Hepatitis C Drugs Approved for Children

The Food and Drug Administration (FDA) recently approved the hepatitis C drugs Harvoni and Sovaldi for use in children. The decision came after two clinical trials showed a 97 to 100 percent cure rate in children and adolescents 12 to 17.  This is a fantastic development in the fight against hepatitis C. Children are often the silent victims of this silent epidemic and being able to treat and cure them as early as possible is important.

Clinical Trial Data Shows Efficacy

The two clinical trials show that in generally 12 weeks we can cure children and adolescents and ultimately give them a better shot at an overall healthy life. In the past the rate of transmission from mother to child has been reported to not exceed 6%. A 2014 study estimates that 23,000 to 46,000 children and adolescents are living with hepatitis C. Surveillance and epidemiology is poor in the areas of mother to child transmission and leaves us with an inaccurate picture of the overall scope and breadth of children and adolescents living with hepatitis C. The risk of youth getting hepatitis C isn’t just childbirth of course, there is also a risk from injection drug use, tattoos, and household exposure. The exploding opioid epidemic has resulted in more indirect exposure risks.

Treatment Approval Process May Be Easier for Children

Youth may also be approved for treatment more easily than adults. Medicaid guidelines and requirements are stricter for children and adolescents. Normally the approval of a drug for pediatric use can take up to ten years after its approval for adult use. Harvoni and Sovaldi were approved in 2014 which makes this an even greater achievement in the field of pediatrics. This landmark drug approval also reflects the concern that is mounting on the number of children of have or will get hepatitis C as well as the long term developmental affects. The fact age is linked to the chance of spontaneously clearing hep C has for some time placed children in a separate category when it comes to hep C treatment. Up until recently a lot of data said mother to child transmission affected 6% of mothers at most. Yet, with poor tracking and reporting such a claim is impossible to be 100% reliable. We of course can only go on what we have but we should always strive to improve how we capture information related to hep C and remember the data we do have is incomplete. The screening recommendations for pregnant mothers most be changed for us to find and cure more kids. Otherwise many kids will keep going undiagnosed and without a treatment that is shown to be 99% effective at curing them.

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