VIDEO: Bulevirtide remains ‘efficacious, well tolerated’ in chronic hepatitis D at 2 years
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Key takeaways:
- Up to 57% of patients with chronic hepatitis D virus achieved combined response with bulevirtide 2 mg at week 144.
- More than 70% of patients achieved virologic response and 59% attained ALT normalization.
In a Healio video exclusive, Anu Osinusi, MD, MPH, reported long-term bulevirtide monotherapy 2 mg and 10 mg remained safe and effective for chronic hepatitis D virus with improved biochemical, fibrosis and virologic markers at 144 weeks.
“The MYR301 study is a phase 3 clinical trial that evaluates the long-term efficacy and safety of bulevirtide, which is our HDV entry inhibitor, in 150 patients with chronic hepatitis D and compensated liver disease,” Osinusi, vice president of virology at Gilead Sciences, said. “The primary endpoint of this pivotal phase 3 study was combined response, defined as undetectable HDV RNA or 2log decline in the HDV RNA from baseline as well alanine transaminase normalization at week 48.”
Patients received either delayed treatment for 48 weeks followed by bulevirtide 10 mg per day for 96 weeks (arm A = 51), bulevirtide 2 mg per day for 144 weeks (arm B = 49) or bulevirtide 10 mg per day for 144 weeks (arm C = 50). Researchers noted 96%, 91.8% and 88% of patients, respectively, remained in the study at week 144.
According to study results, 57% of patients who received bulevirtide 2 mg achieved combined response, with 73% achieving virologic response and 59% attaining ALT normalization, compared with patients who received bulevirtide 10 mg (combined response: 54%; virologic response: 76%; ALT: 60%).
The researchers reported that 56% of patients who received bulevirtide 10 mg per day for 96 weeks achieved a combined response, 92% achieved virologic response and 58% attained ALT normalization.
Both groups that received bulevirtide for 144 weeks experienced undetectable rates of HDV RNA that increased with treatment (arm B: 29%; arm C: 50%), but patients in arm C were faster to attaining undetectable HDV RNA (mean 69.3 weeks) vs. patients in arm B (mean 77.3 weeks).
The researchers noted that baseline predictors of undetectable HDV RNA at 144 weeks included lower HDV RNA log10 IU/mL (bulevirtide 2 mg (OR=2.9; P=.0145); bulevirtide 10 mg (OR=2.1; P= .0258)) and lower hepatitis B surface antigen log10 IU/mL (bulevirtide 2 mg (OR=5.1; P=.0319); bulevirtide 10 mg (OR=6; P= .0390)). The mean change from baseline in HBsAg was –0.36 IU/mL for bulevirtide 2 mg and –0.19 IU/mL for bulevirtide 10 mg.
“What was presented at EASL this year are the final results at week 144 reinforcing that bulevirtide is efficacious and well tolerated as a long-term treatment option for people who have hepatitis delta,” Osinusi, told Healio. “It’s important to note bulevirtide 2 mg remains the only approved treatment for hepatitis delta in the European Union; it is not approved in the U.S. at this time. The 10 mg dose of bulevirtide is an investigational product that is not approved anywhere in the world at this point in time.”
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Lampertico P, et al. Efficacy and safety of 144 weeks of bulevirtide 2 mg or 10 mg monotherapy from the ongoing phase 3 study, MYR302. Presented at: EASL Congress; June 05-08, 2024; Milan (hybrid).
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