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Elebsiran

This article explores the ongoing clinical trials investigating the use of Elebsiran (VIR-2218) for treating chronic hepatitis B virus (HBV) and hepatitis D virus (HDV) infections. Elebsiran is being studied alone and in combination with other therapies to assess its safety, efficacy, and potential to achieve functional cure in patients with these chronic viral liver infections.

Table of Contents

What is ELEBSIRAN?

ELEBSIRAN, also known as VIR-2218, is an investigational drug being developed to treat chronic hepatitis B virus (HBV) and hepatitis D virus (HDV) infections[1]. It belongs to a class of drugs called small interfering RNA (siRNA), which are designed to silence specific genes[2].

Medical Conditions Treated

ELEBSIRAN is being studied for the treatment of:

  • Chronic Hepatitis B Virus (HBV) Infection: A long-term liver infection that can lead to serious health problems if left untreated[3].
  • Chronic Hepatitis D Virus (HDV) Infection: A severe form of viral hepatitis that occurs only in people who are already infected with HBV[1].

How ELEBSIRAN Works

ELEBSIRAN is designed to work by:

  1. Targeting viral genes: It specifically targets genes essential for HBV and HDV replication[2].
  2. Reducing viral proteins: By silencing these genes, ELEBSIRAN aims to reduce the production of viral proteins, including hepatitis B surface antigen (HBsAg)[3].
  3. Suppressing viral replication: The overall goal is to suppress the replication of HBV and HDV in infected liver cells[1].

Administration

ELEBSIRAN is administered as a subcutaneous injection, which means it is injected under the skin[3]. The dosing schedule and duration of treatment may vary depending on the specific clinical trial protocol.

Clinical Trials

ELEBSIRAN is currently being evaluated in several clinical trials:

  • SOLSTICE Study: A Phase 2 trial evaluating ELEBSIRAN in combination with another investigational drug (VIR-3434) for chronic HDV infection[1].
  • PREVAIL Study: A Phase 2 platform study assessing ELEBSIRAN along with other investigational therapies for chronic HBV infection[2].
  • VIR-2218-1006 Study: Another Phase 2 trial examining ELEBSIRAN in combination with VIR-3434 and/or pegylated interferon alfa-2a for chronic HBV infection[3].

Efficacy

The clinical trials are designed to evaluate ELEBSIRAN’s efficacy through various measures, including:

  • Viral suppression: Reduction in HBV DNA and HDV RNA levels[1].
  • HBsAg loss: Proportion of patients achieving undetectable levels of hepatitis B surface antigen[2].
  • Functional cure: Defined as undetectable HBsAg and sustained suppression of HBV DNA for at least 24 weeks after stopping all treatment[3].
  • ALT normalization: Return of liver enzyme levels to normal range, indicating reduced liver inflammation[1].

Safety and Side Effects

As ELEBSIRAN is still in clinical trials, its full safety profile is not yet established. The ongoing studies are closely monitoring for:

  • Treatment-emergent adverse events (TEAEs)[3]
  • Serious adverse events (SAEs)[2]
  • Changes in laboratory values, including liver function tests[1]
  • Immune-related effects, such as the development of anti-drug antibodies[3]

Patients participating in clinical trials are closely monitored for any potential side effects or safety concerns.

Conclusion

ELEBSIRAN represents a promising new approach in the treatment of chronic hepatitis B and D infections. By targeting viral genes and potentially reducing viral proteins, it may offer a novel way to suppress these persistent viral infections. However, as the drug is still in clinical trials, more research is needed to fully understand its efficacy, safety, and long-term benefits for patients with chronic HBV and HDV infections.

Aspect Details
Drug Name Elebsiran (VIR-2218)
Conditions Studied Chronic Hepatitis B Virus (HBV) Infection, Chronic Hepatitis D Virus (HDV) Infection
Administration Subcutaneous injection
Dosing Maximum daily dose: 200 mg; Maximum total dose: 2600-9600 mg
Treatment Duration 48-214 weeks, depending on the trial
Primary Objectives Evaluate efficacy, safety, and tolerability
Key Endpoints HBsAg loss, HBV DNA suppression, ALT normalization, functional cure
Study Phases Phase 2
Combination Therapies Studied alone and in combination with other agents (e.g., VIR-3434, peginterferon alfa-2a)
Patient Population Adults with chronic HBV or HDV infection, meeting specific eligibility criteria

FAQ

  • What is Elebsiran? Elebsiran, also known as VIR-2218, is an investigational drug being studied for the treatment of chronic hepatitis B and D virus infections. It is administered as a solution for injection under the skin (subcutaneously).
  • What are the main goals of the clinical trials using Elebsiran? The main goals are to evaluate the safety, tolerability, and efficacy of Elebsiran alone or in combination with other therapies. Researchers are particularly interested in its ability to reduce levels of hepatitis B surface antigen (HBsAg) and viral DNA, as well as its potential to achieve functional cure of chronic HBV infection.
  • How is Elebsiran being administered in these trials? Elebsiran is being administered as a subcutaneous injection. The maximum daily dose being studied is 200 mg, with a maximum total dose of up to 9600 mg over treatment periods ranging from 48 to 214 weeks, depending on the specific trial.
  • What are some of the key outcomes being measured in these trials? Key outcomes include the proportion of participants achieving HBsAg loss, reduction in HBV DNA levels, normalization of liver enzymes (ALT), and in some cases, changes in liver fibrosis and other markers of liver health. The trials are also closely monitoring for any adverse events or safety concerns.
  • Who is eligible to participate in these clinical trials? Eligibility varies by trial, but generally includes adults aged 18 and older with chronic HBV or HDV infection. Participants must meet specific criteria regarding their viral load, liver function, and overall health status. Some trials require participants to be on existing antiviral therapy, while others have specific exclusion criteria related to liver disease severity or co-infections.

Ongoing Clinical Trials on Elebsiran

  • Study on Tobevibart and Elebsiran for Patients with Chronic Hepatitis D Virus Infection Not Responding to Bulevirtide Treatment

    Recruiting

    3 1 1 1
    Investigated drugs:
    Austria France Germany Italy Romania Spain

  • Study on the Effects of Tobevibart and Elebsiran Compared to Bulevirtide for Patients with Chronic Hepatitis D Virus Infection

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria France Germany Italy The Netherlands +2

  • Study on Tobevibart and Elebsiran for Patients with Chronic Hepatitis D Virus Infection

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Romania

  • Study on the Effects of VIR-2218 and VIR-3434 for Patients with Chronic Hepatitis D Infection

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria France Germany Italy The Netherlands Romania

  • Study on the Safety and Effectiveness of VIR-2218, VIR-3434, and Peginterferon Alfa-2a for Patients with Chronic Hepatitis B

    Not recruiting

    2 1 1 1
    Investigated drugs:
    Germany Romania

  • Study on the Effects of Peginterferon Alfa-2a, Tobevibart, and Elebsiran in Patients with Chronic Hepatitis B Infection

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Romania

Glossary

  • Hepatitis B virus (HBV): A viral infection that attacks the liver and can cause both acute and chronic disease. Chronic HBV infection can lead to serious liver damage, including cirrhosis and liver cancer.
  • Hepatitis D virus (HDV): A virus that requires the presence of hepatitis B virus to replicate. It can cause more severe liver disease in people already infected with HBV.
  • HBsAg: Hepatitis B surface antigen, a protein on the surface of the hepatitis B virus. Its presence in the blood indicates current HBV infection.
  • Functional cure: In the context of HBV, it typically means achieving undetectable HBsAg and sustained suppression of HBV DNA after stopping all treatment.
  • ALT: Alanine aminotransferase, an enzyme found primarily in the liver. Elevated levels in the blood can indicate liver damage.
  • NRTI: Nucleos(t)ide reverse transcriptase inhibitor, a class of antiviral drugs commonly used to treat chronic HBV infection.
  • Cirrhosis: Advanced scarring of the liver caused by long-term liver damage, which can impair liver function.
  • Fibrosis: The formation of scar tissue in the liver as a result of chronic inflammation or injury.
  • HBeAg: Hepatitis B e antigen, a protein produced by the hepatitis B virus. Its presence usually indicates that the virus is actively replicating.
  • Anti-HBs: Antibodies to the hepatitis B surface antigen, which typically indicate recovery from HBV infection or successful vaccination.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effects-of-vir-2218-and-vir-3434-for-patients-with-chronic-hepatitis-d-infection/
  2. http://clinicaltrials.eu/trial/study-on-the-effects-of-peginterferon-alfa-2a-tobevibart-and-elebsiran-in-patients-with-chronic-hepatitis-b-infection/
  3. http://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-vir-2218-vir-3434-and-peginterferon-alfa-2a-for-patients-with-chronic-hepatitis-b/