Tobevibart Combo Shows High Hepatitis D Efficacy: Tarik Asselah, MD, PhD

A substantial proportion of patients with hepatitis D virus (HDV) receiving tobevibart plus elebsiran, a new combination regimen, achieved target-not-detected HDV RNA by week 96, according to phase 2 SOLSTICE trial data (NCT05461170) presented at the European Association for the Study of the Liver 2026 Congress.

In the second and final part of his interview with The American Journal of Managed Care^®, Tarik Asselah, MD, PhD, professor of hepatology at Hôpital Beaujon and the University of Paris-Cité, explained that HDV is a rare but serious disease associated with an elevated risk of cirrhosis and hepatocellular carcinoma.

First identified in the late 1970s by Professor Mario Rizzetto, HDV remained difficult to treat for decades, he noted. Pegylated interferon was previously the standard of care, but its use was limited by adverse effects, poor tolerability, and limited efficacy. The treatment landscape broadened for US patients with HDV, however, with the FDA’s more recent approval of bulevirtide (Hepcludex; Gilead Sciences) on May 22, 2026.

Asselah explained that the SOLSTICE findings are notable not only for the high rate of antiviral response with tobevibart plus elebsiran but also for what that response may mean clinically.

“We know that if you do not detect the virus, it may be associated with a better prognosis: less clinical events, less cancer, less…long-term cirrhosis,” he said.

Asselah noted that the combination of strong efficacy and good safety represents welcome knowledge for the HDV field. However, he acknowledged that the findings came from an early readout of a phase 2 trial with a small sample size. Although the trial demonstrated high antiviral efficacy, with a substantial number of patients achieving undetectable RNA, as well as a favorable safety profile, these findings will require confirmation in the larger, ongoing phase 3 ECLIPSE program (NCT07142811), Asselah said.

The ECLIPSE program encompasses several trials designed to confirm both efficacy and safety in expanded patient populations. Some trials will compare the efficacy of tobevibart plus elebsiran directly with bulevirtide, he noted, while another will evaluate whether patients who fail bulevirtide treatment can be rescued using the newer regimen.

Asselah added that the phase 3 program will also enroll a greater proportion of patients with compensated cirrhosis and more severe disease, allowing for more robust data across a broader population.

“It's a very huge and important program for the field,” he concluded.