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Singapore Health Sciences Authority Approves Vosevi(R) (Sofosbuvir/ Velpatasvir/ Voxilaprevir) for Re-treatment of Adults with Chronic Hepatitis C Virus

Vosevi is the First and Only Single Tablet Regimen for Patients Who Have Previously Failed Therapy with Direct-Acting Antivirals
2019-06-24 14:00 1318

SINGAPORE, June 24, 2019 /PRNewswire/ -- Gilead Sciences, Inc. today announced that the Singapore Health Sciences Authority has approved Vosevi (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg), a once-daily single tablet regimen for the re-treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection.

 

Vosevi is approved as a 12-week treatment regimen for patients with any genotype of chronic HCV infection, without cirrhosis, or patients with genotypes 1, 3 and 4 and compensated cirrhosis, who have previously failed therapy with a direct-acting antiviral (DAA) regimen containing NS5A inhibitor. A 12-week regimen is also approved for use in genotype 1-4 patients, without cirrhosis or with compensated cirrhosis, who had previously failed therapies containing sofosbuvir without an NS5A inhibitor. For DAA-naïve patients with genotype 3 and compensated cirrhosis, the recommended treatment duration is 8 weeks.

Treatment with Vosevi has demonstrated high cure rates regardless of prior treatment regimens.[1],[2] In global, multi-center Phase 3 clinical studies (POLARIS-1 and POLARIS 4), 96 percent of patients treated with Vosevi achieved the primary endpoint of SVR12, defined as maintaining undetectable viral load 12 weeks after completing therapy.

"Direct-acting antivirals have changed the course of HCV treatment, delivering high cure rates across a broad range of people living with HCV. However, certain patient populations have been more challenging to cure with previously available therapies. Vosevi now offers these patients an important new treatment option," said John McHutchison, AO, MD, Chief Scientific Officer and Head of Research and Development, Gilead Sciences.

"Gilead has developed and delivered a portfolio of HCV therapies to enable all people living with HCV to have the opportunity to be cured," said Andrew Hexter, Vice President and General Manager, Asia 5, Gilead Sciences. "Vosevi completes our portfolio of HCV therapies and is a significant step forward as we work together with health authorities, healthcare providers and the broader community toward the World Health Organization's goal of eliminating HCV by 2030."

Vosevi was approved by the U.S. Food and Drug Administration (FDA) and the European Commission in 2017.

[1] VOSEVI Singapore full Prescribing Information

[2] Bourlière, M, Gordon SC, Flamm SL, et al; for the POLARIS-1 and POLARIS-4 Investigators. Sofosbuvir, velpatasvir, and voxilaprevir for previously treated HCV infection. N Engl J Med. 2017;376(22)2134-2146

About Gilead Sciences, Inc. 

Gilead Sciences, Inc. 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 global headquarters in Foster City, California.

For more information on Gilead Sciences, please visit the company's website at www.gilead.com, or follow Gilead on Twitter (@GileadSciences).

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Source: Gilead Sciences, Inc.
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