With an aim to assist sponsors looking to develop hepatitis B virus (HBV) treatments, the US Food and Drug Administration (FDA) on Thursday released draft guidance covering the gamut of development stages.
The guidance includes general considerations on nonclinical toxicology and virology studies, early phase clinical development, clinical pharmacology assessments, and phase 3 safety and efficacy trials.
Phase 3 trial design considerations and efficacy endpoints for the development of combination therapies for the treatment of chronic HBV infection are also discussed in the draft. In addition, development considerations for specific subpopulations, such as patients coinfected with hepatitis D virus or human immunodeficiency virus and pediatric HBV-infected patients, are also included.
Under the section on Phase 3 efficacy trial considerations, the draft features a section on other important endpoints, such as assessing progression of liver disease…