Combination drug “cures” hepatitis C in children and adolescents
No trace of virus found in blood of patients after treatment
The first pediatric study of a combination drug to treat the hepatitis C virus (HCV) infection in children and adolescents demonstrated 100 percent effectiveness in adolescents who completed the 12-week, phase II clinical trial.
If approved for use in teens, ledipasvir-sofosbuvir (a combination of two anti-viral agents marketed as Harvoni®) could dramatically improve care for patients who currently have limited treatment options.
“While not the only way to contract HCV, cases of hepatitis C have been increasing for several years among those who inject opioids, and infections have reached epidemic proportions in most states among this population,” says William Balistreri, MD, medical director emeritus, Pediatric Liver Care Center, at Cincinnati Children’s, and lead author of the study.
“In the Cincinnati Children’s area, there has been an increase of more than 350 percent in HCV infection among people 12 to 29 years old, which of course includes women of childbearing age who may pass the infection on to their newborn infants. We estimate a 450-percent rise in cases of HCV among children and adolescents at Cincinnati Children’s since 2009.”
About 80 percent of adolescents in the study had been infected during the perinatal period, when the virus was transmitted from mother to child. Standard screening for HCV in pregnant women may be appropriate, says Balistreri.
The study is published online ahead of print in the journal Hepatology.
The study was conducted between Nov. 2014 and Oct. 2015 at 24 sites across the United States, the United Kingdom and Australia. One hundred 12 to 17 year olds received Harvoni once daily for 12 weeks in a dosage already proved effective in adults.
The researchers were looking for a reduction of HCV in the blood during treatment and a sustained response – an absence of detectable virus – 12 weeks after treatment. Two patients did not complete the treatment and were lost to follow up, but all 98 patients who completed the trial successfully reached a virologic response. The combination drug showed that all patients were “cured,” meaning that HCV was not detected in the blood 12 weeks after treatment.
No serious adverse events were reported. The most commonly reported adverse events were headache, in 27 percent of patients; diarrhea, in 14 percent of patients; and fatigue, in 13 percent of patients.
It’s estimated that 2.7 to 3.9 million in the United States have chronic hepatitis C.
Funding for this study was provided by Gilead Sciences, Inc.
