A new clinical trial in children is set to begin that will test the blockbuster hepatitis C drug Sovaldi in combination with ribavirin as part of an all-oral regimen.
A new clinical trial in children is set to begin that will test the blockbuster hepatitis C drug Solvaldi and ribavirin as part of an all-oral regimen.
The Saint Louis University Medical Center will take part in the study meant to examine sofosbuvir, also known as Sovaldi (sofosbuvir), in combination with ribavirin, Jeffrey Teckman, MD, professor of pediatrics and the study’s principal investigator at the university, said in a news release.
The FDA approved Sovaldi for the treatment of hepatitis C infection in adults in late 2013. The drug achieved 90% to 100% cure rates in clinical trials with adults. Given the success of new hepatitis C drugs in adults, the study aims to evaluate the safety and efficacy of Sovaldi in children and to determine whether they need more or less treatment than adults, Teckman said.
Current treatment of hepatitis C infection involves shots of interferon combined with ribavirin over six to 12 months, often with serious side effects of flu-like symptoms and depression, according to Teckman.
“Many times patients would be on the traditional medication but quit within a year,” Teckman said in the news release. “It's a very difficult treatment, with a cure rate of 50 percent.”
“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,” he said.
Teckman’s research is part of a multicenter clinical trial sponsored by Gilead Sciences for children and adolescents with genotype 2 or 3 chronic hepatitis C infection. Gilead is recruiting pediatric patients for the study in numerous sites across the United States, as well as abroad in countries that include Australia, Germany, Italy, New Zealand, Russia, and the United Kingdom.
Hepatitis C is a bloodborne virus that can inflame the liver and if left untreated cause cirrhosis or lead to the need for a liver transplant. It has been called a silent killer because it often goes undetected for years.
Most Americans with hepatitis C are not children, noted Teckman in an e-mailed response to questions about the study. “But some are and they need medicine, too,” he said, adding that our medical system often overlooks the needs of children.
“As pediatricians, we are often left trying to treat kids with less than full information, so this is a great opportunity to give kids the same quality as adults,” said Teckman.
In children, there is a 5% chance that the virus can be passed from mother to child during birth, according to Teckman. Like adults, children can also be infected through transfusions of tainted blood and other means and like adults may not experience symptoms or damage for decades, though rapid damage can also occur, he said.
According to information provided on clinicaltrials.gov, the study will have two parts that includes a lead-in phase to evaluate pharmacokinetics (how the drug metabolizes in different aged children) and confirm a dose amount of sofosbuvir for children infected with hepatitis C virus, followed by a rollover treatment of sofosbuvir and ribavirin phase of 12 or 24 weeks.