FRIDAY, June 30, 2023 (HealthDay News) — For patients with hepatitis D virus (HDV), bulevirtide is associated with a reduction in HDV RNA levels and alanine aminotransferase (ALT) levels, according to a study published online June 22 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 21 to 24 in Vienna.
Heiner Wedemeyer, M.D., from Medizinische Hochschule Hannover in Germany, and colleagues randomly assigned patients with chronic hepatitis D, with or without compensated cirrhosis, to receive bulevirtide 2 mg per day or 10 mg per day for 144 weeks or to receive no treatment for 48 weeks followed by bulevirtide 10 mg per day for 96 weeks (control group) (49, 50, and 51 patients, respectively) in an ongoing phase 3 trial.
The researchers found that a primary end point response (combined response of an undetectable HDV RNA level or a level that decreased by at least 2 log10 IU/mL from baseline, and normalization of the ALT level at week 48) occurred in 45, 48, and 2 percent of patients in the 2-mg, 10-mg, and control groups, respectively. At week 48, the HDV RNA level was undetectable in 12 and 20 percent of patients in the 2-mg and 10-mg groups, respectively. Normalization of ALT occurred in 51, 56, and 12 percent of patients in the 2-mg, 10-mg, and control groups, respectively. There were no treatment-related serious adverse events reported.
“The results of the trial by Wedemeyer and colleagues offer a glimmer of hope for an orphan disease, and the final results of the trial are eagerly awaited,” write the authors of an accompanying editorial.
Several authors disclosed ties to pharmaceutical companies, including Gilead Sciences, which developed bulevirtide and funded the study.
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