New Guidance: Hepatitis D

The Food and Drug Administration is announcing the availability of a draft guidance for industry entitled “Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment". The purpose of this draft guidance is to assist sponsors in all phases of development of antiviral drugs for the treatment of chronic hepatitis D virus (HDV) infection. The guidance addresses all phases of drug development, from nonclinical considerations to phase 3 trial design recommendations. The FDA is seeking comments and suggestions on this draft guidance via the associated docket (Docket number: FDA-2019-D-4042). Please refer to the Federal Register notice on how to submit comments and suggestions on this draft guidance. HDV infection occurs only in people who have hepatitis B virus (HBV) infection. Chronic HDV infection can impair liver function and cause long-term liver problems, including liver scarring, liver failure and cancer. These liver-related complications are more common in people who have HBV/HDV coinfection compared to people with HBV infection alone.  There are no FDA approved drugs for the treatment of HDV infection.  Because chronic HDV infection is considered serious and life-threatening condition and there are no FDA approved treatments, investigational anti-HDV drugs may be eligible for FDA’s expedited programs such as fast track, breakthrough therapy, accelerated approval, and priority review designations.

Kimberly Struble Division of Antiviral Products Food and Drug Administration Elizabeth Thompson Division of Antiviral Products Food and Drug Administration Michael Stanfield Jr. Division of Antiviral Products Food and Drug Administration