I remember distinctly the day we got the news about the FDA approval for adolescent HCV treatment – April 7th to be exact. I was reviewing charts for a 15-year-old patient who’d been waiting months for this very announcement, and I couldn’t help but feel a surge of hope. Finally, these kids wouldn’t have to endure the brutal interferon treatments I’d watched so many adults struggle through.
The numbers had always troubled me: somewhere between 23,000 and 46,000 adolescents living with hepatitis C in the US, most of them infected at birth, and until now we’d been forced to treat them with medications that made them feel absolutely terrible. But now we had Harvoni (that’s sofosbuvir/ledipasvir) for genotypes 1, 4, 5, and 6, and Sovaldi (sofosbuvir) plus ribavirin for types 2 and 3, both approved for ages 12 to 17.
I’ve seen the transformation in my adult patients since Sovaldi first arrived in December 2013, and then Harvoni the following year. These direct-acting antivirals changed everything, and now we could finally offer the same hope to our younger patients (as long as they weighed at least 35 kilograms, which is crucial to remember). The dosing is beautifully simple for adolescents – exactly the same as adults for Harvoni and Sovaldi, though we do need to adjust the ribavirin based on weight.
The clinical trial data was nothing short of amazing. Study 1116 looked at Harvoni in 100 adolescents with genotype 1, and the cure rates were incredible – 98% achieved sustained virological response. I think what struck me most was that there were no virological failures or relapses, none at all. The only patients who didn’t officially achieve SVR12 were simply lost to follow-up.
The results for Sovaldi plus ribavirin were just as impressive. In Study 1112, they treated 50 adolescents – everyone with genotype 2 was cured after 12 weeks of treatment, and 97% of those with genotype 3 were cured after 24 weeks. What’s particularly interesting is that despite using ribavirin (which can cause terrible anemia in adults), none of the adolescents developed anemia.
We do need to be careful with certain patient groups, though. I’ve had several patients with HIV co-infection, and while they can use these treatments, we have to watch the drug interactions like hawks. And don’t get me started on hepatitis B – we’ve learned the hard way that these medications can trigger HBV reactivation in co-infected patients.
The landscape keeps shifting under our feet. The latest guidelines from AASLD/IDSA don’t even recommend Sovaldi plus ribavirin alone anymore for genotypes 2 or 3 in adults – they prefer combinations with velpatasvir or daclatasvir. But for our adolescent patients, having these options approved is still a massive step forward from interferon-based therapy.
If you’re considering starting an adolescent patient on these medications, make sure to check their weight (35kg minimum), run a full cirrhosis workup (though most of the trial patients were non-cirrhotic), and carefully document their viral genotype. And always remember to screen for hepatitis B before starting treatment – that’s a lesson we learned the hard way in adult patients.