Generic DAA therapy safely, effectively treats pediatric HCV
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Administration of direct-acting antiviral agents safely and effectively treated children with hepatitis C, according to a presentation at the International Liver Congress.
“The global prevalence of hepatitis C in children is shown clearly in this modeling study from the Center for Disease Analysis where the viremic prevalence of the pediatric population was estimated in 249 countries as 0.13%, corresponding to around 3.26 million children infected,” Manal Hamdy El-Sayed, MD, PhD, said in the presentation.
El-Sayed and colleagues studied the efficacy of the Egyptian Liver Care Society’s (ELCS) ongoing C-free Child Project phase 4 administration of oral DAAs. The multicenter program enrolled 535 children with chronic HCV and weighing more than 35 kg across 7 centers in Egypt between March 2019 and December 2020, according to the abstract.
The ELCS treated patients with generic oral DAAs daily for 12 weeks. Full treatment included baseline and follow-ups at 4, 8 and 12 weeks and at sustained virological response evaluation; ultrasounds; prevention and personal care items during therapy and at SVR assessment at 24 weeks; Fibroscan (Echosens) and medication dispensation. The program trained medical personnel, provided health workshops to children and their families and fully equipped all centers.
During the COVID-19 pandemic, the ELCS held follow-ups and workshops virtually, distributed medication for 12 weeks and provided protective and sanitization measures.
Of all children enrolled, 264 completed SVR evaluation so far, with a median age of 16 years (range, 11.5-17.5 years; M/F, 1.4/1). On an intention-to-treat basis, SVR presented in 249 (94%) of those evaluated, but SVR per protocol was 100%. El-Sayed said this demonstrated the high efficacy and safety of DAA therapy for HCV in children, with only minor adverse events such as headache, dizziness and loss of appetite occurring.
The most common risk factors identified included multiple injections (84%), dental procedures (50%) and informal medical service (50%). Ninety-seven children (37%) had mothers with HCV infection. Cardiac disease, hemophilia, lymphoma and thalassemia affected 12 children; 51 children were cancer survivors, making up 19% of those who completed SVR assessment.
“Children and adolescents are a marginalized population that is often neglected in policies and guidelines,” El-Sayed said. “The NGOs can play a huge role to support the pediatric populations and indeed the high-risk populations, providing models of service delivery, as well as removing stigma and discrimination.”