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Gilead : Treatment With Bulevirtide Achieves Significant Response In Chronic Hepatitis Delta Virus

Gilead Sciences Inc. (GILD) said that treatment with hepcludex or bulevirtide was shown to achieve significant response in chronic hepatitis delta virus after 24 weeks. Interim phase 2b and phase 3 data are consistent with previous results and reinforce the clinical profile of hepcludex in adults with chronic HDV and compensated liver disease.

Interim results from the Phase 3 MYR301 study indicated that after 24 weeks, the proportion of people with HDV achieving the combined virological and biochemical response was 36.7% with bulevirtide 2 mg, 28% in participants receiving bulevirtide 10 mg and 0% in participants currently under observation who have not received antiviral treatment at this stage of the study.

Treatment for 24 weeks with bulevirtide 2 mg or 10 mg had a superior response to the no treatment group, with bulevirtide 2 mg for 24 weeks having a numerically higher response rate compared with bulevirtide 10 mg. Additionally, rapid ALT reduction and normalization were observed in more than 50% of patients in the bulevirtide 2 mg group compared with the bulevirtide 10 mg or no treatment groups.

These results reinforce the efficacy of bulevirtide for the treatment of HDV. The safety profile of bulevirtide at 24 weeks from these interim results is consistent with prior reports, and no serious adverse events or AEs, symptomatic elevations in bile salts or AEs leading to discontinuation related to bulevirtide were reported.

The company noted that data from the Phase 2b MYR204 study assessing the safety and efficacy of bulevirtide monotherapy or in combination with peginterferon alfa-2a, in people living with HDV will also be presented in an oral session on June 26.
The study evaluating 175 people with chronic HDV randomly allocated people across four groups: peginterferon alfa-2a; bulevirtide 2 mg plus peginterferon alfa-2a; bulevirtide 10 mg plus peginterferon alfa-2a; and bulevirtide 10 mg.

The proportion of participants achieving a combined response after 24 weeks of treatment was higher in those treated with bulevirtide, with the highest response rate seen in the monotherapy group.

Treatment with bulevirtide, both as monotherapy or in combination with peginterferon alfa-2a, was well-tolerated, with mostly mild or moderate AEs and no reported serious AEs or AEs leading to discontinuation of bulevirtide. The European Commission granted Hepcludex 2 mg Conditional Marketing Authorization; all other dosing and combinations are investigational.

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