BioCentury
ARTICLE | Politics & Policy

FDA guides development of finite therapies to cure HBV

November 1, 2018 10:27 PM UTC

FDA released draft guidance Thursday to encourage development of finite, curative HBV treatments that have a low risk of virologic relapse and minimal risk of liver disease progression after treatment. FDA recommended developers use a two-pronged primary efficacy endpoint of sustained HBV DNA suppression off-treatment and HBV surface antigen (HBsAg) loss.

Current available treatments, including standard of care nucleoside analogs, achieve sustained HBV DNA suppression while on-treatment but with low rates of HBsAg loss. Clearance of HBsAg is associated with reduced risk of hepatic decompensation and improved survival, FDA said. ...