Research shows bulevirtide and peginterferon alfa-2a best treatment for chronic hepatitis D

The combination of bulevirtide plus peginterferon alfa-2a is superior to bulevirtide monotherapy for achieving undetectable hepatitis D virus (HDV) RNA level at 24 weeks after the end of treatment in patients with chronic hepatitis D, according to a study published online June 6 in the New England Journal of Medicine to coincide with the annual congress of the European Association for the Study of the Liver, held from June 5 to 8 in Milan.

Tarik Asselah, M.D., Ph.D., from Université de Paris-Cité, and colleagues conducted a phase 2b trial in which patients with chronic hepatitis D were randomly assigned to peginterferon alfa-2a alone (180 μg per week) for 48 weeks (24 patients); bulevirtide (daily dose of 2 mg or 10 mg) plus peginterferon alfa-2a (180 μg per week) for 48 weeks (50 patients at each dose), followed by the same daily dose of bulevirtide for 48 weeks; or bulevirtide alone (daily dose of 10 mg) for 96 weeks (50 patients).

The researchers found that 24 weeks after the end of treatment, HDV RNA was undetectable in 17% of the patients in the peginterferon alfa-2a group, 32% of those in the 2-mg bulevirtide plus peginterferon alfa-2a group, 46% of those in the 10-mg bulevirtide plus peginterferon alfa-2a group, and 12% of those in the 10-mg bulevirtide group.

For the primary comparison between the 10-mg bulevirtide plus peginterferon alfa-2a group and the 10-mg bulevirtide monotherapy group, the between-group difference was 34 percentage points. At 48 weeks after the end of treatment, the percentage of patients with HDV RNA that was undetectable was 25, 26, 46, and 12%, respectively, in the four study arms. Most adverse events were grade 1 or 2, and the most frequent were leukopenia, neutropenia, and thrombocytopenia.

"Our results indicate that a regimen of finite duration for chronic hepatitis D led to a sustained undetectable HDV RNA response, as measured by a highly sensitive HDV RNA assay, beyond 24 weeks after the end of treatment," the authors write.

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