Gilead Sciences, Inc announced that the European Commission has granted marketing authorization for Epclusa® (sofosbuvir 400 mg/velpatasvir 100 mg), the first pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection.
The combination of sofosbuvir and velpatasvir (SOF/VEL) for 12 weeks was authorized for use in patients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and in combination with ribavirin (RBV) for patients with decompensated cirrhosis (Child-Pugh B or C). SOF/VEL is also the first single tablet regimen approved for the treatment of patients with HCV genotype 2 and 3, without the need for RBV. Physicians also have the flexibility to consider the addition of RBV for genotype 3 infected patients with compensated cirrhosis.
The Marketing Authorization follows an accelerated review procedure by the European Medicines Agency, reserved for medicinal products expected to be of major public health interest. It allows for the marketing of SOF/VEL in all 28 countries of the European Union.
SOF/VEL is Gilead’s third sofosbuvir-based treatment to be granted Marketing Authorization by the European Commission for the treatment of chronic HCV infection. Sofosbuvir-based regimens are recommended by global guidelines across all HCV genotypes and disease severities. Today, nearly one million patients worldwide have been prescribed a sofosbuvir-based regimen.
“Built on the foundation of sofosbuvir, SOF/VEL offers a highly effective and tolerable choice which is protease inhibitor free and ribavirin free for the majority of patients. For the first time we have a once-daily single tablet treatment option which works across all genotypes including genotype 3, which is often the least responsive to treatment,” said Professor Stefan Zeuzem, Professor of Medicine and Chief of the Department of Medicine at the J.W. Goethe University Hospital, Frankfurt, Germany and an ASTRAL-1, 2 and 3 study investigator. “This approval marks a significant advance in the treatment of HCV and is an important step in our efforts to achieve elimination of the disease throughout Europe.”
The authorization of SOF/VEL is supported by data from four Phase 3 studies, ASTRAL-1, ASTRAL-2, ASTRAL-3 and ASTRAL-4. In the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,035 patients with genotypes 1-6 HCV infection, without cirrhosis or with compensated cirrhosis (Child-Pugh A) received 12 weeks of SOF/VEL. The ASTRAL-4 study randomized 267 patients with genotypes 1-6 HCV infection, with decompensated cirrhosis (Child-Pugh B) to receive 12 weeks of SOF/VEL with or without RBV or 24 weeks of SOF/VEL alone. The primary endpoint for all studies was the sustained viral response rate 12 weeks after treatment (SVR12).
John Milligan, Ph.D., President and Chief Executive Officer of Gilead said, “The burden of hepatitis C across Europe is substantial and growing rapidly with approximately 15 million people chronically infected. The European approval of SOF/VEL reflects our continued focus to bring a cure to all infected patients across the region and we look forward to working with physicians, healthcare providers and governments to make it available as quickly as possible.”
Of the 1,035 patients treated with SOF/VEL for 12 weeks in the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,015 (98 percent) achieved SVR12. In ASTRAL-4, patients with decompensated cirrhosis receiving SOF/VEL with RBV for 12 weeks achieved a higher SVR12 rate (94 percent) compared to those who received SOF/VEL for 12 weeks or 24 weeks without RBV (83 percent and 86 percent, respectively.) The most common adverse events in the four ASTRAL studies were headache, fatigue and nausea, and were comparable in incidence to the placebo group included in ASTRAL-1.
Sofosbuvir as a single agent was granted marketing authorization in the European Union on January 16, 2014 under the trade name Sovaldi®. The fixed-dose combination of sofosbuvir (400mg) and ledipasvir (90mg) received marketing authorization in the European Union on November 18, 2014 under the trade name Harvoni®.
Epclusa was approved by the U.S. Food and Drug Administration on June 28, 2016 for the treatment of adults with genotype 1-6 chronic HCV infection.
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.
For more information on Gilead Sciences, please visit the company’s website at www.gilead.com
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