Monotherapy with bulevirtide well tolerated in patients with chronic hepatitis delta
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Monotherapy with bulevirtide among patients with compensated hepatitis delta was safe and well tolerated, according to a presentation at the International Liver Congress.
“Safety and efficacy were confirmed,” Heiner Wedemeyer, MD, professor and chairman of the clinic for gastroenterology, hepatology and endocrinology, Hannover Medical Hospital, Germany, said during his presentation. “However, these were only 24-week interim data and only a very small number of patients actually had completely undetectable [hepatitis D virus (HDV)] RNA. There was no effect on HBsAg.”
In their phase 3 trial of bulevirtide, Wedemeyer and colleagues randomly assigned 150 patients with chronic HDV infection to either no antiviral treatment for 48 weeks followed by 10 mg once daily for 96 weeks (arm A, n = 51), treatment with bulevirtide 2 mg once daily (arm B, n = 49), or with bulevirtide 10 mg once daily (arm C, n = 50) for 144 weeks with a treatment-free follow-up of 96 weeks. Combined response served as the primary endpoint. Other endpoints included undetectable HDV RNA, decline by 2 log10 IU /mL or more, alanine aminotransferase levels normalization and HBsAg decline by 1 log10 IU/mL or more.
The researchers defined combined response as undetectable HDV RNA or decrease by 2 log10 IU /mL or more and ALT normalization at 48 weeks.
Wedemeyer and colleagues found bulevirtide was well tolerated the first 24 weeks. They observed 421 treatment emergent adverse events (TEAEs); 55 events in 26 patients in arm A, 121 in 32 patients in arm B and 245 in 36 patients in arm C. Of these, 48 TEAEs in arm B and 100 TEAEs in arm C may have been linked to bulevirtide. In arm A, one serious TEAE was reported in one patient.
According to researchers, the proportion of patients after 24 weeks who achieved combined virological and biochemical response was 36.7% in arm B and 28% in arm C (vs. 0% in arm A; P < .0001). At week 24, investigators saw an HDV RNA decrease by 2 log10 IU/mL or more from baseline in 55.1% of patients in arm B and 68% in arm C (vs. 3.8% in arm A; P < .0001). Also at week 24, ALT normalization was reached in 53.1% of arm B and 38% of arm C (vs. 5.9% in arm A; P < .0001). In addition, researchers said one patient treated with 2 mg bulevirtide achieved an HBsAg reduction of 1 log10 IU/mL or more.
“Findings from the phase 2 trial were exactly confirmed,” Wedemeyer said. “We saw a viral decline in most patients. ... Roughly half of the patients also normalized ALT levels. The safety of the compound was confirmed. There were basically no major safety signals in this trial, as to be expected.”
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Wedemeyer H, et al. Abstract: LBP-2730. Presented at: The International Liver Congress; June 23-26 (virtual meeting).
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