Sofosbuvir-based regimens demonstrate durable SVR in children with HCV
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Key akeaways
- Pediatric patients with HCV experienced long-term sustained virologic response with sofosbuvir-based direct-acting antiviral treatment.
- Up to 5 years post-treatment, no impact was seen on growth or sexual development.
BOSTON — Treatment with sofosbuvir-based direct-acting antivirals demonstrated durable sustained virologic response up to 5 years among pediatric patients with hepatitis C virus, according to findings presented at The Liver Meeting.
Daniel H. Leung, MD, FAASLD, FAAP, director of pediatric hepatology and liver transplant medicine at Texas Children’s Hospital and professor of pediatrics at Baylor College of Medicine, and colleagues included 461 children with chronic HCV infection who received sofosbuvir plus ribavirin, ledipasvir/sofosbuvir plus ribavirin, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir in prior clinical trials. The patients, aged 3 years and older, were enrolled in a follow-up registry study over a 5-year period, from October 2015 to June 2021.
“The findings from this study expand on the current limited literature and provide further evidence of the long-term safety and efficacy of sofosbuvir-based regimens in children with hepatitis C,” Leung told Healio. “Prior studies evaluating DAAs had shown high SVR rates and favorable safety profiles in children.”
Baseline for each patient was determined by the day of their last visit in the parent trial, and researchers assessed HCV RNA and z-scores for weight, height and BMI, as well as Tanner pubertal stage, every 6 to 12 months.
Of the patients enrolled in the study, 20% received sofosbuvir plus ribavirin, 42% received ledipasvir/sofosbuvir plus ribavirin, 34% received sofosbuvir/velpatasvir and 4% received sofosbuvir/velpatasvir/voxilaprevir. Mean age was 12 years and median z-scores at enrollment were 0.3 for weight, −0.2 for height and 0.4 for BMI. The median follow-up was 193 weeks, according to the study.
Results from the parent trial showed that most patients (99.5%) achieved SVR.
“In this study, two patients enrolled in the registry study had not achieved SVR in the parent clinical trial, and both had developed NS5A resistance-associated variants in the parent clinical trial,” Leung said.
Of those who achieved SVR, 100% maintained SVR throughout the registry study. The researchers reported a median duration of 4 years of SVR.
“In a combined cohort of over 400 children who were 3 years and older when they received sofosbuvir-containing regimens through clinical trials, all of those who achieved SVR during the treatment study demonstrated durable SVR up to 5 years in this follow-up study,” Leung said. “Also, the study showed no impact on pubertal development, weight, height or BMI z-score in children receiving sofosbuvir-containing regimens up to 5 years posttreatment.”
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Leung DH, et al. Long-term safety and efficacy of sofosbuvir-based direct-acting antivirals in pediatric patients with hepatitis C virus. Presented at: The Liver Meeting; Nov. 10-14, 2023; Boston (hybrid meeting).
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