VIDEO: Combination tobevibart, elebsiran induces ‘rapid virologic suppression’ in HDV
Click Here to Manage Email Alerts
Key takeaways:
- Results showed 41% of patients achieved HDV target not detected at week 24.
- Nearly half of the patients on combination therapy achieved target not detected plus ALT normalization.
SAN DIEGO — Combination tobevibart and elebsiran led to “profound and rapid virologic suppression” as well as normalization of alanine aminotransferase at week 24 in chronic hepatitis D virus infection, according to preliminary data.
In the phase 2 SOLSTICE trial, researchers compared the safety and efficacy of tobevibart 300 mg (Vir Biotechnology) alone or in combination with elebsiran 200 mg (Vir Biotechnology) in patients with chronic HDV. Patients received subcutaneous monotherapy every 2 weeks (n = 33) or combination therapy (n = 32) every 4 weeks for 24 weeks.
Researchers also included 13 patients who transitioned from early monotherapy to combination therapy in the rollover cohort.
According to Mark D. Eisner, MD, chief medical officer at Vir Biotechnology, one of the key endpoints was “target not detected,” defined as complete viral suppression of HDV measured by PCR assay.
Results presented at The Liver Meeting showed that 41% of patients achieved target not detected at week 24, which increased to 64% at week 36, with Eisner noting that “the majority of patients” who achieved target not detected did so with combination therapy. In addition, “about 90%” of patients on the combination regimen reached hepatitis b surface antigen levels of less than 10 IU/mL, and 46% achieved the composite of target not detected plus normalization of alanine aminotransferase compared with 18% on monotherapy.
Treatment-emergent adverse events were mild to moderate and included flu-like symptoms that resolved within 24 hours of the first dose. Few discontinuations occurred.
“We’re really excited here at Vir with our SOLSTICE results for the profound and rapid virologic suppression we’re achieving [and] really strong reduction of ALT,” Eisner said. “We’re excited to move into a phase 3 program called ECLIPSE to study the combination regimen and we'll include both cirrhotic and noncirrhotic patients in the clinical trials. We'll be starting that program in the first half of next year.”