The following is a summary of “A Phase 3, Randomized Trial of Bulevirtide in Chronic Hepatitis D,” published in the July 2023 issue of Infectious Diseases by Wedemeyer et al.
In the retrospective study, researchers aimed to evaluate Bulevirtide’s effectiveness in treating Chronic Hepatitis D. In people with hepatitis D virus (HDV) and chronic hepatitis B, liver disease progression accelerates.
In the phase 3 trial, people were classified into three groups: chronic hepatitis D group, with compensated cirrhosis, and the other without compensated cirrhosis group. Participants were randomly assigned in a 1:1:1 ratio. About 49 participants received bulevirtide at (49) 2 mg (2-mg group), 50 received 10 mg per day (10-mg group), and 51 received no treatment for 48 weeks and then got the 10 mg dose for 96 weeks. After treatment, all groups were observed for another 96 weeks. The primary endpoint was to check if, by week 48, HDV RNA level became undetectable or reduced by at least 2 log10 IU per milliliter from baseline and if ALT became normal. The secondary outcome was checking HDV RNA level at 48 weeks, comparing the 2-mg and 10-mg groups.
Around 45% of patients who received the 2-mg group and 48% of patients In the 10-mg group responded well to the treatment. However, only 2% had a good response in the control group. At week 48, 12% of patients in the 2-mg group had undetectable HDV RNA levels; in the 10-mg group (P=0.41), it was 20%. Additionally, 12% of patients had normal ALT levels in the control group. In contrast, 51% of patients had normal ALT levels in the 2-mg group [95% CI, 20 to 56]), and in the 10-mg group, 56% of patients (difference from control, 44 percentage points [95% CI, 26 to 60]). There was no loss of hepatitis B virus surface antigen (HBsAg) or a decrease in HBsAg level by at least one log10 IU per milliliter in the bulevirtide groups by week 48. Headache, eosinophilia, pruritus, fatigue, injection-site reactions, arthralgia, upper abdominal pain, and asthenia were common in both groups taking bulevirtide compared to the control group. Also, bile acid levels increased more in the 2-mg and 10-mg groups.
The study concluded that HDV RNA and ALT levels were lowered in patients with chronic hepatitis D after 48 weeks of bulevirtide treatment.
Source: nejm.org/doi/full/10.1056/NEJMoa2213429
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