Andrew Cox, Pharm.D., MBA

Capsid assembly modulators (CAM) work by assembling flawed hepatitis B capsids and preventing the formation of new infectious viruses.

Gilead’s hepatitis D antiviral, bulevirtide, was dealt a setback last year when the FDA issued a complete response letter. Positive results from a phase 3 trial of bulevirtide, were reported in July.

To add precision to the nomenclature and nosology and remove stigma, experts are moving to rename nonalcoholic fatty liver disease as metabolic dysfunction-associated steatotic liver disease.

Based on the results published in the New England Journal of Medicine, the FDA has granted breakthrough status to the FGF21 analogue. The drug's maker is planning a phase 3 trial.