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Gilead Announces 100 Percent Sustained Virologic Response Rate (SVR4) For An Interferon-Free Regimen Of Sofosbuvir (GS-7977), GS-5885 And Ribavirin In Treatment-Naïve Genotype 1 Hepatitis C Infected Patients
Gilead Sciences (Nasdaq: GILD) today announced interim data from the ongoing Phase 2 ELECTRON study examining a 12-week course of therapy with the investigational nucleotide sofosbuvir (formerly referred to as GS-7977), the NS5A inhibitor GS-5885 and ribavirin in patients with genotype 1 chronic hepatitis C virus (HCV) infection. Among treatment-naïve patients receiving this combination, 100 percent (n=25/25) remained HCV RNA undetectable four weeks after completing therapy (SVR4). These data will be presented on Tuesday, November 13
th at the 63rd annual meeting of the American Association for the Study of Liver Diseases (The Liver Meeting 2012) in Boston.
“These results indicate that adding GS-5885 to sofosbuvir-based regimens may enhance SVR rates, potentially offering HCV genotype 1 infected patients a convenient 12-week course of oral therapy,” said Professor Edward Gane, MD, Deputy Director and Hepatologist, New Zealand Liver Transplant Unit, Auckland City Hospital in New Zealand, and principal investigator of the ELECTRON study. “Along with other data from the ELECTRON study, these results add to the growing body of evidence supporting the potential for effective sofosbuvir-based all-oral regimens.”
Gilead recently initiated the first Phase 3 trial (ION-I) evaluating a fixed-dose combination of sofosbuvir and GS-5885 in treatment-naïve genotype 1 patients. This four-arm study is evaluating the fixed-dose combination with and without ribavirin for 12-and 24-week durations in 800 patients, 20 percent of whom have evidence of cirrhosis.
Data from five additional arms of the ELECTRON study examining sofosbuvir-based therapy in various patient populations also will be presented:
Sofosbuvir + ribavirin for 12 weeks
GT 1 treatment-naïve
84% (21/25) SVR12
GT 1 null responders
10% (1/10) SVR12
GT 2/3 treatment-experienced
68% (17/25) SVR12
Sofosbuvir + ribavirin for 8 weeks
GT 2/3 treatment-naïve
64% (16/25) SVR12
Sofosbuvir + ribavirin (800 mg) for 12 weeks
GT 2/3 treatment-naïve
60% (6/10) SVR8
Preliminary data from a subset of an ongoing cohort in the ELECTRON study in which nine genotype 1 previous null responders were treated with sofosbuvir, GS-5885 and ribavirin for 12 weeks also will be presented on Tuesday. Thus far, three of the nine patients have reached the four-week post-treatment time point and all three remain HCV negative.