NHS Launches Trial for Revolutionary Treatment of Liver Disease

The NHS is set to begin a clinical trial for a groundbreaking treatment aimed at tackling acute-on-chronic liver failure (ACLF), a severe condition that can lead to organ failure. Thirteen major hospitals across the UK will employ a device known as Dialive, which purifies the blood of patients suffering from this debilitating disease, often linked to obesity, alcohol consumption, and hepatitis.

ACLF is particularly dangerous, with three out of four patients diagnosed only when their condition is critical. The prognosis is grim, as approximately 70% of affected individuals do not survive beyond 28 days. Currently, the only effective remedy is a liver transplant, which is available to only a limited number of patients. The trial will involve 72 seriously ill participants and is expected to commence in March 2024.

The Dialive device aims to enhance recovery by removing dysfunctional albumin—a protein produced by the liver—and replacing it with healthy, functional albumin. This “intensive care liver support system” draws parallels to established haemodialysis treatments for kidney failure. Patients will be connected to Dialive for multiple sessions within the first ten days of treatment, assisting their organs in recovering and improving their survival odds.

Rajiv Jalan, a senior liver specialist and co-principal investigator of the trial, emphasizes the importance of this research. He noted that the goal is to demonstrate a higher resolution rate of ACLF compared to standard care, thereby potentially reducing both hospital stays and mortality rates.

“This is a critical trial for gravely ill patients facing multi-organ failure,” said Jalan, who also founded Yaqrit, the medical innovation company responsible for developing Dialive. “We have a desperate need for effective treatments globally, and Dialive could help prevent further damage while allowing the liver to regenerate.”

The urgency of addressing liver disease is underscored by alarming statistics. In the UK alone, an estimated 2 million people live with some form of liver disease, with rates quadrupling over the past half-century. Each year, liver disease claims more than 12,000 lives, with around 60,000 individuals suffering from cirrhosis—severe liver scarring that significantly increases mortality risk.

Funding for this £2.2 million trial comes from the National Institute for Health and Care Research (NIHR), which previously conducted a smaller study in 2023 that indicated Dialive’s potential. In that study, ten out of 15 patients who received Dialive treatment experienced a reversal of ACLF, while only five out of 15 patients receiving standard treatment saw similar results.

Dr. Rohit Saha, a consultant at the Royal Free Hospital in London and another trial co-principal investigator, expressed optimism about Dialive’s potential. “Many patients with ACLF succumb to a cycle of inflammation that current treatments cannot reverse. Dialive offers new hope, with the potential to put this condition into remission.”

The initial participating hospitals include King’s College Hospital and University College London Hospitals, along with the Queen Elizabeth Hospital in Birmingham. Dr. Mansoor Bangash, also a principal investigator, added that if Dialive proves effective, it could support more patients in recovering, decreasing the need for transplants.

The NIHR’s commitment to funding this trial stems from the potential impact on patient care. Prof. Mike Lewis, the NIHR’s scientific director for innovation, stated, “If this trial of Dialive is successful, it will provide a much-needed treatment for ACLF, ultimately saving lives and reducing hospital stays. This research exemplifies taxpayer-funded initiatives aimed at making critical treatments available through the NHS.”

As the trial unfolds, the medical community is hopeful that Dialive might revolutionize treatment options for those battling severe liver disease, offering a new path forward for patients and healthcare providers alike.