Integrated Therapies for Alcoholic Hepatitis

(ITAALD Trial)

This trial tests new treatments for individuals with severe alcohol-associated hepatitis (sAH) and alcohol use disorder (AUD). It aims to determine if combining sAH therapy with various types of care for AUD improves liver health and reduces alcohol use over six months. One part of the study compares a drug called IL-22 (F-652) with prednisone to assess which is safer and more effective. Individuals who have experienced jaundice (yellowing of the skin and eyes) and have been drinking heavily for at least six months might be suitable candidates. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants an opportunity to contribute to significant medical advancements.

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using naltrexone or acamprosate.

Research has shown that F-652, also known as IL-22, is generally safe and doesn't cause major side effects. In earlier studies, patients taking F-652 did not experience serious issues, and the treatment was considered safe. It also improved liver health, as demonstrated by tests assessing liver function.

Prednisone is already a common treatment for severe alcoholic hepatitis. Studies indicate it is usually safe and helps extend life expectancy. Its effects are well-known due to its widespread use.

Researchers are excited about the treatments being studied for alcoholic hepatitis because they offer new approaches beyond the usual treatments like corticosteroids and supportive care. IL-22 (F-652) is unique as it utilizes a novel mechanism by potentially promoting liver regeneration and reducing inflammation, which could be a game-changer for patients. Unlike prednisone, which is a steroid that suppresses the immune system, IL-22 specifically targets liver cells, possibly offering a more precise treatment with fewer side effects. Additionally, combining behavioral therapies like motivational interviewing (MI) and motivational enhancement therapy (MET) with medications such as acamprosate could enhance recovery by addressing both the physical and psychological aspects of alcohol use disorder (AUD).

Research has shown that IL-22 (F-652), one of the treatments in this trial, might be promising for alcoholic hepatitis. It reduces liver cell damage, stress, and swelling while supporting liver healing. Patients using F-652 have demonstrated improved liver function. Prednisone, another treatment option in this trial, is a steroid commonly used for severe alcohol-related hepatitis. Studies indicate it can significantly improve survival rates, with some cases showing a 90.8% chance of survival. Both treatments offer potential benefits, but their effectiveness can vary among individuals.¹²³⁴⁵