FDA is announcing the availability of a draft guidance for industry entitled “Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment.” The purpose of this guidance is to assist sponsors in the clinical development of drugs and biologics for the treatment of chronic HBV infection from the initial IND through the NDA/BLA and postmarketing phases. The guidance includes general considerations for nonclinical toxicology and virology studies, early phase clinical development, clinical pharmacology assessments, and phase 3 safety and efficacy trials. The guidance discusses phase 3 trial design considerations and efficacy endpoints for the development of combination therapies for the treatment of chronic HBV infection. Drug 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.
Please refer to the guidance and Federal Register Notice for more details
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