Hepatitis C Information Central

(Background Information)

In treating a patient with worsening liver disease, a physician faces enormous challenges, because the management of patients is costly, complex, and limited by the paucity of treatment options that might help to relieve the stress on the liver and allow it to regenerate.

Until now, clinical management of patients with rapidly worsening liver disease has been directed primarily at treating complications, while hoping to "buy time" for the liver to regenerate or a donor organ to become available. Liver transplantation is an effective but complicated, very expensive treatment (approx. $250,000). In addition, despite extensive efforts to increase the number of organ donations, only about 4,500 livers are available each year, while more than 16,000 patients are on the transplant waiting list.

Treatment options are similarly limited if a patient suffers liver damage due to ingestion of drugs or poisons. Current antidotes are most effective if the patient receives treatment within 12 to 24 hours post-overdose. Even then, some studies show a mortality rate of almost 20%. Interestingly, a common form of overdose is when a patient takes acetaminophen therapeutically, without suicidal intent or knowing that alcohol ingestion can greatly increase the potential toxicity of this common, valuable pain reliever. Such patients are more likely to present for treatment at a time when current antidotes have limited effectiveness and the likelihood of serious liver damage is high.

In the treatment of other life-threatening conditions, extracorporeal kidney-support, heart-support, and lung-support devices have long been considered essential to the provision of comprehensive, high-quality care. Now, the first liver dialysis system has received the necessary FDA market clearance for clinical use.

Liver Dialysis is indicated for the treatment of

1) acute hepatic encephalopathy*, due to worsening of chronic liver disease (acute-on-chronic) or sudden-onset liver failure (fulminant hepatic failure) and

2) severe drug overdose, as with acetaminophen, tricyclic antidepressants, and all drugs that are dialyzable and will bind to charcoal.

(*Acute hepatic encephalopathy – changes in consciousness and brain function resulting from build-up of toxins in the blood due to deteriorating liver function.)

The Liver Dialysis Unit has been used for the treatment of over 150 patients to date. Data collection continues, but the results are compelling enough that since the launch of the product this past May 1999, a number of institutions have already chosen to include Liver Dialysis ( as part of liver disease management.

Sites include:

• Tulane
• University of Tennessee-Bowld
• University of Texas- San Antonio
• Loyola University
• University of Iowa
• California Pacific Medical Center
• University of California at San Diego
• New York University

A Meta analysis, prepared with the assistance of Dr. Thomas Kuczek Department of Statistics Purdue University, was done of 75 treated patients. Overall, patients with Acute-on-chronic liver failure treated with the Liver Dialysis Unit had significantly improved outcomes. This analysis also demonstrated a positive effect on patient neurologic status and physiologic status. Clinical experience suggests that use of the Liver Dialysis Unit early in the disease process may avert respirator use, avoid or decrease days in the ICU, shorten length of stay, and obviate or postpone the need for transplant or improve the likelihood of successful transplant by stabilizing the patient’s health prior to surgery.

By removing toxins from the blood—whether those toxins come from inside or outside the body—the Liver Dialysis Unit can prevent further clinical deterioration to multi-organ failure (kidneys, lungs, cardiovascular system, and brain). The Liver Dialysis Unit uses a proprietary sorbent suspension that includes finely powdered activated charcoal, cation exchangers, electrolytes, proprietary flow-inducing agents, and other chemicals. The sorbent suspension removes toxins, without coming into direct contact with the blood.

Stephen Ash, MD, who invented the Liver Dialysis Unit, decided to start with charcoal--the most simple and effective material for removing toxins—but to use it in such a way that treatment would be both safe and highly effective. To achieve his goal, he developed a unique dialyzer membrane that not only ensures that the blood never comes into direct contact with charcoal but also produces a gentle pumping motion that avoids damage to red blood cells. Second, he created a unique sorbent suspension, which uses charcoal that has been finely pulverized to achieve a surface area the size of (approximately the size of 60 football fields).

During treatment, a small amount of blood is drawn from the patient and passed across the dialyser membrane in the Liver Dialysis Unit. On the other side of the membrane, the sorbent suspension serves as a "sink" that draws toxins from the blood. The treated blood is then returned to the patient. Treatment is usually done for 2-5 consecutive days lasting 4-6 hours.

The Liver Dialysis Unit offers an important new therapeutic option at a time when liver disease is the tenth leading cause of death among adults in the United States. Forty percent of chronic liver disease is related to Hepatitis C Virus (HCV) infection. This type of liver disease is the most frequent indication for liver transplantation among adults, and an estimated four million persons now show evidence of HCV infection. Most HCV-infected persons are aged 30 to 49 years, and thus approaching the age at which complications from chronic liver disease typically occur. These and millions of other patients who suffer from various forms of chronic liver disease are at greatly increased risk of liver failure.

In recent years, several companies have undertaken research with BioArtificial livers (devices that contain either liver cells or cells taken from either pigs or human tumors). Ongoing clinical evaluation will determine if these technologies are effective, however, it is not yet clear whether they can be made practical for routine use. In any case, it is expected that they will not be available for anything other than experimental use for many years.

While not a cure and not effective in every case, the Liver Dialysis Unit offers new hope for people who suffer potentially life-threatening damage to this complex, vital organ with its unique ability to regenerate—when given the chance.

For more information visit Hemo Therapies website.

table Of Contents

http://hepatitis-central.com