New Patients Receive Strong Warnings about Potential Risk to Fetus with Combination Therapy


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Expanded Indications Bring More Complications in Hepatitis C Treatment New Patients Receive Strong Warnings about Potential Risk to Fetus with Combination Therapy

February 8, 1999 (Philadelphia) - After just six months on the market, revised safety information tells doctors and patients to be even more cautious in the use of combination therapy to treat hepatitis C. A "black box" warning in the revised prescribing information for Rebetron (Schering-Plough) warns that patients and their partners must use two forms of contraception because of the risk of birth defects or loss of a pregnancy from combination therapy.

Even if only one partner is taking Rebetron, both members of the couple need to use adequate contraception during therapy and for six months after the end of treatment. Rebetron consists of interferon-alfa plus ribavirin. It is the ribavirin component that is blamed for the risks to the fetus.

The U.S. Food and Drug Administration recently approved Rebetron combination therapy for patients with hepatitis C who had never been treated before. Previously, only people who had failed a previous treatment could receive Rebetron. But at the same time as it allowed wider use, the FDA increased the warnings to reflect the danger of the combination therapy during pregnancy. Ever since Rebetron was first approved, Schering-Plough has maintained a registry to track people on the therapy who become pregnant.

Dr. Enrique Molina, a hepatologist and assistant professor of clinical medicine at the Center for Liver Diseases, University of Miami, Florida, says no patients with pregnancy-related complications from Rebetron treatment have been referred to his practice yet. However, he feels physicians need to counsel patients carefully before prescribing Rebetron and says, "If a patient is not willing to practice strict contraception, that's certainly a contraindication for ribavirin. It makes a bigger difference for younger patients than for older ones. Many of our patients are 40 or 50 and already practicing contraception so it's not a big issue for them, but for those that are younger, it's definitely an important point for physicians to stress."

Dr. Molina also considers other potential risk factors before prescribing the combination therapy. He is particularly concerned about the anemia that ribavirin can cause. "A patient at high risk for cardiac disease or hemolysis or one with existing severe anemia that might be complicated by ribavirin is better off starting on Infergen." Infergen is a newer bioengineered interferon that differs from standard interferons, such as Intron A.

The side effects of combination treatment should also be reviewed carefully with each patient, according to Dr. Molina. "I explain that side effects at the beginning of interferon therapy are worse in some patients-not only the headaches, fever and flu-like illness, but general fatigue and malaise-and are probably made even worse by the addition of anemia from ribavirin. The patients with the worst anemia are the patients with the worst fatigue. There is an additive effect, and the two drugs together cause worse side effects," he says.

"Patients should know that during the first week or two of treatment, the side effects are going to be at their worst no matter how mild or how bad, but by the end of a month they'll be tolerable," Dr. Molina says. "Most patients will be able to carry on normal lives with some limitations, and they will be able to continue treatment.

"When patients are taking Rebetron, it's vital they are tested every two weeks at the beginning of treatment, especially their CBC [complete blood count] and platelets, not only to monitor efficacy but also side effects. Liver chemistry should be checked monthly, but tests for anemia are the most important," Dr. Molina says. He recommends patients have ANA [antinuclear antibody test] and thyroid tests before beginning treatment, especially if they have an autoimmune background. These tests should be rechecked after three months.

According to Dr. Molina, treatment should last for a year. "At the end of three months of interferon monotherapy, we recheck to see if the treatment is effective. When a patient is on combination therapy, we should probably wait longer than three months to decide whether he is responding or not. Many patients respond to Rebetron after the three-month mark."

Distributed by: Patients NewsWire
Link to FDA page with link to updated Rebetron warnings:

Patients Newswire
Contact: Derek Moran (610) 525-1589

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