British Public Health Organization Recommends Hepatitis D Therapy

The British public health body, NICE, has offered its recommendation for use of Gilead’s bulevirtide (Hepcludex) for the treatment of hepatitis D (HDV) in adults with compensated liver disease as an option if it meets certain criteria.

Specifically, NICE wrote in its recommendation that the therapy be offered as an option for treating HDV only if:

• there is evidence of significant fibrosis (METAVIR stage F2 or above or Ishak stage 3 or above) and
• their hepatitis has not responded to peginterferon alfa-2a (PEG-IFN) or
• they cannot have interferon-based therapy.

NICE explained part of its reasoning for this recommendation was that the therapy met a medical need, as there are no other licensed treatments for hepatitis D.

“People with hepatitis D also have hepatitis B. There are no other licensed treatments specifically for hepatitis D. Standard care usually involves treating symptoms and the hepatitis B. People with significant fibrosis (scarring) in their liver can be offered PEG-IFN, but it is not licensed for this use,” the authors wrote. "The company [Gilead] positioned bulevirtide for people with chronic hepatitis D who have tried PEG-IFN and whose condition did not respond to it, or for people who cannot have interferon-based therapy."

This would make it the first therapy to be conditionally licensed for HDV infection in Great Britain.

Bulevirtide has seen reviews in front of committees of other regulatory bodies including the European Medicines Agency (EMA) and the FDA.

Regarding the EMA, earlier this month, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) offered a favorable opinion on the use of bulevirtide for HDV and compensated liver disease.

The CHMP looked favorable on the data associated with Gilead’s application, and the European Commission (EC) will review the CHMP recommendation. If adopted, bulevirtide will be fully authorized in the European Union.

Last fall, the FDA sent Gilead a Complete Response Letter on bulevirtide. In the letter, the federal agency said it had concerns about the manufacture and delivery of the therapy.

“While we are disappointed with this outcome, we remain confident in the benefits bulevirtide could potentially bring to people living with HDV in the US. Today’s news does not change the safety and efficacy profile observed in clinical trials to date,” Gilead Chief Medical Officer Merdad Parsey, MD, PhD, said in a statement at the time. “We look forward to continuing our active discussions with FDA so that we may bring bulevirtide to people living with HDV in the US as soon as possible.”

It is important to note that FDA did not ask Gilead for further studies for bulevirtide, and it is expected that bulevirtide will be back in front of the FDA again as the company will seek full federal approval in the US.