VIR-2218 + VIR-3434 for Liver Cirrhosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two treatments, VIR-2218 and VIR-3434, to evaluate their effects both individually and combined in people with liver cirrhosis. The goal is to understand how the body absorbs these treatments and to assess their safety and tolerability. The trial seeks participants with stable liver issues for at least a month, excluding those with hepatitis B or D. Participants will be grouped by the severity of their liver condition to receive different treatment combinations. This trial suits individuals with chronic liver problems who are otherwise in stable health. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive these new treatments.
Will I have to stop taking my current medications?
If you are a healthy participant, you must stop taking any prescription or over-the-counter medications (except vitamins and hormonal contraceptives) 30 days before the study. If you have liver impairment, you need to be on a stable dose and regimen of your current medications.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that VIR-2218 is generally well-tolerated. In one study, individuals with chronic hepatitis B did not experience serious heart problems after a single dose. Any side effects were related to their liver condition, not to VIR-2218.
For VIR-3434, early results suggest it is safe and helps reduce certain viruses in the liver. Studies have found no major safety issues.
The combination of VIR-2218 and VIR-3434 is also under investigation. Early data from these studies show promising safety results, with only mild increases in liver enzymes in some cases, a common and manageable side effect.
Overall, these treatments appear well-tolerated, but further research is needed to fully confirm their safety.12345Why are researchers excited about this trial's treatments?
Researchers are excited about VIR-2218 and VIR-3434 because they offer a new approach to treating liver cirrhosis. Unlike traditional treatments that mainly focus on managing symptoms and slowing disease progression, these drugs aim to directly target the underlying causes of liver damage. VIR-2218 is a small interfering RNA (siRNA) therapy that reduces the production of harmful proteins by silencing specific viral genes, while VIR-3434 is an antibody that neutralizes viruses and clears them from the body. This combination could potentially provide a more effective way to combat liver cirrhosis by addressing the root of the disease rather than just its symptoms.
What evidence suggests that this trial's treatments could be effective for liver cirrhosis?
Studies have shown promising results for VIR-2218 and VIR-3434 in treating liver conditions. VIR-2218, administered to participants in some trial arms, has significantly lowered hepatitis B surface antigen (HBsAg) levels, indicating infection in chronic hepatitis B. VIR-3434, another treatment option in this trial, is a potent antibody that has also reduced HBsAg levels in studies with special mice that mimic human liver conditions. In certain trial arms, participants receive a combination of VIR-2218 and VIR-3434, which has led to a noticeable drop in HBsAg levels, specifically by 2.7-3.1 log10 IU/mL. This combination has also shown positive results, with some participants losing HBsAg, an important step toward controlling the virus. Overall, these findings suggest that both treatments could benefit liver conditions.26789
Are You a Good Fit for This Trial?
This trial is for adults aged 18-70 with liver cirrhosis or impairment, stable health, and a BMI of 18.5-40 kg/m2. They must have a CPT score indicating mild to severe hepatic impairment but can't be on certain medications, have unstable heart conditions, active infections like HIV/HBV/HCV/HDV/HEV (with some exceptions), recent variceal bleeding, or be listed for liver transplantation.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of VIR-2218 up to 200 mg SC or VIR-3434 at 300 mg SC monotherapy or a combination of VIR-2218 and VIR-3434
Follow-up
Participants are monitored for safety and pharmacokinetic exposure after treatment
What Are the Treatments Tested in This Trial?
Interventions
- VIR-2218
- VIR-3434
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vir Biotechnology, Inc.
Lead Sponsor