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Friday 24 May 2019
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Chronic hepatitis C patients able to access combination therapy after NICE approval

Gilead Sciences has welcomed the Technology Appraisal Guidance (TAG) issued by the National Institute for Health and Care Excellence (NICE), which recommends Vosevi® (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg; SOF/VEL/VOX).1

 

Although direct-acting antiviral (DAAs) have been shown to be highly effective in the majority of people with chronic HCV, a small percentage have been unable to be cured1 with current therapies.  This guidance from NICE for SOF/VEL/VOX represents a new treatment for this population of HCV patients, and marks a significant next step in supporting NHS England’s plan to make the UK the first country in the world to eliminate hepatitis C which was announced last month.   

 

SOF/VEL/VOX is a 12-week treatment regimen for patients with any genotype of chronic HCV infection, without cirrhosis or with compensated cirrhosis, who have previously failed therapy with a DAA-containing regimen. A 12-week regimen is recommended in DAA-naïve patients with compensated cirrhosis infected with any HCV genotype, with an option to shorten therapy to 8 weeks for those infected with genotype 3. For DAA-naïve patients without cirrhosis, the recommended treatment duration is 8 weeks.2

 

SOF/VEL/VOX is Gilead’s fourth sofosbuvir-based treatment to be recommended for the treatment of chronic HCV infection, and complements the existing portfolio in demonstrating high cure rates across a range of DAA - experienced and naïve patients, with a 12 or 8 week single tablet regimen.3,4 Sofosbuvir-based regimens are recommended by global guidelines across HCV genotypes and disease severities,5-7 and have been used to treat more than 1.5 million patients worldwide.8

 

In line with health technology appraisal process, the NHS in Wales must provide funding and resources for SOF/VEL/VOX within two months of the first publication of the final appraisal determination and  NHS England must do the same within three months

 

References

  1. National Institute for Health and Care Excellence (NICE).Technology Appraisal Guidance. Sofosbuvir/velpatasvir/voxilaprevir for treating chronic hepatitis C. 21 February 2018. Available from: https://www.nice.org.uk/guidance/ta507/chapter/1-Recommendations [Accessed February 2018]
  2. National Institute for Health and Care Excellence (NICE). Final appraisal determination. Sofosbuvir/velpatasvir/voxilaprevir for treating chronic hepatitis C. Janurary 2018. Available from https://www.nice.org.uk/guidance/gid-ta10175/documents/final-appraisal-determination-document [Accessed February 2018]  
  3. Bourlière M, et al. Sofosbuvir, Velpatasvir, and Voxilaprevir for Previously Treated HCV Infection. (2017). Available from https://www.ncbi.nlm.nih.gov/pubmed/28564569 [Accessed February 2018]
  4. Jacobson I.M, Efficacy of 8 Weeks of Sofosbuvir, Velpatasvir, and Voxilaprevir in Patients With Chronic HCV Infection: 2 Phase 3 Randomized Trials. (2017). Available from https://www.ncbi.nlm.nih.gov/pubmed/28390869 [Accessed February 2018]
  5.  AASLD: American association for the study of liver diseases. Recommendations for Testing, Managing, and Treating Hepatitis C. (2016). Available from: http://www.hcvguidelines.org/. [Accessed February 2018].
  6. EASL: European association for the study of the liver. EASL Recommendations on Treatment of Hepatitis C. (2016). Available from: https://www.easl.eu/medias/cpg/HCV2016/English-report.pdf. [Accessed February 2018].
  7. WHO: Guidelines for the screening, care and treatment of persons with chronic hepatitis C infection (2016). Available from: http://apps.who.int/iris/bitstream/10665/205035/1/9789241549615_eng.pdf. [Accessed February 2018].
  8.  Gilead Sciences, Inc. Q2 2017 and Q4 2016 Earnings Results. Available from http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-earnings [Accessed February 2018]

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