Orsini to Serve as Contracted Specialty Pharmacy for Gilead’s Hepcludex® (bulevirtide‑gmod)
Hepcludex® is a first-in-class entry inhibitor approved for the treatment of adults with chronic hepatitis delta (HDV) infection.
ELK GROVE VILLAGE, Ill., May 26, 2026 /PRNewswire/ - Orsini, a leader in rare disease pharmacy solutions, announced today 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 U.S. Food and Drug Administration (FDA). 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 a confirmatory trial(s).
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 U.S. 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. In clinical trials, Hepcludex® demonstrated a statistically significant improvement versus placebo in a composite virologic and biochemical response.
“We are incredibly honored to partner with Gilead to support the HDV community,” Orsini CEO Brandon Tom said. “At Orsini, our deep experience in rare diseases positions us to help remove barriers, simplify access to Hepcludex® and ensure patients can receive this important therapy as quickly and seamlessly as possible.”
About Orsini
Providing patients with comprehensive and compassionate care since 1987, Orsini is a leader in rare diseases and gene therapies. Orsini partners with biopharma innovators, healthcare providers and payors to support patients and their families in accessing revolutionary treatments for rare diseases. Through integrated rare disease pharmacy solutions including pharmacy distribution, patient services, clinical management and convenient home infusion services, Orsini simplifies how patients connect to advanced therapies. Orsini’s high-touch care model centers on experienced and trained therapy care teams that provide personalized patient care to ensure that No Patient is Left Behind™.
Orsini holds accreditations with the Accreditation Commission for Health Care (ACHC), URAC and NABP. Orsini has earned URAC’s Rare Disease Pharmacy Center of Excellence Designation and ACHC’s Distinction in Rare Diseases and Orphan Drugs. For more information, visit www.orsini.com.
Orsini Contact
Claire Noble
cnoble@orsinihc.com