New hepatic dialysis device shows promise in the treatment of hepatic failure

New hepatic dialysis device that rids the body of dysfunctional albumin and replaces it with fresh albumin has dramatically improved survival rates in patients with chronic acute liver failure, according to a presenter at the International Liver Congress.

“What we saw was that in patients treated with Dialive, two-thirds of them achieved complete resolution of ACLF – restoration of their baseline liver disease – and significant improvement in function. other non-hepatic extrahepatic organs, in particular brain function, which is assessed on the basis of hepatic encephalopathy ‘, Banwari Agarwal, MD, of the Royal Free Hospital in the UK said at a press conference. Although the primary endpoint of this study is safety, Agarwal and colleagues also reported on the initial efficacy. This resolution of ACLF then resulted in continuous improvement as well as 28 day survival.

Thirty-two patients with ACLF grades 1 to 3a and alcoholic cirrhosis received either Dialive (Yaqrit; n = 17) or standard of care (n = 15); 30 were included in the assessment. In the safety study, patients had to undergo at least one session.

Agarwal reported that four patients died in the Dialive group, with the first two deaths resulting in a change in protocol due to hypotension. After these complications, Dialive was only administered in intensive care with regular monitoring. Three patients in the standard care group died of progressive liver failure. Serious AEs were observed in 64.7% of the Dialive group and 53.3% in the standard care group.

Looking at the organ failure score from the European Foundation for the Study of Chronic Hepatic Failure (CLIF), the Dialive group showed significant improvement in the liver (P = .045) and the brain (P <.001 while the standard care group showed a deterioration in their pulmonary sub-score>P = .002). Overall, the result was a significant overall effect of treatment on the CLIF organ failure score (P = 0.045 on day 10 and P = 0.023 on day 14).

More patients in the Dialive group reached ACLF 0 stage than in the standard care group (66.7% vs. 33.3%; logrank P = .0357) and did it 2.8 times faster (Wald test P = 0.059). The same percentages of patients showed ACLF-free survival to day 28.

“The Kaplan Meier curve for ACLF resolution time showed that two-thirds of patients in the Dialive arm and one-third in the SOC arm achieved resolution on day 14. In the Dialive arm, one-quarter of these patients reached resolution on day 2, ”Agarwal said in his presentation. “This ACLF resolution persisted and resulted in a survival benefit, which was significantly better in the Dialive arm compared to the SOC arm.”

The CLIF-C ACLF score for the Dialive group was -5.4 lower than the standard care group (P = 0.064) while the MELD score was lower in Dialive at day 5 (P = .049) and 10 (P = .028).

“Dialive is safe. Dialive significantly improves organ function, especially the liver and brain. It dramatically reduces CLIF organ failure score, ACLF score, and MELD score. This leads to a significantly faster and greater proportion of patients and sustained resolution of ACLF, which results in significantly higher survival, ”Agarwal said. “The data, I suggest, justifies the start of late-stage clinical trials.”

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International Liver Congress