Ribavirin (RBV) could drop out of hepatitis C virus (HCV) therapy for genotype 1 (GT1) patients, as a result of Gilead Sciences Inc.’s triumph in the Phase III program known as ION, which tested the once-daily, fixed-dose combination of its approved nucleotide analog polymerase inhibitor Sovaldi (sofosbuvir) and the NS5A inhibitor ledipasvir, with and without RBV.
Sustained viral response at 12 weeks after treatment stopped (SVR12, or cure) reached 95 percent to 98 percent among treatment-naïve patients with the 12-week regimen, a rate that held even among hard-to-treat people with cirrhosis. Among treatment-experienced patients given the same regimen, the SVR12 was 94 percent to 96 percent, which jumped to 99 percent when patients took the drug for 24 weeks.
The ION program consisted of three trials. In treatment-naïve patients given the regimen for eight weeks, SVR totaled 93 percent to 94 percent.
Ivonne Fuller, CEO of the