Tobevibart–elebsiran combo demonstrates therapeutic potential against hepatitis D

Patients with chronic hepatitis D virus (HDV) infection appear to respond to treatment with the combination of tobevibart plus elebsiran, according to the phase II, open-label SOLSTICE trial.

A total of 65 patients were randomly assigned to receive tobevibart plus elebsiran every 4 weeks (n=32) or tobevibart monotherapy every 2 weeks (n=33). The primary endpoint was a combined response at week 24. Combined response was defined by an HDV RNA level below the limit of detection or a decrease in the HDV RNA level of at least 2 log₁₀ IU per millilitre from baseline (virologic response) and normalization of the alanine aminotransferase (ALT) level.

At week 24, the primary endpoint occurred in 47 percent of patients in the tobevibart–elebsiran combination group and in 70 percent of those in the tobevibart monotherapy group. In the respective groups, 100 percent and 82 percent of patients achieved virologic response, and 47 percent and 76 percent achieved normalization of the ALT level.

At week 48, a combined response was observed in 56 percent of patients in the combination group and in 61 percent of those in the monotherapy group, with 66 percent and 48 percent of patients, respectively, having undetectable HDV RNA. In the respective combination and monotherapy groups, normalization of the ALT level occurred in 56 percent and 61 percent of patients, while an HBsAg level <10 IU/mL was documented in 91 percent and 21 percent.