GSK3965193 for Hepatitis B

This trial tests a new treatment called GSK3965193 for individuals with long-term hepatitis B. The goal is to determine if this drug can safely reduce the hepatitis B virus in the body and improve health outcomes. Some participants will take the drug alone, while others will combine it with another treatment, bepirovirsen, to assess if the combination is more effective. The trial seeks individuals who have had chronic hepatitis B for at least six months and are currently on stable hepatitis B medication. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.

The trial does not specify if you need to stop taking your current medications. However, participants in Parts 3 and 4 must be on stable NA therapy (like tenofovir or entecavir), so you may need to continue those medications.

Research has shown that bepirovirsen is generally safe and well-tolerated in people with chronic hepatitis B. For instance, a Phase 2b study tested bepirovirsen for 12 to 24 weeks and found it safe for those already on stable hepatitis B treatments. Larger studies are ongoing to confirm its safety and effectiveness.

GSK3965193 is undergoing its first tests in humans. In these early trials, researchers closely monitor for side effects and test different doses to determine the safest and most effective amount. As this is a Phase 1/2a study, the primary goal is to ensure GSK3965193's safety before proceeding to larger studies.

Researchers are excited about GSK3965193 for Hepatitis B because it offers a novel approach compared to existing treatments like nucleos(t)ide analogs and interferon therapies. Unlike most treatments that typically focus on suppressing the virus, GSK3965193 is designed to work in fasted conditions and is being tested in various dosing regimens, potentially allowing for more flexible and tailored treatment options. Additionally, the treatment is being explored in combination with bepirovirsen, which could enhance its effectiveness by targeting the virus through a complementary mechanism. This multi-faceted strategy could lead to improved outcomes for patients with Hepatitis B, offering hope for more effective and efficient management of the condition.

Research has shown that bepirovirsen, which participants in this trial may receive, has potential in treating hepatitis B. In earlier studies, up to 29% of patients had no detectable virus levels after 24 weeks of treatment with bepirovirsen. This treatment stops the virus from replicating and reduces its presence in the blood. GSK3965193, another treatment option in this trial, is still under investigation for its effectiveness, but researchers will test its ability to lower hepatitis B virus levels. Although GSK3965193 is new, combining it with bepirovirsen is based on encouraging early results.²³⁶⁷⁸