Rare disease pharmacy solutions provider Orsini announced on Tuesday that it is the contracted specialty pharmacy for Gilead's Hepcludex (bulevirtide-gmod) 8.5 mg, a subcutaneous injection for the treatment of chronic hepatitis delta (HDV) infection in adults without cirrhosis or with compensated cirrhosis, which has received accelerated approval from the US Food and Drug Administration (FDA).

Orsini noted that an improvement in disease-related clinical outcomes has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

A co-infection in individuals who have hepatitis B, HDV is the most severe form of viral hepatitis and affects approximately 40,000 people in the United States. Those living with HDV often experience faster progression to liver fibrosis, cirrhosis and hepatic decompensation, and they have a higher risk of liver cancer and death. The company says that in clinical trials, Hepcludex demonstrated a statistically significant improvement versus placebo in a composite virologic and biochemical response.