AbbVie releases positive Phase III results for oral hepatitis C program

US drugmaker AbbVie (NYSE: ABBV) has released the first Phase III results for the investigational three direct-acting-antiviral (3D) regimen plus ribavirin in patients chronically infected with genotype 1 (GT1) hepatitis C virus (HCV).

In the 631-patient SAPPHIRE-I study, 96% of patients new to therapy receiving 12 weeks of the 3D regimen achieved a sustained virologic response at 12 weeks post-treatment (SVR12). The majority of patients were GT1a, considered the more difficult-to-treat subtype, and the SVR12 rates of GT1a and GT1b were 95% and 98%, respectively. The rate of virologic relapse or breakthrough was low, occurring in 1.7% of patients receiving the 3D regimen.

AbbVie’s multinational HCV program is the largest all-oral, interferon-free clinical program in GT1 patients being conducted to date. GT1 (with subtypes 1a and 1b) is the most prevalent genotype worldwide, with a higher prevalence of 1a in the USA and 1b in Europe. SAPPHIRE-I is the first of six Phase III trials supporting AbbVie’s investigational 3D regimen for the treatment of GT1 hepatitis C patients.