In final guidance issued today, the National Institute of Clinical Excellence (NICE) has approved Epclusa (sofosbuvir 400mg/velpatasvir 100mg), for the treatment of adults with chronic hepatitis C genotypes 1-6 infection, thus confirming a draft guidance from the medicines cost-effectiveness watchdog for England and Wales issued last September.
US biotech major Gilead Sciences (Nasdaq: GLD), the drug’s maker, welcomes the NICE’s recommendation, noting that Epclusa is the only all-oral single tablet regimen licensed for all genotypes (1-6) of chronic hepatitis C virus. It is also the first single tablet regimen licensed in the UK for the treatment of patients with hepatitis C genotypes 2 and 3 (without decompensated cirrhosis), without the need for ribavirin.
It is estimated that around 214,000 people in the UK have chronic hepatitis C, but many remain undiagnosed. Without treatment, hepatitis C can cause serious liver damage and potentially life-threatening complications, such as liver cancer, and may also lead to significant implications on the NHS.
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