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# Developing Drugs for Hepatitis D Virus Infection
- URL: https://www.fdaweb.com/developing-drugs-for-hepatitis-d-virus-infection/
- Published: 2019-10-31T12:00:00.000Z
- Updated: 2026-09-14T15:51:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145389

FDA has issued a guidance, *Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment*, to assist sponsors in clinical development of drugs to treat chronic hepatitis D virus (HDV) infection. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/chronic-hepatitis-d-virus-infection-developing-drugs-treatment-guidance-industry?ref=fdaweb.com) specifically addresses the agency’s current recommendations for the overall development program and clinical trial designs for the development of drugs and biologics to support an indication for treating chronic HDV infection.

The agency says it encourages sponsors to communicate with the CDER Division of Antiviral Products through the pre-IND consultation program to discuss the development of drugs with unique considerations based on mechanism of action, novel treatment approaches, or the use of novel biomarkers. It says the guidance is intended to be a focus for continued discussions among FDA, pharmaceutical sponsors, the academic community, and the public.

The guidance focuses on considerations specific to HDV drug development. It says that general topics in early phase drug development, statistical analysis, and clinical trial design are available in documents produced by the International Conference on Harmonization and FDA.

Contents of the draft guidance are Introduction, Background, Development Program (general drug development considerations, Phase 3 efficacy trial considerations, and other considerations) and References.