New Treatments Offer Hope For Kids With Hepatitis C

Eliminating hepatitis C virus infection in children and adolescents in the U.S. is now more attainable than ever. That’s thanks to U.S. Food and Drug Administration (FDA) approval of three direct-acting antiviral (DAA) agents that can cure the infection without requiring administration by a specialist.

William Balistreri, MD, an expert in liver disease at Cincinnati Children’s, led research and clinical studies over the course of six years to gauge the agents’ safety and efficacy. This work culminated in FDA approval of three DAAs to treat hepatitis C virus (HCV) in children ages 3 and older.

The drugs are more than 97% successful in curing HCV infection. They’re also safe and easy to administer.

“It’s an amazing success story,” Balistreri says. “I’ve been working in medicine for 50 years, and this has been one of the most rewarding experiences I’ve had. This is something that can be done simply, and can cure the patient.”

Yet while the path forward is clear, Balistreri cautions more work remains: “We have the way. But do we have the will? Unfortunately, we’re not making the progress we should. Not because the drugs don’t work, but because of roadblocks in the cascade of care.”

Working to Reverse a Troubling Trend

Balistreri’s efforts to find safe and effective treatments for children with HCV infection span nearly a quarter of a century. In 2000, he pulled together a group of pediatric hepatologists from centers across the U.S. and Canada to study effective medications for pediatric patients with HCV.

“It was prompted by the need,” he says. “There was an epidemic of injection drug use.” This clearly impacted children, primarily via maternal to infant transmission of the HCV.

Since 2010, rates of acute and chronic HCV infections have been rising in the U.S., leading to increasing rates of HCV infections during pregnancy. Around 6% to 7% of perinatally exposed infants and children acquire HCV infection.

To reverse this trend, in 2016, the World Health Organization (WHO) called for the elimination of HCV, which it defines as reducing new HCV infections by 90% and deaths by 65% before 2030.

In 2023, the Centers for Disease Control and Prevention (CDC) released screening recommendations for all perinatally exposed infants and children in the U.S. to increase awareness, diagnoses and treatment.

Efforts to Train Non-Specialist Providers

Even though the FDA-approved DAA agents can cure HCV infection in children as young as 3, many perinatally infected children aren’t getting the testing or care they need.

Indeed, there remains a great urgency to increase screening and case-finding efforts, says Balistreri, who continues to work at several levels to address these concerns.

In 2018, Balistreri and his co-investigators helped launch the Kentucky Hepatitis Academic Mentorship Program (KHAMP), developed in conjunction with the Kentucky Rural Health Association and the Kentucky Department of Public Health Viral Hepatitis Prevention and Control Program. KHAMP staff train non-specialist providers to treat people with HCV.

“We knew that, unfortunately, Kentucky is a hotbed of opioid use,” Balistreri says. “We knew we needed to target high-risk, low-resource populations in a rural state with a limited number of specialists and many residents lacking the resources to travel to a major city. To do that, we needed to get past the issue of having these DAAs prescribed only by consultation with a specialist hepatologist.”

At the time, Kentucky had only three hepatologists, but none specializing in pediatrics. Balistreri and his team set out to train providers in disciplines including internal medicine, family medicine, general pediatrics and emergency medicine to screen, diagnose and treat HCV infection.

To date, they’ve trained close to 300 providers in Kentucky who have conducted close to 3,000 HCV consultations, Balistreri says.

“Our data clearly show that curative agents for HCV can be effectively administered by non-specialist providers,” Balistreri says. “In Kentucky, they have successfully treated patients with chronic HCV and have achieved an SVR [sustained virologic response] in over 95% of treated subjects. None of these practitioners had previously treated patients with HCV.”

Since KHAMP’s launch, Balistreri and his team have established similar models in West Virginia (WVHAMP) and Ohio (OHIO-HAMP), with more in the works. Further, all state initiatives now fall under the umbrella of the United States Hepatitis Academic Mentorship Program (US-HAMP).

Treatment for Every Child

Ultimately, to reach the WHO’s goal of hepatitis C elimination by 2030, it’s “going to take all of us,” Balistreri says. “It’s awareness, and it’s understanding that these drugs cure hepatitis C in children. We just need to focus on screening efforts and empowering primary care doctors to prescribe HCV treatments.”

He continues: “The message—not just to pediatric gastrointestinal providers but to primary care pediatric providers—is that every child with hepatitis C should be detected and treated, period.”

To learn more about establishing a Hepatitis Academic Mentorship Program in your state, contact William Balistreri at william.balistreri@cchmc.org.

(Published November 2024)