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A phase 3 randomized clinical trial was conducted to evaluate the impact of Bulevirtide on chronic hepatitis D management.
In individuals suffering from chronic hepatitis D, Bulevirtide administration is safe and significantly reduces both hepatitis D virus RNA and alanine aminotransferase levels.
A phase 3 randomized clinical trial was conducted to evaluate the impact of Bulevirtide on chronic hepatitis D management.
In this ongoing clinical study, individuals afflicted by chronic hepatitis D, without or with compensated cirrhosis, were randomized into three groups, each consisting of an equal number of participants. The first group received a subcutaneous dose of 2 mg of Bulevirtide per day (referred to as the 2-mg group), and the second group received 10 mg per day (referred to as the 10-mg group) for a duration of 144 weeks. The third group (control group) initially received no treatment for 48 weeks, followed by a subcutaneous dose of 10 mg per day for the subsequent 96 weeks.
Following the conclusion of their individual treatment courses, all volunteers will undergo monitoring for an additional 96 weeks. The primary outcome of the study was defined as a combined response at week 48, characterized by either an undetectable level of hepatitis D virus ribonucleic acid (HDV RNA) or a reduction of at least 2 log10 IU per milliliter from the baseline level, coupled with the normalization of alanine aminotransferase (ALT) levels. A key secondary outcome was set to compare the 2-mg group with the 10-mg group, with a specific emphasis on achieving an undetectable HDV RNA level by week 48.
In this study, 51 patients were assigned to the control group, 50 to the 10-mg group, and 49 to the 2-mg group. The primary outcome response was noted in a mere 2% of individuals in the control group, 48% in the 10-mg group, and 45% in the 2-mg group. This difference was statistically significant with a p-value of less than 0.001 when comparing each dose group with the control group.
By the 48-week mark, the HDV RNA level had become undetectable in 12% of patients in the 2-mg group and 20% in the 10-mg group, with no notable disparity between these two groups. In terms of ALT level normalization, 12% of the individuals in control group achieved it, compared to 51% in the 2-mg group (a 39 percentage point difference from the control group) and 56% in the 10-mg group (a 44 percentage point difference from the control group).
Significantly, by week 48, there were no instances of hepatitis B virus surface antigen (HBsAg) loss or a substantial decrease in HBsAg levels of at least 1 log10 IU per milliliter observed in the Bulevirtide groups. Certain side effects, such as asthenia, arthralgia, upper abdominal pain, injection-site reactions, eosinophilia, fatigue, pruritus, and headache were more prevalent in the combined 2-mg and 10-mg groups compared to the control group. No serious treatment-related adverse events were noted. Furthermore, there were observed elevations in bile acid levels that depended on the dosage in both the 10-mg and 2-mg groups.
Following 48 weeks of Bulevirtide treatment, patients with chronic hepatitis D exhibited favorable reductions in HDV RNA and ALT levels.
New England Journal of Medicine
A Phase 3, Randomized Trial of Bulevirtide in Chronic Hepatitis D
Heiner Wedemeyer et al.
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