Blog Exposure – Gilead Announces Approval of Epclusa in China

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LONDON, UK / ACCESSWIRE / June 1, 2018 / If you want access to our free research report on Gilead Sciences, Inc. (NASDAQ: GILD), all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=GILD as the Company’s latest news hit the wire. On May 30, 2018, the Company announced that the China Drug Administration (CDA) has approved Epclusa® for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. The Chinese regulator also approved Epclusa in combination with ribavirin (RBV) for adults with HCV and decompensated cirrhosis. Register today and get access to over 1,000 Free Research Reports by joining our site below:

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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Gilead Sciences most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:

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Epclusa is the first pan-genotypic HCV single tablet regimen (STR) approved in China.

The Supporting Studies

Gilead noted that the approval of Epclusa in China is supported by five international Phase-3 studies – ASTRAL-1, ASTRAL-2, ASTRAL-3, ASTRAL-4, and ASTRAL-5. The Company stated that high overall rates of SVR12, ranging from 92%-100%, were achieved across difficult-to-cure patient populations including treatment-experienced patients and those with compensated or decompensated cirrhosis.

In the ASTRAL-1, ASTRAL-2, and ASTRAL-3 studies, 1,035 treatment-naïve and treatment-experienced patients with genotype 1-6 HCV infection, without cirrhosis or with compensated cirrhosis, received 12 weeks of Epclusa. Gilead stated 98% of patients achieved SVR12.

The ASTRAL-4 study assessed the safety and efficacy of 12 weeks of Epclusa with or without RBV or 24 weeks of Epclusa in 267 HCV-infected patients with genotypes 1-4 and 6 decompensated cirrhosis (Child-Pugh B). Gilead stated that Patients with decompensated cirrhosis receiving Epclusa with RBV for 12 weeks achieved 94% SVR12.

In the ASTRAL-5 study, 106 treatment-naïve and treatment-experienced patients with genotype 1-6 HCV infection, without cirrhosis or with compensated cirrhosis, who were coinfected with HIV and on a stable antiretroviral therapy, received 12 weeks of Epclusa. The Company stated 95% of patients achieved SVR12.

Reactions

The most common adverse reactions experienced by patients treated with Epclusa in ASTRAL-1, ASTRAL-2, ASTRAL-3, and ASTRAL-5 were headache and fatigue. The placebo-treated patients in the ASTRAL-1 experienced headache and fatigue at a similar frequency. The most common adverse reactions experienced by HCV-infected patients with decompensated cirrhosis treated with Epclusa and RBV in ASTRAL-4 were fatigue, anemia, nausea, headache, diarrhea and insomnia. Four patients treated with Epclusa with RBV, discontinued treatment due to adverse events.

Why Epclusa is Important

HCV is the fourth-most commonly reported infectious disease in China, with approximately 10 million people infected. HCV genotypes 1, 2, 3, and 6 accounts for more than 96% of all cases.

As the first once-daily, interferon-free single tablet regimen for HCV patients regardless of genotype, Epclusa offers physicians in China an important new option for effectively treating their patients while potentially helping to reduce the burden of HCV at a population level.

Epclusa received marketing approval from the US Food and Drug Administration (FDA) and the European Commission in 2016 as the first pan-genotypic STR for HCV infection. It is also approved for use in 54 countries.

About Gilead Sciences, Inc.

Gilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need. The Company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.

Stock Performance Snapshot

May 31, 2018 – At Thursday’s closing bell, Gilead Sciences’ stock was marginally down 0.43%, ending the trading session at $67.40.

Volume traded for the day: 12.41 million shares, which was above the 3-month average volume of 7.17 million shares.

Stock performance in the past twelve-month period – up 3.87%

After yesterday’s close, Gilead Sciences’ market cap was at $87.83 billion.

Price to Earnings (P/E) ratio was at 9.91.

The stock has a dividend yield of 3.38%.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry.

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