The National Institute for Health and Care Excellence (NICE) Issues Positive Guidance for AbbVie’s MAVIRET (glecaprevir/pibrentasvir) for the Treatment of Adults with All Major Genotypes (GT1-6) of Chronic Hepatitis C in England and Wales.
By David Rowlands, Dec 12 2017 11:11AM
The National Institute for Health and Care Excellence (NICE) published guidance in the form of a Final Appraisal Determination (FAD), confirming that AbbVie’s Maviret®, a once-daily, ribavirin-free treatment that combines glecaprevir (100mg), an NS3/4A inhibitor and pibrentasvir (40mg), an NS5A inhibitor (glecaprevir/pibrentasvir), is recommended within its marketing authorisation, as an option for treating chronic hepatitis C infection in adults.
Maviret® is licensed as a treatment in the EU for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6). It is also licensed for patients with specific treatment challenges, including those with compensated cirrhosis across all major genotypes, and those who previously had limited treatment options, such as patients with severe chronic kidney disease (CKD) or those with genotype 3 (GT3) chronic HCV infection.
Chronic HCV is a silent, progressive disease that can lead to liver damage (fibrosis or cirrhosis), liver cancer and death. More than 200,000 people in the UK are estimated to be chronically infected with hepatitis C. Of those chronically infected, only an estimated three percent receive treatment each year, despite the advent of treatments that can offer viral elimination.
David Rowlands, HCV patient champion for the Leicester Operational Delivery Network explains: “This is great news. People living with hepatitis C have been eagerly awaiting these new pan-genotypic treatments and it is now vital that NHS England ensures patients have access to them as quickly and widely as possible. These drugs are cost effective and allow patients to be cured in as little as 8 weeks, so the UK government should now seize the opportunity in front of it to make good on its publically stated commitment to eliminate hepatitis C as a public health threat by the World Health Organization’s target of 2030. As a minimum, we need to work together to develop community outreach clinics to find people who are not yet engaged in treatment. As a minimum, we need to work together to develop community outreach clinics to find people who are not yet engaged in treatment.”
Dr Alice Butler, UK Medical Director, AbbVie said: “We welcome the NICE decision as we believe that treatments, like MAVIRET®, have an important role to play in not only helping people clear the hepatitis C virus and move on with their lives, but also in opening up new approaches to how and where patients can be treated. Rather than traditionally focusing on treating within hospital settings, once-daily, pan-genotypic options enable treatment to be delivered to patients more locally, within their own communities. This could be an important strategy to reach patients who don’t typically engage with healthcare services.
We look forward to seeing NHS England implementing the NICE guidance swiftly and in full as soon as possible to benefit all eligible patients”, Dr Butler concluded.