Harvoni joins other direct-acting antivirals in demonstrating safety and high efficacy in younger pediatric patients with chronic hepatitis C, specifically those aged 3 years to younger than 6 years, according to results published in Hepatology.
“In children who become chronically infected, the course of infection is usually slower than in adults; however, liver disease can progress during early life, and cases of cirrhosis, hepatocellular carcinoma, and end-stage liver disease requiring liver transplantation in childhood have been reported,” Kathleen B. Schwarz, MD, from Johns Hopkins Hospital in Maryland, and colleagues wrote. “The availability of an all-oral, direct-acting antiviral regimen for young children with chronic HCV infection would represent a significant advance in the care of patients who currently have limited treatment options.”
The study comprised 34 pediatric patients who received treatment with Harvoni (ledipasvir/sofosbuvir, Gilead Sciences) during the 2017 year. Patients were treatment-naive and had no known cirrhosis.
The overall sustained virologic response was 97%. One patient, aged 3 years, discontinued treatment due to an adverse event of “abnormal drug taste” and experienced grade 1 vomiting after administration of the drug.
Twenty-five patients experienced at least one adverse event, most commonly vomiting (24%), cough (21%) and pyrexia (21%). No patient experienced a serious adverse event.
Schwarz and colleagues also noted that study treatment did not affect pubertal development through 12 weeks of posttreatment follow-up.
“There remains a significant unmet medical need for an all-oral, interferon-free, direct-acting antiviral regimen for younger children,” the researchers wrote in reference to poor outcomes in pediatric patients treated with interferon. “Similar to prior observations in children 6 to [younger than] 18 years old, treatment with ledipasvir-sofosbuvir was well tolerated in this younger population.” – by Talitha Bennett
Disclosure: Schwarz reports she has received grants from Bristol-Myers Squibb, Gilead and Roche/Genentech; consults for Gilead, Roche/Genentech and UpToDate; and that the study was funded by Gilead Sciences. Please see the full study for all other authors’ relevant financial disclosures.