(By Balaseshan) Gilead Sciences Inc. (NASDAQ: GILD) shares soared 9.69% in premarket after the biopharmaceutical company posted positive results from a mid-stage hepatitis C study.
On Saturday, Gilead 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-naive patients receiving this combination, 100% remained HCV RNA undetectable four weeks after completing therapy (SVR4). These data will be presented on November 13 at the 63rd annual meeting of the American Association for the Study of Liver Diseases (The Liver Meeting 2012) in Boston.
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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.
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% of whom have evidence of cirrhosis.
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Both sofosbuvir in combination with ribavirin and sofosbuvir in combination with GS-5885 and ribavirin were well tolerated in the ELECTRON study. In the sofosbuvir combined with GS-5885 and ribavirin groups, there was one discontinuation due to an adverse event unrelated to study drugs. Despite stopping therapy at week 8, this patient also achieved SVR4.
The most common adverse events were headache, fatigue, upper respiratory tract infection and nausea. The most common clinically significant grade 3/4 laboratory abnormality was a hemoglobin reduction.
GILD closed Friday's regular session up 0.25% at $65.01. The stock has been trading between $34.45 and $70.39 for the past 52 weeks.