MONDAY, June 10, 2024 (HealthDay News) — 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 percent of the patients in the peginterferon alfa-2a group, 32 percent of those in the 2-mg bulevirtide plus peginterferon alfa-2a group, 46 percent of those in the 10-mg bulevirtide plus peginterferon alfa-2a group, and 12 percent 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 percent, 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.
The study was funded by Gilead Sciences, the manufacturer of bulevirtide.
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