The National Institute for Health and Care Excellence is endorsing Gilead's pan-genotypic hepatitis C drug Epclusa for routine NHS use in England and Wales.
Draft guidelines back use of the drug for all types of hepatitis C (HCV), after trials showed high cure rates of 89 percent and above.
Epclusa is a once-daily, fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF/VEL; approved as Sovaldi) and the pan-genotypic NS5A inhibitor velpatasvir - is the first all-oral, single tablet regimen cleared for the treatment of adults with genotype 1-6 chronic HCV.
It is also the first single tablet regimen licensed in Europe for the treatment of patients with HCV genotype 2 and 3, without the need for ribavirin, which can cause side effects, but physicians may consider the addition of RBV for genotype 3 infected patients with compensated cirrhosis.
Welcoming the decision, Professor Carole Longson, director of the NICE centre for health technology evaluation, said: "Other drugs currently available treat only certain genotypes or can cause unwanted side effects if they have to be taken in combination with earlier anti-viral treatments."
"Our positive recommendation of sofosbuvir-velpatasvir means that more tolerable treatment options will become available to all patients with hepatitis C."
Epclusa's list price £38,980 for a 12 week course of treatment and, if taken in combination with ribavirin, around £40,000. However, Gilead has agreed a confidential discount to the NHS to improve the drug's cost-effectiveness.
There are an estimated 214,000 individuals chronically infected with hepatitis C in the UK, according to a recent government report.