Real-world Experience Treating HCV in the Youngest Eligible Children – Role for Cupcake Sprinkles?
Emily E Adler, Jonathan R HoneggerAbstract
Background
Perinatally acquired hepatitis C virus infections have risen sharply in the U.S. because of the ongoing opioid crisis. Pan-genotypic direct-acting antiviral (DAA) regimens are approved for children aged 3-17 years, achieving cure rates approaching 100% after completion of an 8- or 12-week treatment course. However, in registry studies, cure rates as low as 83% were seen in the youngest cohorts (aged 3-5 years) due to challenges swallowing the pellet formulations used for children who cannot swallow tablets. DAA pellet formulations are film-coated to mask a bitter taste and must be swallowed without chewing. Few reports of real-world experience using the pellet formulation in young children are available. Here we reviewed our initial experience with HCV treatment in young children and assess impact of requiring successful practice swallowing candy sprinkles before prescription.
Methods
HCV viremic children aged 3-5 years initiated on DAA pellet formulations in the HCV clinic at Nationwide Children’s Hospital before 6/1/2024 were included in this analysis. Phone assessments of medication adherence and tolerance were attempted early by clinic staff and then monthly by specialty pharmacy staff. HCV RNA testing was conducted at 12 weeks post treatment completion to assess for sustained virologic response (SVR12). Successful swallowing practice was defined as caregiver report that the patient had demonstrated ability to swallow candy cake-decorating sprinkles in a DAA-compatible food without chewing. SVR12 achievement was compared between those with and without documented successful swallowing practice using Fisher’s exact test.
Results
During the study period, 25 children (aged 3-5 years) initiated treatment with DAA pellet formulations (1 glecaprevir/pibrentasvir, 7 ledipasvir/sofosbuvir, 19 sofosbuvir/velpatasvir). Overall, 20/25 (80%) completed therapy and achieved SVR12. All failures to achieve SVR12 were attributable to early discontinuation due to difficulty swallowing the pellets, often related to the taste of the pellets after inadvertently chewing them. Those with documented success swallowing candy sprinkles prior to the DAA prescription had numerically higher SVR12 rates [14/15 (93%)] versus those without [6/10 (60%)], though this was not statistically significant (p = 0.12, Fisher’s exact test).
Conclusion
DAA treatment exhibited excellent efficacy in the young children in our cohort who completed therapy, though challenges related to swallowing the formulations led to early discontinuation of therapy in 20%. As best practices are refined, inclusion of a practice step ensuring ability to swallow candy sprinkles without chewing prior to DAA prescription may further boost successful deployment of DAA therapies in the youngest eligible children.