148 0 Kommentare Vir Biotechnology Presents New Clinical Data from Ongoing Trials of VIR-2218 and VIR-3434 in Patients with Chronic Hepatitis B Virus Infection at the International Liver Congress 2021 - Seite 2

VIR-2218: Key Data
Results from a Phase 2 multiple-ascending dose trial of VIR-2218 in 32 patients with chronic HBV infection evaluating the safety and antiviral activity of two doses of VIR-2218 (20 to 200 mg) administered subcutaneously four weeks apart demonstrate:

Dose-dependent reductions in HBsAg through 48 weeks in both trial participants with hepatitis B e antigen (HBeAg), a marker of actively replicating HBV, and those without.
Of the 12 participants who received the 100 mg or 200 mg dose, four participants experienced sustained HBsAg reductions of >1 log₁₀ IU/mL and absolute HBsAg levels below 100 IU/mL through Week 48.
Treatment with VIR-2218 achieved dose-related reductions in other viral biomarkers; one patient receiving 200 mg experienced HBeAg loss at Week 24 and anti-HBe seroconversion at Week 16 that was sustained through Week 48.
Adverse events were mild, and no dose-dependent changes in post-treatment ALT levels (a signal of liver damage) occurred. No trial participants discontinued treatment.

Oral Presentation: Prof. Edward Gane, M.D., professor of medicine at the University of Auckland and chief hepatologist, transplant physician and deputy director of the New Zealand Liver Transplant Unit (Abstract #44).

In a separate ongoing Phase 2 trial, 47 adult patients with chronic HBV infection were assigned to receive subcutaneously injected VIR-2218 alone or in combination with PEG-IFN-α. Preliminary results through Week 12 of the treatment period demonstrate:

VIR-2218 alone and in combination with PEG-IFN-α were associated with HBsAg reductions of >1 log₁₀ IU/mL by Week 12.
Co-administration of VIR-2218 with PEG-IFN-α (Cohort 3) resulted in a more rapid and substantial HBsAg decline compared to VIR-2218 alone.
In Cohort 3, the mean HBsAg decline from baseline was 2.0 log₁₀ IU/mL at Week 12 and 0.6 log₁₀ IU/mL greater than in the two cohorts evaluating VIR-2218 alone.
In published studies, PEG-IFN-α alone in virally suppressed patients was associated with ≤ 0.25 log₁₀ IU/mL HBsAg decline, on average, over the first 12 weeks.
No treatment-related grade ≥3 treatment-emergent adverse events or serious adverse events were reported with VIR-2218 alone or in combination with PEG-IFN-α, and the combination did not appear to increase the known side effects of PEG-IFN-α.

Poster Presentation: Prof. Man-Fung Yuen, D.Sc., M.D., Ph.D., chair professor and chief of the division of gastroenterology and hepatology, deputy head of the department of medicine and Li Shu Fan Medical Foundation professor in medicine at The University of Hong Kong (Abstract #824).