Additional Relevant Details The NDA for TAF is supported by 48-week data from two Phase 3 studies, which met their primary objective of non-inferiority in efficacy compared to Gilead’s Viread among treatment-naïve and treatment-experienced adults with HBeAg-negative and HBeAg-positive chronic HBV. In both studies, changes in renal and bone laboratory safety parameters favored the TAF regimen. Overall, patients receiving TAF experienced a significantly smaller mean percentage decrease from baseline in hip and spine bone mineral density at week 48 compared to patients receiving Viread. Additionally, the overall median change in serum creatinine from baseline to week 48 favored TAF. Rates of discontinuations due to adverse events and the most commonly reported adverse events were similar in patients receiving TAF or Viread.