Gilead’s pan-genotypic treatment for hepatitis C Vosevi has won the National Institute for Health and Care Excellence’s seal of approval for use on the NHS.
Vosevi (sofosbuvir/velpatasvir/voxilaprevir; SOF/VEL/VOX) was cleared by European regulators in July last year as the first and only single tablet regimen for patients with any genotype of chronic hepatitis C virus infection.
The therapy was authorised as a 12-week treatment regimen, for patients without cirrhosis or with compensated cirrhosis, on the back of clinical data showing high cure rates.
Clinical data from two Phase III clinical trials, involving around 750 HCV patients without cirrhosis or with mild cirrhosis, showed that 96-97 percent of those who received Vosevi had no virus detected in the blood 12 weeks post treatment.
In final guidelines, NICE has approved NHS funding for the therapy to treat patients with hepatitis C genotypes 1-6 following prior treatment with direct-acting antivirals (DAA), and for DAA treatment-naïve patients with genotype 3.
Vosevi costs £14,942.33 per 28-day pack, but Gilead has agreed a nationally available price reduction on the therapy with the Commercial Medicines Unit, the level of which remains confidential.
HCV infection is considered a major public health challenge, with around 15 million people chronically infected across the UK and the disease representing the most common single cause of liver transplantation in the region.
Last month, NHS England laid out plans for England to become the first country to eliminate hepatitis C, at least five years earlier than the World Health Organisation’s target date of 2030.
February is set to see the single largest medicines procurement ever undertaken by the NHS, which will see new agreements drawn up with drug companies that will involve collaboration to identify more people who are living with hepatitis C who need to be treated, the organisation said.