Provisional NICE recommendation for Gilead’s Hepatitis C treatment
pharmafile | September 28, 2016 | News story | Research and Development, Sales and Marketing | Epclusa, NICE, hepatitis C
NICE has issued provisional guidance recommending the use of Gilead Sciences’ Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg) for the treatment of adult chronic hepatitis C genotype 1-6 patients in England and Wales.
This is the third sofosbuvir-based treatment to be recommended by NICE for treatment of the disease. Hepatitis C, if untreated, can cause serious liver damage and potentially life-threatening complications such as liver cancer.
The drug received marketing authorisation in Europe in July and is the first and only oral single tablet regimen for all genotypes (1 – 6) of the virus, including 2 and 3 without the need for ribavirin.
“This positive draft guidance marks an important step towards giving patients in England and Wales the chance to benefit from this once-daily single tablet treatment option which works across all genotypes including genotype 3, which has often been the least responsive to treatment and yet very common across the UK,” said Professor William Rosenberg, clinical lead for Viral Hepatitis, UCL Institute for Liver and Digestive Health, London. “The recommendation confirms the value of sofosbuvir/velpatasvir as a treatment for hepatitis C and supports its use as a clinically and cost-effective option.”
“We know the robustness of the NICE assessment process and are pleased that NICE has found this treatment to be a valuable option for people with chronic hepatitis C and an effective use of NHS resources,” added Stelios Karagiannoglou, general manager, UK and Ireland, Gilead Sciences. “We are committed to working with NICE to ensure a positive final recommendation can be reached quickly for the benefit of patients. However, as we work towards the elimination of hepatitis C as a public health threat by 2030, it is critical that NHS England also commit to adequately tackling hepatitis C by improving diagnosis and care, and making curative treatments available for all people with the virus and not just for a selected few.”
Matt Fellows
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