Abbvie reports SAPPHIRE-1 study 3D regimen for Hepatitis C
AbbVie released the first phase III results for the investigational three direct-acting-antiviral (3D) regimen (ABT 450/r and ABT 267 and ABT 333) plus ribavirin in patients chronically infected with genotype 1 (GT1) Hepatitis C virus (HCV). In the 631-patient SAPPHIRE-I study patients new to therapy receiving 12 weeks of AbbVie's 3D regimen achieved a sustained virologic response at 12 weeks post-treatment (SVR12) of 96 percent. The majority of patients were GT1a, considered the more difficult-to-treat subtype, and the SVR12 rates of GT1a and GT1b were 95 percent and 98 percent, respectively. The rate of virologic relapse or breakthrough was low, occurring in 1.7 percent of patients receiving the 3D regimen. In addition, discontinuation rates due to adverse events were low, and of an equal percentage (0.6 percent) in both active and placebo groups.