Two New Experimental Treatments for Autoimmune Hepatitis

Two new studies have given some hope to autoimmune hepatitis patients that they may not have to face a lifetime on immunosuppressive steroids to control the disease.

The uses of steroids to control autoimmune hepatitis, usually in combination with another immunosuppressive drug, azathioprine, has been used for over 20 years with the risk of severe side effects.

In a new study, reported in the New England Journal of Medicine, 60 of 72 patients on this combined therapy were successfully taken off prednisolone, a steroid, and continued to have their hepatitis remain in remission by taking an increased dose of azathioprine.

The patients remained in remission from one to ten years, which was defined as normal liver function tests and no symptoms.

“The superiority of azathioprine over corticosteroids in maintaining remission and its efficacy as long-term maintenance therapy have been clearly shown by these studies,” an editorial in the Journal concluded.

The greatest risk in the uses of azathioprine at a relatively high dose (2 mg per kilogram of body weight) is the development of cancer, which occurred in five patients, four of whom died because of it.

“The risks of osteoporosis (reduction in bone mass) and obesity, the most serious dose-dependent adverse effects of corticosteroids,” the editorial said, “have to be weighed against the risk of cancer due to relatively high doses of azathioprine.”

In a much smaller study reported in Gastroenterology three patients with autoimmune hepatitis did not respond in the combined therapy with azathioprine.

The azathioprine was replaced with 6-mercaptopurine, a derivative of azathioprine that is believed to have less severe side effects, but not as potent immunosuppressive properties.

In one case (a 13 year old girl) the steroid methylprednisolone was discontinued successfully and the maintenance therapy with 6-mercaptopurine continued. In the other two cases the prednisone or methylprednisolone was reduced.

The use of corticosteroids frequently results in cosmetic effects, such as weight gain, and leaves patients at greater risk to develop diabetes mellitus, cataracts, osteoporosis and hypertension.

Autoimmune hepatitis is an inflammation of the liver without a specific cause. Most of the afflicted patients are women and an estimated 70% will be forced to continue drug therapy for the rest of their lives or in some cases be candidates for a liver transplant. An estimated 10% to 30% will be able to discontinue all drug therapy after a remission of four years.

In another small study, two patients with acute autoimmune hepatitis in Germany achieved remission in a year being treated with budeosnide, another steroid that investigators believe has less severe side effects than prednisone.

A Patient’s Story

Melody Ott:
Fighting Autoimmune Hepatitis

“In 1994, my life completely changed,” said Melody. “It all started when I donated blood. A few days later, I received a letter saying some of my tests were abnormal, and I should see a doctor right away. I didn’t feel sick at all, but I was really frightened. ”

Melody’s doctor told her that her liver was damaged. To assess the damage and make a diagnosis, he needed to biopsy her liver. “I went in for the biopsy in December of 1994,” said Melody, “but my liver was so scarred the doctor couldn’t get any tissue.”

Melody and her mother went to the Mayo Clinic in Jacksonville, Fla. for further tests. “After testing me for every kind of hepatitis, the doctors finally told me I had autoimmune hepatitis, ” Melody said. “At that point, I began to get very sick. I was exhausted and weak all the time. It got so bad that I had to drop out of school. I just didn’t have the energy to sit through an entire day.”

Melody’s health continued to deteriorate, and in May of 1995, her name went on the liver transplant list. “At this point, I mostly stayed at home,” she recalled. “I didn’t have the energy to do much. Once in a while, I’d go visit a friend who lived in a nearby apartment. The apartment complex had a pool, and I’d sit in the sun. For some reason, the sunshine made me feel better.”

At the pool, Melody met a young man named Ingmar Ott. Because Ingmar had worked as a medical technician, he understood what Melody was going through. The two became close friends, and Ingmar was always there when Melody needed someone to talk to.

“My life was on hold waiting for that transplant,” Melody continued, “but my doctor warned me not to get my hopes up. He explained that a transplant is not a cure. It’s just trading one set of problems for another. The difference is that you can live with the new problems.”

Melody grew sicker and sicker waiting for her transplant. She became listless and lethargic and suffered from a loss of memory. Doctors treated her with medication that added several pounds to Melody’s slender frame, and she was no longer model-thin. “I didn’t even care that much about the weight gain,” she said. “All my feelings felt totally wiped out. I didn’t feel happy or sad. I didn’t feel anything at all.”

Finally, on December 2, 1995, a liver became available, and Melody received a transplant. “The first few days following my surgery are a blur,” she said, “but immediately after that, I felt 100 percent better. It was an unbelievable feeling.”

After two weeks, Melody went home from the hospital feeling like a brand-new person. “Every day I get up and can’t believe how good I feel,” she said. “I have the energy to do most of the things I want to do. I’ve lost all of the weight I gained, too.

“Even though I feel great, I’m not the same person I was before this experience,” Melody said thoughtfully. “For one thing, I know I’ll never be a model–not with this scar. I don’t know what I’ll do. I’d like to find a job, but I have to give myself time. Still, I’m very happy to have my health back.”

Melody has many reasons to be happy. This winter, she and Ingmar were married. They still live in Stockbridge, and Melody is involved with a transplant support group. She is looking forward to starting a family in a year or so, when she has completely regained her health. “My doctor tells me I can start thinking about having a baby a year after my surgery. I’m looking forward to that. I’m looking forward to a lot of things!”

American Liver Foundation
1425 Pompton Avenue
Cedar Grove, NJ 07009
1-800-GO LIVER (465-4837)

The American Liver Foundation is a national voluntary health organization dedicated to preventing, treating, and curing hepatitis and other liver and gallbladder diseases through research and education.

Copyright © 1996 The American Liver Foundation