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November 15, 2012
07:22 EDTGILDGilead's single tablet Stribild shows positive results in two HIV studies
Gilead announced two-year results from two pivotal Phase 3 studies evaluating the company’s newest single tablet HIV regimen, StribildTM, among treatment-naïve patients with HIV-1 infection. Data show that Stribild was non-inferior after two years of treatment to two standard of care HIV regimens, Atripla in Study 102 and a protease-based regimen of ritonavir-boosted atazanavir plus Truvada in Study 103. The regimen was approved by the FDA on August 27 for use by treatment-naïve HIV-positive adults based on 48-week results from Studies 102 and 103. A marketing application for Stribild is currently under review in the European Union.
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July 27, 2015
05:56 EDTGILDStocks with implied volatility movement; CRM GILD
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July 24, 2015
06:27 EDTGILDGilead price target raised to $131 from $120 at Piper Jaffray
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July 23, 2015
12:45 EDTGILDGilead July weekly volatility elevated into Q2 and outlook
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July 21, 2015
14:12 EDTGILDGilead reports study of E/C/F/TAF met primary endpoint
Gilead Sciences announced detailed 48-week data from an open-label Phase 3 study evaluating its investigational once-daily single tablet regimen of elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg, or E/C/F/TAF, among 1,436 virologically suppressed adult patients switching from tenofovir disoproxil fumarate-containing regimens. The study met its primary endpoint by demonstrating non-inferiority of E/C/F/TAF to the TDF-based regimens at Week 48. The study also demonstrated statistical superiority among patients with HIV-1 RNA levels less than 50 copies/mL at Week 48 and statistically significant improvements in bone and renal laboratory parameters. These data were presented in an oral session at the 8th IAS Conference on HIV Pathogenesis, Treatment & Prevention in Vancouver, Canada. Among the 1,436 patients who were randomized in the study, virologic success rates at Week 48 were higher in patients taking E/C/F/TAF, 97% versus 93% for all TDF-based regimens; difference in percentages: 4.1%, 95% CI: 1.6% to 6.7%. The rates of virologic failure were similar between the two arms, with E/C/F/TAF, 1.0% and TDF-based regimen, 1.3%. General safety was similar between the two arms through 48 weeks of treatment, with similar percentages of patients in each group having any adverse events. Adverse events leading to treatment discontinuation were more common among patients treated with a TDF-based regimen.
July 20, 2015
07:33 EDTGILDInternational AIDS Society to hold a conference
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