The Particulars: Little is known about the safety and efficacy of combination oral antiviral therapy regimens when targeting multiple stages of hepatitis C virus (HCV) replication in patients who have historically been difficult to treat.
Data Breakdown: Treatment-naïve patients with an HCV genotype 1a mono-infection and high HCV viral loads participated in study. They were randomized to receive one of the following treatment regimens:
1) A fixed-dose combination (FDC) of sofosbuvir plus ledipasvir for 12 weeks (arm A).
2) FDC plus GS-9669 (a non-nucleoside NS5B inhibitor) for 6 weeks (arm B).
3) FDC plus GS-9669 and GS-9451 (an HCV protease inhibitor) for 6 weeks (arm C).
Sustained viral response after 12 weeks of therapy was achieved in 100% of patients in arm A, 90% in arm B, and 95% in arm C. The FDC was well tolerated, and no grade 4 adverse events or drug discontinuations were observed.
Take Home Pearl: The addition of a third agent to an HCV antiviral therapy regimen appears to successfully eradicate HCV in 6 weeks for this difficult-to-treat population.