ST. LOUIS - The results of one of the pivotal trials that lead to the FDA approval of telaprevir, also known as Incivek, now have been published, and hepatitis C researchers have found that the addition of the new medicine to standard treatment raised the cure-rate to 79 percent, up from 46 percent. The ADVANCE study findings, which specifically looked at patients who were receiving hepatitis C treatment for the first time, were reported in the June 23 issue of the New England Journal of Medicine.
|Adrian Di Bisceglie, M.D.|
In addition, the study suggests patients may be cured with shorter treatment times, welcome news for those undergoing the difficult treatment regimen.
A member of the international research team, Adrian Di Bisceglie, M.D., chair of internal medicine at Saint Louis University, studied the effects of the new antiviral drug.
"The data from this study are very promising, as is the fact that protease inhibitors like telaprevir are now FDA approved and available for doctors to prescribe to their patients," said Di Bisceglie. "The fact that a shorter time treatment is needed is also very good news for patients."
Hepatitis C is caused by a virus, transmitted by contact with blood, and may initially be asymptomatic. For patients who develop a chronic hepatitis C infection, inflammation of the liver may develop, leading to fibrosis and cirrhosis (scarring of the liver), as well as other complications including liver cancer and death. Worldwide, experts estimate that nearly 180 million people are infected with the virus.
The Phase 3, placebo-controlled study enrolled 1,088 hepatitis C, genotype-1 patients worldwide who had not previously been treated with standard hepatitis C drugs, ribavirin and peginterferon. Patients who were given telaprevir plus the standard treatment for 12 weeks, followed by several weeks more of ribavirin and peginterferon fared best, with a 79 percent cure rate. The majority of study participants who received telaprevir were able to finish treatment in 24 weeks, half of the time required by the standard treatment.
FDA approval for telaprevir was granted earlier this month, and the drug is now available. The ADVANCE study was funded by Vertex Pharmaceuticals.
Established in 1836, Saint Louis University School of Medicine has the distinction of awarding the first medical degree west of the Mississippi River. The school educates physicians and biomedical scientists, conducts medical research, and provides health care on a local, national and international level. Research at the school seeks new cures and treatments in five key areas: cancer, liver disease, heart/lung disease, aging and brain disease, and infectious disease.