The following is an abstract from the “Phase 3 Randomized Trial of Bulevirtide in Chronic Hepatitis D,” published in the July 2023 issue of infectious diseases Wedemeyer et al.
In this retrospective study, researchers aimed to evaluate the effectiveness of bulevirtide in treating chronic hepatitis D. Liver disease progression is accelerated in patients with hepatitis delta virus (HDV) and chronic hepatitis B.
In the Phase 3 trial, people were divided into three groups: chronic hepatitis D, compensated cirrhosis, and uncompensated cirrhosis. Participants were randomly assigned in a 1:1:1 ratio. Approximately 49 participants were treated with (49) 2 mg of bleuvirtide (2 mg group), 50 participants were treated with the 10 mg daily dose (10 mg group), and 51 participants did not receive any during 48 weeks. treatment, followed by a 10 mg dose for 96 weeks. After treatment, all groups were observed for an additional 96 weeks. The primary endpoint was to examine whether HDV RNA levels became undetectable or decreased by at least 2 log by week 4810 IU per milliliter and ALT are normal compared to baseline. Secondary outcomes were HDV RNA levels examined at 48 weeks, comparing the 2 mg and 10 mg groups.
Forty-five percent of patients in the 2 mg group and 48% of patients in the 10 mg group responded well to the treatment. However, only 2% of people in the control group had a good response. At week 48, 12% of patients in the 2 mg group had undetectable HDV RNA levels; 20% of patients in the 10 mg group (P=0.41). In addition, 12% of patients in the control group had normal ALT levels. In contrast, 51% of patients in the 2 mg group had normal ALT levels (95% CI, 20 to 56) and 56% in the 10 mg group (a difference of 44 percentage points from the control group (95% CI). CI, 26 to 60)). No loss of hepatitis B virus surface antigen (HBsAg) or a decrease in HBsAg levels of at least 1 log10 Changes in IU/mL in the bulevirtide group through week 48. Headache, eosinophilia, pruritus, fatigue, injection site reactions, arthralgia, epigastric pain, and fatigue were common in both groups taking bulevirtide compared with the control group. Additionally, bile acid levels increased more in the 2 mg and 10 mg groups.
The study concluded that HDV RNA and ALT levels were reduced in patients with chronic hepatitis D treated with bulevirtide for 48 weeks.
source: nejm.org/doi/full/10.1056/NEJMoa2213429