The investigational therapy from Gilead showed effectiveness and safety at 96 weeks.
Gilead recently reported data from its phase 3 trial, MYR301, for its investigational, first-in-class entry inhibitor, bulevirtide (Hepcludex), which showed long-term safety and efficacy for patients with chronic Hepatitis D.
The data assessed bulevirtide at 96 weeks and it builds upon previous data at Week 48 that was shared at EASL’s ILC 2022. Study participants who received either 2 mg or 10 mg bulevirtide achieved similar combined responses (ALT normalization and virological response).
The combined virological and biochemical response rates continued to increase through Week 96 compared to Week 48, with response rates of 55% and 56% with 2 mg and 10 mg bulevirtide respectively. The safety profile at Week 96 is consistent with what was observed at Week 48, with no resistance observed and no serious adverse events attributed to bulevirtide treatment. Increases in bile acids without a correlation to pruritus or other symptoms were noted with bulevirtide treatment. Injection site reactions occurred in a higher proportion of study participants receiving 10 mg of bulevirtide.
The new data was presented at the recent European Association for the Study of the Liver (EASL) Congress 2023.
“This latest data adds to the growing body of evidence establishing bulevirtide as an effective and well tolerated treatment for HDV when used for a longer duration. Importantly, we saw a response at 96 weeks even in people who initially showed only a partial decline in HDV viral load,” Heiner Wedemeyer, MD, director, Department of Gastroenterology, Hepatology, Infectious Diseases and Endocrinology at Hannover Medical School, said in a statement. “These findings demonstrate to clinicians and patients that with prolonged bulevirtide treatment, clinical benefit may be possible.”
Bulevirtide has been seeking approval through regulatory bodies. Last 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.”
Bulevirtide is expected to be back in front of the FDA again as the company will seek full federal approval in the US.