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China's National Medical Products Administration Approves Harvoni®

China’s National Medical Products Administration Approves Harvoni® (Ledipasvir/Sofosbuvir) for Treatment of Chronic Hepatitis C Virus Genotype 1-6

--Harvoni Offers Highly Effective, Short-Duration, Pan-Genotypic Treatment for Chinese Patients with HCV Infection--

--Harvoni Achieved Cure Rate (SVR12) of 100 Percent in Clinical Trial of Chinese Patients with Genotype 1--

FOSTER CITY, Calif.--(BUSINESS WIRE)--Dec. 4, 2018-- Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the National Medical Products Administration (NMPA) has approved Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg) in China for the treatment of chronic hepatitis C virus (HCV) genotype 1-6 infection in adults and adolescents aged 12 to 18 years.

Hepatitis C is a significant public health challenge. Nearly 10 million people in China are estimated to have chronic HCV, with approximately 58 percent having HCV genotype 1 infection.

“The multicenter clinical trials in China have shown that the once-daily single tablet treatment regimen of Harvoni achieved a 100% SVR12 (defined as undetectable HCV RNA 12 weeks after completing therapy) rate in treatment patients with genotype 1 HCV infection,” said Professor Lai Wei, Peking University People’s Hospital and Institute of Hepatology, Beijing.

“Gilead has continued to develop and deliver new treatments for HCV to help enable people with HCV the potential to be cured,” said John McHutchison, AO, MD, Chief Scientific Officer, Head of Research and Development, Gilead Sciences. “We are pleased to offer an important new treatment option that can help patients achieve HCV cure and further support efforts to stem the epidemic in China.”

The approval of Harvoni in China is supported by an open-label, Phase 3b study, which was conducted at 18 study centers in mainland China between May 2016 and July 2017. The study evaluated 12 weeks of treatment with Harvoni in 206 genotype 1 HCV patients, including treatment-naïve and treatment-experienced patients without cirrhosis or with compensated cirrhosis.

https://www.gilead.com/news/press-releases/2018/12/chinas-national-medical-products-administration-approves-harvoni-ledipasvirsofosbuvir-for-treatment-of-chronic-hepatitis-c-virus-genotype-16 

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