March 31, 2011
Researchers are in the final steps of evaluating two new drugs to add to the existing treatment for hepatitis C.
An estimated 170 million people worldwide have the liver infection known as hepatitis C. The standard, two-drug treatment is not effective for a lot of patients. The new medications could improve that treatment.
In one study, scientists are comparing the existing two-drug therapy with a proposed three-drug treatment that adds a protease inhibitor called boceprevir.
Using today's standard recommended treatment, doctors cure only about 40 percent of hepatitis C patients. Saint Louis University researcher Bruce Bacon says that's about the cure rate experienced by the control group in his study.
"But in the boceprevir-treated patients, it was around 66-70 percent of patients [who] were cured. So, almost a 30 percent [percentage point] incremental improvement in response rates. So, quite dramatic."
Bacon is co-principal investigator on a study testing boceprevir. He has also worked with the other new hepatitis C drug, telaprevir.
Expert advisory committees of the U.S. Food and Drug Administration will consider the results of studies of the two drugs at the end of April, and Bacon says they could be on the market as early as June.
"They're roughly equivalent in terms of their efficacy or effectiveness, and they have a slightly different side-effect profile between the two of them."
Those side effects include anemia, skin rash, and a metallic aftertaste.
Boceprevir is only expected to be effective against one variety of hepatitis C, known as genotype 1. It's the most prevalent form of the disease in the Americas, Europe, and East Asia, but represents only a minority of cases in Africa, the Middle East, and South Asia.
Saint Louis University researcher Bruce Bacon reports the latest results from the ongoing study of boceprevir in The New England Journal of Medicine. An editorial in the journal says the new drugs represent the beginning of "a new era" of successful hepatitis C therapy.