November 29, 2023
1 minute read
Key takeaways
- Pediatric patients with hepatitis C experience long-term sustained virological responses using sofosbuvir-based direct-acting antiviral therapy.
- No effects on growth or sexual development were found up to 5 years after treatment.
BOSTON — Treating pediatric patients with hepatitis C virus with a sofosbuvir-based direct-acting antiviral drug can produce durable virologic responses for up to 5 years, according to study results presented at a liver meeting.
Daniel Liang
Daniel H. Leung, MD, FAASLD, FAAPMedical director of pediatric hepatology and liver transplantation at Texas Children’s Hospital and professor of pediatrics at Baylor College of Medicine and colleagues enrolled 461 children with chronic HCV infection who received sofosbuvir plus ribavirin, ledipasvir/sol Fosbuvir plus ribavirin, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/wocillaprevir in previous clinical trials. The patients, aged 3 years and older, participated in a 5-year follow-up registry study from October 2015 to June 2021.
“The results of this study expand the current limited literature and provide further evidence of the long-term safety and effectiveness of sofosbuvir-based treatment regimens in children with hepatitis C,” Leung told Healio. “Previous studies evaluating DAAs have shown high SVR rates and a favorable safety profile in children“.
Each patient’s baseline was determined based on the date of the last visit in the parent trial, and investigators assessed HCV RNA and z-scores for weight, height, and BMI, and Tanner pubertal stage every 6 to 12 months.
Of the patients in the study, 20% received sofosbuvir plus ribavirin, 42% received ledipasvir/sofosbuvir plus ribavirin, 34% received sofosbuvir/velpatasvir, and 4% received sofosbuvir/vitamin Pertavir/vocilaraprevir. The mean age was 12 years, median weight z-score at entry was 0.3, height was -0.2, and BMI was 0.4. The study showed that the median follow-up time was 193 weeks.
Results from the parent trial showed that the majority of patients (99.5%) achieved SVR.
“In this study, two patients enrolled in the registry did not achieve SVR in the parent clinical trial, and both developed NS5A resistance-associated variants in the parent clinical trial,” Leung said.
Of patients who achieved SVR, 100% maintained SVR throughout the registry. The researchers reported that the median duration of SVR was 4 years.
“In a combined cohort of more than 400 children 3 years and older who received sofosbuvir-containing regimens through clinical trials, all children who achieved SVR during the treatment study showed improved outcomes up to 5 years in this follow-up study. Durable SVR, Liang said. “In addition, the study showed that children receiving sofosbuvir-containing regimens had no effects on pubertal development, weight, height, or BMI z-score 5 years after treatment. “
Source/Disclosure
collapse
Liang DH et al. Long-term safety and efficacy of sofosbuvir-based direct-acting antivirals in pediatric patients with hepatitis C virus. Published in: Liver Meeting; November 10-14, 2023; Boston (Hybrid Meeting).
Disclosure: Leung reports receiving clinical trial support from AbbVie and Gilead Sciences. Please see this post for relevant financial disclosures for all other authors.
Discovery of Hepatitis C Virus