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GILEAD SCIENCES (GILD)
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Gilead Sciences : Presents Results From Phase 3 Study Evaluating Patients Who Switched to Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine

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10/06/2017 | 11:07am CET

Release date- 05102017 - FOSTER CITY, Calif. - Gilead Sciences, Inc.(NASDAQ: GILD) today announced detailed 48-week results from a Phase 3 study (Study 1878) evaluating the efficacy and safety of switching virologically suppressed HIV-1 infected adult patients from a multi-tablet regimen containing a boosted protease inhibitor (bPI) to a fixed-dose combination of bictegravir (50 mg) (BIC), a novel investigational integrase strand transfer inhibitor (INSTI), and emtricitabine/tenofovir alafenamide (200/25 mg) (FTC/TAF), a dual-NRTI backbone.

In the ongoing study, BIC/FTC/TAF was found to be statistically non-inferior to regimens containing bPIs and demonstrated no treatment-emergent resistance at 48 weeks. The data are being presented at IDWeek 2017 in San Diego (Session 228).

'These data demonstrate the potential of BIC/FTC/TAF to match the efficacy of a boosted protease inhibitor regimen while also offering a high barrier to resistance and fewer interactions with other drugs,' said Eric Daar, MD, Chief of the Division of HIV Medicine at Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center and lead author of Study 1878. 'The findings, along with data from three other Phase 3 studies in both treatment-experienced and treatment-naive patients, suggest that the investigational regimen of BIC/FTC/TAF may be appropriate for a broad range of people living with HIV.'

In Study 1878, a total of 577 virologically suppressed adults with HIV taking regimens of boosted atazanavir (ATV) or darunavir (DRV) + abacavir/lamivudine (ABC/3TC) or FTC/tenofovir disoproxil fumarate (TDF) were randomized 1:1 to continue their bPI regimen or to switch to open-label coformulated BIC/FTC/TAF once daily. At the primary endpoint of Week 48, switching to BIC/FTC/TAF was non-inferior to continuing on a bPI regimen with 1.7 percent of patients in each group having HIV-1 RNA 50 c/mL (difference: 0.0 percent, 95 percent CI: -2.5 percent to 2.5 percent, p=1.00); the proportion of patients with HIV-1 RNA

(c) 2017 Electronic News Publishing -, source ENP Newswire

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Financials ($)
Sales 2017 25 804 M
EBIT 2017 15 658 M
Net income 2017 10 508 M
Debt 2017 12 756 M
Yield 2017 2,67%
P/E ratio 2017 10,18
P/E ratio 2018 13,41
EV / Sales 2017 4,49x
EV / Sales 2018 5,10x
Capitalization 103 B
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Mean consensus OUTPERFORM
Number of Analysts 29
Average target price 85,6 $
Spread / Average Target 8,4%
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Managers
NameTitle
John F. Milligan President, Chief Executive Officer & Director
John C. Martin Executive Chairman
Kevin B. Young Chief Operating Officer
Robin L. Washington Chief Financial Officer & Executive Vice President
Norbert W. Bischofberger Chief Scientific Officer & Executive VP-Research
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