Liver Events Assessment
If Yes, stop investigational product, complete date stopped on Investigational Product form, contact GSK within 24 hours of occurrence, complete Liver Events Form and obtain the following tests: • PK blood sample within 24 hours of last dose (or 3x the investigational product half-life or t1/2). • Hepatitis A: Hepatitis A lgM antibody. • Hepatitis B: Hepatitis B surface antigen and Hepatitis B Core Antibody (lgM). • Hepatitis C: Hepatitis C RNA. • Hepatitis E IgM antibody (if subject resides or has travelled in past 3 months outside the USA or Canada). • Cytomegalovirus IgM antibody (CMV) • EBV (Epstein Barr viral capsid antigen IgM antibody) or if unavailable, obtain heterophile antibody or monospot testing. • CPK (serum creatine phosphokinase) • LDH (lactate dehydrogenase) • Bilirubin fractionation, if bilirubin >1.5xULN The following are only needed when ALT >3xULN and bilirubin >1.5xULN (>35% direct) • Anti-nuclear antibody • Anti-smooth muscle antibody • Type 1 anti-liver kidney microsomal antibodies (if available) • Liver Imaging (ultrasound, magnetic resonance, or computerised tomography)
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