Gilead's Hepatitis C Drug Epclusa® (Sofosbuvir/Velpatasvir) Approved in China as First Pan-Genotypic Single-Tablet Regimen

SHANGHAI, May 30, 2018 /PRNewswire/ -- Gilead Sciences, Inc. (NASDAQ:Gilead Sciences, Inc. (GILD) announced today that the National Medical Products Administration has approved Epclusa^®(Sofosbuvir 400 mg/Velpatasvir 100 mg) is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1–6 infection. The National Medical Products Administration has also approved Epclusa^®The combination with ribavirin (RBV) can be used for adult patients with hepatitis C and decompensated cirrhosis. Epclusa^®It is China's first approved pan-genotypic HCV single-tablet regimen (STR).

Epclusa^®Approval in China was primarily based on five international, multicenter Phase 3 clinical trials: ASTRAL-1, ASTRAL-2, ASTRAL-3, ASTRAL-4, and ASTRAL-5. In patient populations that are difficult to cure—including treatment-experienced patients and those with compensated or decompensated cirrhosis—the overall SVR12 rate (defined as undetectable HCV RNA at 12 weeks after completion of therapy) was high, ranging from 92% to 100%.

"Epclusa"^®"The safety and efficacy have been confirmed by a large number of clinical trials and real-world data," said Professor Wei Lai from the Institute of Hepatology at Peking University People's Hospital, "due to Epclusa"^®“It offers high cure rates for hepatitis C patients of all genotypes, potentially eliminating the need for genotype testing during treatment, which has positive implications for expanding hepatitis C treatment.”

In China, HCV is the fourth most common infectious disease, with approximately 10 million people infected. Among these cases, HCV genotypes 1, 2, 3, and 6 account for more than 96% of all infections.¹

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.^®Treatment. SVR12 was achieved in 98% (1,015/1,035) of patients. In the ASTRAL-5 study, 106 treatment-naïve and treatment-experienced patients with genotype 1–6 HCV infection, without cirrhosis or with compensated cirrhosis, received 12 weeks of Epclusa^®Treatment; they were also co-infected with HIV and receiving stable antiretroviral therapy. Among them, 95% (101/106) of patients achieved SVR12.

The ASTRAL-4 study evaluated 267 patients with decompensated cirrhosis (Child-Pugh class B) infected with genotype 1–4 or genotype 6 hepatitis C virus (HCV) who received 12 weeks of Epclusa^®With or without ribavirin (RBV) therapy, or 24 weeks of Epclusa^®The safety and efficacy of the treatment. Among them, those who received 12 weeks of Epclusa^®Patients with decompensated cirrhosis treated with RBV combination therapy achieved an SVR12 rate of 94% (82/87).

In ASTRAL-1, ASTRAL-2, ASTRAL-3, and ASTRAL-5, patients receiving Epclusa^®The most common adverse reactions in treated patients (>=10%) included headache and fatigue. In the ASTRAL-1 study, the incidence of headache and fatigue in the placebo group was similar. In ASTRAL-4, patients with HCV infection and decompensated cirrhosis received Epclusa^®The most common adverse reactions after treatment with ribavirin (RBV) (>=10%) include fatigue, anemia, nausea, headache, insomnia, and diarrhea. Four patients taking Epclusa^®Patients receiving RBV combination therapy discontinued treatment due to adverse reactions.

"As the first once-daily single-tablet regimen for HCV patients, regardless of genotype and liver fibrosis stage, Epclusa"^®“...has greatly simplified the treatment of hepatitis C patients by physicians in China, while holding promise to alleviate the substantial public health burden posed by HCV,” said the President and Chief Executive Officer of Gilead Sciences, Inc.John F. MilliganDr. stated, “Gilead has launched two direct-acting antiviral treatment regimens in China, and we remain committed to providing corresponding support for patient screening and treatment efforts to help address the HCV epidemic in China.”

2016, Epclusa^®Received marketing authorization from the U.S. Food and Drug Administration (FDA) and the European Commission, becoming the first pan-genotypic single-tablet regimen for HCV infection. In addition, Epclusa^®It has also been approved in 54 countries.

Sovaldi^®(Sofosbuvir), as a single-tablet formulation, was approved by the China Food and Drug Administration in 2017 and is an important component of combination antiviral therapy regimens for the treatment of genotype 1、2、3、4、Adults and adolescents (aged 12–18 years, genotypes 2 and 3) with HCV infection of genotype 5 or 6.

Epclusa^®, Sovaldi^®is a registered trademark of Gilead Sciences, Inc. or its affiliates.

Gilead Sciences in China

In China, Gilead is committed to addressing unmet medical needs with innovative products. Since entering the Chinese market in 2007, Gilead started with drug manufacturing and gradually transformed its operations, officially establishing its China headquarters in Shanghai in 2016 for commercial operations.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops, and commercializes innovative therapies in areas of unmet medical need. The company’s mission is to improve and simplify treatment regimens for patients with serious diseases worldwide. Gilead operates in more than 35 countries around the world, with its headquarters located in Foster City, California.

Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, which are subject to risks, uncertainties, and other factors, including physicians’ prescribing of Epclusa^®Risks That May Not Be Foreseeable. Due to numerous risks and uncertainties, actual results may differ materially from those currently expected. Readers are cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Annual Report on Form 10-K for the year ended December 31, 2017, which has been filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and does not commit to update any such forward-looking statements.

For more information about Gilead Sciences, please visit the company's official website.www.gileadchina.com, or follow the official WeChat account of Gilead Sciences.

¹ China HCV Guidelines 2015.