VIDEO: Bulevirtide plus PEG-IFN a-2a potentially ‘viable finite therapy’ for chronic HDV
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Key takeaways:
- Study results suggest that combination bulevirtide 10 mg with PEG-IFN a-2a was superior to bulevirtide monotherapy in achieving undetectable HDV RNA.
- Results were sustained through week 48 of treatment.
In a Healio video exclusive, Anu Osinusi, MD, MPH, reports that combination bulevirtide 10 mg with pegylated interferon alfa-2a for chronic hepatitis D virus infection resulted in the highest rates of undetectable HDV RNA through 48 weeks.
“The MYR204 study is a randomized, open-label, controlled, parallel-group, multicenter phase 2b study in which a total of 175 patients with hepatitis delta were randomized to receive one of four different treatments,” Osinusi, vice president of virology at Gilead Sciences, said. “The primary endpoint was undetectable HDV RNA at 24 weeks after end of treatment.”
Enrolled patients were grouped based on the absence or presence of compensated cirrhosis and were randomly assigned to PEG-IFN a-2a for 48 weeks (group A = 24), bulevirtide 2 mg with PEG-IFN a-2a (group B = 50), bulevirtide 10 mg with PEG-IFN a-2a for 48 weeks followed by 48 weeks of monotherapy with bulevirtide 2 mg or 10 mg (group C = 50) or bulevirtide 10 mg for 96 weeks (group D = 50). The baseline demographics were similar across groups.
At 24 and 48weeks following end of treatment, 17% and 25% those in group A, respectively, achieved undetectable HDV RNA, as did 32% and 26% in group B, 46% and 46% in group C and 12 % and 12% in group D. Researchers observed hepatitis B surface antigen loss only in patients treated with bulevirtide.
Overall, bulevirtide was well-tolerated. One patient discontinued due to a treatment-related adverse event and three patients experienced related serious adverse events in the post-treatment period.
“The results suggest that combination bulevirtide 10 mg with pegylated interferon was superior to bulevirtide monotherapy in achieving this undetectable HDV RNA 24 weeks after the end of treatment, with similar results when we followed patients out till 48 weeks after the end of treatment,” Osinusi said, noting that bulevirtide 10 mg is an investigational product and not currently approved. “This shows that the bulevirtide combination with pegylated interferon has potential as a viable finite therapy for patients living with chronic hepatitis delta.”
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Asselah T, et al. 48-week off-therapy efficacy and safety of bulevirtide in combination with pegylated interferon alfa-2a in patients with chronic hepatitis delta: final results from the phase 2b, open-label, randomized, multicenter study MYR204. Presented at: EASL Congress; June 5-8, 2024; Milan (hybrid).
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