 - Severe hepatic Child-Pugh C andor kidney failure creatinine clearance estimated Glomerular Filtration Rate - eGFR 30 mlmin1.73m2 andor serum creatinine above 1.5 fold of Upper Limit Normal ULN andor Alanine-Amino Transferase AST or Asparagine-Amino Transferase ALT above 3 fold ULN at baseline. 