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Gsk3965193B

This article discusses the ongoing clinical trials of GSK3965193B, a promising drug being studied for the treatment of chronic hepatitis B infection. The trials aim to assess the safety, tolerability, and effectiveness of GSK3965193B when used alone and in combination with another drug called bepirovirsen. These studies involve both healthy participants and those living with chronic hepatitis B, focusing on how the drug affects the body and its potential to combat the hepatitis B virus.

Table of Contents

What is GSK3965193B?

GSK3965193B is an investigational drug being developed by GlaxoSmithKline for the treatment of chronic hepatitis B (CHB). It is currently undergoing clinical trials to assess its safety, effectiveness, and how it interacts with the body.[1]

What condition does GSK3965193B target?

GSK3965193B is specifically designed to treat chronic hepatitis B. Chronic hepatitis B is a long-lasting liver infection caused by the hepatitis B virus (HBV). This condition can lead to serious liver problems, including cirrhosis and liver cancer, if left untreated.[1]

How does GSK3965193B work?

While the exact mechanism of action is not detailed in the provided information, GSK3965193B is being studied for its ability to affect the levels of hepatitis B surface antigen (HBsAg) in the blood. HBsAg is a protein found on the surface of the hepatitis B virus and is used as a marker for active infection.[1]

Current research on GSK3965193B

GSK3965193B is being studied in a multi-part clinical trial:[1]

  • Part 3: This part of the study examines GSK3965193B as a monotherapy (used alone) in patients with chronic hepatitis B who are already on stable nucleos(t)ide analog (NA) therapy. It involves 28 days of treatment followed by a two-week observation period.
  • Part 4: This part investigates the combination of GSK3965193B with another drug called Bepirovirsen in patients with chronic hepatitis B who are on stable NA therapy.

How is GSK3965193B administered?

GSK3965193B is administered orally in the form of a tablet. In the current trials, it is given daily for 28 days.[1]

Combination therapy with Bepirovirsen

One of the key aspects of the research is studying GSK3965193B in combination with another drug called Bepirovirsen. This combination therapy is being investigated to see if it can provide better results than either drug alone. The main goal is to achieve a complete response, which is defined as undetectable levels of both HBV DNA and HBsAg in the blood for 6 consecutive months after the planned end of treatment.[1]

Who is eligible for GSK3965193B trials?

The trials have specific eligibility criteria. Some key points include:[1]

  • Participants must be between 18 and 65 years old
  • They must have documented chronic HBV infection for at least 6 months
  • Participants should be on stable nucleos(t)ide analog therapy
  • They must have specific levels of HBsAg and HBV DNA in their blood
  • Certain medical conditions, such as liver cirrhosis, hepatocellular carcinoma, or co-infection with other viruses like HIV or hepatitis C, would exclude a person from participating

Safety monitoring during trials

During the trials, participants are closely monitored for safety. This includes:[1]

  • Tracking the occurrence of adverse events (side effects)
  • Regular blood tests to check liver function and other health markers
  • Monitoring of vital signs and heart function
  • Tests to check for any effects on nerve function

It’s important to note that GSK3965193B is still in the experimental stage. While it shows promise, more research is needed to fully understand its effectiveness and safety profile in treating chronic hepatitis B.

Aspect Details
Drug Name GSK3965193B
Condition Studied Chronic Hepatitis B
Study Design Randomized, Double-blind, Multi-center, Placebo-controlled
Study Parts Part 3: Monotherapy followed by optional bepirovirsen
Part 4: Combination therapy with bepirovirsen
Primary Objectives 1. Assess safety and tolerability
2. Evaluate pharmacodynamic effects
3. Determine efficacy in combination with bepirovirsen
Key Inclusion Criteria 1. Age 18-65
2. Chronic HBV infection ≥6 months
3. Stable NA therapy
4. HBsAg >100 IU/mL
5. HBV DNA <90 IU/mL
Key Exclusion Criteria 1. Significant health issues
2. Liver cirrhosis
3. Recent immunosuppressive treatment
4. Co-infection with HCV, HIV, or HDV
Primary Endpoints 1. Adverse events incidence
2. HBsAg reduction (Part 3)
3. Complete response rate (Part 4)

FAQ

  • What is GSK3965193B? GSK3965193B is an investigational drug being studied for the treatment of chronic hepatitis B infection. It is currently undergoing clinical trials to evaluate its safety, effectiveness, and how it interacts with the body.
  • What are the main objectives of the clinical trials involving GSK3965193B? The main objectives are to assess the safety and tolerability of GSK3965193B when used alone and in combination with bepirovirsen, evaluate its pharmacodynamic effects in people living with chronic hepatitis B, and determine its efficacy when combined with bepirovirsen.
  • Who can participate in these clinical trials? Participants must be between 18 and 65 years old, have documented chronic hepatitis B infection for at least 6 months, be on stable nucleos(t)ide analog therapy, and meet specific criteria regarding hepatitis B surface antigen (HBsAg) and HBV DNA levels. There are also several exclusion criteria, such as having certain other medical conditions or recent treatments.
  • How long do the different parts of the trial last? Part 3 of the trial involves 28 days of GSK3965193B or placebo treatment, followed by a two-week washout period. Some participants may then receive 24 weeks of bepirovirsen treatment. Part 4 is a 24-week study combining GSK3965193B or placebo with bepirovirsen in participants who did not take part in Part 3.
  • What are the primary outcomes being measured in these trials? The primary outcomes include the incidence of adverse events and significant changes in laboratory parameters, vital signs, and cardiac function. For Part 3, researchers will measure the maximum reduction in HBsAg levels over 6 weeks. In Part 4, they will assess the achievement of a complete response, defined as undetectable HBV DNA and HBsAg for 6 consecutive months after treatment ends.

Ongoing Clinical Trials on Gsk3965193B

  • Study of GSK3965193 and Bepirovirsen for People Living with Chronic Hepatitis B Infection and Healthy Participants

    Not recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    France Italy

Glossary

  • Chronic Hepatitis B: A long-lasting liver infection caused by the hepatitis B virus that can lead to serious liver damage if left untreated.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Pharmacodynamics (PD): The study of how a drug affects the body, including its mechanism of action and the relationship between drug concentration and effect.
  • HBsAg: Hepatitis B surface antigen, a protein on the surface of the hepatitis B virus that is used as a marker for infection.
  • HBV DNA: Hepatitis B virus DNA, genetic material of the virus used to measure the amount of virus in the blood.
  • Nucleos(t)ide analog (NA) therapy: A type of antiviral medication used to treat chronic hepatitis B by suppressing viral replication.
  • Bepirovirsen: Another investigational drug being studied in combination with GSK3965193B for the treatment of chronic hepatitis B.
  • ALT: Alanine aminotransferase, an enzyme found primarily in the liver that can indicate liver damage when levels are elevated.
  • Cirrhosis: Severe scarring of the liver, often as a result of long-term liver damage, which can be caused by chronic hepatitis B.
  • Complete response: In this study, it refers to undetectable levels of both HBV DNA and HBsAg for 6 consecutive months after treatment ends.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-effects-of-gsk3965193-alone-and-with-bepirovirsen-for-patients-with-chronic-hepatitis-b/