Bulevirtide + Peginterferon Alfa-2a Best Treatment for Chronic Hepatitis D
By Lori Solomon HealthDay Reporter
MONDAY, June 10, 2024 -- 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.
Abstract/Full Text (subscription or payment may be required)
Editorial (subscription or payment may be required)
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2024 HealthDay. All rights reserved.
Posted June 2024
Read this next
ACOG Guideline Addresses Hepatitis in Pregnancy
TUESDAY, Aug. 22, 2023 -- In a clinical practice guideline issued by the American College of Obstetricians and Gynecologists and published online Aug. 17 in Obstetrics &...
Recommendations Developed for Management of Acute Liver Failure
WEDNESDAY, July 12, 2023 -- In a clinical guideline issued by the American College of Gastroenterology and published in the July issue of the American Journal of Gastroenterology...
Bulevirtide Linked to Decline in Hepatitis D Virus RNA Levels
FRIDAY, June 30, 2023 -- For patients with hepatitis D virus (HDV), bulevirtide is associated with a reduction in HDV RNA levels and alanine aminotransferase (ALT) levels...
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.