AbbVie Releases First of Six Phase III Results from Investigational All-Oral, Interferon-Free, 12-week Regimen, Showing 96 Percent SVR12 in Genotype 1 Hepatitis C Patients New to Therapy.
http://abbvie.mediaroom.com/2013-11-18-AbbVie-Releases-First-of-Six-Phase-III-Results-from-Investigational-All-Oral-Interferon-Free-12-week-Regimen-Showing-96-Percent-SVR12-in-Genotype-1-Hepatitis-C-Patients-New-to-Therapy
- Confirms results of phase II studies, with consistent virologic response and tolerability profile
- Largest all-oral, interferon-free clinical program in genotype 1 (GT1) patients to date(1)
- On track for major regulatory submissions in Q2 2014
- Worldwide, about 160 million people are chronically infected with hepatitis C(2), most with GT1
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.
