New Hepatitis C Combination Treatment Approved FDA Warns of Side Effects -- Overlooks Concerns About Pre-packaged Doses


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June 25, 1998 -- Early this month, the Food and Drug Administration approved Rebetron combination therapy for chronic hepatitis C but only for patients who have relapsed following previous treatment with interferon alone. Rebetron comprises fixed doses of Intron A (interferon alfa-2b, recombinant) injection and Rebetol (ribavirin) capsules packaged together. While the new treatment promises to be almost 10 times better than standard treatment, it doesn't come without serious side effects and major concern about its packaging.

On May 4 of this year, the Antiviral Drugs Advisory Committee of the FDA unanimously concluded that Schering-Plough's Rebetron combination therapy was safe and effective as a treatment for chronic hepatitis C as long as patients are carefully selected and sufficiently monitored for adverse effects. The Committee noted that of the patients studied in clinical trials, 70-percent of those on the combination therapy had significant side effects. The panel had concerns that packaging these two drugs together might not serve the best interests of patients or physicians who intend to follow the best medical practices.

This sentiment was voiced in a letter sent to the FDA Advisory Committee for Antiviral Drugs by Thomas Najarian, M.D, a hepatologist from Belmont, Massachusetts. "As a physician with clinical experience treating Hepatitis C patients, it is my belief that providing these two drugs in a fixed dose package would likely lead to increased medical costs because the dosage of both drugs must be altered often due to side effects of the medication," wrote Najarian. "When two medications are to be given by different routes as with Intron A and ribavirin, especially when both medications have common but different side effects that require dose adjustment, it makes no sense to package them together." Intron A is administered by injection three times a week, and ribavirin is taken orally on a twice-daily schedule. In addition, Dr. Najarian expressed his concern that doctors might be misled into thinking that the pre-packaged doses are appropriate for all hepatitis C patients and will neglect to monitor side effects and make dose adjustments.

At the May 4 hearing, a member of the Antiviral Drugs Advisory Committee, Judith Feinberg, M.D., said about the packaging, "I'm concerned that we don't exactly have the optimum doses of either component in this regimen." Her concerns included questions about the toxicity of the drugs separately and in combination, and the difficulty physicians will have in customizing therapy in response to monitoring the side effects, changes in viral load, and other measures of treatment outcome. She concluded, "I'd hate to see physicians locked into one way of doing this."

Doctors prescribing Rebetol will also be discouraged from prescribing such other types of interferon as Roferon-A (interferon alfa-2a) made by Roche, or Infergen (interferon alfacon-1) by Amgen, which has performed well in clinical studies. One randomized, multi-center study comparing the efficacy of two different doses of Infergen with interferon alfa-2a showed that response rates at the end of treatment were 70% and 66% for the two dose levels of Infergen and 54% for interferon alfa-2a. At the end of a six month observation period of the same patients, the response rates of the patients given Infergen were 79% and 58% for the two doses as compared to 53% of those given interferon alfa-2a.

Hepatitis C is as a major worldwide health problem with rates of infection reaching 15% of the population in some parts of Eastern Europe and Africa. According to the Centers for Disease Control and Prevention, some four million Americans are now chronically infected with the virus, which contributes to the death of 8,000 to 10,000 Americans each year. This toll is expected to triple by the year 2010 at which point it will have surpassed the death rate from AIDS.

The cost of treatment for hepatitis C is expected to become a significant global expense in the near future. Packaging such promising drugs as Intron A, Infergen, and Rebetol separately in variable doses would theoretically decrease the cost of treating hepatitis C on a global scale. In addition, doctors and patients would be more able to choose the most beneficial combination of drugs and doses with the least amount of side effects.


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