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.
- 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]
- 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]
- 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]
- 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]
- 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].
- 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].
- 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].
- 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]