Jan. 22, 2001 (Washington) -- Federal health regulators on Monday approved the first long-acting treatment for the liver infection hepatitis C, offering at least some patients the option of an easier treatment regimen.
This means that patients with persistent, or chronic, infection can now have a once-weekly injection, instead of three times a week, at twice the effectiveness. And although there is still one other regimen out there that is considered the best option for many people, this new treatment has its advantages.
The most frightening thing about hepatitis C is its tendency to cause chronic liver disease. At least 75% of patients with acute hepatitis C ultimately develop a chronic infection, and most of these patients have accompanying persistent liver disease. Chronic hepatitis C can cause cirrhosis, liver failure, and liver cancer.
Two different regimens previously have been approved as therapy for hepatitis C in the U.S. -- therapy with interferon-alpha alone, which has anticancer properties, and also is effective in fighting viral infections, or combination therapy with interferon-alpha and ribavirin, which also is effective at treating some viral infections
The newly approved drug, Peg-Intron, is a once-a-week version of interferon-alpha.
But studies have indicated that the best therapy currently available for hepatitis C infection is the combination therapy.
The safety and effectiveness of Peg-Intron was demonstrated in a clinical trial involving about 1,200 adult patients, in which 24% of the study population responded to Peg-Intron treatment, compared to 12% of those patients on the interferon-alpha alone.
However, in a second trial involving about 1,700 patients, the combination therapy still proved best. Approximately 40% of the study population responded to the interferon-alpha and ribavirin vs. about 15% of those patients on interferon-alpha alone.
This FDA approval does not include approval of Peg-Intron for use in combination with ribavirin.
Still, the approval of Peg-Intron represents an important development, says Richard W. Zahn, president of Schering Laboratories, the maker of both Rebetron (the combination drug) and Peg-Intron.
Zahn explains that because patients can take the drug weekly, they may take it more readily and stick to treatment.
Peg-Intron also will offer an alternative to patients that suffer severe side effects to combination therapy, adds John McHutchison, MD, a director of Scripps Clinic and Research Foundation in La Jolla, Calif.
And according to the FDA, the newly approved drug also may offer some patients a safer treatment alternative. The ribavirin and interferon therapy combination has been linked to heart dysfunction and a type of anemia, the agency points out.
Otherwise, the FDA says, the side effects of the two treatment options are relatively similar with flu-like symptoms and depression topping the list.
But for many Americans, it may come down to a simple matter of cost. Treatment with Peg-Intron will cost about $1,000 a month compared to about $500 per month for interferon alone, whereas the combination therapy with Rebetron costs about $1,500 per month.
But pure numbers alone suggest that at least some patients will stand to benefit.
According to the CDC, about 4 million Americans are infected with hepatitis C. The disease contributes to the death of an estimated 8,000 to 10,000 Americans each year, and the still increasing toll is expected to exceed the annual number of AIDS deaths by 2010, the CDC says.
Peg-Intron is expected to be available early next month. It currently is sold in the European Union, where it was approved in May 2000.