• •Clinically apparent pancreatitis.
• •Serum amylase \> 3 x upper limit of normal (patients with sicca syndrome and salivary gland disease may have elevated amylase levels)
• •Pregnancy or breast-feeding a child.
• •Sexually active patients of child bearing age and not using effective contraception.
• •Allergic reaction to Combivir like drugs
• •Clinical evidence of myositis
• •Weight of \< 50 Kg