GPT and Hyperbilirubinemia: The FDV solution given as single doses of 4–1,200 mg was generally well tolerated: AEs were consistent with the known FDV safety profile; tolerability was reasonable, with increases in gastrointestinal symptoms and indirect hyperbilirubinemia at higher doses; increases in indirect bilirubin concentrations were reversible and not associated with decreases in alanine transaminase, hemoglobin, or neutrophil count.