So Far, DAAs Look Safe for Kids with HCV

In what researchers said was the first study of DAAs in children with HCV, UK researchers reported the drugs were effective and well tolerated. Questions remain about whther they might have any negative effects farther out.

When children have hepatitis C infection, parents generally want them cured quickly.

But standard treatment for children and adolescents is still ribavirin and peg-interferon for 48 weeks, a long and sometimes difficult course.

Reporting today at the International Liver Congress in Barcelona, Sanjay Bansal, MD a consultant pediatric hepatologist at King’s College Hospital, London, UK said his team had successfully used the directing acting antiviral combo ledipasvir/sofosbuvir to treat adolescents.

Discussing the study at a news conference this morning, Bansal said 100 infected patients with a mean age of 15 had been enrolled and treated.

They got the drugs in a single tablet taken daily for 12 weeks.

Of 78 of the 96 patients in the study who are four weeks past completing treatment, all have achieved a sustained viral response (SVR). All 78 patients who reached post-treatment week 12 have also had a sustained response.

Side effects were mild, he said.

“The 12-week regimen of LDV/SOF 900mg/400mg has resulted in high SVR rates and is well-tolerated, the authors concluded in their study.

At the news conference, Bansal said there were concerns about whether the drugs would cause problems with children’s growth, questions that will take time to answer.

But he also said he empathized greatly with mothers of these children, since in almost all cases they transmitted the virus to their teenagers as infants.

“These mothers can feel terrible guilt and want their children treated quickly,” he said in an interview after the conference.

He also agreed with colleagues who pointed out that social pressures on both the parents and children are tremendous, once it becomes known that a child has HCV.

“Send a kid with HCV to kindergarten and it would be a disaster, said Heiner Wedemeyer, a hepatology professor in Hannover, Germany, “The other parents would kill you.”

Bansal said the doses of the drugs used were equivalent to those given to adults.

Next he and colleagues plan to enroll children as young as three in a similar trial, a decision made partly because of the safety profile of patients in the study reported today.

Hepatits infection in children is a major problem in some regions, he added.

The infection rate in adolescents in the US and Europe is 0.4%, but in Egypt it is 6%.

“This is an important treatment,” he said.