The National Institute for Health and Care Excellence has now published final guidance endorsing Epclusa as an option for the treatment of adults with chronic hepatitis C genotype 1-6 infection on the NHS in England and Wales.
Epclusa - 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.
Epclusa's approval in Europe is based on data from the Phase III ASTRAL trials, which showed that, of the 1,035 patients treated with the combination for 12 weeks - 21 percent of which had compensated cirrhosis and 28 percent of which had failed prior treatments - 98 percent achieved the primary efficacy endpoint of a sustained virologic response.
"The decision by NICE to recommend Epclusa is a positive step for patients who have previously been faced with limited treatment options. Making Epclusa available across England ensures equitable access to effective treatments for all patients with hepatitis C, regardless of genotype," commented William Rosenberg, professor of Hepatology, University College of London and the Royal Free Hospital.
The Hepatitis C Trust also welcomed the decision, which, it stressed, "allows for people with hepatitis C in England to now have another interferon-free treatment available to them, particularly one which is effective across different genotypes".
"This is a huge step forward in ensuring that everyone can access interferon-free treatment and helps take us closer to the elimination of hepatitis C in England as a serious public health concern," noted that charity's chief executive, Charles Gore.
Epclusa's list price is £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, and said it is committed to working with NHS England to ensure that all eligible patients get access.
It is estimated that around 214,000 individuals in the UK are chronically infected with hepatitis C, a virus most commonly transmitted through blood-to-blood contact. Without adequate treatment, hepatitis C can cause serious liver damage and potentially life-threatening complications.