By: Marcus J. Hopkins, Blogger
In April of this year, the Food and Drug Administration (FDA) approved the use of Sovaldi and Harvoni (Gilead) for use in treating Hepatitis C (HCV) in pediatric patients aged 12-17. This is an important step in treating HCV in no small part because children and teenagers are considered a vulnerable population. They are, for the most part, not properly equipped to make well-informed decisions about their health, leaving treatment decisions in the hands of the adults who care for them.
Treating pediatric patients is a much riskier prospect, because people outside of the medical community consider children to just be “small adults;” virtually every treatment regimen for every disease must be modified to achieve commensurate outcomes. There are a variety of reasons why this is so, from bodyweight variances between children and adults, to the various ways that physical and chemical changes that occur during the growth and development process from childhood to adulthood can impact how medications behave in pediatric patients. Essentially, “results may vary.”
The new FDA ruling that expands treatment to pediatric patients allows patients weighing at least 77 lbs. to take an unmodified regimen. While access to treatment in adults has proven fraught with hurdles to overcome before being approved by payers, children covered by Medicaid may, in fact, face fewer hurdles than adults. This is due to the following provision: under Federal law, state Medicaid programs must cover “…early and pediatric screening, diagnostic, and treatment services” for children under age 21 that are necessary to correct or ameliorate physical and mental illnesses (Andrews, 2017). While that’s great for patients covered by Medicaid, those covered by private insurers may have a tougher road to hoe, as most within the industry expect the latter payers to largely maintain similar restrictions in pediatric clients as adults.
One of the reason pediatric patients are so vulnerable is that the majority of HCV-infected patients acquire the disease in the womb; only about 20% acquire it through drug use (Andrews). That said, the likelihood is very low – only a 6% chance that babies will acquire HCV if the mother has it.
Hopefully, pediatric patients will face an easier time gaining access to Sovaldi and Harvoni than adults, but only time will tell.
- Andrews, M. (2017, April 19). FDA Approval Of Hepatitis C Drugs For Kids Is Likely To Speed Treatment. National Public Radio: NPR Science Desk: Shots. Retrieved from: http://www.npr.org/sections/health-shots/2017/04/19/524373963/fda-approval-of-hepatitis-c-drugs-for-kids-is-likely-to-speed-treatment – mainContent
Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.