3:27 PM
Nov 01, 2018
 |  BC Extra  |  Politics & Policy

FDA guides development of finite therapies to cure HBV

FDA released draft guidance Thursday to encourage development of finite, curative HBV treatments that have a low risk of virologic relapse and minimal risk of liver disease progression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...

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