Safety and Effectiveness of Tenofovir Alafenamide in Usual Clinical Practice Confirms Results of Clinical Trials: TARGET-HBV.

Challenge

TAF was approved for chronic hepatitis B in 2016 based on clinical trial data, but its safety and effectiveness in the more heterogeneous US real-world population—including patients previously treated with other antivirals and those with more advanced liver disease—had not been established post-authorization.

Solution

The TARGET-HBV longitudinal cohort was used to characterize the clinical outcomes of 500 TAF-treated patients in usual clinical practice across academic and community US sites, comparing effectiveness and safety signals against the registration trial (POISE) population.

Impact

Confirming that TAF achieves comparable virological suppression and safety outcomes in a broader, more advanced real-world population validates the generalizability of registration trial results and provides the post-authorization effectiveness evidence required for prescriber confidence and payer negotiations.