Breakthrough Therapy Bulevirtide was Safe, Effective, and Improved Quality of Life for Hepatitis Patients


Three posters on the subject were presented at The Liver Meeting and were among the meeting’s key presentation highlights called “Best of the Liver Meeting.”


Bulevirtide is a potential treatment option for people living with chronic hepatitis delta virus (HDV), according to a key presentation from The Liver Meeting, which took place earlier this month. The research was selected to be part of the “Best of the Liver Meeting” highlights.

Investigators from Gilead conducted phase 2 and Phase 3 studies of bulevirtide in order to evaluate its 48-week integrated safety and efficacy among those living with chronic HDV. Bulevirtide (Hepcludex in the European Economic Area and United Kingdom) is Gilead’s first-in-class investigational treatment for chronic HDV. The drug was granted Breakthrough Therapy and Orphan Drug designations by the FDA, according to a company statement.

In the first study, 269 patients were either treated with bulevirtide alone at 2 mg daily (64 patients) or 10 mg daily (115 patients), while 39 patients received Peg-IFNα, and 51 patients served as controls. After 48 weeks, overall incidence of participants who experienced adverse events was similar between the 2 groups that received bulevirtide (85 and 86 percent) compared to 89 percent in the Peg-IFNα group and 76 percent in the control group. However, the study authors wrote that most adverse events were mild or moderate in their severity. They ultimately concluded that bulevirtide 2 mg daily was safe and well-tolerated, including in patients with compensated cirrhosis as well as among patients who were not naïve to interferon.

A second study explored the effects of bulevirtide 2 mg daily or bulevirtide 10 mg daily on 64 and 65 patients, respectively, compared to 51 control patients receiving no active anti-HDV treatment during a 48-week analysis period. The study authors determined that treatment with bulevirtide had similar endpoints between the 2 mg and 10 mg groups; additionally, treatment with bulevirtide offered better results than the control group, which received no treatment.

Finally, the investigators examined quality of life among patients with HDV. A total of 150 patients were randomized into equal groups to receive either bulevirtide 2 mg daily, bulevirtide 10 mg daily, or no treatment until week 48 followed by bulevirtide 10 mg afterwards until 3 years.

The patients self-rated their quality of life at baseline and at week 48. Those who received bulevirtide 2 mg daily reported statistically significant quality of life improvements through week 48, the study authors observed, and these improvements were significantly better in terms of a change from baseline compared to control. Quality of life improvements among patients who received bulevirtide 10 mg daily did not reach statistical significance, the study authors reported.

Taken together, this body of research underscores “the clinical utility of bulevirtide as a potential treatment option for people living with chronic HDV,” the company statement said.

“Our latest research helps to address some of the most significant needs of people living with liver diseases globally,” Anu Osinusi, vice president, Clinical Research for Hepatitis, Respiratory and Emerging Viruses at Gilead, said in the press release. “It includes analyses from our clinical program on bulevirtide for the treatment of chronic hepatitis delta virus and preclinical data demonstrating the progress Gilead is making on the journey towards a potential cure for hepatitis B. Through our ongoing research programs, we continue our longstanding commitment to address the unmet needs of people impacted by liver diseases.”

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