Hepatitis C is an infection of the liver caused by the hepatitis C virus (HCV). HCV can lead to liver failure, liver cancer, or chronic liver disease, and is a leading reason for liver transplants in the United States. HCV is more common in adults than in children. Children who have HCV most often acquired it as newborns from their mother. Unfortunately, there’s no vaccine to protect against hepatitis C.
When Kelly Hill discovered that her son Kagen’s birth mother had Hepatitis C, she took him to a subspecialist at a local hospital for evaluation. Kagen’s blood tests revealed that he had active hepatitis C virus infection.
“Long-term outcomes for children with hepatitis C vary and depend on the type of infection. Children with chronic hepatitis C need long-term treatment and monitoring. Children with acute infections may be cured; while children with a serious chronic condition that affects their liver could potentially require a liver transplant. Skilled hepatologists (liver specialists) can recognize if a child’s condition deteriorates and recommend additional treatment as needed,” says Jeffrey Teckman, MD, Director – Pediatric Gastroenterology and Hepatology at Saint Louis University School of Medicine and SSM Health Cardinal Glennon Children’s Hospital.
Kagen saw his liver doctor for a physical exam each year, and had bloodwork done every six months to monitor his chronic Hepatitis C infection. He had liver biopsies at age 4 and age 8. Fortunately for Kagen, his liver and testing remained “stable”. The first two United States approved treatments for children with chronic hepatitis C (Interferon therapy and Ribavirin therapy) are highly toxic and not very effective for HCV; therefore, they weren’t used proactively in kids, and Kagen wasn’t sick enough to need them.
Kelly thought frequently about Kagen’s future and the possibility that his liver could one day deteriorate and affect his health and quality of life. She candidly admits, “I asked our specialist each year if there were any new treatments available to try. I was always told ‘no’, so I felt compelled to do my own homework,” said Kelly. “I started googling clinical trials with Hepatitis C drugs in children. That’s where I found Dr. Teckman,” Kelly recalls enthusiastically. “I found an article about a study he had done at SSM Health Cardinal Glennon and Saint Louis University using a drug called Solvadi to treat pediatric patients with Hepatitis C. The article listed contact information for the nurse coordinator of the study. I sent her a message, and almost immediately, I received a call from her. We talked about Kagen, and she suggested that he was a perfect candidate for a NEW study using a promising drug called Harvoni,” said Kelly.
Dr. Teckman states, “Harvoni was FDA approved for adults, but was not yet FDA approved for use with children. It had a 99% cure rate for adults with Hepatitis C. Within two months of FDA approval in adults, the drug’s manufacturer (Gilead Sciences, Inc.) opened up clinical trials with children. SSM Health Cardinal Glennon was the only children’s hospital in the state and region that was enrolled and involved as part of this worldwide trial. Our ability to participate was in large part due to support for our group from the SSM Health Cardinal Glennon Children’s Foundation,” says Dr.Teckman.
Kelly requested further information about the trial and eligibility requirements, and set up a pre-screening appointment with the study coordinator and Dr. Teckman. This appointment took place on January 5, 2016, when Kagen was 11 years old. Kagen had some baseline bloodwork done, and Kelly signed consent for trial participation. Just a couple weeks later on January 28, Kagen started taking Harvoni. He would take one pill per day for 12 weeks. He was required to come to the hospital for weekly visits initially, then bi-monthly visits for both bloodwork and physician exams. After only one week of medication, blood testing at his first week visit revealed he was virus free!
SSM Health Cardinal Glennon enrolled six children total over the two years that Gilead Sciences, Inc. offered the drug to be available for trial in pediatrics. All six children were cured of their chronic disease, and at no cost to the families. SSM Health Cardinal Glennon’s participation led to FDA approval of the drug for children worldwide age 7 and over. This is significant because the drug costs more than $1000 per pill and insurance will often not cover the drug (in adults OR children) if the patient is not significantly symptomatic.
Kagen is still part of the Harvoni trial. He finished the drug trial in April 2016, but he continues follow-ups per protocol that include bloodwork and physical exams. He has been considered ‘cured’ since the first week into the trial, and is now 14 years old.
Kelly and Kagen proudly sing the praises of their experience at SSM Health Cardinal Glennon and Saint Louis University. “They had cutting edge research available for my child, when no one else did,” Kelly asserts. “They cured him, and he is living his best life. I can’t say a bad thing, and the whole staff is always available and responsive,” Kelly says.