FDA Approves New Hepatitis C Combo Treatment

From the WebMD Archives

Aug. 9, 2001 (Washington) -- The 4 million hepatitis C patients in the U.S. now have another weapon in their arsenal to combat the liver-attacking disease.

The FDA recently approved the combination of two drugs that are already available by themselves as treatments for hepatitis C: PEG-Intron and Rebeto. Schering-Plough makes both drugs, which are more effective when used in combination than when used alone.

Company spokesman Bob Consalvo tells WebMD that the combo should be available this fall.

Hepatitis C infection, which usually happens through contact with infected blood, kills 8,000 to 10,000 people annually in the U.S., according to the FDA. Most of those infected do not develop severe liver disease and some may not need treatment. About 10-20% of patients develop cirrhosis or scarring of the liver and 1-5% develop liver cancer.

Rebetol had previously been used with another drug, Intron-A, to treat hepatitis C, but clinical trials found the new Rebetol/PEG-Intron combo to be more effective, the FDA said.

More than half of the patients, 52%, who received the PEG-Intron combination had undetectable levels of hepatitis C virus in their blood 6 months after the drugs were stopped, the agency said. This was true for just less than half of the patients, 46%, who received the Intron A combo.

In addition, the PEG-Intron combination was more effective than the paired Intron A product in patients who had a strain of the virus known as genotype 1 that is particularly difficult to treat.

Patients must take the combo for one year, and one of the advantages of the new one is that PEG-Intron, which is administered by injection, only has to be given once a week, whereas Intron A has to be given 3 times a week, Consalvo says. The other half of the combo, Rebetol, comes in pill form and has to be taken daily.

The PEG-Intron combo comes with the same side effects as the Intron A combo, which include flu-like symptoms, and psychiatric disorders, such as depression and suicidal behavior, Consalvo says.

Sarah Brown of the American Liver Foundation, which endorses the new approval, tells WebMD that side effects associated with these drugs "have been a problem." Depression is of particular concern because it can force people to stop taking the drugs, she says.

Patty Krueger of the National Hepatitis C Coalition insists that the psychiatric disturbances are being minimalized. "That's real and that happens more than what [is being reported]," she tells WebMD.

Other side effects include pancytopenia, a decrease in oxygen-carrying red blood cells and infection-fighting white blood cells. In addition, Rebetrol, which is considered to be a carcinogen or cancer-causing chemical, can cause birth defects or death of an unborn child.

The FDA noted that patients who take the new combo "must be carefully monitored by their physicians and get regular blood tests to check for side effects."

Patients need "to do their own homework on it first" so they understand the side effects, says Krueger, whose husband has hepatitis C. The drugs can be very harsh to the body, so "if they have any other kind of health problem, don't do the treatment," she says.