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After the success of a new drug treatment in adults with hepatitis C infection, a Saint Louis University pediatric researcher is testing the safety and efficacy of the medications in children. Part of a multi-center clinical study, SLU is the only center in the region that will examine a combination of two drugs – Sofosbuvir and Ribavirin – in children between ages 3 and 17. The aim of the study is to cure the infection with few side effects.
The current approach to treat the hepatitis C infection is with interferon shots combined with Ribavirin, a therapy that takes about six to 12 months and also causes many side effects including, flu-like symptoms and depression.
“Many times patients would be on the traditional medication but quit within a year. It’s a very difficult treatment, with a cure rate of 50 percent,” says Jeffrey Teckman, MD, professor of pediatrics and principal investigator of the study at SLU. "The new study will consist of all oral medication. That would mean no shots or flu-like side effects, and also much shorter course of treatment."
The medication has shown 90 to 100 percent cure rate in adults and Teckman hopes to see the same results in children. His main aim is to test if the side effects would be as low in children as they were in adults, and to see if children need extra time for the drugs to work.
For this study, the team will test Sofosbuvir, a new drug, and Ribavirin, which is used in the treatment with interferon. Teckman said the new medication could cause lesser side effects, like already seen in adults.
“I think this treatment is a real game changer,” says Teckman, who is also a SLUCare pediatric gastroenterologist at SSM Cardinal Glennon Children’s Medical Center. “The previous treatments were arduous. People would often start the treatment, but eventually drop out. This new therapy is a revolution that affects people around the world.”
Teckman believes, unlike studies for adults, research for children is lagging behind.
“A lot of times studies for children don’t get approved. The exciting part with our study is that the medication has already been tested in adults, and we are moving rapidly to test in children,” he says.
Hepatitis C is a viral disease that leads to inflammation of the liver. The CDC says about 3.2 million people in the United States are affected by the hepatitis C infection, out of which Teckman believes 5 percent are children.
“Hepatitis C takes a long time to damage the body, but eventually it can be fatal. It’s important to cure people,” Teckman says.
Source: Saint Louis University Medical Center