FDA releases draft guidance on hepatitis B virus drug development

The Food and Drug Administration (FDA) has released draft guidance which aims to help sponsors who are looking to develop hepatitis B virus (HBV) treatments. The guidance covers general considerations on non-clinical toxicology and virology studies, early phase clinical development, clinical pharmacology assessments, and phase 3 safety and efficacy trials.

The draft guidance also discusses phase 3 trial design considerations and efficacy endpoints for the development of combination therapies for the treatment of chronic HBV infection. Furthermore, development considerations for specific subpopulations, for example patients co-infected with hepatitis D virus or human immunodeficiency virus and paediatric HBV-infected patients are also included. The guidance also covers clinical virology considerations, pharmacokinetic/pharmacodynamic considerations and labelling.

The guidance states that “except for patients with advanced or decompensated cirrhosis, a statistically rigorous evaluation of endpoints of liver progression can be challenging because these events occur infrequently until late in the course of CHB (chronic hepatitis B). However, treatment effects on these endpoints provide useful clinical information, and trials evaluating them could be used to support an expanded indication or patient population and could be summarised in appropriate sections of the label”.

The FDA also noted that the development of new HBV therapies is targeted at treatment regimens “of finite duration with low risk of virologic relapse and minimal risk of liver disease progression after the treatment is stopped.”

To read the FDA draft guidance on chronic HBV infection: developing drugs for treatment, please click here.