Extended Drug Therapy for Hepatitis Is Challenged

By RONI CARYN RABIN
05 dec 2008--Patients who do not initially respond to standard drug therapy for treatment of hepatitis C are unlikely to respond to long-term maintenance therapy as well, according to a new study.
Yet many patients who do not at first respond to drugs are placed on maintenance therapy, which is expensive and can be both physically and psychologically grueling, in hopes that long-term treatment will keep the disease in check. The practice is ineffective and possibly harmful, the study’s authors said.
“To the extent there are still patients out there who are on this form of maintenance therapy, there is a real take-home message: It should be stopped,” said the lead author, Dr. Adrian M. Di Bisceglie, professor of internal medicine and co-director of the liver center at St. Louis University School of Medicine.
The maintenance therapy failed despite the fact that it was effective at lowering the amount of virus in patients’ blood and reducing conventional signs of liver damage, Dr. Di Bisceglie said.
The report appears in Thursday’s issue of The New England Journal of Medicine.
The standard treatment for hepatitis C is a regimen of two potent drugs, peginterferon and ribavirin, that can produce side effects like fever, debilitating fatigue and depression. But the treatment clears the virus from the body in about half of all patients.
Those who do not respond to the initial one-two punch in six months to a year are often advised to continue with a lower, maintenance dose of peginterferon alone for an indefinite period.
The new study, conducted at multiple medical centers and supported by the National Institute of Diabetes and Digestive and Kidney Diseases, followed 1,050 patients with advanced liver disease who had failed to respond to initial treatment for three and a half years. Most of the subjects were men, and their mean age was 51. About half received low doses of peginterferon, while half received no therapy.
Patients on long-term peginterferon fared just as poorly as nonresponders who were not taking the drug, the investigators found.
About a third in each group developed serious complications of hepatitis C, like liver cancer and liver failure.
Eight patients on peginterferon died, compared with two who were not taking the drug, a statistically significant difference, researchers said.
“This is a treatment that should not be done,” said Dr. Howard Worman, professor of medicine at Columbia University College of Physicians and Surgeons, who was not involved in the study. “Patients should just sit tight and wait for new treatments or drugs to be added, which will happen within a few years.”
Dr. David Bernstein, chief of gastroenterology and hepatology at North Shore University Hospital on Long Island, said there might still be a “glimmer of hope,” though very little evidence, that some hepatitis C patients who failed the initial course of treatment might benefit from extended maintenance treatment.
But for now, Dr. Bernstein added, “there’s no reason to make someone feel sicker than they generally feel.”