Hepcludex Shows Efficacy Treating Chronic Hepatitis Delta Virus

Gilead Sciences Inc has announced results at 48 weeks from a phase 3 clinical trial evaluating the first-in-class entry inhibitor bulevirtide (Hepcludex) for the treatment of chronic hepatitis delta virus (HDV) infection.

Findings from the study highlighted the efficacy and safety of bulevirtide for the treatment of HDV and were presented at the International Liver Congress (ILC) 2022 Official Press Program.

At week 48, the data showed the positive impact of bulevirtide on patient-reported-outcomes in individuals living with chronic HDV. Investigators said that these data reinforce the clinical utility of bulevirtide as a monotherapy for the treatment of chronic HDV. There are currently no other approved treatment options for HDV.

“These results presented at ILC 2022 not only highlight the important clinical role that bulevirtide has to play as a safe and effective treatment option for chronic HDV, but critically also demonstrate that with prolonged treatment, we can achieve higher response rates so we can better manage this rare, life-threatening disease in more people,” Heiner Wedemeyer, MD, director of Clinic for Gastroenterology, Hepatology and Endocrinology at Hannover Medical School, said in a statement.

At week 48, the individuals administered bulevirtide as a monotherapy, at either 2 mg or 10 mg once a day, achieved a significantly greater combined virological and biochemical response compared to individuals who had not received antiviral treatment at this stage of the study.

The combined response was defined as undetectable HDV RNA or a decrease by 2 log₁₀ IU/mL from baseline and ALT normalization.

Similarly, when the week 48 data are considered with the integrated week 24 analyses of the ongoing phase 2 studies and the interim week 24 phase 3 data, combined response rates of bulevirtide increased from week 24 to week 48, highlighting an improved response of bulevirtide with prolonged treatment, according to the study authors.

“The consequences of living with a serious and chronic condition like HDV can have a profound impact on the individual’s quality of life, affecting the physical and mental well-being of people living with HDV,” Anu Osinusi, vice president of Clinical Research for Hepatitis, Respiratory, and Emerging Viruses at Gilead, said in a statement. “What we now see is that treatment with bulevirtide not only improves clinical measures associated with viral control but can significantly improve, and maintain, a range of quality-of-life markers in people living with HDV, ultimately improving the overall management of the condition.”

The safety profile of bulevirtide at week 48 is consistent with prior reposts, with no individuals having adverse events (AEs) leading to discontinuation and no serious AEs attributed to bulevirtide treatment.

Additionally, the safety profile at both week 24 and 48 reinforce the safety and tolerability profile of bulevirtide.

In an oral presentation, Gilead will also share an exploratory analysis of the week 48 data from the phase 3 MYR301 study, evaluating the impact of bulevirtide at the 2 mg strength on PROs in individuals living with chronic HDV. The individuals treated with bulevirtide showed significant improvements from baseline at 48 weeks in almost all assessed health-related quality-of-life domains of the Hepatitis Quality of Life questionnaire.

Further, individuals receiving bulevirtide reported significant improvements in performance of daily activities related to hepatitis, emotional impact of hepatitis, and improvement in work compared with controls.

Reference

Treatment with Hepcludex (bulevirtide) meets primary endpoint and achieves significant response in chronic hepatitis delta virus at 48 weeks. Gilead. News release. June 23, 2022. Accessed June 28, 2022. https://www.gilead.com/news-and-press/press-room/press-releases/2022/6/treatment-with-hepcludex-bulevirtide-meets-primary-endpoint-and-achieves-significant-response-in-chronic-hepatitis-delta-virus-at-48-weeks