May 30, 1997

Hepatitis C trial ready to shine

Hepatitis C trial ready to shine

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Dr. Lloyd King Jr. talks with patient Frank Haynie about his photopheresis treatment for chronic hepatitis C.

Vanderbilt University Medical Center researchers, in conjunction with the Veterans Administration Hospital, are testing an innovative new treatment for hepatitis C.

The phase III trial combines the standard treatment of hepatitis C ‹ the drug interferon alfa-2a ‹ with extracorporeal photochemotherapy, otherwise known as photopheresis. In this process, a patient¹s extracted white blood cells are treated with ultra-violet light and a photoactive drug and reintroduced into the body.

The two-pronged assault, proven safe in previous trials and approved by the Food and Drug Administriation to treat certain lymphomas, is showing promising results in treating chronic hepatitis C, said Dr. Lloyd E. King Jr., professor of Medicine and director of the Division of Dermatology.

"What we are testing is that some people who had failed treatments before with interferon alone are showing tangible results with photopheresis. Basically, interferon knocks the virus down and photopheresis takes out the infected, or bad cells," King said.

Previous studies have shown that approximately 33 percent of patients with hepatitis C responded to photopheresis alone, so it is hoped that combining this process with the standard treatment of interferon alfa 2-a will further boost response rates, King said.

King and Dr. Joseph A. Awad, associate professor of Medicine, are leading the study at Vanderbilt, which is one of four institutions nationwide participating in the study. VUMC is also the only institution in the state using the UVAR photopheresis system, developed by a subsidiary of Johnson & Johnson, which is funding the national study.

As a process, photopheresis has the advantage of a relative lack of harsh side effects, King said.

"It's easier on people. A lot of patients can't tolerate the many side-effects of interferon. With photopheresis, patients just don't get as sick."

Minor fever reactions have been observed in less than 2 percent of prior study participants, and in one patient, abnormal liver function. Since the photopheresis process involves a needle stick and blood outside the body, there is a slight risk of infection, as opposed to the list of side effects connected to interferon alfa-2a ‹ fever, tiredness, muscle aches, chills, cardiovascular effects, renal toxicity, protein in the urine, joint aches, decreased appetite, nausea, vomiting, abdominal pain and diarrhea. Interferon may also cause depression, dizziness, hair loss, weight loss and rashes.

The study at VUMC gives patients with chronic hepatitis C the opportunity to take advantage of a safe, potentially beneficial, new treatment for their condition, King said.

"This is a chance to take a shot at a new kind of treatment, one that has been showing impressive results," King said.

A stipulation of the Vanderbilt trial is that participants must have failed or had a relapse after other treatments, including at least a 12-week course of interferon alfa-2a, for hepatitis C. For more information on the trial, call the division of Dermatology at 327-4751.