AbbVie (NYSE: ABBV) released phase III results for the investigational three direct-acting-antiviral (3D) regimen plus ribavirin in patients with chronic, genotype 1 (GT1) hepatitis C virus (HCV) infection. In the 394-patient SAPPHIRE-II study, 96 percent of patients who previously failed pegylated interferon and ribavirin treatment, including approximately 49 percent of who were prior null responders, achieved sustained virologic response at 12 weeks (SVR12) with the regimen. The majority of patients were GT1a, considered a difficult-to-treat subtype, and the SVR12 rates of GT1a and GT1b were 96 percent and 97 percent, respectively. Virologic relapse or breakthrough was noted in 2 percent of patients receiving the 3D regimen plus ribavirin. In addition, the discontinuation rate due to adverse events was 1 percent.
Globally, approximately 160 million people are chronically infected with hepatitis C. 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 U.S. and 1b in Europe.
RESULTS FURTHER CONFIRM PHASE II STUDIES, WITH CONSISTENT VIROLOGIC RESPONSE AND TOLERABILITY PROFILE--SAPPHIRE-II IS THE SECOND OF SIX PHASE III TRIALS STUDYING THE INVESTIGATIONAL 3D REGIMEN--FUTURE DATA ANTICIPATED FROM ABBVIE'S CLINICAL TRIALS EXAMINES 3D REGIMEN WITH AND WITHOUT RIBAVIRIN, AS WELL AS TREATMENT OF HEPATITIS C IN PATIENTS WITH CIRRHOSIS-