A 12-week regimen of ledipasvir-sofosbuvir, without ribavirin, resulted in a sustained virologic response of 97% or higher in patients with previously untreated hepatitis C (HCV) genotype 1 according to a randomized, open-label phase 3 trial involving 870 participants (Afdhal N et al. N Engl J Med. doi:10.1056/NEJMoa1402454 [published online April 12, 2014]). The trial was funded by Gilead Sciences.
Patients were randomized to 4 treatment groups: ledipasvir-sofosbuvir for 12 weeks, ledipasvir-sofosbuvir plus ribavirin for 12 weeks, ledipasvir-sofosbuvir for 24 weeks, or ledipasvir-sofosbuvir plus ribavirin for 24 weeks. After treatment, all groups had very high levels of sustained virologic response: 94% to 100% among patients with cirrhosis, 97% to 99% among those with HCV genotype 1a infection, 97% to 99% among those with a non-CC IL28B allele, and 91% to 100% among black patients.