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Press Release

NICE PROVISIONALLY RECOMMENDS GILEAD’S NEW HEPATITIS C TREATMENT EPCLUSA®? (SOFOSBUVIR/VELPATASVIR) FOR USE IN ENGLAND & WALES

Gilead Sciences
Posted on: 26 Sep 16

London UK, 26th September 2015 – Gilead Sciences welcomes provisional guidance published from the National Institute for Health and Care Excellence (NICE) recommending Epclusa® (sofosbuvir 400 mg/velpatasvir 100 mg) as an option for treating the majority of adult chronic hepatitis C genotype 1-6 patients in England and Wales.1

 

Sofosbuvir/velpatasvir is the third sofosbuvir-based treatment to be recommended by NICE for the treatment of chronic hepatitis C infection. Today, over one million people worldwide have been prescribed a sofosbuvir-based regimen.2

 

Sofosbuvir/velpatasvir received European marketing authorisation in July 2016 and is the first and only all-oral single tablet regimen for all genotypes (1-6) of chronic hepatitis C virus. It is also the first single tablet regimen licensed for the treatment of patients with hepatitis C genotypes 2 and 3, without the need for ribavirin,3 in the UK where genotype 3 represents one of the two most common strains of the hepatitis C virus.4

 

Without treatment, hepatitis C can cause serious liver damage and potentially life-threatening complications like liver cancer5 and may lead to a significant impact on the NHS, as well as increasing economic and societal costs.6

 

“This positive draft guidance marks an important step towards giving patients in England and Wales the chance to benefit from this once-daily single tablet treatment option which works across all genotypes including genotype 3, which has often been the least responsive to treatment and yet very common across the UK. The recommendation confirms the value of sofosbuvir/velpatasvir as a treatment for hepatitis C and supports its use as a clinically and cost-effective option,” said Professor William Rosenberg, Clinical Lead for Viral Hepatitis, UCL Institute for Liver and Digestive Health, London. 

 

Treatment with sofosbuvir/velpatasvir has been provisionally recommended by NICE for the following populations:1,3

HCV genotype

Liver disease stage

Treatment history

Untreated

Treated

1

With or without compensated cirrhosis

12 weeks

2

Without cirrhosis

Recommended only for people who cannot tolerate interferon or it is not suitable for them - 12 weeks

12 weeks

Compensated cirrhosis

12 weeks

3

Without cirrhosis

12 weeks

Compensated cirrhosis

With or without ribavirin for 12 weeks

4

With or without compensated cirrhosis

12 weeks

5

With or without compensated cirrhosis

12 weeks

6

With or without compensated cirrhosis

12 weeks

1-6

Decompensated cirrhosis

With ribavirin for 12 weeks

Treated = the person’s hepatitis C has not adequately responded to interferon-based treatment.

 

“We know the robustness of the NICE assessment process and are pleased that NICE has found this treatment to be a valuable option for people with chronic hepatitis C and an effective use of NHS resources. We are committed to working with NICE to ensure a positive final recommendation can be reached quickly for the benefit of patients.” said Stelios Karagiannoglou, General Manager, UK and Ireland, Gilead Sciences Ltd. “However, as we work towards the elimination of hepatitis C as a public health threat by 2030, it is critical that NHS England also commit to adequately tackling hepatitis C by improving diagnosis and care, and making curative treatments available for all people with the virus and not just for a selected few.”

Editor's Details

Mike Wood
PharmiWeb.com
www.pharmiweb.com
editor@pharmiweb.com

Last updated on: 26/09/2016

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