Combination Antiretroviral Therapy (cART) for PBC

Prior treatment

• use of non-standard or experimental therapy within the last 6 months,
• previous allergic reaction to study medications;

Other illness

• secondary diagnosis such as HIV, viral hepatitis, drug induced liver injury, extrahepatic biliary obstruction, primary sclerosing cholangitis, metabolic liver - regular use of \> 30g alcohol/day in the last year;
• a predicted survival of less than 3 years from malignant or other life threatening disease;

Lab values

• subjects with baseline total bilirubin \> 2 x ULN,(patients meeting inclusion criteria stabilized on second line therapies including obeticholic acid or bezafibrate over 12 months or more may be enrolled).
• advanced liver disease: INR \> 1.2 ULN, Albumin \< 35 g/L lower limit of normal, platelets \< 120,000/microL unless varices with risk of bleeding excluded by endoscopy within the last 6 months, Childs Pugh class B or C cirrhosis, presence of grade 2 varices or previous variceal hemorrhage, encephalopathy, ascites or need for liver transplantation within the next two years;

Other

• hepatic mass consistent with hepatocellular carcinoma ;
• Glomerular Filtration Rate less than \< 30 mL/min as measured Cockcroft-Gault formula;
• pregnancy, breast-feeding or pre-menopausal patients not using contraception.

• over 18 years old of either sex,
• Anti-mitochondrial antibody +ve or liver histology compatible with PBC,
• stable UDCA dose of 13-15 mg/kg for \> 12 months or intolerant to UDCA,
• ALP at least 1.67 x ULN or abnormal bilirubin less than 2x ULN
• able to read and sign informed consent form.